AbbVie and Teva USA recently got slapped with an antitrust class action suit regarding an old Hatch-Waxman reverse payment settlement agreement between Barr Pharmaceuticals, Inc. (“Barr”) and Kos Pharmaceuticals Inc., (“Kos”) regarding Niaspan®, the most effective drug on the market for raising a person’s “good” HDL cholesterol. According to the Complaint, the two companies entered into an alleged “Market Allocation Agreement,” in order to extend Kos’ Niaspan® monopoly. Unless the Supreme Court affirms the Eleventh Circuit’s “scope of the patent” test in Federal Trade Comm’n v. Actavis Inc., et al, (formerly captioned Federal Trade Comm’n v. Watson Pharmaceuticals, Inc., et al.) you can bet that an avalanche of similar antitrust class action suits will follow. [Read more...]
Niapsan Antitrust Suit Underscore High Stakes in Supreme Court Pay-for-Delay Decision
Government One-Two Punches Novartis and Exposes Dangers of Speaker Programs
Late last month, the Government stung Novartis with separate False Claims Act (FCA) suits only days apart. On April 23rd, the Government charged that Novartis paid kickbacks to numerous pharmacies in the form of discounts and rebates in order to induce the pharmacies to switch kidney transplant patients to Novartis’ Myfortic® from rival branded and generic drugs. And while that case presents a good blog topic in its own right, it is the Government’s second case that should really make everyone stand up and take notice. In the April 26th FCA Complaint, the Government reveals that Novartis spent $65 million on 38,000 speaker programs from 2002 through 2011 in support of sales for the hypertension drugs Lotrel® and Valturna®, and the diabetes drug Starlix® and has charged that the Company’s Speaker Programs were essentially nothing but kickbacks, providing little or no educational value. The problem is that much of what happened at Novartis has happened (and may well continue to happen) elsewhere. [Read more...]
Amphastar’s Qui Tam Suit Against Aventis Shows Importance of Patents
In a recent ground-breaking qui tam ruling, a California federal court denied Aventis Pharma’s (a division of Sanofi-Aventis) efforts to dismiss costly and embarrassing False Claims Act (FCA) allegations brought by “whistleblower” and generic rival Amphastar Pharmaceuticals. In its qui tam suit, Amphastar alleged that Aventis overcharged the Government by inflating prices of enoxaparin, more commonly known as Lovenox®, based on an “inequitable conduct” patent ruling from several years ago. Although Amphastar’s suit may have been motivated by financial gain, vindictiveness or both, its theory that FCA liability can be predicated on branded drug sales where the drug’s underlying patent(s) have been invalidated is worrisome and could signal a new line of attack for a relator’s bar hungry for new avenues into big pharma’s deep pockets. [Read more...]
U.K. Jumps on “Pay-to-Delay” Bandwagon
The U.K. Office of Fair Trading (“OFT”) jumped on the ”pay-to-delay” bandwagon last week when it issued a “Statement of Objections,” indicating a potential future adverse decision against GlaxoSmithKline (“GSK”) and several generic rivals under the U.K. Competition Act of 1998 in connection with previous patent litigation settlements. As part of the settlements, GSK made “reverse payments” to the generic companies, which agreed to a delayed entry of generic paroxetine (also known as Seroxat and Paxil) into the U.K. market. The U.K.’s actions only increases the stakes for branded and generic drug manufacturers awaiting the Supreme Court’s decision (expected in June) on the legality of reverse payment patent litigation settlements under the U.S. antitrust laws. [Read more...]
First Circuit Slams Pfizer in Three Neurontin RICO Suits; Affirms $142 Million Verdict
Pfizer, Inc., must pay a $142 million jury verdict to Kaiser Foundation Health Plan, Inc. (“Kaiser”) for “damages” related to the off-label promotion of Neurontin®, the First Circuit ruled last week. Unfortunately, for Pfizer and other companies that have pleaded guilty to misbranding violations based on off-label promotion, the First Circuit’s ruling could spell even more trouble ahead. [Read more...]
Generics Demand Brand Drug Samples for ANDA Filings
Tensions between branded pharma companies and their generic competitors are boiling over into court battles over the “right” of generics to demand, and the “right” of branded manufacturers to withhold, brand drug samples for generic bioequivalence testing, a precursor to an ANDA filing. Free-market principles, antitrust law and the intent of the Hatch-Waxman Act are at the heart of litigation between Swiss drug manufacturer Actelion Pharmaceuticals and generic drug producers Apotex Inc. and Roxane Laboratories and a recently filed suit involving generic Accord Healthcare and branded Acorda Therapeutics. The key questions posed in both cases is whether and to what extent can a branded drug company be forced to sell products to a generic competitor? [Read more...]
The Importance of Keeping (Trade) Secrets
Plans by Gilead Sciences to hire a Field Medical Associate Director from Vertex Pharmaceuticals in anticipation of highly competitive battle in the hepatitis C market turned into a court brawl last week when Vertex filed a trade secrets lawsuit against Gilead. [Read more...]
Pay for Delay and Drug Design Defect Cases Take Center Stage at Supreme Court
While the NCAA “March Madness” Tournament is always the lead sports story this time of year – did anybody out there watch Florida Gulf Coast College over the weekend?! –March can also provide a madness of sorts for high-profile Supreme Court arguments. Last March, the Supreme Court set aside an unprecedented number of days for lengthy arguments over the constitutionality of President Obama’s Affordable Care Act. Although this year the mainstream media will be focusing on the arguments regarding the constitutionality of California’s Proposition 8 and the Defense of Marriage Act (regarding gay marriage), two significant cases with far-reaching consequences for the branded and generic drug industries were also argued this month. How the Supreme Court rules on so-called “pay for delay” settlements in patent infringement litigations and a First Circuit decision holding that generic drug makers can be held liable for personal injuries on a “design defect” theory, even if federal preemption would bar an identical suit on a “failure to warn” theory, should decide the course for much drug industry litigation for years to come. [Read more...]
More Trouble Ahead for Diabetes Drug Makers
The pressure on Merck, Bristol-Myers Squibb (BMS) and other manufacturers of incretin mimetic drugs used to treat type 2 diabetes appears to be increasing both from the FDA and plaintiff’s lawyers specializing in products liability and mass tort litigation. Unpublished research results are behind a recent FDA Drug Safety Communication relating to incretin mimetic drugs and the FDA is collecting information on how this class of drugs might contribute to inflammation of the pancreas as well as pre-cancerous conditions (known as pancreatic duct metaplasia) in patients with type 2 diabetes. After several years of tighter label warnings and published reports of pancreatitis and pancreatic cancer in patients taking Januvia (Merck), Byetta (Amylin/BMS) and Victoza (Novo Nordisc), the number of lawsuits and lawyers trolling for clients on the web are proliferating. [Read more...]
Navigating FDA Guidance on Facebook and Social Media
The FDA recently warned AMARC Enterprises, Inc., a California-based dietary supplement company, that its Facebook page (https://www.facebook.com/poly.mva) was not in compliance with FDA guidelines. Poly MVA, the AMARC brand name used on Facebook, inappropriately “liked” a consumer testimonial, the FDA’s December, 2012 warning letter noted. The consumer post read, in part, “Poly MVA … enabled me to keep cancer at bay without the use of chemo and radiation.” The agency further criticized a May, 2010 Facebook posting that offered information on how supplement ingredients, “… can nutritionally support the body during cancer and cancer therapy.” Criticism of Poly MVA’s use of social media comes at the end of a long list of other FDA violations, all revolving around failure to comply with various aspects of the Federal Food, Drug, and Cosmetic Act (FDCA). [Read more...]
