Justia Drugs & Biotech Opinion Summaries

Consolidated appeals involve allegations that the patent-holders for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in a monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents, 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 several 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’ claims. Plaintiffs plausibly allege the existence of agreements between the patent holders and the generic manufacturers. The court remanded one of the Lipitor appeals, brought by California pharmacists, and involving claims solely under California law, for determination of whether remand to state court was appropriate. The Lipitor plaintiffs made plausible allegations of fraudulent patent procurement and enforcement, and other related misconduct. View "In re: Lipitor Antitrust Litigation" on Justia Law

Direct purchasers of Wellbutrin XL, a drug for treating depression, sued, alleging that GSK violated the Sherman Antitrust Act by entering into an unlawful conspiracy with Biovail, GSK’s partner in the development of Wellbutrin XL, to delay the launch of generic versions of the drug. Indirect-purchasers asserted similar theories under state law. The purchasers claim that GSK delayed the launch of generic versions by supporting baseless patent infringement suits and a baseless FDA Citizen Petition aimed at generic drug companies and by entering into an unlawful reverse payment settlement agreement with potential competitors. The district court granted GSK summary judgment, finding insufficient evidence that GSK’s patent litigation was a sham or that the settlement delayed the launch of generic Wellbutrin XL. The court granted GSK’s Daubert motion to exclude the testimony of the purchasers’ economic expert; decertified the indirect-purchaser class for lack of ascertainability; dismissed the indirect-purchaser claims brought under the laws of states that were not the home of a named class representative; and denied Aetna’s motion to intervene. The Third Circuit affirmed. After considering the Supreme Court’s 2013 decision, FTC v. Actavis, the court concluded that the purchasers failed to establish a genuine dispute of fact either as to whether GSK engaged in sham litigation or whether GSK’s actions delayed the launch of generic Wellbutrin XL. View "In re: Wellbutrin XL Antitrust Litigation" on Justia Law

The Biologics Price Competition and Innovation Act, 42 U.S.C. 262, establishes a scheme for adjudicating claims of patent infringement in the FDA's approval of “biological products.” To obtain FDA approval, the sponsor of a new biological product must demonstrate that it is “safe, pure, and potent.” For a “biosimilar” product based on an approved “reference” product, a party may submit an abbreviated “subsection (k)” application that “piggybacks” on the showing made for an approved reference product but must provide the reference product's sponsor with its subsection (k) application and information that describes the manufacturing process. The parties then collaborate to identify patents for immediate litigation. The second phase is triggered by the applicant’s notice of commercial marketing and involves any patents that were included on the lists but not previously litigated. Hospira's subsection (k) application sought approval of a biosimilar of EPOGEN®, Amgen’s FDA-approved product, Although Amgen asserted that Hospira failed to disclose the composition of the cell-culture medium used during manufacturing, the parties began identifying patents. Amgen claimed that it could not assess the reasonableness of asserting infringement claims concerning other patents for culturing cells and moved to compel discovery on the composition of Hospira’s cell-culture medium in its suit on listed patents. The court denied Amgen’s motion, stating that the information had no relevance to the asserted patents. Amgen appealed that interlocutory order. The Federal Circuit dismissed, holding that it lacked jurisdiction under the collateral order doctrine and that Amgen failed to satisfy the prerequisites for mandamus. View "Amgen, Inc.. v. Hospira, Inc.." on Justia Law

The specifications of the three Soft Gel patents describe a method for dissolving CoQ10. The patented inventions include a composition, a soft gelatin capsule, and a method of making such a soft gelatin capsule, each involving a solution of CoQ10 dissolved in a monoterpene. CoQ10, also called ubiquinone, is a coenzyme, i.e., a chemical compound that is required for the biological activity of certain proteins and is necessary for certain metabolic processes and for the production of cellular energy; it has a secondary role as an antioxidant. In clinical trials, CoQ10 has been shown to be effective in regulating blood pressure and cholesterol levels, improving cardiovascular health, and “thwarting various diseases such as certain types of cancers.” It is “sparingly soluble in hydrophilic solvents such as water.” According to the patents, at the time of the inventions, most solvents that were used to administer CoQ10 in liquid form could dissolve, at most, only about 5 to 10 percent of the CoQ10. Jarrow requested inter partes reexaminations of the three Soft Gel patents. The Patent Board invalidated several claims. The Federal Circuit affirmed, finding the claims invalid as obvious in light of prior references, 35 U.S.C. 103(a). View "Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc." on Justia Law

