Justia Drugs & Biotech Opinion Summaries

LAB’s 903 patent claims a method of “arresting or regressing” penile fibrosis, which can result in erectile dysfunction and penile deformation, by the long-term, daily administration of type 5 phosphodiesterase (PDE5) inhibitors. At Eli Lilly’s request, the Patent Trial and Appeal Board conducted inter partes review. The patent claimed priority from a 2002 Provisional Application. The Board first rejected LAB’s argument for the earlier priority date, finding that the specification of the provisional application did not disclose the dosage limitation, then construed: “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis”; “arresting or regressing the at least one of the penile tunical fibrosis and corporal tissue fibrosis”; and “continuous long-term regimen.” The Board concluded that the claim limitation requiring the delivery of a dosage of up to 1.5 mg/kg/day for at least 45 days “would meet the claim requirement of a continuous, long-term regimen,” and that the combination of three prior references rendered the claims unpatentable as obvious. The Federal Circuit vacated, finding two claim constructions erroneous and that the Board did not make factual findings as to whether there was an apparent reason to combine the references to treat penile fibrosis and whether a person of skill in the art would have had a reasonable expectation of success from such a combination. View "Los Angeles Biomedical Research Institute v. Eli Lilly & Co." on Justia Law

Shire sued Watson for infringing the 720 patent by filing an Abbreviated New Drug Application (ANDA) with the FDA seeking to market a generic version of Shire’s drug, LIALDA®. The patent is directed to a controlled-release oral pharmaceutical composition of mesalamine used to treat inflammatory bowel diseases. The district court rejected Watson’s invalidity arguments that the patent lacked written description and enablement, and held that Watson infringed two claims. On appeal, and again after remand from the Supreme Court, the Federal Circuit stated that the matrix compositions are “limited by the Markush groups” added during prosecution “to overcome the examiner’s rejection of the claims as obvious” and that “the correct construction requires that the inner volume contain substances from the group described for the inner lipophilic matrix (which are all lipophilic substances), and that the outer volume separately contain substances from the group described for the outer hydrophilic matrix (which are all hydrophilic).” On remand, the district court concluded that Watson’s ANDA Product satisfied the “inner lipophilic matrix” and “outer hydrophilic matrix” limitations and satisfied the Markush limitations because the excipients falling outside the respective Markush groups were “unrelated” to the invention since they did not drive the water-affinity property of their respective matrices. The Federal Circuit reversed and remanded with instructions to enter judgment of non-infringement. Watson’s ANDA Product does not satisfy the Markush group requirements. View "Shire Development, LLC v. Watson Pharmaceuticals, Inc." on Justia Law

Plaintiffs filed a class action alleging that Takeda prevented competitors from timely marketing a generic version of Takeda’s diabetes drug ACTOS by falsely describing two patents to the FDA. Plaintiffs claimed that these false patent descriptions channeled Takeda’s competitors into a generic drug approval process that granted the first-filing applicants a 180-day exclusivity period, which in turn acted as a 180-day "bottleneck" to all later-filing applicants. 9 out of 10 generic applicants took that route. Teva was prevented from seeking approval via another regulatory mechanism when the FDA announced that all generic manufacturers would be required to take the bottlenecked route. Plaintiffs alleged that they were wrongfully obligated to pay monopoly prices for ACTOS when Takeda's patent on the active ingredient in ACTOS expired when the mass of generic market entry occurred. The district court dismissed plaintiffs' antitrust claims. The court affirmed to the extent that plaintiffs' theory posits a delay in the marketing of generic alternatives to ACTOS by all the generic applicants other than Teva, because plaintiffs' theory presupposes that these applicants were aware of Takeda’s allegedly false patent descriptions when they filed their applications, which is not supported by well-pleaded allegations. However, the court concluded that plaintiffs' theory as to Teva does not require any knowledge of the false patent descriptions. Therefore, the court reached other issues as to Teva and found plaintiffs plausibly alleged that Takeda delayed Teva's market entry. Accordingly, the court affirmed in part, vacated in part, and remanded for further proceedings. View "In re ACTOS End-Payor Antitrust Litigation" on Justia Law

