• The "Genetically Engineered Food Right to Know Act" (H.R. 5577) would amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, and the Poultry Products Inspection Act to require that food that contains a genetically engineered material, or that is produced with a genetically engineered material, be labeled accordingly. The bill states that "[t]he process of genetically engineering foods results in the material change of such foods," and asserts that "Federal agencies have failed to uphold Congressional intent by allowing genetically engineered foods to be marketed, sold and otherwise used without labeling that reveals material facts to the public." The bill, which has been referred to the House Committees on Agriculture and Energy and Commerce, was co-sponsored by Rep. Peter DeFazio (D-OR), Barney Frank (D-MA), Raul Grijalva (D-AZ), Barbara Lee (D-CA), Jim McDermott (D-WA), Pete Stark (D-CA), and Lynn Woolsey (D-CA).
• The "Genetically Engineered Safety Act" (H.R. 5578) would "prohibit the open-air cultivation of genetically engineered pharmaceutical and industrial crops, . . . prohibit the use of common human food or animal feed as the host plant for a genetically engineered pharmaceutical or industrial chemical, . . . establish a tracking system to regulate the growing, handling, transportation, and disposal of pharmaceutical and industrial crops and their byproducts to prevent human, animal, and general environmental exposure to genetically engineered pharmaceutical and industrial crops and their byproducts, [and] amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of genetically engineered foods." Noting that "[m]any of the novel substances produced in pharmaceutical crops and industrial crops exhibit high levels of biological activity and are intended to be used for particular medical or industrial purposes, under very controlled circumstances," and that "[n]one of these substances is intended to be incorporated in food or to be spread into the environment," the bill declares that the risks of contamination "necessitate a zero tolerance standard for the presence of pharmaceutical crops and industrial crops and their byproducts in crops used to produce human food or animal feed." The bill, which has been referred to the House Committees on Agriculture and Energy and Commerce, was co-sponsored by Rep. Peter DeFazio (D-OR), Barney Frank (D-MA), Raul Grijalva (D-AZ), Barbara Lee (D-CA), Pete Stark (D-CA), and Lynn Woolsey (D-CA).
• The "Genetically Engineered Technology Farmer Protection Act" (H.R. 5579) would "provide additional protections for farmers and ranchers that may be harmed economically by genetically engineered seeds, plants, or animals, . . . ensure fairness for farmers and ranchers in their dealings with biotech companies that sell genetically engineered seeds, plants, or animals, [and] assign liability for injury caused by genetically engineered organisms." The bill states that "[p]olicies promoted by biotech corporations, such as patenting of seeds, depriving farmers the right to save seed, unreasonable seed contracts, and intrusion into everyday farm operations, have systematically acted to remove basic farmer rights enjoyed since the beginning of agriculture and essential for agricultural sustainability and the survival of family farms," and asserts that "[t]he introduction of genetically engineered crops has also created obstacles for farmers, including the loss of markets and increased liability concerns." The purpose of H.R. 5579 is "[t]o mitigate the abuses upon farmers, a clear set of farmer rights must be established." Among the rights that would be created by the bill are (1) a requirement for biotech companies to fully disclose the risks of using genetically engineered animals, plants, or seeds, and (2) the prohibition of certain terms and limitations in contracts for the sale of genetically engineered animals, plants, or seeds, including a provision that would "prohibit the purchaser from retaining a portion of the harvested crop for future crop planting by the purchaser or that charge a fee to retain a portion of the harvested crop for future crop planting." H.R. 5579 would allow for a maximum $100,000 penalty to be assessed for violations of the Act. The bill, which has been referred to the House Agriculture, Energy and Commerce, and Judiciary Committees, was co-sponsored by Rep. Peter DeFazio (D-OR), Barney Frank (D-MA), Raul Grijalva (D-AZ), Barbara Lee (D-CA), Pete Stark (D-CA), and Lynn Woolsey (D-CA).
To ensure we can maximize benefits and minimize hazards, Congress must provide a comprehensive regulatory framework for all Genetically Engineered products. Structured as a common-sense precaution to ensure [Genetically Engineered] foods do no harm, these bills will ensure that consumers are protected, food safety measures are strengthened, farmers’ rights are better protected and biotech companies are responsible for their products.
The release noted that Rep. Kucinich had introduced similar bills in previous sessions of Congress.
The Supreme Court waited until the eleventh hour to issue its long-awaited decision in Bilski v. Kappos, affirming the Federal Circuit's determination that an application directed to hedging risk in energy commodities was not patent eligible while determining that the Federal Circuit's machine-or-transformation test is not the sole test for assessing patent eligibility under 35 U.S.C. § 101 (see Patent Docs report on decision). Reaction to the Supreme Court's decision in Bilski has, not surprisingly, come much quicker.
