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A penumbra is normally understood as a partial or imperfect shadow surrounding a complete shadow cast by a solid body, but it has taken on a different meaning in U.S. constitutional law. Justice Oliver Wendell Holmes referred to a penumbra of the Fourth and Fifth Amendments in his 1928 dissent in the case of Olmstead v. U.S, 277 U.S. 438 (1928). The concept of penumbras extending from some of the provisions of the Bill of Rights was given its place in the canon of constitutional law in the majority decision of Justice William Douglas in Griswold v. Connecticut, 391 U.S. 145 (1965).
The Court had grappled with the meaning of due process in Amendment Fourteen since 1873, when it first decided the Slaughterhouse Cases, 83 U.S. 36 (1873). Various formulae had been proposed to capture precisely what was meant by the statement ‘‘nor shall any state deprive a person of life, liberty or property without due process of law.’’ The proper interpretation was complicated by the use of the exact same language with reference to the national government in Amendment Five. In his dissent in Hurtado v. California, 110 U.S. 516 (1884), Justice John Marshall Harlan, Sr. had argued that the due process clause in Amendment Four referred to all of the provisions in the first eight amendments or a system of total incorporation. Justice Benjamin Cardozo had proposed in Palko v. Connecticut, 302 U.S. 319 (1937) that due process referred to those portions of the first eight amendments to the Constitution that ‘‘were fundamental of a scheme of ordered liberty and justice.’’ Application of Cardozo’s formula has been labeled ‘‘selective incorporation’’ and permitted inclusion of only those truly important rights enumerated in the Bill of Rights.
When Douglas approached his opinion in Griswold, neither of those tests would apply to intrusions into the intimacies of marriage, specifically the decision to use contraceptive devices. He proposed that ‘‘specific guarantees in the Bill of Rights have penumbras, formed by emanations from those guarantees that help give them life and substance.’’ To buttress his argument, Justice Douglas noted that the Court had found the right to educate one’s children as one chooses in Pierce v. Society of Sisters (268 U.S. 510, 1925), a right to study the German language in Meyer v. State of Nebraska (262 U.S. 390, 1923), a right to association and privacy of those associations in NAACP v. Alabama (357 U.S. 44, 1958), and a right of belief in West Virginia Board of Education v. Barnette (319 U.S. 624, 1943).
Those earlier decisions led Justice Douglas to the conclusion penumbras for other parts of the first eight amendments created a right to privacy. The right of association, derived from Amendment One, implies a zone of privacy, as does the provision in Amendment Three against quartering soldiers in homes during peacetime. Amendment Four guarantees that one’s person, house, papers, and effects are safe from unlawful searches and seizures and thus created a zone of privacy, as did the guarantee in Amendment Five against self-incrimination. To complete the argument, Justice Douglas relied on Amendment Nine, which provides that ‘‘the enumeration in the Constitution of certain rights shall not be construed to deny or disparage others retained by the people.’’ Those guarantees, taken together, protected the marriage relationship, which lies within the zone of privacy created by these various rights.
Justice Douglas concluded that the Connecticut law forbidding the use of contraceptives by married couples was unconstitutional. Nonetheless, his formulation did not carry the full weight of the Court; five justices concurred in the result, but not with the reasoning in the majority opinion, and two others dissented. That left the value of the penumbras argument somewhat in question, but the term and its related meaning have passed into our understanding of constitutional law. The concept that enumerated rights in the first eight amendments are not the only ones encompassed by due process in Amendment Four has come to be known as the theory of total incorporation plus. Since no single theory of incorporation beyond a flexible case-by-case ‘‘fairness’’ approach has yet won the backing of a majority Court, the concept of penumbras emanating from the enumerated rights remains one viable theory.

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§ 222.60 Authority and definitions.
§ 222.61 Administration of wild free-roaming horses and burros and their environment.
§ 222.63 Removal of other horses and burros.
§ 222.64 Use of helicopters, fixed-wing aircraft and motor vehicles.
§ 222.65 Protection of wild free-roaming horses and burros when they are upon other than the National Forest System or public lands.
§ 222.66 Removal of wild free-roaming horses and burros from private lands.
§ 222.67 Maintenance of wild free-roaming horses and burros on privately-owned lands.
§ 222.69 Relocation and disposal of animals.
§ 222.70 Disposal of carcasses.
§ 222.71 Loss of status.
§ 222.72 Use of non-Forest Service personnel.
§ 222.74 National Advisory Board.
7 U.S.C. 1011; 16 U.S.C. 551, 1331-1340; 43 U.S.C. 1901 note.


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Leonard Archuleta, appearing pro se, seeks a certificate of appealability ("COA") pursuant to 28 U.S.C. § 2253(c) to challenge the district court's denial of his petition for a writ of habeas corpus pursuant to 28 U.S.C. § 2241. While incarcerated in a private correctional facility in New Mexico, Archuleta filed the instant petition in United States District Court for the District of New Mexico challenging his transfer to, and incarceration in, a private facility. Construing his pro-se petition liberally, as we must under Haines v. Kerner, 404 U.S. 519, 520-21 (1972), Archuleta claims his incarceration in a private facility violates various state laws as well as his rights under the First, Eighth, and Fourteenth Amendments to the United States Constitution.(1) Because we conclude that Archuleta has not "made a substantial showing of the denial of a constitutional right," we decline to grant COA. 28 U.S.C. § 2253(c)(2).
1. Because the § 2241 petition in this case is nearly identical to those filed in Davis v. Williams, No. 00-2250 (10th Cir., filed August 4, 2000), and Hall v. Williams, No. 00-2239 (10th Cir., filed August 28, 2000), our orders and judgments in those cases are virtually identical to that in the instant case.


Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.
On February 6, 2019, the Federal Circuit issued its latest opinion on patentable subject matter under 35 U.S.C. § 101 in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 2017-2508, slip. Op. (Fed. Cir. Feb. 6, 2019). Judge Lourie wrote for the majority in this split decision, expressing some regret but affirming an order invalidating a diagnostic patent involving proteins. Judge Newman dissented, voicing a concern that § 101 jurisprudence has become counterproductive to the goals of patent law. Though unsurprising, the decision further narrows an already shrinking space for patents to diagnostic methods. It is unclear from this decision what diagnostic methods, if any, are safe from future § 101 challenges.
Last week, the Federal Circuit issued its long-awaited opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, slip op. (Fed. Cir. Feb. 7, 2019). While many had hoped the decision would provide clarity on whether a biosimilar maker who has not yet filed an aBLA has standing to appeal a PTAB decision upholding an innovator patent, the Federal Circuit instead dismissed the appeal for lack of standing and mootness based on post-appeal developments making it clear that Momenta had abandoned its efforts to develop the biosimilar in question. Nevertheless, Momenta is important in that it illustrates the continued risk to biosimilar makers of unappealable IPR decisions when they bring IPRs years before filing an aBLA.
Last October, the Trump Administration announced its plan to lower prescription drug prices by adopting foreign price controls on certain drugs covered by Medicare Part B. Many Medicare Part B drugs treat serious illnesses such as cancer. Over the months that have followed, the announcement has stirred debate and led to competing proposals.
On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about the perceived lack of predictability and clarity in determining subject matter eligibility under 35 U.S.C. § 101. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019). The guidance, which is intended for use by USPTO personnel in evaluating subject matter eligibility, “revises the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas).” Id. This new guidance represents an attempt by the USPTO to address “the legal uncertainty surrounding Section 101,” recognizing that “[m]any stakeholders, judges, inventors, and practitioners across the spectrum have argued that something needs to be done to increase clarity and consistency in how Section 101 is currently applied.” Id.
On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S. history. While many federal offices and services are completely closed, agencies that impact biologics—including the FDA, the USPTO, and the Federal Judiciary—remain open in various capacities, at least for now. Nevertheless, if the shutdown continues, the biotech/pharmaceutical industry could begin to feel its effects.
Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing denied, 890 F.3d 1369, address what qualifies as patent-eligible subject matter under 35 U.S.C. § 101 and how courts should resolve that question. These cases expose divisions within the court on § 101 issues, however, and leave uncertainty in their wake. Many stakeholders, including judges, are therefore calling for guidance from the Supreme Court as to how to resolve such issues or seeking the aid of Congress.
In a pair of decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP). In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays). And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., the court clarified that its holding in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), i.e., that a later-issuing, earlier-expiring patent can invalidate an earlier-issuing, later-expiring patent for ODP, applies only to post-URAA (Uruguay Round Agreements Act) patents. Under Breckenridge, where a later patent expires earlier only because of URAA’s change in patent term, the post-URAA patent is not an ODP reference against the pre-URAA patent. The two decisions provide certainty for the biopharma industry and put an end to post-Gilead ODP challenges to pre-URAA patents and patents with PTE based on term granted by Congress.