In July 2003, plaintiff Andrew McCarrell filed a products-liability action alleging that Hoffmann-La Roche, Inc. (Roche) had failed to provide adequate warnings about the risks and side effects associated with taking Accutane. Plaintiff timely filed this products-liability action within New Jersey's statute of limitations, but Alabama's limitations period had expired by the time of the filing. The issue is which state's statute of limitations applied under New Jersey s choice-of-law jurisprudence. Roche moved for summary judgment, citing Alabama's two-year statute of limitations. The trial court denied the motion, finding that the governmental-interest test set forth in "Gantes v. Kason Corp.," (145 N.J.478 (1996)), directed that New Jersey's statute of limitations governed the case. The jury found in favor of McCarrell on the failure-to-warn claim, but the Appellate Division reversed based on evidentiary issues. The Appellate Division approved the trial court's application of New Jersey's statute of limitations to the case, however, and the Court denied Roche's petition for certification. After a new trial, a jury found Roche liable for failure to warn, awarding McCarrell $25,159,530. Roche challenged the verdict on the ground that the governmental-interest test had been supplanted by the most-significant-relationship test of sections 146, 145, and 6 of the Second Restatement of Conflicts of Law and argued that, under this test, Alabama's statute of limitations applied. The trial court denied the challenge as untimely. An appellate panel expressly declined to apply section 142 of the Second Restatement, vacated the jury's verdict and award, dismissed McCarrell's complaint as untimely, and did not reach the remaining issues raised by Roche on appeal. McCarrell's petition for certification was granted. The Supreme Court reversed and reinstated the jury's verdict and award. Analysis under section 142 of the Second Restatement lead to the conclusion that New Jersey's statute of limitations was properly applied to this action. The matter was remanded to the Appellate Division for consideration of unaddressed issues remaining on appeal. View "McCarrell v. Hoffmann-La Roche, Inc." on Justia Law

In 2009, Pfizer, settled claims that it had violated the False Claims Act (FCA), 31 U.S.C. 3729, and entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services. Months later, Booker and Hebron, former Pfizer sales representatives, brought a qui tam action, allegedly on behalf of the United States and several states, asserting that Pfizer had continued to violate the FCA and state analogues. They alleged that Pfizer had continued to knowingly induce third parties to file false claims for payment for Pfizer drugs with government programs like Medicaid by marketing the drug Geodon for off-label uses, in violation of 21 U.S.C. 301, and paying doctors kickbacks for prescribing the drugs Geodon and Pristiq, in violation of the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), (g). They also alleged that Pfizer had violated the FCA "reverse false claims" provision, 31 U.S.C. 3729(a)(1)(G), by failing to pay the government money owed it under Pfizer's Agreement with HHS, and that Pfizer had violated the FCA's anti-retaliation provision, by terminating Booker's employment. All of these claims were resolved against relators, one on a motion to dismiss and the rest on summary judgment. None of the sovereigns intervened. The First Circuit affirmed the merits decisions and found no error in its management of discovery. The court found relators’ data “woefully inadequate to support their FCA claim.” View "Booker v. Pfizer, Inc." on Justia Law

After Plaintiff gave birth to a son, she filed a complaint against Merck & Co., Inc. and the United States, alleging that a community health center physician negligently failed to insert into her arm an implant manufactured by Merck that was designed to prevent pregnancy as a result of Merck’s defective applicator. The federal court certified questions of state law to the Maine Supreme Judicial Court. The Court answered (1) the protection of Maine’s Wrongful Birth statute extends to Merck as a drug manufacturer and distributor; and (2) pursuant to the Wrongful Birth statute, Plaintiff may not recover any damages on her claims against either defendant because of the nature of the procedure she underwent. View "Doherty v. Merck & Co., Inc." on Justia Law

