Justia Drugs & Biotech Opinion Summaries

The consolidated appeals involve allegations that the companies holding the patents for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in an overarching monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents and then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed most of plaintiffs’ claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ well-pleaded claims. The court remanded one of the Lipitor appeals, brought by a group of California pharmacists and involving claims solely under California law, for jurisdictional discovery and determination of whether remand to state court was appropriate. View "In re: Lipitor Antitrust Litigation" on Justia Law

Navartis’s 283 patent relates to a solid pharmaceutical composition suitable for oral administration, comprising a sphingosine-1 phosphate (S1P) receptor agonist and a sugar alcohol, which the patent explains is useful for the treatment of certain autoimmune diseases such as multiple sclerosis. According to the specification, S1P receptor agonists generally exhibit properties that make formulations suitable for oral administration of a solid composition difficult to create. However, “solid compositions comprising a sugar alcohol provide formulations which are particularly well suited to the oral administration of S1P receptor agonists." They also “provide a convenient means of systemic administration of S1P receptor agonists, do not suffer from the disadvantages of liquid formulations for injection or oral use, and have good physiocochemical and storage properties.” On inter partes review, the Patent Trial and Appeal Board found all original claims of the 283 patent and proposed substitute claims unpatentable as obvious. The Federal Circuit affirmed. The Board discussed independent grounds supporting the motivation to combine prior art, fingolimod and mannitol, in a solid oral composition. View "Novartis AG v. Torrent Pharmaceuticals, Limited" on Justia Law

Bivalirudin is a synthetic peptide used to prevent blood clotting in patients undergoing cardiac catheterization. Bivalirudin’s pharmacological properties were known before the filing of Medicines’ 727 and 343 patents and were covered by Medicines’ 404 patent, which expired in 2015. The claimed inventions of the 727 and 343 patents are directed to minimizing impurities in batches of bivalirudin, an active ingredient, typically distributed as a dry powder that must be compounded with a base before being administered to a patient as an intravenous injection. Medicines received FDA approval to market a base-compounded bivalirudin drug product in 2000, and has sold the approved product since 2001 under the tradename ANGIOMAX®, before the critical date of the 727-343 patents. Mylan submitted an Abbreviated New Drug Application, seeking to market a generic version of ANGIOMAX. The district court held that the 343 patent was not infringed because Mylan did not satisfy the “efficient mixing” limitation of asserted claims and that the 727 patent was infringed because its asserted claims did not include an “efficient mixing” limitation. Without addressing the validity of the patents, the Federal Circuit reversed as to the 727 patent and affirmed as to the 343 patent. Both include a “batches” limitation that requires batch consistency, which, according to the patents, is achieved through efficient mixing. Efficient mixing is required by the asserted claims of both patents. View "The Medicines Co. v. Mylan, Inc." on Justia Law

The 631 application, entitled “Glenoid Implant for Minimally Invasive Shoulder Replacement Surgery,” describes an invention related to “rotator cuff sparing procedures and associated devices for shoulder replacement surgery.” The application improves on the prior art by offering “simple and less invasive perpendicular access to the humeral and glenoid joint surfaces,” which “spares the rotator cuff tendons and allows for a quicker and more functional recovery.” The surgery described in the application involves two main steps. First, the surgeon removes “a minimal amount of bone from the peripheral surface of the glenoid”—a process called reaming. Second, the surgeon places an implant in the reamed cavity. The Patent Trial and Appeal Board concluded that several claims were anticipated by prior art, 35 U.S.C. 102(b). The Federal Circuit reversed; the finding of anticipation was not supported by substantial evidence. View "In re: Chudik" on Justia Law

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, construed three terms, and 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. In a separate opinion, the court specifically addressed one prior reference, Whitaker, stating that it may “suggest” long-term daily treatment by noting the beneficial effects of daily treatment (better erectile response and decreased side effects), but that is not enough. Whitaker does not disclose the claimed treatment regimen with sufficient clarity to satisfy the demanding standard for anticipation. View "Eli Lilly & Co, v. Los Angeles Biomedical Research Institute" on Justia Law

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

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