Earlier this month, the President signed into law the Patient Right to Know Drug Prices Act (Public Law 115-263). The Act mainly focuses on eliminating so-called “gag clauses” that prevent pharmacists from telling patients when paying for a drug out of pocket is cheaper than paying through insurance. In addition, the Act amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) to require branded drug companies and biosimilar applicants to disclose settlement agreements relating to the “manufacture, marketing, or sale” of biosimilar products to the Federal Trade Commission (“FTC”) and U.S. Department of Justice (“DOJ”) for evaluation under the antitrust laws. The new legislation brings biosimilar litigation in line with ANDA litigation, for which the same disclosure requirements were already in place.
In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a formulation of Orencia® (abatacept) in an IPR brought by Momenta before having filed a biosimilar marketing application. The Federal Circuit is expected to decide whether a petitioner must have filed a marketing application in order to have Article III standing to appeal from an unfavorable PTAB decision. As months have passed without a decision, Momenta and BMS have both used the time to further press their case.
Earlier this month, AbbVie filed suit against Sandoz’s proposed biosimilar to AbbVie’s HUMIRA® (adalimumab). Invoking the Biosimilar Price Competition and Innovation Act (“BPCIA”), AbbVie asserts two patents protecting Humira, a fraction of the 84 patents AbbVie wished to litigate. Taking full advantage of the pre-litigation “patent dance,” Sandoz limited the number of patents-in-suit to just two. As this case illustrates, following the patent dance affords biosimilar makers considerable control and power over the scope of biosimilar lawsuits.
The Supreme Court of the US handed patent owners a significant victory in WesternGeco v ION by overturning the Federal Circuit’s bright-line rule prohibiting recovery of lost profits accrued overseas as a result of domestic patent infringement under § 271(f)(2) of the Patent Act.§ 271(f)(2) prohibits supplying components of a patented invention from the US with the intent that they be combined abroad.
To continue reading Irena Royzman and Jordan Engelhardt's article from Intellectual Property Magazine, please click here.
Today FDA approved the first-ever “small interfering RNA” (siRNA) product, marking a significant milestone in the story of RNA interference (RNAi) technology and clearing the way for a new type of therapeutic. Alnylam® secured approval and Orphan Drug Designation for its siRNA product Onpattro (patisiran), a therapy for the rare hereditary disease transthyretin-mediated amyloidosis in adult patients. The disease is caused by mutations in a protein called “transthyretin” which leads to symptoms of neuropathic pain, loss of sensation in the hands and feet, and wheel-chair confinement. In Alnylam’s Phase III clinical trial, Onpattro improved multiple clinical manifestations of the disease and demonstrated safe administration of a siRNA product.
On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen® (filgrastim). Pfizer’s product, Nivestym™, is the second biosimilar of Neupogen to be approved after Sandoz’s Zarxio®, the first approved biosimilar in the United States. Pfizer’s Nivestym gained approval for all eligible Neupogen indications.
Amgen has sued Apotex in connection with Apotex’s efforts to market biosimilar versions of Amgen’s cancer drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim). In a complaint filed on August 7 in the Southern District of Florida, Amgen alleges infringement of U.S. Patent No. 9,856,287. This is the third time that Amgen has filed a BPCIA lawsuit against Apotex in connection with its filgrastim and pegfilgrastim biosimilars.
Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March 2016 draft guidance. That approach largely treats biosimilars like generic drugs for purposes of labeling, even though biosimilars, unlike generic drugs, are not exact copies of innovator products.
On July 18, FDA released its long-awaited Biosimilars Action Plan (“BAP”). In prepared remarks to the Brookings Institution the same day, FDA Commissioner Scott Gottlieb described the BAP as “enabling a path to competition for biologics from biosimilars” in order to “reduc[e] costs and to facilitat[e] more innovation.” While the BAP is straightforward, the Commissioner’s remarks included unexpected jabs at innovator drug makers for what FDA believes is anticompetitive conduct. The speech was likely driven by the Trump Administration’s American Patients First plan, which sets as a top FDA priority the reduction of prescription drug prices, including by reducing “gaming” of regulatory requirements, but what the speech achieves given the role of FDA remains unclear.
Allergan’s attempt to shield its Restasis patents from inter partes review by assigning the patents to the Saint Regis Mohawk Tribe was rejected last week by a unanimous Federal Circuit panel. The Federal Circuit affirmed the PTAB’s February 2018 decision holding that tribal sovereign immunity does not bar IPRs.
On Friday, June 22, 2018, the Supreme Court issued its decision in WesternGeco LLC v. ION Geophysical Corporation, 585 U.S. ___, Slip. Op. No. 16-1011 (June 22, 2018), reversing the Federal Circuit and holding that WesternGeco’s award for lost foreign profits was a permissible application of the damages provision of the Patent Act, 35 U.S.C. § 284. Justice Thomas wrote the opinion for a seven-justice majority while Justice Gorsuch wrote a dissent joined by Justice Breyer.
Analytical studies to demonstrate that a biosimilar is highly similar to its reference product are central to the biosimilar development and approval process. For this reason, there have been calls from industry for more guidance from FDA on its expectations for evaluating and demonstrating analytical similarity.
As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is seeking to stave off Amgen’s infringement claims for three of the patents in suit by pointing to its recent amendment to the Erelzi label, which “carves out” certain treatment indications listed on the Enbrel reference label and, Sandoz argues, moots any claim that Erelzi infringes Amgen’s patents covering the use of etanercept to treat those conditions.
Generics and biosimilar makers have increasingly used inter partes reviews, proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines. Senator Orrin Hatch, co-author of the Hatch-Waxman Act, has introduced an amendment that would require these manufacturers either to take advantage of the abbreviated regulatory approval pathways provided by the Hatch-Waxman Act and BPCIA and challenge innovator patents in district court or to challenge innovator patents in IPRs before the PTAB, but not both. Senator Hatch explains that while he strongly supports IPRs and the America Invents Act and that IPRs are of particular importance to the tech community to fight “patent trolls,” they are also “producing unintended consequences in the Hatch-Waxman context” and “threaten to upend the careful Hatch-Waxman balance by enabling two separate paths to attack a brand patent.” If enacted, generics and biosimilar makers that choose to take advantage of the abbreviated regulatory process will challenge innovator patents in court rather than in IPRs before the PTAB.
Two recent Federal Circuit decisions address when a party has standing to challenge the validity of a patent. Though the cases arose in different contexts, they both center on the question of what it means for a party to be facing an imminent and cognizable injury. In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., 17-1487, the Federal Circuit upheld a party’s standing to appeal from a post-grant review where it was at risk of an infringement suit. In AIDS Healthcare Foundation v. Gilead Sciences, Inc. et al., 16-2475, however, the court reached the opposite conclusion and determined that the immediacy requirement to bring a declaratory judgment action was not met for a party that had an interest in purchasing generic drugs, but did not itself produce them.
The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce clause. The legislation, like many others, was enacted in the wake of the Martin Shkreli case, where the former Turing Pharmaceutical CEO raised the price of a vital and old prescription drug by 5,000 percent. Although the Circuit sympathized with consumers affected by this type of conduct, it held, in a majority opinion written by Judge Stephanie Thacker, that Maryland overstepped its constitutional limits in seeking to compel manufacturers of off-patent or generic drugs to act in accordance with Maryland law outside of Maryland.
Yesterday, Pfizer announced that FDA had approved Retacrit® (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa). Epoetin alfa (EPO) is a blockbuster treatment for anemia. Retacrit is the first EPO biosimilar approved in the United States. EPO biosimilars have been marketed in the EU for over a decade. Hospira (now a Pfizer company) initially filed an application for approval of its EPO biosimilar in 2014. FDA rejected that application in a complete response later and Hospira later resubmitted it after addressing FDA's concerns. While Retacrit received a favorable FDA advisory committee recommendation in May 2017, it was rejected again in a second complete response letter due to concerns with the proposed manufacturing site for the biosimilar. Nearly a year later, FDA approved Retacrit. Pfizer plans to launch Retacrit this year.
Last week, the Supreme Court upheld the constitutionality of inter partes review (IPR), as expected by most observers. However, it was the Court’s decision in a second IPR-related case that will have an immediate impact on patent practitioners. In SAS Institute Inc. v. Iancu, the Supreme Court, in a 5-4 decision, held that the PTO’s practice of “partial review”—instituting an IPR on some but not all claims challenged in a petition for IPR—is inconsistent with the text of the AIA. The decision will lead to immediate consequences, not the least of which is a major increase in the number of claims tried before the PTAB.
In a highly anticipated ruling, the Supreme Court upheld the constitutionality of inter partes review proceedings. Justice Thomas, writing for the seven-member majority in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, held that the Patent Trial and Appeal Board could reconsider and cancel patent claims through inter partes review without violating Article III or the Seventh Amendment of the Constitution.
On Monday, April 16, 2018, the Supreme Court heard oral argument in WesternGeco LLC, v. ION Geophysical Corporation, No. 16-1011, a case with broad implications for patent holders that sell products abroad. The case addresses whether lost profits accrued outside of the United States can be recovered for patent infringement occurring domestically. In the decision below, 791 F.3d 1340 (Fed. Cir. 2015), the Federal Circuit adopted a per se bar to recovery of such foreign damages, even when domestic patent infringement is established and proximately caused. Although WesternGeco involves infringement under 35 U.S.C.§ 271(f) – which prohibits the supply of components of a patented invention in the U.S. with the intent that they be combined abroad – in its argument in support of the petitioner, the Solicitor General framed the question more broadly as whether lost profits accrued outside of the United States can be recovered for any domestic act of patent infringement under § 271. Four key takeaways from the oral argument are discussed below.
