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Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,” which have the potential to further delay and discourage market entry in the context of drug-device combination products.
Combination products are defined by the U.S. Food and Drug Administration (FDA) to include therapeutic products that combine a drug with a device, such as an inhaler or injector pen. These products can sometimes offer life-changing or life-sustaining treatment, as with naloxone (Narcan) for opioid overdose or epinephrine (EpiPen) for severe allergic reactions. In recent years, these and other similar products have been the subject of substantial controversy related to their prices and prolonged lack of generic competition.
I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016.
Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being a native German, living in Sweden and commuting every week over the bridge to Copenhagen in Denmark – most recently with thousands of terrified refugees and border controls on the way back to Sweden – this year has left me with much astonishment and concern about the state of the European Union and our global situation. It appears to me as if the EU and other global leaders have focused far too much on tiny technicalities, while leaving the bigger issues untouched and disregarding crucial lessons of history. There are so many things that we must learn from 2015’s terrible events and alarming decisions, but also from the hope-giving agreements, incidents and initiatives. For me one of the most important take-aways is that everything is connected and that sustainable, realistic solutions not only require immediate actions. In my view, we need to think about long-term strategies both in more detail and from a bigger perspective. Due to the complexity of our most pressing problems this is a colossal task. It demands more knowledge, better communications, more collaboration and a more effective coordination of the considerable skills and different competences that are already out there.
In one view, payment caps are needed to “prevent coercion and exploitation in the egg-donation process.” But one also can view the guidelines as an “illegal conspiracy to set prices in violation of antitrust laws.” More to come in a case that could go to trial next year.
Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?
Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.
This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.
Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.
Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit.
The suit concerns Actavis’ attempt to extend monopoly protection for its drug Namenda. Namenda is one of only a few FDA approved drugs to treat Alzheimer’s disease, and the only approved drug in a class of medications that act on the glutamatergic system by blocking NMDA receptors. Namenda is also Actavis’ largest revenue generating drug; it brought in $1.5 billion in sales last year. Unfortunately for Actavis, Namenda’s patent protection is due to expire in 2015. Once the patent protection for Namenda has expired, Actavis should ordinarily expect to see a dramatic reduction in sales revenue, as much as 90% in the first year, as consumers switch to a lower-cost generic version.
Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct? The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.
Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case. He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here. Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.
In 2013 the U.S. Supreme Court issued two important rulings in cases involving the marketing of generic drugs. In Federal Trade Commission v. Actavis, the Court addressed the law governing a controversial pharmaceutical marketing practice known as reverse payment agreements, or pay for delay – a byproduct of the Hatch-Waxman Act. This occurs when a generic drug company identifies a vulnerable patent held by a brand-name drug manufacturer and seeks Food and Drug Administration (FDA) approval for a generic version before the patent expires, provoking a lawsuit by the brand-name company for alleged infringement. A subsequent settlement involves the brand-name company paying the generic company to delay commercialization of its product (but not beyond the expiration of the patent). The FDA alleged that reverse payment agreements violate antitrust laws. The Supreme Court held that their validity would be evaluated on a case-by-case basis using the “rule of reason” standard. According to this standard, only those agreements that restrain trade will be viewed as violations of anti-trust law.
In the second case, Mutual Pharmaceutical v. Bartlett, the Court affirmed its 2011 ruling in Mensing v. PLIVA and held that generics manufacturers are substantially immune from civil claims regarding injuries caused by their products whether the tort claim be based upon failure to warn (Mensing) or design defect (Bartlett). The basis of the decision resides in the FDA requirement that generic drug labels be consistent with the label of the brand-name equivalent. Just days after the Bartlett decision issued, the FDA indicated its intent to propose a revision to the labeling requirements for generic drugs to create parity with branded drugs. If adopted, this revision could vitiate the law set forth in Mensing and Bartlett.
For more coverage of these cases, see the New England Journal of Medicine essay here.
Amidst all the news about various Supreme Court decisions there is one that ought not be overlooked for its impact both on public health and healthcare reform—FTC v. Actavis. Today the Court decided, by a vote of five to three, that Big Pharma companies can be sued over deals with generic companies to not bring generic drugs to market. In so deciding, the Court endorsed the idea that Big Pharma companies with weak patents on their drugs may not pay off other companies that want to make cheaper generic versions to not do so. This practice, known as pay-for-delay, has run rampant in the pharmaceutical industry over the last two decades costing American consumers billions and restricting access to cheaper versions of drugs.
In FTC v. Actavis, the Federal Trade Commission had alleged a pay-for-delay arrangement between Solvay Pharmaceuticals and Actavis that was intended to keep Actavis from producing a generic version of Solvay’s blockbuster AndroGel testosterone drug. A lower court—the Eleventh Circuit Court of Appeals—dismissed the FTC’s complaint. Now the Supreme Court has reversed that dismissal.

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