The Supreme Court [on Monday] affirmed the USPTO's decision that Mr. Bilski's invention was not patentable subject matter as his claims were drawn to an abstract idea. Significantly, the Court ruled that the "machine or transformation" test is not the sole determinant of patent eligible subject matter for process claims, but is nevertheless an important "investigative tool" for evaluating their patent eligibility. The Court also indicated that a business method is, at least in some circumstances, eligible for patenting under Section 101.
The USPTO will be issuing guidance further interpreting the decision as soon as possible. The USPTO is distributing interim guidance for the examining corps today.
The Biotechnology Industry Organization (BIO), which along with the Advanced Medical Technology Association, Wisconsin Alumni Research Foundation (WARF), and the Regents of the University of California, submitted an amici brief in the case, issued a press release in which BIO President and CEO Jim Greenwood said the organization was "pleased that the Justices crafted a narrow opinion" in which the Court "overturn[ed] the lower court's rigid new test for determining whether a method or process is eligible for patenting." Noting that this was the position BIO had advocated for in its amici brief, Mr. Greenwood stated that "[t]he Court was clearly conscious of the potential negative and unforeseeable consequences of a broad and sweeping decision" and "recognized that the lower court's ruling could have created uncertainty in fields such as advanced diagnostic medicine techniques."
Pointing to the Supreme Court's decision in Diamond v. Chakrabarty -- which coincidentally celebrated its thirtieth anniversary on June 16th (see "BIO Celebrates Anniversary of Chakrabarty Decision") -- Mr. Greenwood observed that in that case the Court had "defined patent-eligible subject matter in a flexible and inclusive way that has fostered the tremendous growth of biotechnology for the benefit of millions of patients, farmers, and other consumers around the world." Mr. Greenwood offered that in Bilski, "the Court made it clear . . . that the patent system was designed to be broad and inclusive in order to promote innovation."
In a release issued by the American Intellectual Property Law Association (AIPLA), the national bar association, which also submitted an amicus brief in the case, said it was "gratified that the Supreme Court in its Bilski decision . . . continues to interpret the Patent Act as open to the broadest range of subject matter, preserving the incentives for yet unknown areas of innovation." AIPLA Executive Director Q. Todd Dickinson stated that the organization was "generally pleased that the Court's majority today confirmed that broad patent protection is critical to innovation and economic growth," and that "[t]hey recognized that the patentability of next generation technology should not be judged by a last century view of the law." Mr. Dickinson noted that this was the position that the AIPLA had advocated for in its own amicus brief. The AIPLA release also notes that "like many others filing amicus (i.e., "friend of the court") briefs, [the AIPLA] believes that excluded subject matter must be kept to a minimum because this is the only way to keep the patent system open to crucial but unforeseen innovations of the future," adding that "because the course of technology can take an unexpected path, the threshold test for patentable subject matter ought not become a barrier to the next life-altering innovation."
The Licensing Executives Society (LES) offered its comments on the "long-awaited" decision in a release issued on Monday. Noting that "[t]he decision has important implications for industries from health care to high tech," the professional society whose members are engaged in the transfer, use, development, and marketing of intellectual property, said that "[m]any throughout the industry, including a strong representation of our membership, have expressed the view that a rigid application of that test might stifle both innovation and business on a global scale, particularly in the Information Age." LES Public Policy Chair Brian O'Shaughnessy stated that "[o]verall, we believe the Supreme Court's decision represents an important step towards maintaining a balanced, effective patent system that promotes innovation and opportunity for both inventors and consumers."
The U.S. Patent and Trademark Office announced in a notice published in the Federal Register (75 Fed. Reg. 33584) that it is considering changes to restriction practice aimed at improving the quality and consistency of restriction requirements made by Office personnel. The USPTO has begun to solicit public comment regarding these potential changes. In particular, the Office is seeking comments on what should be included in an Office action that requires restriction, methods to expedite the process of traversing or requesting reconsideration of a restriction requirement, the treatment of Markush claims, rejoinder of non-elected claims, and other areas that could be improved upon with respect to current restriction practice.
The first issue for which comments are being sought is what should be included in an Office action that sets forth a restriction requirement. Currently, the M.P.E.P. requires that inventions must be independent or distinct as claimed and that there must be a serious burden on the examiner in order to require a restriction. To clarify the requirements for a restriction, the Office is considering that a restriction requirement must always articulate reasons why the inventions are independent and distinct and why there would be a serious burden on the examiner. In addition, the Office is considering a change to the serious burden prong of a restriction requirement. In particular, the Office is considering whether to specify that a serious burden would be present when the prior art applicable to one invention would not be applicable to another invention. Further changes include revision of the M.P.E.P to specify that a serious burden on the examiner encompasses search burden and/or examination burden. The examination burden encompasses non-prior art issues such as a § 112, first paragraph, issue.