Last month, Amgen sued Adello for patent infringement under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in connection with Adello’s proposed biosimilar of Amgen’s Neupogen. Adello elected to bypass the pre-suit procedures of the BPCIA and did not provide any information regarding its biosimilar or how it is manufactured to Amgen. In its lawsuit, Amgen asserts 17 patents against Adello blind. The lawsuit illustrates the consequences of the Supreme Court’s and Federal Circuit’s recent decisions holding that provisions of the BPCIA requiring production of information to the innovator company are not enforceable under federal or state law and that information needed to assess infringement can only be obtained by filing a patent infringement lawsuit.
Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing application. Such early IPRs are attractive to biosimilar makers, because they provide a chance to challenge innovator patents years before the biosimilar maker files a marketing application with FDA. Since a petitioner need not have Article III case-or-controversy standing to bring an IPR, the remoteness and uncertainty of future infringement in such circumstances does not preclude these early IPRs. Under settled precedent, however, a biosimilar maker must have Article III standing to seek a Federal Circuit appeal if the PTAB issues a final decision upholding the challenged patent. A decision expected from the Federal Circuit this quarter in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017) will address how and when a biosimilar maker can establish that standing.
On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). The test, offered by the personal genomics company 23andMe, analyzes DNA from a consumer’s self-collected saliva sample for three mutations in the BRCA genes. Mutations in the BRCA genes are associated with an increased risk of developing breast and ovarian cancer in women, and breast and prostate cancer in men. However, the test only detects a small fraction of the more than 1,000 known mutations in the BRCA genes. The three mutations that the test does identify are most prevalent in people of Ashkenazi Jewish descent and are rarely present in individuals of other ethnic groups.
Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal Circuit’s recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit recently denied Amgen’s petition for rehearing and rehearing en banc in Amgen, confirming that Amgen is the law for written description for antibodies.
In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal Board rejected tribal sovereign immunity to IPRs. The PTAB’s decision also raised doubts about the effectiveness of assignments even in cases where the sovereign assignee has immunity but the assignor effectively still owns the patent. The portion of the decision broadly holding that tribal sovereign immunity does not apply to IPRs came as a surprise to some commentators, who observed that the PTAB could have reached the same result on narrower grounds. Following on the heels of the PTAB’s December 2017 University of Minnesota decision holding that a sovereign waives immunity to IPRs when it asserts the patent at issue in district court, Saint Regis Mohawk Tribe deals another blow for patentees seeking to avoid IPRs with sovereign immunity.
In a hard-fought patent battle involving “groundbreaking” work by both parties, Chief Judge Stark of the U.S. District Court for the District of Delaware ruled that plaintiff Idenix’s patent for treating Hepatitis C virus (HCV) infection was invalid as a matter of law for lack of enablement. The decision overturns a $2.5 billion award to Idenix, a Merck subsidiary. The opinion provides valuable insight into the court’s thinking on enablement of method of treatment claims encompassing a large genus of therapeutic agents.
2017 was a record-setting year for biosimilar approvals in the U.S. and Europe. In the U.S., five complex antibody products were approved, two of which are in new therapeutic areas for U.S. biosimilars. In Europe, 16 biosimilars were approved. The number of approved biosimilars in Europe has doubled in the past two years. These approvals have expanded European biosimilars into new therapeutic areas and new classes of biologics. In both markets, biosimilars of pegylated biologic products, such as pegfilgrastim, continue to pose challenges for biosimilar makers.
The Federal Circuit’s recent decision in Amgen v Sandoz provides a measure of clarity for innovator companies and biosimilar makers eyeing patent litigation. While the Supreme Court of the US held in June that initiating the pre-litigation information exchanges set out in the Biologics Price Competition and Innovation Act (BPCIA) – colloquially referred to as the “patent dance” – cannot be enforced under federal law, the Federal Circuit’s decision goes a step further. It holds that initiation of the exchanges cannot be enforced under state law, either. As a result, innovators seeking to compel disclosures from biosimilar makers have no recourse other than to sue for infringement. For a number of reasons, however, the decision might not prove as impactful in the long run as it may seem.
To continue reading Irena Royzman and Michael Fresco's article from Intellectual Property Magazine, please click here.
On December 19, 2017, FDA approved Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec-rzyl), the United States’ first gene therapy approved to treat an inherited genetic disease. This approval follows that of Novartis’ Kymriah (tisagenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel), both gene therapies approved earlier this year to treat certain forms of cancer. Gene therapy has arrived, and although the genetic material central to these new treatments is not expressly listed in the statutory definition of “biological product,” FDA is regulating these products as biologics, giving them twelve-year non-patent exclusivity.
2017 has been a record-setting year for biosimilar approvals in Europe. Although the first biosimilars to the European market were approved in 2006 and 2007, the number of approved biosimilars has doubled in the past two years. These approvals have expanded the market into new therapeutic areas and new classes of biologics.
Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s Humira and Janssen’s Remicade, FDA has approved the first two biosimilars for the treatment of cancer. All five of the products approved this year are biosimilars of complex blockbuster therapeutic antibodies.
The Federal Circuit ruled that Amgen’s state law unfair competition claims, which were premised on Sandoz’s failure to follow the patent dance, are preempted by the BPCIA. The decision largely affirms the status quo, making clear that biosimilar applicants may opt out of the patent dance without incurring any consequences besides those specified in the statute.
Inter partes review proceedings for biosimilar products are soaring. Biosimilar makers are taking advantage of IPR proceedings to challenge patents protecting some of the world's most important biologic medicines due to the advantages that these proceedings offer: no standing requirement, no presumption of validity, a lower burden of proof and potentially broader claim construction. More than half of the IPR petitions challenging these patents were filed in fiscal 2017. But the results are mixed, with the Patent Trial and Appeal Board denying a high percentage of the petitions. Many of these patents are ultimately litigated in district court under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s Neulasta and Neupogen. Judge James Cohn of the Southern District of Florida ruled in Apotex’s favor in September 2016 after a bench trial. On appeal, the Federal Circuit found sufficient evidence in the record to support the judgment of noninfringement.
The Federal Circuit’s recent decision in Promega Corp. v. Life Technologies Corp. is a cautionary tale that failure to present evidence of damages closely tied to each alternative basis of liability may result in a hollow victory – infringement with no corresponding damages. The Federal Circuit, on remand from the Supreme Court, affirmed the district court’s rulings in a patent suit against Life Technologies that both overturned the jury’s $52 million infringement verdict in favor of Promega, and denied Promega’s motion for a new trial on damages and infringement. The Federal Circuit held that Promega was not entitled to any damages under the narrow “all-or-nothing” damages strategy that Promega had pursued throughout the litigation, and that Promega had waived any alternative damages arguments.
On Oct. 5, the Federal Circuit issued a decision in Amgen Inc. v. Sanofi (No. 2017-1480), a closely watched case involving functional antibody claims, claims that define antibodies not by their sequence or structure but by their function, such as the ability to bind a biological target. The Federal Circuit held that although written description and enablement of such claims are assessed at the priority date, post-priority-date evidence is relevant to determining the breadth of the functional claims and whether antibodies representative of the claimed genus have been disclosed. The court also held that the disclosure of a new therapeutic target does not provide a written description of the antibodies that may bind and inhibit that target, even if it is routine to make such antibodies. These holdings have important ramifications for the biotech industry.
To continue reading Irena Royzman and Andrew Cohen's article from Law360, please click here.
Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On October 6, in a complaint filed in the Central District of California, Amgen brought an action seeking a declaratory judgment that 27 of Genentech’s patents are not infringed, invalid, and unenforceable. Amgen’s suit appears to be the first post-approval declaratory judgment action brought by a biosimilar applicant under the young U.S. biosimilar statute, the Biologics Price Competition and Innovation Act (BPCIA). Shortly after Amgen filed its declaratory judgment action, Genentech filed its own suit in the District of Delaware, alleging that Amgen had failed to honor promises made during the pre-suit BPCIA process and infringed Genentech’s patents. Amgen then promptly moved to transfer the Delaware case to California. Genentech then filed another complaint in the District of Delaware, followed by another Amgen motion to transfer.
In Sandoz v. Amgen, the Supreme Court interpreted the U.S. biosimilars statute, the Biologics Price Competition and Innovation Act (BPCIA), for the first time. The Court held unanimously that provisions of the BPCIA requiring disclosure allowing innovator companies to assess whether their patents are infringed cannot be enforced under federal law. The ruling also allows biosimilar makers to provide notice of commercial marketing long before FDA approval of the biosimilar. The Court’s decision introduces uncertainty into provisions of the BPCIA that many viewed as necessary and enforceable. But, due to the value of certainty for both biosimilar makers and innovators alike in resolving patent disputes for blockbuster biologics, the impact of the Supreme Court’s decision may ultimately be modest.