Cumberland Pharmaceuticals owns the 445 patent, which describes acetylcysteine compositions substantially free of chelating agents. It is listed in the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) as covering Cumberland’s chelating-agent-free formulation of Acetadote®, an intravenous antidote for overdoses of acetaminophen. When Mylan filed an abbreviated new drug application to market its own chelating-agent-free acetylcysteine formulation, Cumberland filed a patent-infringement action. Mylan stipulated to infringement but asserted invalidity based on derivation of the claimed invention from someone at the FDA and obviousness. The district court rejected both challenges, finding that Mylan proved neither that anyone at the FDA conceived of the claimed invention before the named inventor nor that there was a reasonable expectation that the claimed formulations, without any chelating agents, would succeed. The Federal Circuit affirmed. Mylan offered evidence that there is no need to chelate trace metal ions because degradation may be effectively avoided by an inert vial atmosphere together with modern manufacturing practices that leave very low levels of metal contaminants, but the evidence did not establish that relevant skilled artisans would have reasonably expected success for those reasons in 2005. The district court had sufficient evidence to find otherwise. View "Cumberland Pharmaceuticals, Inc. v. Mylan Institutional LLC" on Justia Law

Eli Lilly’s 209 patent, issued in 2010, relates to methods of administering the chemotherapy drug pemetrexed disodium after pretreatment with common vitamins—folic acid and vitamin B12. Pemetrexed is an antifolate that kills cancer cells by inhibiting the function of folates, a class of nutrients necessary for cell reproduction. The vitamin pretreatments reduce the toxicity of pemetrexed. Eli Lilly markets pemetrexed under the brand name ALIMTA®, and the drug is used to treat certain types of lung cancer and mesothelioma. Around 2008–2009, Defendants notified Eli Lilly that they had submitted Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of ALIMTA®. After the 209 patent issued, Defendants filed Paragraph IV certifications under 21 U.S.C. 355(j)(2)(A)(vii)(IV), declaring that the 209 patent was invalid, unenforceable, or would not be infringed. Eli Lilly filed suit for infringement under 35 U.S.C. 271(e)(2). The district court found and the Federal Circuit affirmed that, while no single actor performs all steps of the asserted claims because the actions of both physicians and patients are required, under Akamai Technologies (Fed. Cir. 2015), there was direct infringement attributable to physicians. Defendants are liable for inducing that infringement. The court asserted claims were not invalid for indefiniteness, obviousness, or obviousness-type double patenting. View "Eli Lilly and Co. v. Teva Parenteral Medicines, Inc." on Justia Law

The 856 patent generally relates to “huMab4D5 ANTI-ErbB2 antibody-maytansinoid conjugates.” The claimed methods of treatment purport to combat a variety of cancers. ImmunoGen provided Genentech with a “worldwide exclusive license,” which Genentech uses to produce the drug Kadcyla®TM. Phigenix, “a for-profit discovery stage biotechnology, pharmaceutical, and biomedical research company” that focuses “on the use of novel molecular therapeutics” designed to fight cancer, sought inter partes review. The Patent Board found the asserted claims of the 856 patent nonobvious. The Federal Circuit dismissed an appeal for lack of standing, finding that Phigenix has not offered sufficient proof establishing that it has suffered an injury in fact. Phigenix does not contend that it faces risk of infringing the 856 patent, that it is an actual or prospective licensee of the patent, or that it otherwise plans to take any action that would implicate the patent. Phigenix only claimed that it has suffered an actual economic injury because the 856 patent increases competition between itself and ImmunoGen; “‘[i]ncreased competition represents a cognizable Article III injury,’” View "Phigenix, Inc. v. Immunogen, Inc." on Justia Law

Ethicon’s 844 patent relates to intraluminal medical devices for the local delivery of drugs, e.g., drug-eluting stents, and methods for maintaining drugs on those devices. Angioplasty can be used to alleviate blockages of blood vessels, but expansion of the balloon catheter during angioplasty can result in injury to the smooth muscle cells within the vessel wall, which can lead to restenosis, the gradual re-closure of the vessel. The 844 patent teaches that stent coatings themselves, and stent coatings delivering drugs locally, may be capable of reducing restenosis. Following inter partes reexamination, the Patent Trial and Appeal Board affirmed the examiner’s rejection of several claims as obvious. The Federal Circuit affirmed. Substantial evidence supports the Board’s factual findings that the claimed invention is merely the simple substitution of a coating known to be useful in in vivo applications, including stents, in a weight ratio known to provide a good balance between strength and elasticity, for that coating. View "In re: Ethicon, Inc." on Justia Law