The second area where the Office is seeking comments is the effectiveness of traversing or requesting reconsideration of a restriction requirement. The public has expressed dissatisfaction with the process of requesting reconsideration or traversing a restriction, and now the Office is inviting the public to comment on better methods to improve accurate, timely, and cost effective review.
The third topic for which the Office is seeking comment regards restriction between related product inventions or related process inventions. Currently, there is no M.P.E.P. section that addresses this topic and the Office is considering adding a section that would address restriction between related product inventions and related process inventions. The new section would specify that there must be two-way distinctness and a serious burden for a restriction requirement to be issued.
The fourth area of potential change is the revision of Markush practice. The Office is considering a number of changes with respect to this practice. First, if the examiner determines that the elected species is allowable, the Office is considering specifying that the examination of the Markush-type claim will be extended to the extent necessary to determine the patentability of the claim. Also under consideration are situations where restriction may be proper between a subcombination and a combination when a subcombination sets forth a Markush grouping of alternatives.
[T]he practice of withdrawing a restriction requirement as between some or all groupings of claims and reinstating certain claims previously withdrawn from consideration that occurs when the following conditions are met: (1) All claims to the elected invention are allowable; and (2) it is readily apparent that all claims to one or more nonelected inventions are allowable for the same reasons that the elected claims are allowable.
In addition, the Office is considering whether examiners should be instructed to rejoin nonelected claims when the elected claims are found to be allowable and withdraw the restriction requirement.
Finally, the Office is seeking comment on any areas that are not directly addressed in the notice, but which would improve restriction practice.
Comments must be received by August 13, 2010 and can be submitted to electronically to Restriction_Comments@uspto.gov or by regular mail addressed to Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450 and marked to the attention of Linda S. Therkorn.
The Supreme Court decided Bilski v. Kappos today and, as anticipated, agreed with the Federal Circuit that Bilski's claims to methods for "hedging" risk in commodities trading are not patent-eligible subject matter. After that, the opinion elevates the analysis to nothing short of advanced tea-leaf reading (including ample evidence regarding the prejudices and opinions of the various members of the Court on the topic of patent-eligibility).
The "majority" (comprising Justice Kennedy, who wrote the opinion, joined by the Chief Justice and Justices Alito, Thomas, and Scalia, the latter parting company on one aspect of the decision) takes the more conservative approach, deciding narrowly as to the claims before the Court. Somewhat predictably, and consistent with the Court's treatment of other "bright line" rules crafted by the Federal Circuit (KSR, eBay, Quanta), the Court teaches that while the "machine or transformation" test is a useful test, it is not the only test for patent-eligibility of process claims. The Court notes that while this test may have been sufficient for determining patent-eligibility in the "Industrial Age," it may be less useful in the (present) "Information Age" (although Justice Scalia not joining this part of the opinion robs it of any precedential value). As a consequence, the Court believes it best to be cautious in crafting preclusive tests that could prevent patenting new, unforeseen technologies. The Court does provide a measure of clarity in one aspect: it states that "nothing in today's opinion should be read as endorsing interpretations of §101 that the Court of Appeals for the Federal Circuit has used in the past," specifically the "useful, concrete and tangible result" test enunciated by the Federal Circuit in State Street Bank & Trust Co. v. Signature Financial Group, Inc. and repudiated by the en banc court in Bilski (while particularly recommending to "[s]tudents of patent law" that they would be "well advised to study the [Federal Circuit's five] scholarly opinions" in Bilski).
This Court's precedents establish that the machine-or-transformation test is a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under §101. The machine-or-transformation test is not the sole test for deciding whether an invention is a patent-eligible "process."
In making distinctions between the "Industrial Age" and the "Information Age," the Court seemed to credit several amici who made this argument, and to be convinced that the more prudent approach was to avoid setting forth exclusionary rules based on current or foreseeable technology. The Court was careful, however, to avoid any implication that its opinion endorsed the "patentability of any particular invention" or that any of the putative Information Age technologies "should or should not receive patent protection."
On the other hand, the opinion did firmly reject the idea that business method patents should be outside the scope of patent-eligibility per se, saying that "at least some" business method patents could be patent-eligible (although Bilski's was not). The Court based this conclusion in part on consistency in statutory interpretation, in view of Congressional recognition of business method patents in the "prior user defense" provisions of 35 U.S.C. § 273. Instead, the opinion turned to prior precedent on the patent-ineligibility of abstract ideas to provide "useful tools" for its analysis (Justice Scalia did not join this part of the opinion, either). Here, the Court suggested that the Federal Circuit could use such tools to distinguish business method claims on grounds "in accord with controlling precedent." But the Court provided no further guidance on how the Federal Circuit might achieve that goal.