To read the article by Irena Royzman and Nathan Monroe-Yavneh in Nature Biotechnology, please click here.
Amgen filed patent infringement claims against Mylan over Mylan’s proposed Neulasta biosimilar. The suit is the latest in a number of litigations over the blockbuster drug.
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents protecting Epogen®. The jury found that Pfizer’s subsidiary Hospira, in manufacturing its proposed biosimilar ahead of FDA approval, was not protected by the statutory safe harbor, 35 U.S.C. § 271(e)(1). This action provides an important lesson in the potential value of expired or soon-to-expire patents in BPCIA litigation. Because a biosimilar maker’s pre-approval activity may not be covered by the statutory safe harbor, patents that are expired at the time of approval may still have been infringed.
FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi is the seventh biosimilar approved in the United States under the BPCIA and the first biosimilar approved by FDA for cancer treatment. Mvasi was approved for all six indications of Avastin that are not protected by orphan drug exclusivities, with Avastin’s other indications protected by exclusivities expiring in 2021 and 2023.
On August 10, 2017, the Federal Circuit issued its decision in Amgen v. Hospira. It dismissed Amgen’s interlocutory appeal from a discovery order on jurisdictional grounds and denied a writ of mandamus ordering the district court to compel manufacturing discovery for patents that Amgen did not assert against Hospira’s biosimilar of Epogen. In denying Amgen’s request for mandamus, the Federal Circuit explained that Amgen did not establish an indisputable right to Hospira’s manufacturing information and therefore did not meet the requirement for mandamus. The decision has important implications for innovator companies that do not receive needed information under the Biologics Price Competition and Innovation Act of 2009 (BPCIA): innovators need to sue blind or risk not obtaining discovery for unasserted patents. The Federal Circuit also confirmed that Rule 11 is satisfied in such blind lawsuits due to an applicant’s withholding of information.


Is a Driving With a Suspended License or Driving With No License in Virginia a simple traffic ticket or a criminal offense ?
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A. Any person, whether licensed by Virginia or not, who drives a motor vehicle on the highways in the Commonwealth shall thereby, as a condition of such driving, consent to pay all lawful fines, court costs, forfeitures, restitution, and penalties assessed against him for violations of the laws of the Commonwealth; of any county, city, or town; or of the United States. For the purpose of this section, such fines and costs shall be deemed to include any fee assessed by the court under the provisions of § 18.2-271.1 for entry by a person convicted of a violation of § 18.2-51.4 or § 18.2-266 into an alcohol safety action program.
B. In addition to any penalty provided by law, when any person is convicted of any violation of the law of the Commonwealth or of the United States or of any valid local ordinance and fails or refuses to provide for immediate payment in full of any fine, costs, forfeitures, restitution, or penalty lawfully assessed against him, or fails to make deferred payments or installment payments as ordered by the court, the court shall forthwith suspend the person's privilege to drive a motor vehicle on the highways in the Commonwealth. The driver's license of the person shall continue suspended until the fine, costs, forfeiture, restitution, or penalty has been paid in full. However, if the defendant, after having his license suspended, pays the reinstatement fee to the Department of Motor Vehicles and enters into an agreement under § 19.2-354 that is acceptable to the court to make deferred payments or installment payments of unpaid fines, costs, forfeitures, restitution, or penalties as ordered by the court, the defendant's driver's license shall thereby be restored. If the person has not obtained a license as provided in this chapter, or is a nonresident, the court may direct in the judgment of conviction that the person shall not drive any motor vehicle in Virginia for a period to coincide with the nonpayment of the amounts due.
C. Before transmitting to the Commissioner a record of the person's failure or refusal to pay all or part of any fine, costs, forfeiture, restitution, or penalty or a failure to comply with an order issued pursuant to § 19.2-354, the clerk of the court that convicted the person shall provide or cause to be sent to the person written notice of the suspension of his license or privilege to drive a motor vehicle in Virginia, effective 15 days from the date of conviction, if the fine, costs, forfeiture, restitution, or penalty is not paid prior to the effective date of the suspension as stated on the notice. Notice shall be provided to the person at the time of trial or shall be mailed by first-class mail to the address certified on the summons or bail recognizance document as the person's current mailing address, or to such mailing address as the person has subsequently provided to the court as a change of address. If so mailed on the date of conviction or within five business days thereof, or if delivered to the person at the time of trial, such notice shall be adequate notice of the license suspension and of the person's ability to avoid suspension by paying the fine, costs, forfeiture, restitution, or penalty prior to the effective date. No other notice shall be required to make the suspension effective. A record of the person's failure or refusal and of the license suspension shall be sent to the Commissioner if the fine, costs, forfeiture, restitution, or penalty remains unpaid on the effective date of the suspension specified in the notice or on the failure to make a scheduled payment.
E. Any person otherwise eligible for a restricted license may petition each court that suspended his license pursuant to this section for authorization for a restricted license. A court may, upon written verification of employment and for good cause shown, authorize the Department of Motor Vehicles to issue a restricted license to operate a motor vehicle for any of the purposes set forth in subsection E of 18.2-271.1. No restricted license may be issued unless each court which suspended the person's license pursuant to this section provides authorization for a restricted license. Such restricted license shall not be issued for more than a six-month period. No restricted license issued pursuant to this subsection shall permit a person to operate a commercial motor vehicle as defined in the Commercial Driver's License Act (§ 46.2-341.1 et seq.).
The court shall forward to the Commissioner a copy of its authorization entered pursuant to this section, which shall specifically enumerate the restrictions imposed and contain such information regarding the person to whom such a license is issued as is reasonably necessary to identify the person. The court shall also provide a copy of its authorization to the person, who may not operate a motor vehicle until receipt from the Commissioner of a restricted license. A copy of the restricted license issued by the Commissioner shall be carried at all times while operating a motor vehicle. Any person who operates a motor vehicle in violation of any restrictions imposed pursuant to this section shall be punished as provided in subsection C of 46.2-301.
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A. In addition to any other penalty provided by this section, any motor vehicle administratively impounded or immobilized under the provisions of 46.2-301.1 may, in the discretion of the court, be impounded or immobilized for an additional period of up to 90 days upon conviction of an offender for driving while his driver's license, learner's permit, or privilege to drive a motor vehicle has been suspended or revoked for (i) a violation of 18.2-36.1, 18.2-51.4, 18.2-266, 18.2-272, or 46.2-341.24 or a substantially similar ordinance or law in any other jurisdiction or (ii) driving after adjudication as an habitual offender, where such adjudication was based in whole or in part on an alcohol-related offense, or where such person's license has been administratively suspended under the provisions of 46.2-391.2. However, if, at the time of the violation, the offender was driving a motor vehicle owned by another person, the court shall have no jurisdiction over such motor vehicle but may order the impoundment or immobilization of a motor vehicle owned solely by the offender at the time of arrest. All costs of impoundment or immobilization, including removal or storage expenses, shall be paid by the offender prior to the release of his motor vehicle.
B. Except as provided in 46.2-304 and 46.2-357, no resident or nonresident (i) whose driver's license, learner's permit, or privilege to drive a motor vehicle has been suspended or revoked or (ii) who has been directed not to drive by any court or by the Commissioner, or (iii) who has been forbidden, as prescribed by operation of any statute of the Commonwealth or a substantially similar ordinance of any county, city or town, to operate a motor vehicle in the Commonwealth shall thereafter drive any motor vehicle or any self-propelled machinery or equipment on any highway in the Commonwealth until the period of such suspension or revocation has terminated or the privilege has been reinstated or a restricted license is issued pursuant to subsection E. A clerk's notice of suspension of license for failure to pay fines or costs given in accordance with 46.2-395 shall be sufficient notice for the purpose of maintaining a conviction under this section. For the purposes of this section, the phrase "motor vehicle or any self-propelled machinery or equipment" shall not include mopeds.
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C. A violation of subsection B is a Class 1 misdemeanor. A third or subsequent offense occurring within a 10-year period shall include a mandatory minimum term of confinement in jail of 10 days. However, the court shall not be required to impose a mandatory minimum term of confinement in any case where a motor vehicle is operated in violation of this section in a situation of apparent extreme emergency which requires such operation to save life or limb.
D. Upon a violation of subsection B, the court shall suspend the person's license or privilege to drive a motor vehicle for the same period for which it had been previously suspended or revoked. In the event the person violated subsection B by driving during a period of suspension or revocation which was not for a definite period of time, the court shall suspend the person's license, permit or privilege to drive for an additional period not to exceed 90 days, to commence upon the expiration of the previous suspension or revocation or to commence immediately if the previous suspension or revocation has expired.
E. Any person who is otherwise eligible for a restricted license may petition each court that suspended his license pursuant to subsection D for authorization for a restricted license, provided that the period of time for which the license was suspended by the court pursuant to subsection D, if measured from the date of conviction, has expired, even though the suspension itself has not expired. A court may, for good cause shown, authorize the Department of Motor Vehicles to issue a restricted license for any of the purposes set forth in subsection E of 18.2-271.1. No restricted license shall be issued unless each court that issued a suspension of the person's license pursuant to subsection D authorizes the Department to issue a restricted license. Any restricted license issued pursuant to this subsection shall be in effect until the expiration of any and all suspensions issued pursuant to subsection D, except that it shall automatically terminate upon the expiration, cancellation, suspension, or revocation of the person's license or privilege to drive for any other cause. No restricted license issued pursuant to this subsection shall permit a person to operate a commercial motor vehicle as defined in the Commercial Driver's License Act ( 46.2-341.1 et seq.). The court shall forward to the Commissioner a copy of its authorization entered pursuant to this subsection, which shall specifically enumerate the restrictions imposed and contain such information regarding the person to whom such a license is issued as is reasonably necessary to identify the person. The court shall also provide a copy of its authorization to the person, who may not operate a motor vehicle until receipt from the Commissioner of a restricted license. A copy of the restricted license issued by the Commissioner shall be carried at all times while operating a motor vehicle.
F. Any person who operates a motor vehicle or any self-propelled machinery or equipment in violation of the terms of a restricted license issued pursuant to subsection E of 18.2-271.1 is not guilty of a violation of this section but is guilty of a violation of 18.2-272.
§ 46.2-370. Revoked driver's licenses, special identification cards, certificates of title, license plates, registration cards to be returned; Commissioner may take possession of them.
A. Any person whose driver's license, special identification card, certificate of title, registration card, or license plates have been suspended, cancelled, or revoked as provided in this title or in Title 18.2 and have not been reinstated, shall immediately return every such license, unless it has been surrendered to the court as required by law, special identification card, certificate of title, registration card, and set of license plates or decals held by him to the Commissioner.
B. The Commissioner may take possession of any driver's license, special identification card, certificate of title, registration card, or set of license plates or decals on their suspension, cancellation, or revocation under the provisions of this title or in Title 18.2 or may direct any law-enforcement officer to take possession of and return them to the office of the Commissioner. Whenever any person fails or refuses to surrender a driver's license, special identification card, certificate of title, registration card, license plates, or decals requiring a representative of the Department designated by the Commissioner to serve the order of suspension, cancellation, or revocation, or whenever the Department directs a sheriff to effect service of a decision, order, or notice pursuant to 46.2-416, the person sought to be served shall, in addition to any other required statutory fees, pay a fee of ten dollars to partially defray the cost of administration incurred by the Department and the Commissioner. No such revoked, cancelled, or suspended license, special identification card, certificate of title, or registration items shall be reinstated before the ten-dollar fee is paid. All fees collected under the provisions of this section shall be paid by the Commissioner into the state treasury and shall be set aside as a special fund to be used to meet the expenses of the Department.
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§ 46.2-391.2. Administrative suspension of license or privilege to operate a motor vehicle.
A. If a breath test is taken pursuant to 18.2-268.2 or any similar ordinance and (i) the results show a blood alcohol content of 0.08 percent or more by weight by volume or 0.08 grams or more per 210 liters of breath, or (ii) the results, for persons under 21 years of age, show a blood alcohol concentration of 0.02 percent or more by weight by volume or 0.02 grams or more per 210 liters of breath or (iii) the person refuses to submit to the breath test in violation of 18.2-268.3 or any similar ordinance, and upon issuance of a petition or summons, or upon issuance of a warrant by the magistrate, for a violation of 18.2-51.4, 18.2-266, or 18.2-266.1, or any similar ordinance, or upon the issuance of a warrant or summons by the magistrate or by the arresting officer at a medical facility for a violation of 18.2-268.3, or any similar ordinance, the person's license shall be suspended immediately or in the case of (i) an unlicensed person, (ii) a person whose license is otherwise suspended or revoked, or (iii) a person whose driver's license is from a jurisdiction other than the Commonwealth, such person's privilege to operate a motor vehicle in the Commonwealth shall be suspended immediately. The period of suspension of the person's license or privilege to drive shall be seven days, unless the petition, summons or warrant issued charges the person with a second or subsequent offense. If the person is charged with a second offense the suspension shall be for 60 days. If not already expired, the period of suspension shall expire on the day and time of trial of the offense charged on the petition, summons or warrant, except that it shall not so expire during the first seven days of the suspension. If the person is charged with a third or subsequent offense, the suspension shall be until the day and time of trial of the offense charged on the petition, summons or warrant.
A law-enforcement officer, acting on behalf of the Commonwealth, shall serve a notice of suspension personally on the arrested person. When notice is served, the arresting officer shall promptly take possession of any driver's license held by the person and issued by the Commonwealth and shall promptly deliver it to the magistrate. Any driver's license taken into possession under this section shall be forwarded promptly by the magistrate to the clerk of the general district court or, as appropriate, the court with jurisdiction over juveniles of the jurisdiction in which the arrest was made together with any petition, summons or warrant, the results of the breath test, if any, and the report required by subsection B. A copy of the notice of suspension shall be forwarded forthwith to both (a) the general district court or, as appropriate, the court with jurisdiction over juveniles of the jurisdiction in which the arrest was made and (b) the Commissioner. Transmission of this information may be made by electronic means.
The clerk shall promptly return the suspended license to the person at the expiration of the suspension. Whenever a suspended license is to be returned under this section or 46.2-391.4, the person may elect to have the license returned in person at the clerk's office or by mail to the address on the person's license or to such other address as he may request.
B. Promptly after arrest and service of the notice of suspension, the arresting officer shall forward to the magistrate a sworn report of the arrest that shall include (i) information which adequately identifies the person arrested and (ii) a statement setting forth the arresting officer's grounds for belief that the person violated 18.2-51.4, 18.2-266, or 18.2-266.1, or a similar ordinance or refused to submit to a breath test in violation of 18.2-268.3 or a similar ordinance. The report required by this subsection shall be submitted on forms supplied by the Supreme Court.
C. Any person whose license or privilege to operate a motor vehicle has been suspended under subsection A may, during the period of the suspension, request the general district court or, as appropriate, the court with jurisdiction over juveniles of the jurisdiction in which the arrest was made to review that suspension. The court shall review the suspension within the same time period as the court hears an appeal from an order denying bail or fixing terms of bail or terms of recognizance, giving this matter precedence over all other matters on its docket. If the person proves to the court by a preponderance of the evidence that the arresting officer did not have probable cause for the arrest, that the magistrate did not have probable cause to issue the warrant, or that there was not probable cause for issuance of the petition, the court shall rescind the suspension, or that portion of it that exceeds seven days if there was not probable cause to charge a second offense or 60 days if there was not probable cause to charge a third or subsequent offense, and the clerk of the court shall forthwith, or at the expiration of the reduced suspension time, (i) return the suspended license, if any, to the person unless the license has been otherwise suspended or revoked, (ii) deliver to the person a notice that the suspension under 46.2-391.2 has been rescinded or reduced, and (iii) forward to the Commissioner a copy of the notice that the suspension under 46.2-391.2 has been rescinded or reduced. Otherwise, the court shall affirm the suspension. If the person requesting the review fails to appear without just cause, his right to review shall be waived.
The court's findings are without prejudice to the person contesting the suspension or to any other potential party as to any proceedings, civil or criminal, and shall not be evidence in any proceedings, civil or criminal.
D. If a person whose license or privilege to operate a motor vehicle is suspended under subsection A is convicted under 18.2-36.1, 18.2-51.4, 18.2-266, or 18.2-266.1, or any similar ordinance during the suspension imposed by subsection A, and if the court decides to issue the person a restricted permit under subsection E of 18.2-271.1, such restricted permit shall not be issued to the person before the expiration of the first seven days of the suspension imposed under subsection A.
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§ 46.2-391.4. When suspension to be rescinded.
Notwithstanding any other provision of 46.2-391.2, a subsequent dismissal or acquittal of all the charges under 18.2-36.1, 18.2-51.4, 18.2-266, and 18.2-268.3 or any similar ordinances, for the same offense for which a person's driver's license or privilege to operate a motor vehicle was suspended under \ 46.2-391.2 shall result in the immediate rescission of the suspension. In any such case, the clerk of the court shall forthwith (i) return the suspended license, if any, to the person unless the license has been otherwise suspended or revoked, (ii) deliver to the person a notice that the suspension under § 46.2-391.2 has been rescinded and (iii) forward to the Commissioner a copy of the notice that the suspension under § 46.2-391.2 has been rescinded.
No person, except those expressly exempted in \46.2-303 through 46.2-308, shall drive any motor vehicle on any highway in the Commonwealth until such person has applied for a driver's license, as provided in this article, satisfactorily passed the examination required by 46.2-325, and obtained a driver's license, nor unless the license is valid.
Upon conviction under this section, the court may suspend the person's privilege to drive for a period not to exceed 90 days.