The Court dispatched the Bilski claims in the final portion of its opinion, using the Benson/Flook/Diehr cases to determine that Bilski's claims were directed to "an unpatentable abstract idea" and that "[a]llowing petitioners to patent risk hedging would preempt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea."
The "minority" (comprising Justice Stevens, who wrote a concurring opinion joined by Justices Breyer, Ginsberg, and Sotomayor) believe that business methods are not patent-eligible subject matter and would have overruled the Federal Circuit's State Street Bank decision expressly. In an extensive opinion, Justice Stevens reviews the history of the Patent Act, both in this country and under the Statute of Monopolies in England, to find no basis for including business methods as patent-eligible subject matter. Indeed, the opinion cites commentators and judicial decisions alike as believing (prior to State Street) that business methods were not patent-eligible. The opinion asserts that such a decision by the Court would "restore patent law to its historical and constitutional moorings" which have been loosed by consideration of business methods as being patent-eligible. These four Justices take a much more restrictive view of patent-eligibility than the "majority," stating that "it would be a grave mistake to assume that anything with a 'useful, concrete and tangible result' . . . may be patented." Justice Stevens warns that insofar as the Court's opinion may be read to conclude that "any series of steps that is not itself an abstract idea or law of nature may constitute a 'process' within the meaning of §101" it can "only cause mischief." For this group of Justices, the determination is definitional: business methods are not patent-ineligible per se, they are patent-ineligible because they describe a method of doing business that is not a process under § 101.
Justice Stevens criticizes the Court's opinion for construing the statute based on the "ordinary, contemporary, common" meaning of the words, which is "a deeply flawed approach to a statute that relies on complex terms of art developed against a particular historical background." In this regard, the concurrence cites a number of "comical" types of methods that could be patent-eligible under the Court's approach, including "[a] process for training a dog, a series of dance steps, a method for shooting a basketball, maybe even words, stories or songs if framed as the steps of typing letters or uttering sounds." Justice Stevens believes it improper to make the "industrial":"information" distinctions, which introduces an unprecedented disparate application of the law to different technologies. He also believes that the Court's opinion does not provide "a satisfying account of what constitutes an unpatentable abstract idea," which analysis ("or lack thereof") he says "may have led to the correct outcome in this case but . . . means that the Court's musings on this issue stand for very little."
The concurrence further makes a constitutional argument related to the requirement that patents "promote the Progress of the Useful Arts." Justice Stevens opines that business methods by their nature are "sequential and complementary," intended to stimulate imitation as a "spur to innovation," citing Bessen & Maskin ("Sequential Innovation, Patents and Imitation," 2009, 40 RAND J. Econ. 611, 613). The concurrence posits the case of frequent-flyer miles offered by airlines, imitation of which could have been prevented if the first airline to offer them had obtained a patent (presumably on a method for engendering customer loyalty by providing this perk). Citing Dreyfuss ("Are Business Method Patents Bad for Business?," 2000, 16 Santa Clara Computer & High Tech. L.J. 263, 274-277), business methods are closer to the "top" of a hypothetical pyramid of ideas where exclusivity incurs greater social cost and hinders innovation. This, the concurrence states, makes these methods more akin to phenomena of nature, mental processes and abstract ideas that should not be patent-eligible. And the danger lurks that "many business decisions, no matter how small, could be potential patent violations" (emphasis in original) should business method claims get the Court's imprimatur as patent-eligible subject matter.
• First, "although the test of §101 is broad, it is not without limit," citing Chakrabarty, Benson, and Diehr.
• Second, the "machine-or-transformation" test "has repeatedly helped the Court to determine what is 'a patentable process.'"
• Third, while the "machine-or-transformation" test "has always been a 'useful and important clue,' it has never been the 'sole test' for determining patentability." It is rather "an important example of how a court can determine patentability under 101"; the Federal Circuit's mistake was in treating it as the "exclusive test" (emphases in original).
• Fourth, "although the machine-or-transformation test is not the only test for patentability, this by no means indicates that anything which produces a "useful, concrete and tangible result' . . . is patentable." Indeed, Justice Breyer states that insofar as the Federal Circuit repudiated that standard from State Street, "nothing in today's decision should be taken as disapproving of that determination."
With these insights in mind, it is clear that the Court as currently constructed will continue to apply a patent-limiting approach to these types of questions. It is equally evident that the Court is not inclined to make sweeping pronouncements or establish bright-line tests on patenting matters, preferring to take a case-by-case approach to developments in this area and to restrict the Federal Circuit when it strays from this path.
Opinion concurring in the judgment by Justice Breyer, joined in part by Justice Scalia.
Infringement of U.S. Patent No. RE37,314 ("Pyrimidine Derivatives," issued August 7, 2001) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of AstraZeneca's Crestor® (rosuvastatin calcium, used to treat high cholesterol). View the complaint here.
Pfizer Inc. et al. v. Mylan Inc. et al.