A driver who is charged and convicted of driving with suspended drivers license, driving with no license or diring with revoked drivers license will be guilty of a criminal Class 1 misdemeanor, with a possibility of license suspension. Driving with a revoked license or driving with a suspended license in Virginia is also called DWS & DOS. Driving without a license in Virginia is also a criminal offence. American Lawyers Group, PLLC attorneys will defend you in most Virginia Traffic cases. Our Virginia driving with suspended license lawyers will review your case and provide legal defense based on our Virginia defense experience.


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(C) The law enforcement officer shall immediately deliver to the underage person from whom the driver's license, driver's permit, or other evidence of driving privilege was seized a temporary driving permit, as provided by § 5-65-402 .
(2) Refusal to submit to a chemical test under this subsection is a strict liability offense and is a violation.
(C) Revocation for a third or subsequent offense.
(2) A revocation issued under this subsection continues until the underage person reaches twenty-one (21) years of age or for a period of three (3) years, whichever is longer.
(2) A suspension or revocation of driving privileges for an arrest for a violation of § 5-65-310 when the person was not subsequently acquitted of the criminal charge.
(2) One (1) year for a second or subsequent offense.
(e) When an underage nonresident's driving privilege to operate a motor vehicle in this state has been suspended under this section, the office shall notify the entity of issuance of that underage person's nonresident motor vehicle driving privilege of action taken by the office.
(f)(1)(A) A driving privilege that is suspended under this section may be reinstated by the office upon payment of twenty-five dollars ($25.00) for each occurrence of an offense that resulted in an order of administrative suspension under § 5-65-310 .
(B) As used in this subsection, “occurrence” means each separate calendar date when an offense or offenses take place.
(B) A de novo review of the administrative suspension order by the office resulted in the removal.
(3) Forty percent (40%) of the revenues derived from the fee under this subsection shall be deposited into the State Treasury as special revenues and credited to the Public Health Fund to be used exclusively for the Blood Alcohol Program of the Department of Health.
(4) The fee under this subsection is supplemental to and in addition to any fee imposed under § 5-65-119 , § 5-65-304 , § 27-16-508 , or § 27-16-808 .

matches: § 5 § 5 § 5 § 5 § 5 § 27 § 27


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If you are interested in the image of media law in film, check out movies like The Front Page, first filmed in 1931, and based on the Ben Hecht play. It was remade in 1945 and in 1974, and as His Girl Friday in 1940 with Rosalind Russell in the role of the journalist who simply can't walk away from the big story (in this case an execution) and as Switching Channels with Kathleen Turner in the Rosalind Russell role. It's also been adapted for television. The journalists in The Front Page and its adaptations push the First Amendment to its limits, as do the newspapermen and women in movies like Libeled Lady (1936), a farce featuring Spencer Tracy as a big city editor threatened with a defamation action by socialite Myrna Loy. The People vs. Larry Flynt (1996) dramatizes the well-known Supreme Court case as well as lesser known events in Flynt's life. All the President's Men (1976), based on the Bob Woodward/Carl Bernstein bestseller spotlights the Watergate break-in and the Washington Post's relentless coverage of the resulting coverup. Reckless Disregard (1985) features Leslie Nielsen in a dramatic role as a journalist accused of defaming a physician in the course of reporting a story about drug trafficking. Absence of Malice (1981) centers on a young reporter (Sally Field) who writes a provocative story about a liquor distributor suggesting that he may be involved in the disappearance of a crime figure. The US attorney has used her to leak the information and the distributor (Paul Newman) threatens a lawsuit. The little known Word of Honor (1981) stars Karl Malden as a journalist who promises not to reveal his source for a story in spite of the fact that the defendant may go free. Quiz Show (1994) dramatizes the true story of the scandal surrounding the game show Twenty-One. The wonderful film Roxie Hart (1942) features a down-on-her-luck entertainer (Ginger Rogers) who admits to a murder in order to get some helpful publicity. It was adapted into the musical Chicago and ran for months on Broadway, then was filmed with Renee Zellweger in the Ginger Rogers part and Richard Gere as her lawyer, the very slick Billy Flynn. Gere is quite enjoyable to and others in the Oscar winning film are also good, including Catherine Zeta-Jones as Zellweger's eventual partner Velma Kelly. The amount of pretrial publicity surrounding Roxie's trial would put the current celebrity proceedings in the news to shame and Flynn is eager to chase down even more. Roxie Hart is loosely based on the real trials of Belva Gaertner and Beulah Annan. For more on journalists in popular culture see the website maintained by the Norman Lear Center at the University of Southern California.
The Mississippi Supreme Court has ruled 5 to 3 to overturn the decision of a trial judge banning Jackson television station WLBT from coverage of the 2004 sentencing of former Madison County David Richardson. While the majority recognized that the judge was concerned about the defendant's fair trial rights, it held that the Mississippi Rules for Electronic and Photographic Coverage of Judicial Proceedings (MREPC) required that Judge Marcus Gordon provide specific findings of fact supporting his denial of the request to cover the proceeding. Justice Waller, writing for the majority, elaborated, "It is generally better for the courts to limit or terminate coverage as needed than to exclude camera and television coverage altogether. MREPC 3 speaks of ensuring fair administration of justice and protecting the rights of parties and witnesses. These words envision real and substantial rights that are at risk. The learned circuit judge, while expressing concern that things covered in the sentencing hearing "may" impact the companion case--not that there was a probability that such would be the case-stated no specific prejudice. The proper standard for restricting press coverage is that there is a "substantial probability" that the accused will be deprived of a fair trial. In Press-Enterprise II, the Supreme Court rejected the lesser standard of "reasonable likelihood" applied by the California Supreme Court and went on to point out that "the First Amendment right of access cannot be overcome by the conclusory assertion that publicity might deprive the defendant of that right." Press-Enterprise II, 478 U. S. at 14, 106 S. Ct. at 2743. The decision to restrict press access, whether by closing proceedings or by eliminating the use of the tools of the trade must be supported by specific, on the record findings of fact which show in what manner the coverage will cause a party to lose the right to a fair trial. See Hand, 571 So. 2d at 944. Butler, the defendant in the related case, is not, in the words of MREPC 3, a party "in the pending case." The judge did not indicate that Butler's trial is imminent, a circumstance which could be a factor in limiting or restricting coverage if the trial of that case was to take place shortly after the sentencing hearing. Butler sought no opportunity to intervene and raised no objection to having cameras in the courtroom." In re WLBT Inc., Miss., No. 2004-M-02239-SCT, 1/20/05.
The Scotsman reports that Operation Christian Vote, a Christian political party, has asked for an official investigation into whether the BBC broke the law by airing the program Jerry Springer--The Opera on BBC2. The musical is currently running in London's West End. The broadcast attracted both a large audience (nearly 2 million viewers) and a large number of objections (47,000). The head of Operation Christian Vote, the Reverend George Hargreaves, identified a particular scene in the show as blasphemous. (Kate Foster, Springer TV Opera Faces Blasphemy Complaint, January 16, 2005).
For its part, the BBC defends the transmission. The Times reports that BBC Chairman Michael Grade checked with BBC Director-General Mark Thompson to make certain that the performance would not be considered either criminal or offensive. Both the network and Ofcom (the British agency empowered to regulate UK communications industries) are preparing to investigate the matter. (Adam Sherwin, BBC Chief Defends Jerry Springer, Times Online, January 13, 2005).
A BBC Radio 3 producer has left his post over the matter, citing a matter of conscience. The Times quotes Anthony Pitts' letter of resignation as indicating his dismay over the extent of the offense.
The protests over Jerry Springer--The Opera follow by just a few weeks objections by some in the Birmingham, England Sikh community to the staging of a play called Behzti (Dishonor) by the Birmingham (England) Repertory Company. Dan Tench, a specialist in public and media law at Olswang, offers an interesting review of the application of blasphemy law in England and Scotland over the past 400 years. Tench surveys the use of the charge against booksellers and publishers through the 1970s. He points out that even the European Convention on Human Rights with its protections for freedom of expression does not quite succeed in overcoming the presumption that the charge has a legitimate purpose.(Dan Tench, The Guardian, January 17, 2005). But as he points out, we cannot tell exactly what "blasphemy" means in the English legal scheme. He reviews the Gay News case which proceeded throughout the British courts to the European Court of Human Rights. (See R v. Lemon, R v. Gay News Ltd.,  Appeal Cases 617,  1 All England Law Reports 898,  2 Weekly Law Reports 281).
Court TV is reporting that U. S. District Judge Peter K. Leisure has now allowed part of former California Congressman Gary Condit's defamation lawsuit against writer Dominick Dunne to go forward. Condit originally filed the suit against Dunne in December of 2002, after Dunne appeared on various talk shows including "Larry King Live" and theorized about the disappearance of intern Chandra Levy. Court TV elaborates that according to the judge, Dunne also connected Condit to the disappearance by saying, "I believe firmly that he knows more than what he has ever said." Condit had also claimed that statements Dunne made in newspapers were also defamatory, but Leisure dismissed those parts of the suit.