• Plaintiffs: Pfizer Inc.; Pharmacia & Upjohn Co.; Pharmacia & Upjohn Company LLC; Sugen, Inc.; C.P. Pharmaceuticals International C.V.
• Defendants: Mylan Inc.; Mylan Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 6,573,293 ("Pyrrole Substituted 2-Indolinone Protein Kinase Inhibitors," issued June 3, 2003), 7,125,905 (same title, issued October 24, 2006), and 7,211,600 ("Methods of Modulating c-kit Tyrosine Protein Kinase Function with Indolinone Compounds," issued May 1, 2007) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Pfizer's Sutent® (sunitinib malate, used to treat gastrointestinal stromal tumor and advanced renal cell carcinoma). View the complaint here.
Abbott Laboratories et al. v. Sandoz Inc.
Infringement of U.S. Patent Nos. U.S. Patent Nos. 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002), and 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia). View the complaint here.
Schering Corporation et al. v. Mylan Pharmaceuticals Inc. et al.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.
Infringement of U.S. Patent Nos. RE37,721 ("Hydroxy-substituted Azetidinone Compounds Useful as Hypocholesterolemic Agents," issued May 8, 2002) and 5,846,966 ("Combinations of Hydroxy-Substituted Azetidinone Compounds and HMG CoA Reductase Inhibitors," issued December 8, 1998) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Plaintiffs' Zetia® (ezetimib, used to treat elevated cholesterol levels). View the complaint here.
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices.
• Medical device essentials: Premarket and post-market requirements.
A complete brochure for this conference, including an agenda, list of speakers, and registration form can be obtained here.
The registration fee for this conference is $2,195. Those registering on or before July 23, 2010 will receive a $200 discount. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of ACI's FDA Boot Camp conference.
• Meeting the enablement and written description requirements.
The registration fee for the audioconference is $197 ($247 for registration and CLE processing). Those interested in registering for the audioconference, can do so here or by calling 239-263-0605.
• IP Counsel “Pow-Wow” – What Keeps Them Up at Night?
• Identifying and Conveying the Evidence of Fraud in Patent Cases.
On Saturday, August 7th, Hon. Randall R. Rader of the U.S. Court of Appeals for the Federal Circuit will be the keynote speaker at the ABA IPL section luncheon. A schedule of programs and events being offered by the Section of Intellectual Property Law at the ABA Annual Meeting can be found here. The registration fee for individual CLE programs ranges from $35 for government lawyers and judges to $75 for all other attendees. An All-Access CLE Badge ranges from for $75 (law school member) to $875 (non-ABA members). Additional information regarding registration fees can be found in the ABA IPL section program schedule or the ABA Registration Information booklet. Those interested in registering for the Annual Meeting can do so here.
Practising Law Institute (PLI) will be holding a two-day seminar entitled: "Advanced Patent Prosecution Workshop 2010: Claim Drafting & Amendment Writing" on July 26-27, 2010 in New York, NY and on August 16-17, 2010 in San Francisco, CA.
• Roundtable Discussions and Wrap Up.
• Amendment Workshops -- class to split into technology groups, including biology/chemistry group.
A complete program schedule, including descriptions of the presentations and a list of speakers, for the New York seminar can be found here, and a program schedule and list of speakers for the San Francisco seminar can be found here.
The registration fee for the conference is $1,595. Those interested in registering for the conference can do so here (New York) or here (San Francisco).
Graceway Pharmaceuticals' suit against Nycomed alleging infringement of a patent for skin lesion treatment Aldara continues to move forward, after a ruling denied both defendant Nycomed's motion for dismissal and plaintiff Graceway's motion for a preliminary injunction.
Graceway filed suit in February, alleging that Nycomed's generic Aldara drug infringes Graceway's U.S. Patent No. 7,655,672, which covers Aldara (see "Court Report," February 28, 2010). The complaint also named Perrigo Co. as a defendant, but Perrigo settled with Graceway in April and became the authorized generic distributor for Aldara. Recently, in March, Graceway's motion for a temporary restraining order against Nycomed was denied.
On June 10, Judge William Martini of the U.S. District Court for the District of New Jersey rejected Nycomed's argument for dismissal due to Graceway's failure to perform a pre-filing infringement investigation of Nycomed's product. The judge found that while Graceway did not obtain a sample of Nycomed's allegedly infringing product before filing suit in February, it did engage in other investigations, including testing generic formulations similar to Nycomed's. The judge found that this was enough to support a conclusion that Nycomed's product was substantially the same, and thus protected by the patent.
In a separate order issued that same day, Judge Martini rejected Graceway's motion for a preliminary injunction. The judge found that Graceway had not established a likelihood of success on the merits because Nycomed has raised a substantial question regarding the validity of the patent due to obviousness, and that Graceway had not made a sufficient showing of irreparable harm.