Roy Paul, the Los Angeles judge presiding over the divorce trial of Ron and Janet Burkle, has set a February 18, 2005 date to hear arguments over whether records should continue to be sealed pursuant to California Family Code Section 2024.6 in the case of Burkle v. Burkle. Lawyers for the Los Angeles Times, the Associated Press and the California Newspaper Publishers Association, as well as Mrs. Burkle's attorneys, have challenged the code section's constitutionality on various grounds. The Briefs read in part: "...Mr. Burkle is asking this Court to seal virtually the entire court file and proceedings--including court orders and judgments--in his acrimonious divorce case. Mr. Burkle is relying on a new secrecy statute, Family Code [section] 2024.6, which requires the automatic sealing of any divorce court document that discloses the financial assets of one of the parties. Curiously, this new statute was signed into law as "urgency legislation" by Gov. Arnold Schwarnegger on June 7, 2004--just months after this Court denied Mr. Burkle's previous request to seal divorce court records containing financial information--and shortly before Mr. Burkle and his companies donated $121,200 to the governor's political committees on March 1, 2004....This Court should reject Mr. Burkle's latest bid to hide his divorce proceedings and his financial asset information...Even assuming that Family Code [Section] 2024.6 provided for the blanket sealing of the entire divorce file--which it does not--this hastily enacted statute is flatly unconstitutional because it requires the trial court to seal divorce court records, including court orders and judgments, without providing for the document-by-document analysis and threshold inquiries required by the First Amendment." Read more of the Intervenors' Briefs here and here.
On January 7, a new law entitled the Access to Information and Protection of Privacy Amendment Act went into effect in Zimbabwe. Together with the Access to Information and Protection of Privacy Act (AIPPA), which was passed in 2002, it allows the government to prosecute journalists caught working without government permission. Zimbabwe's Media and Information Commission oversees the independent media in the country. Article 19, an NGO registered as a charity in the UK, has released a report on the AIPPA. The report begins, "The Access to Information and Protection of Privacy Act, commonly referred to as AIPPA, was passed by the Parliament of Zimbabwe on 31 January 2002 and signed into law by President Mugabe on 15 March 2002. It may accurately be described as the leading weapon of the government and the ruling ZANU PF party in their ongoing campaign to stifle independent media reporting in Zimbabwe." Zimbabwe's next general elections are scheduled for March of this year.
Those interested in the rights of student journalists anxiously await the 7th Circuit’s ruling in Hosty v. Carter, a case argued January 8, 2004. The University in Hosty claims the right to practice prior review of its student newspaper, The Innovator, which has now been shut down. Governors State University Dean of Student Affairs Patricia Carter halted publication of the bimonthly paper in 2000 after it printed articles criticizing the university administration. The Managing Editor of the paper, Margaret Hosty, and two other students filed suit in federal district court charging First Amendment violations. In November 2001 the district court allowed the suit to proceed and in 2002 the university appealed, citing Hazelwood v. Kuhlmeier. The 7th Circuit eventually found in favor of Hosty, April 10, 2003. However, in July 2003 the Illinois Attorney General, Lisa Madigan, successfully intervened on behalf of the University. The 7th Circuit vacated the April 10th decision and agreed to a re-hearing en banc. The Student Press Law Center (SPLC) has an informative page on the case on its website.
The Federal Communications Commission has refused to rule that a word in general, and vulgar, use as an alternative for the male sexual organ was indecent when spoken by characters on episodes of "Dawson's Creek," or when alluded to on an episode of "Friends." It also ruled that an episode of "King of the Hill", a cartoon series, did not reach a level of indecency when it depicted--briefly--a boy entering a shower after removing his towel. In FCC 04-279 and FCC 04-280, the FCC dismissed more than 30 complaints involving indecent language on network TV that the Parents Television Council has filed since 2001. Both Commissioner Martin and Commissioner Copps approved in part and dissented in part; Commissioner Martin will issue a statement at a later date. Commissioner Copps issued a statement today, charging that the FCC had merely lumped together these complaints, failing to analyze them carefully or to provide any meaningful guidance for viewers or for broadcasters attempting to determine when the FCC might hold them accountable for indecent or patently offensive language. Perhaps in an attempt to ward off criticism, Fox, which drew a $1.2 million fine from the agency for its show "Married by America", has decided to rename its cable channel sport talk show "Best Damn Sports Show Period" "Best Darn Super Bowl Road Show Period." "Married by America" garnered a reported 90 complaints (written by 23 people) about its content. However, blogger Jeff Jarvis reported that most of those complaints seem to have come on form letters generated by the Parents Television Council. Frank Ahrens discusses the FCC rulings in an article in the Washington Post today at page E01. See Frank Ahrens, "FCC Dismisses 36 Indecency Complaints as Not "Patently Offensive".
Stephen Colbert is the interviewee on Terry Gross' show Fresh Air today, January 24, 2005. Colbert is the "newsman" on Jon Stewart's Daily Show. NPR also offers a related story on "Comedy as News," its Talk of the Nation, March 4, 2004, broadcast.
Nick Ciarelli, facing a lawsuit by Apple Computer over information he revealed on his Think Secret website, will be represented by Terry Gross of the San Francisco firm of Gross & Belsky. Ciarelli, who uses the online pseudonym of Nick de Plume, had considered abandoning his website if Apple agreed to drop the lawsuit, according to a story reported today on National Public Radio, but the Electronic Frontier Foundation, which has worked with Gross in the past, put the Harvard student in touch with the attorney. While Apple contends that Ciarelli revealed trade secrets, Gross plans to respond that the First Amendment protects the budding journalist's writing, since nothing that Ciarelli published was illegally obtained. Pamela Samuelson has published an interesting working paper on the conflict between protecting trade secrets and freedom of speech, in which she also reviews the literature by other scholars in the area including Andrew Beckerman-Rodau, RIchard Epstein, David Greene, Mark Lemley, and Eugene Volokh.
FCC Chair Michael Powell, who joined the agency in 1998, becoming its head in 2001, may be set to leave long before his term ends in 2007. Sources say he will announce his resignation later today. Powell's leadership has been characterized by battles with the networks over obscenity and indecency, the latest over Howard Stern's comments on talk radio and Janet Jackson's "wardrobe malfunction" on a 2004 Super Bowl half-time show. Powell also backed the controversial media ownership rule changes many of which the Third Circuit stayed later in the year pending further justification by the agency. (The Third Circuit's page providing links to media ownership rules documents is available here). Powell has also tried to promote digital broadcasting, a move that broadcasting have resisted since most viewers continue to balk at the price of HDTV units.
The Cincinnati Enquirer has been denied its request for an order requiring that the city of Cincinnati's health department release the names and other information about property owners in violation of the city's "no lead" provisions. Since 1994 the city has targeted these owners; in 2004 the newspaper asked the city for a list of names. The city refused, citing HIPAA (the Health Insurance Portability and Accountability Act). On December 30, 2004 the First Appellate District Court of Appeals (Hamilton County) decided in favor of the city, citing the state's Public Records Act (R.C. 149.43) as well as HIPAA. The court recognized that competing interests were at stake, but found that the city met its burden of showing an exception to disclosure by referring to medical information included that could be protected from disclosure under the state's public records act. Since the information was unredacted and no waivers were provided for, the court upheld the city's refusal to disclose at this time. Here is the case: State ex rel. Cincinnati Enquirer v. Adcock, Ohio Ct. App., No. C-0400064, decided Dec. 30, 2004.
A California law that Governor Arnold Schwarnenegger signed on June 7, 2004 that permits some divorce records to be sealed at the request of either party is at the center of a constitutional challenge. Section 2024.6 of the California Family Code allows either party to petition the court to list financial assets and then seal the information. The code section provides that "[t]he request may be made by ex parte application." In billionaire Ron Burkle's pending divorce from wife Janet, attorneys for the investor have invoked this section to seal what observers believe might be some extremely interesting financial information. Lawyers for Mrs. Burkle and some media attorneys, including representatives for the Associated Press and the L. A. Times, have now challenged the move before a judge in Los Angeles County Superior Court.
It's not entirely clear why the Family Code was amended in this way, but the bill passed both houses as "urgency" legislation. Two lawmakers who supported the measure, John Burton of San Francisco and Christine Kehoe of San Diego, have not commented so far. Kehoe has championed privacy rights legislation in the past. Some commentators suggest that wealthy political supporters like Burkle have an interest in protecting information about their assets in case of divorce. Attorneys for Burkle had apparently unsuccessfully tried to seal some financial records shortly before the change in the code.
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1. A bilateral hearing loss disability was not manifest during service or within one year of separation. Bilateral sensorineural hearing loss disability is not attributable to service.
2.  Tinnitus is not attributable to service.
1. The criteria for entitlement to service connection for bilateral hearing loss have not been met. 38 U.S.C. §§ 1101, 1110, 1112, 1113, 1137 (2012); 38 C.F.R. §§ 3.102, 3.303, 3.304, 3.307, 3.309, 3.385 (2017).
2. The criteria for entitlement to service connection for tinnitus have not been met. 38 U.S.C. §§ 1110, 1154 (2002); 38 C.F.R. §§ 3.102, 3.303 (2017).
The Veteran served on active duty from September 1967 to September 1969.
This matter was before the Board of Veterans’ Appeals (Board) on appeal from a March 2016 rating decision issued by the RO.
This appeal was processed using the Veterans Benefits Management System (VBMS) paperless claims processing system.
Service connection may be established for disability resulting from personal injury suffered or disease contracted in line of duty in the active military, naval, or air service. 38 U.S.C. §§ 1110, 1131. Establishing service connection generally requires (1) evidence of a current disability; (2) evidence of in-service incurrence or aggravation of a disease or injury; and (3) evidence of a nexus between the claimed in-service disease or injury and the present disability. Shedden v. Principi, 381 F.3d 1163, 1167 (Fed. Cir. 2004); see also Caluza v. Brown, 7 Vet. App. 498, 506 (1995), aff’d per curiam, 78 F.3d 604 (Fed. Cir. 1996) (table); 38 C.F.R. § 3.303.
In addition, for Veterans who have served 90 days or more of active service during a war period or after December 31, 1946, certain chronic disabilities, including organic disease of the nervous system, are presumed to have been incurred in service if they manifested to a compensable degree within one year of separation from service. 38 U.S.C. §§ 1101, 1112, 1113, 1131, 1137; 38 C.F.R. §§ 3.307, 3.309.
That an injury or disease occurred in service is not enough; there must be chronic disability resulting from that injury or disease. If there is no showing of a resulting chronic condition during service, then a showing of continuity of symptomatology after service is required to support a finding of chronicity. 38 C.F.R. §§ 3.303(b), 3.309; Walker v. Shinseki, 708 F.3d 1331 (Fed. Cir. 2013). As noted, organic disease of the nervous system is a chronic disease.  38 U.S.C. § 1101. Therefore, section 3.303(b) is potentially applicable.
Service connection may also be granted for any injury or disease diagnosed after discharge, when all the evidence, including that pertinent to service, establishes that the disease or injury was incurred in service. 38 C.F.R. § 3.303(d).
When there is an approximate balance of positive and negative evidence regarding any issue material to the determination of a matter, the VA shall give the benefit of the doubt to the claimant.  38 U.S.C. § 5107(b).
Specific to claims of service connection, impaired hearing is considered a disability for VA purposes when the auditory threshold in any of the frequencies of 500, 1000, 2000, 3000, or 4000 Hertz is 40 decibels or greater; the thresholds for at least three of these frequencies are 26 or greater; or when speech recognition scores using the Maryland CNC Test are less than 94 percent. 38 C.F.R. § 3.385 (2017).
The Veteran asserts that noise exposure in service from truck noise, mortar attacks and helicopter noise caused his bilateral hearing loss disability and tinnitus.
The service treatment records show no complaints or findings of hearing loss disability.
However, that the absence of in-service evidence of hearing loss disability is not fatal to the claim, see Ledford v. Derwinski, 3 Vet. App. 87, 89 (1992). Evidence of a current hearing loss disability (i.e., one meeting the requirements of section 3.385, as noted above) and a medically sound basis for attributing such disability to service may serve as a basis for a grant of service connection for hearing loss. See Hensley v. Brown, 5 Vet. App. 155, 159 (1993).
A July 2015 VA audiology consult treatment record reflects that the Veteran received treatment for decreased bilateral hearing. The Veteran reported that he had experienced hearing loss for at least five years and complained that he had difficulty hearing. There was no history of otologic disorder or family history of hearing loss. The Veteran did not have reports of tinnitus or vertigo. He was not a previous hearing aid user. Objectively, pure tone audiometry results revealed mild sloping to severe, profound bilateral sensorineural hearing loss.
A February 2016 VA audiology record reflects that the Veteran returned for hearing aid followup treatment. He reported that had extreme difficulty hearing bilaterally, left ear worse than the right ear. He reported that he had been experiencing the extreme difficulty hearing for approximately three to four weeks. The Veteran’s hearing aids were reprogrammed.
Speech audiometry revealed speech recognition ability of 44 percent in the right ear and 56 percent in the left ear. Thus, he demonstrated bilateral hearing loss disability for VA purposes.
The audiologist noted there was not a permanent positive threshold shift (worse than reference threshold) greater than normal measurement variability at any frequency between 500 and 6000 hertz in the right or left ears. The audiologist opined that the Veteran’s right and left ear hearing loss was not at least as likely as not caused by or a result of an event during the Veteran’s period of service. The audiologist noted that service enlistment examination, Bekesey tracing and separation examination all showed normal pure tone thresholds at 500 through 6000 hertz bilaterally with no shift in hearing. The audiologist concluded that there was no evidence of hearing loss during the Veteran’s period of military service.
The audiologist explained that in an Institute of Medicine (IOM), National Academy of Sciences 2006 article, the IOM concluded that based on current knowledge of cochlear physiology, there was no sufficient scientific basis for the existence of delayed-onset hearing loss. The IOM did not rule out that delayed onset might exist but concluded, based on current knowledge of acoustic trauma and the instantaneous or rapid development of noise-induced hearing loss, there was no reasonable basis for delayed-onset hearing loss. Thus, the audiologist opined that the Veteran’s hearing loss was not due to or the result of his period of military service.
Regarding his tinnitus, the Veteran complained of recurrent bilateral tinnitus that onset over 20 years earlier. The Veteran did not recall a specific incident of onset. The audiologist noted that the Veteran had a diagnosis of clinical hearing loss and opined that the Veteran’s tinnitus was at least as likely as not a symptom associated with the hearing loss as tinnitus was known to be a symptom associated with hearing loss.
The audiologist opined that the Veteran’s tinnitus was less likely than not caused by or a result of military noise exposure. The audiologist noted that the service treatment records showed normal pure tone thresholds at 500 through 6000 hertz bilaterally with no shift in hearing. The audiologist determined that there was no evidence of hearing loss or complaint of tinnitus during the Veteran’s period of service. The audiologist concluded that given that the Veteran did not experience hearing loss and/or a shift in hearing during his period of service, his tinnitus was not due to military noise exposure.
Though the Veteran has current bilateral sensorineural hearing loss and tinnitus, the preponderance of the evidence is against a finding of a linkage between the onset of the disabilities and a period of service. Rather, the evidence shows that the Veteran’s current bilateral hearing loss disability had no etiological relationship to in-service noise exposure. The audiologist in March 2016 noted that the service treatment records documented normal hearing bilaterally without shift in hearing and explained that based on current knowledge of acoustic trauma and the instantaneous or rapid development of noise-induced hearing loss, there was no reasonable basis for delayed-onset hearing loss. Thus, the Veteran’s hearing loss was not due to or the result of his period of military service.
The Veteran’s tinnitus was at least as likely as not a symptom associated with his hearing loss. Given that the Veteran did not experience hearing loss and/or a shift in hearing during his period of service, his tinnitus was not due to military noise exposure (see March 2016 report of VA examination).
There is no competent evidence or opinion that suggests that there exists a medical relationship, or nexus, between any current hearing loss disability and tinnitus and a period of the Veteran’s service.
Additionally, there is no evidence of sensorineural hearing loss disability in service. To determine that a chronic disease was shown in service, the disease identity must be established. 38 C.F.R. § 3.303(b); Walker, 708 F.3d at 1339. No examiner in service, or since, has established chronicity or an underlying chronic disease process in service. In sum, characteristic manifestations sufficient to identify the disease (other organic disease of the nervous system) entity were not noted.  Further, there is no demonstration of continuity of symptomatology or evidence of sensorineural hearing loss disability within one year of separation from service. Thus, service connection cannot be awarded on a presumptive basis. 38 U.S.C. § 1101, 1110, 1112, 1113, 1131, 1137; 38 C.F.R. §§ 3.303(b), 3.307, 3.309.
(3) lay testimony describing symptoms at the time supports a later diagnosis by a medical professional.
Jandreau v. Nicholson, 492 F. 3d 1372 (Fed. Cir. 2007); see also Davidson v. Shinseki, 581 F.3d 1313 (Fed. Cir. 2009) (where widow seeking service connection for cause of death of her husband, the Veteran, the Court holding that medical opinion not required to prove nexus between service connected mental disorder and drowning which caused Veteran’s death).
The Veteran is competent to state that he sustained in-service noise exposure. However, he is a lay person and is not competent to establish that his current bilateral hearing loss or tinnitus disabilities onset as a result of any in-service-noise exposure. The Veteran is not competent to offer an opinion as to etiology of any current bilateral hearing loss or tinnitus disabilities. The question regarding the etiology of such a disability is a complex medical issue that cannot be addressed by a layperson. For these reasons, his allegations are no more than conjecture and do not rise to the type of evidence addressed by Jandreau.
The claims of entitlement to service connection for a bilateral hearing loss disability and tinnitus must be denied. The preponderance of the evidence is against the claims and the benefit-of-the-doubt doctrine is not applicable. See 38 U.S.C. § 5107(b); 38 C.F.R. § 3.102; Gilbert v. Derwinski, 1 Vet. App. 49, 53-56 (1990).