Judge Martini's order denying Nycomed' dismissal can be found here.
Judge Martini's order denying Graceway's preliminary injunction can be found here.
Infosint SA's $15 million infringement verdict against defendants H. Lundbeck A/S and Forest Laboratories Inc. in the Lexapro dispute has been overturned, following a ruling that the patent related to the antidepressant drug's manufacture was invalid.
Infosint sued Lundbeck and Forest in 2006, claiming the processes Lundbeck uses to make their generic Lexapro infringe U.S. Patent No. 6,458,973, which covers an improved process for making 5-carboxyphthalide. Lundbeck and Forest contended the patent was invalid because it was anticipated by the prior art and obvious. The defendants also said a number of the '973 patent claims interfered with claim 1 of Lundbeck's U.S. Patent No. 6,403,813. However, in June 2009, the District Court invalidated claim 1 of the '813 patent because it found that the company had suppressed its invention. The case went to trial in 2009, and in October, a jury found for Infosint, awarding the company $15 million as a reasonable royalty (see "Biotech/Pharma Docket," October 21, 2009). However, both sides were disappointed by the verdict and moved for judgment as a matter of law.
On June 17, Judge Lewis Kaplan of the U.S. District Court for the Southern District of New York granted the defendants judgment as a matter of law, finding Infosint's '973 patent invalid for obviousness. Judge Kaplan rejected Infosint's arguments for nonobviousness as being unpersuasive, and ruled that the method in the '973 patent was merely an obvious optimization. The judge was not convinced that any of the improvements claimed, including temperature optimization and the use of a specific reactor type, would have been beyond someone with ordinary skill in the art. Consequently, Judge Kaplan declared the '973 patent invalid, and granted the defendant's motion for judgment as a matter of law. Judge Kaplan also denied Infosint's motion to increase the $15 million reasonable royalty award to $43 million by adding additional damages and interest.
Judge Kaplan's order can be found here.
GlaxoSmithKline PLC, Mitsubishi Chemical Corp. and Encysive Pharmaceuticals Inc. enjoyed a victory in their patent infringement battle with Barr Laboratories over the anti-blood-clotting drug Argatroban, after a ruling that rejected Barr's claims of patent invalidity and enjoined Barr from producing a generic version of the drug until after the Argatroban patent has expired.
Encysive holds the approved NDA for Argatroban and has licensed the North American marketing rights for the drug to GlaxoSmithKline. Mitsubishi Chemical holds U.S. Patent No. 5,214,052, issued in May 1993, which covers use of Argatroban to treat thrombocytopenia induced by the blood thinner Heparin. The plaintiffs launched their suit on December 28, 2007 after Barr submitted an ANDA for generic Argatroban injections with the FDA in September of that year. In response to the complaint, Barr argued that the '052 patent was invalid, unenforceable, and would not be infringed by its manufacture and sale of a generic version of the drug.
On June 16, Judge John Koeltl of the U.S. District Court for the Southern District of New York issued his findings of fact and conclusions of law, ruling that the '056 patent is valid. Barr's argued that several prior art references, including a 1986 article written by a Mitsubishi employee on the results of a preclinical study of Argatroban, anticipated the claims of the patent and rendered the drug's formula obvious. Judge Koeltl rejected this argument, determining that the Mitsubishi article and other prior art did not enable a person skilled in the art of pharmaceuticals to produce the drug. He also relied on evidence of failed attempts by others to develop Argatroban to support his finding that the '052 patent was not obvious. Finally, the judge enjoined Barr from producing a generic version of the drug until after June 30, 2014 when the '052 patent expires.
Judge Koeltl's (156 page) order can be found here.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a third-year law student at the Northwestern University School of Law. Dr. DeGiulio was a member of MBHB's 2009 class of summer associates, and he can be contacted at degiulio@mbhb.com.
a) The industrial application requirement for patentability was modified to include a need to demonstrate the possibility of "practical utility" of the invention, and to fully support such utility in the written description.
b) In a period of six months after the publication of the patent application, information related to patentability of an invention can be filed before the Mexican Patent Office (IMPI) by any third party. If filed, the information may be considered at the Examiner's discretion and it will not suspend the application process. The person filing the information will not be considered a party to the application, and will not have access to the patent file, nor immediate legal standing to challenge a granted patent, as was intended in the initial project of reform.
c) After a patent is granted, any third party can inform IMPI of causes of invalidity. The authority may consider such information discretionally to initiate an ex officio cancellation proceeding.
d) A provision is added defining the act of attempting an infringement action when a previous request for infringement has been denied, referring to the same patent. This provision is not very clear and it is likely to cause controversy in the future.
e) According to the Mexican IP Law, injunctions can be imposed during the course of a patent infringement action, and the title holder will have to post a bond in order to secure possible damages arising from those injunctions, if the infringement is denied. Likewise, the injunctions can be immediately lifted if the alleged infringer files a counterbond in favour of the plaintiff. A paragraph has been added to the corresponding article, indicating that the amount of the counterbond will have to be 40% higher than the amount of the bond.
It is noteworthy that the original project of reform was promoted by National Association of Drug Manufacturers (ANAFAM), the member companies of which participate mostly in the generic drugs market.
This initial project included, among other issues, two separate pre and post grant opposition proceedings, which would practically delay the granting and therefore the possibility for effective enforcement of patent rights. The project also intended to include additional causes of invalidity related the use of patent rights in activities in violation of the Federal Competition Law.
This project was reviewed (and modified) by the Senate, which determined that the majority of the amendments proposed were unnecessary, including the two issues mentioned above. The final project was ratified by the Chamber of Deputies, without further modification, and will come into force on September 20, 2010.
Juan Serrano is a Mexican Attorney with a Master of Laws Degree from the University of Toronto. He can be contacted at jls@olivares.com.mx.
Our opinions are always (perhaps inevitably) informed by our experience. And when our experience is limited, particularly when those limitations are coupled with passion, those limitations equally inform our opinions.
An issued patent is property just like a piece of land or a house (citing Consolidated Fruit-Jar Co. v. Wright, 84 U.S. 92, 96 (1872) and Patlex Corp. v. Mossinghoff, 758 F.2d 594, 599 (Fed. Cir. 1985)). When a federal judicial decision dramatically changes the law, such that a valid patent becomes invalid, has the federal government taken private property in violation of the federal Constitution? Application of the Fifth Amendment is not clearly limited to legislative and executive action; nothing in its text bars extension of the takings clause to judicial action.
Her prescription to "justly compensate" private companies for the takings effects of judicial decisions and the Hatch-Waxman Act was to increase the term of data exclusivity under Hatch-Waxman from 5 to 14 years, and to give appellate courts discretion to have a decision have prospective effect only, should it overrule prior interpretation of patent law. She professed the belief that these changes would "substantially increase the number of drugs in the R&D pipeline, which would greatly benefit patients and ultimately benefit generic drug companies."
They also cite the benefits of generic drugs facilitated by the Hatch-Waxman regime since 1984, correctly citing statistics showing the percentage of prescribed drugs that are generic and the reduced prices charged for them. However, their statement that "Hatch-Waxman has been preserving the precarious balance between public welfare and industry incentive for drug innovation by providing affordable medicine" is a sentiment (or maybe a belief) unsupported by evidence cited or otherwise (perhaps they thought it was self-evident).
In her response (also published in the June 11th issue of Science), Ms. Knowles, now a private consultant, cites several studies contradicting the assertions in the medical students' letter. These include a National Academies study that recommends an increase in the exclusivity period (from 5 years to 12-14 years) under the Hatch-Waxman Act, based on more recent assessments of "the complexity and length of drug development today" and a Congressional Budget Office study showing that the number of new molecular entities by innovator drug companies "spiked in the mid- to late 1990's and have been decreasing since 2000."She points out that the Public Citizen study was not peer-reviewed and would predict outcomes not reported in any study of the pharmaceutical industry, and notes analytical deficiencies in the Kaiser Family Foundation study. She also cites economic statistics that contradict the Kaiser study, including that "the share prices of many of the largest global pharmaceutical companies have declined dramatically" since 2000, some by as much as 60%, and attributes much of this decline to the effects of generic competition on investment in new drugs. She rebuts the argument that governments and non-profits fund "the majority of research" on drug development with another CBO study. Finally, with regard to reverse payment agreements, she cites the facts: that since 2004 every settlement agreement must be filed with the Federal Trade Commission, and that of the 152 settlements only a "very small number" of these have been challenged by the FTC (and that the government has lost more of these challenges than it has won).
Earlier this year, as a medical student at Duke University, I saw a patient with Crohn's disease, an inflammatory intestinal disease associated with substantial disability and mortality that affects more than 500,000 individuals nationwide. This patient required hospitalization for a flare that she attributed to not being able to afford the month's Humira, a biologic medicine used to treat severe, active Crohn's disease.
The drug is priced by Abbott Laboratories at a staggering $22,000 a year. This patient would clearly have benefited from the availability of an affordable, generic version.
This is their experience, seeing firsthand the consequences of the dysfunctional U.S. medical system that lets private insurance companies rather than doctors determine who gets care and how much they can afford. This experience is not the same as understanding how such medicines actually get developed, the subject of Ms. Knowles' piece. It is unfortunate that the politics of medical care provides an incentive for individuals providing care to oppose individuals providing the new drugs that improve our ability to treat and cure patients (which should be the goal for all of us). But acting on the incentive to demonize biotech and pharmaceutical companies is self-defeating. Generic drug companies, for all their benefits, do not invest the time and resources to produce any new drugs; without innovator biotechnology and pharmaceutical companies, generic drug makers would have nothing to copy or sell. It would be well for the medical students and others on their side of the debate to consider where novel therapies will come from without companies with experience in obtaining (and financing) regulatory approval of such drugs, protecting them with patents, and having the business resources to bring such drugs to market. It is certainly the case that these companies are for-profit (it's capitalism, after all), but the costs of R&D and regulatory approval, as well as scale-up, production, and distribution are realities that cannot be ignored. That is where experience, specific experience with drug development, is invaluable. Frankly, it is precisely this experience that the medical students lack.
Last month, in addition to Photocure ASA v. Kappos and Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., the Federal Circuit completed the hat trick of patent term extension cases with Wyeth Holdings Corp. v. Sebelius. In this case, the Court affirmed the statutory construction decision of the U.S. District Court for the District of Columbia regarding when the testing phase ends and the approval phase begins for particular New Animal Drug Applications (NADA).
For those not completely familiar with the patent term extension scheme, despite the rash of PTE cases at the Federal Circuit, 35 U.S.C. § 156 provides that a patent holder can obtain an extension of patent term due to the potentially lengthy regulatory process that is equal to one half of the "testing phase" and the entire "approval phase." 35 U.S.C. § 156(c). This extension is limited to five years, however. 35 U.S.C. § 156(g)(6)(A). The present case involved an application for a new animal drug (as opposed to a drug for use in humans). Normally, for animal drugs, the "testing phase" begins when the sponsor submits to the FDA an Investigational New Animal Drug ("INAD"), and the "approval phase" begins when a New Animal Drug Application ("NADA") is filed with the FDA. However, the FDA introduced a "phased review" program available only for animal drugs. In phased review, the sponsor can submit various technical sections before submitting the entire NADA. After the FDA completes review of each of these sections, it sends a "complete letter" to the sponsor. All of the complete letters can be combined with some additional administrative information in what is termed an "administrative NADA." The goal of phased review is to create a stream-lined process and speed the drug development process. Moreover, a sponsor is able to switch to the traditional NADA at any point during the process and still incorporate by reference any of the complete letters received. And, similar to the traditional NADA application, the FDA marks the beginning of the approval phase as the date the sponsor submits the administrative NADA.
Wyeth sought FDA approval to market Cydectin for the treatment and control of internal and external parasites in beef and dairy cattle. Wyeth opted to use the phased review procedure, and after it filed its administrative NADA, the FDA approved the Cydectin 16 days later. Wyeth then sought patent term extension of U.S. Patent No. 4,916,154. However, Wyeth believed that the approval phase should begin on the date that the first technical section was submitted, not the date that the administrative NADA was filed. Wyeth asserted that this was the point at which agency review could be commenced. The FDA maintained its position that the approval phase does not commence until the marketing application was complete, including all technical sections and the complete letters. Because it did not receive the full term that it thought it deserved, Wyeth filed a complaint in the district court. However, the District Court entered judgment in favor of the FDA.
(4) (A) In the case of a product which is a new animal drug, the term means the period described in subparagraph (B) to which the limitation described in paragraph (6) applies.
(emphasis added). The issue was whether Congress intended "initially submitted" to apply to the administrative NADA or the individual technical sections. The District Court found, and the Federal Circuit agreed, that Congress did not define "application," nor did it define "initially submitted." Therefore, for the purposes of the administrative NADA, Congress was ambiguous as to the interpretation of 35 U.S.C. § 156(g).
The second step in a Chevron analysis is to determine whether the agency's interpretation is based on a permissible construction. In its analysis, the Federal Circuit provided an Administrative Law lesson by explaining that it does not matter whether Wyeth's construction is reasonable -- the only relevant consideration is the FDA's interpretation. And the Court found that the FDA's interpretation was, indeed, permissible. Section 156(g) did not define "application." The FDA's interpretation tracked the requirements of 21 U.S.C. § 360b(b) -- the section of the statute that provides the requirements for a new animal drug application, such as information on drug safety, efficacy, and manufacturing. As the administrative NADA is the first document to contain all of these parts, it is reasonable to interpret this date as the "initially submitted" date. Besides, the Federal Circuit noted that this was a trade-off for a more fluid review process, and in so doing, rejected Wyeth's assertion that the new FDA process upset the balance established between the interests of the pioneer and generic drug manufacturers.
Wyeth also argued that the FDA was acting in an arbitrary and capricious manner because the implementation of the phased review program was inconsistent with the "fast track" program available for human drugs. However, the Federal Circuit pointed out that the two programs differed in many respects. Nevertheless, for a fast track application, the approval phase does not begin until the sponsor submits all of the required information. As a result, the Court found no inconsistencies between these two programs.