Millennium developed the patented product for the treatment of oncology diseases, particularly multiple myeloma and mantle cell lymphoma. The product has the brand name Velcade®. Sandoz and others filed abbreviated new drug applications (ANDAs), admitting infringement and seeking to invalidate various claims of the 446 Patent. The district courts held that certain claims were invalid as obvious, 35 U.S.C. 103. In consolidated appeals, the Federal Circuit concluded that the district court erred and that invalidity was not established. Sandoz identified no reference or combination of references that show or suggest a reason to make the claimed compound. The district court clearly erred in its examination of the objective indicia of unexpected results and long-felt need. View "Millenium Pharmaceuticals, Inc. v. Sandoz, Inc." on Justia Law

The claims at issue involve testing methods for fetal aneuploidies, conditions in which a fetus either has an abnormally high number of chromosomes (e.g., Down’s syndrome) or an abnormally low number (e.g., Turner’s syndrome). Previously, physicians diagnosed fetal aneuploidies using invasive amniocentesis or chorionic villus sampling or less invasive methods, such as ultrasonography and biochemical marker detection that had suboptimal accuracy. In three interference proceedings between Stanford and Chinese University, the Patent Trial and Appeal Board found that Stanford’s claims were unpatentable for lack of written description. The Federal Circuit vacated, finding that the Board relied on improper evidence and did not cite other substantial evidence to support its key findings. Whether a patent claim satisfies the written description requirement, 35 U.S.C. 112, depends on whether the description clearly allows persons of ordinary skill in the art to recognize that the inventor invented what is claimed. On remand, the Board should examine whether a person of ordinary skill would have understood that the patent’s specification disclosed random MPS sequencing and would have known, as of the priority date, that the specification’s reference to Illumina products meant random MPS sequencing as recited in the claims, by examining the record evidence as to pre-filing date art-related facts on Illumina products. View "Stanford University v. Chinese University of Hong Kong" on Justia Law

When an artery is damaged or inflamed, the body releases the enzyme myeloperoxidase (MPO). Prior art taught that MPO could be detected in an atherosclerotic plaque or lesion that required a surgically invasive method; could be indirectly detected in blood; or could be detected in blood with results that were not predictive of cardiovascular disease. Cleveland Clinic purportedly discovered how to “see” MPO in blood and correlate that to the risk of cardiovascular disease. True Health, a diagnostic laboratory, purchased the assets of Diagnostics, which had contracted with Cleveland Clinic to perform MPO testing. Rather than continue that relationship, True Health performed its own MPO testing. Cleveland Clinic sued, asserting infringement of the patents. The district court found all the claims patent-ineligible under 35 U.S.C. 101; dismissed the contributory and induced infringement claims of the 260 patent; denied leave to amend; and held that it was proper to consider section 101 at the motion to dismiss stage.. The court found that the claims were directed to a law of nature, with no saving inventive concept. The Federal Circuit affirmed. Cleveland Clinic provided no proposed construction of any terms or proposed expert testimony that would change the analysis. The claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. View "Cleveland Clinic Foundation v. True Health Diagnostics. LLC" on Justia Law

The Biologics Price Competition and Innovation Act, concerning FDA approval of a drug that is biosimilar to an already-licensed biological “reference product,” 42 U.S.C. 262(k), treats submission of a biosimilar application as an “artificial” patent infringement. An applicant must provide its biosimilar application and manufacturing information to the reference product’s sponsor. The parties collaborate to identify patents for immediate litigation. Second phase litigation is triggered when the applicant gives the sponsor notice at least 180 days before commercially marketing the biosimilar. Amgen claims patents on methods of manufacturing and using filgrastim. Sandoz sought FDA approval to market a biosimilar, Zarxio, and notified Amgen that it had submitted an application, that it intended to market Zarxio immediately upon receiving FDA approval, and that it did not intend to provide application and manufacturing information. Amgen sued for patent infringement and asserted that Sandoz engaged in “unlawful” conduct under California law by failure to provide its application and manufacturing information and by notification of commercial marketing before obtaining FDA licensure. The FDA licensed Zarxio. Sandoz provided Amgen another notice of commercial marketing. The Supreme Court unanimously held that section 262(l)(2)(A) is not enforceable by injunction under federal law, but the Federal Circuit should determine whether a state-law injunction is available. Submitting an application constitutes artificial infringement; failing to disclose the application and manufacturing information does not. Section 262(l)(9)(C) provides a remedy for failure to turn over the application and manufacturing information, authorizing the sponsor, but not the applicant, to bring an immediate declaratory-judgment action, thus vesting in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation. An applicant may provide notice under section 262(l)(8)(A) before obtaining FDA licensure. View "Sandoz Inc. v. Amgen Inc." on Justia Law

Apicore owns, and Mylan Is the exclusive licensee of, the 992, 616, and 050 patents, which relate to isosulfan blue (ISB), a triarylmethane dye used to map lymph nodes. The 992 and 616 patents (together, “the process patents”) are directed to a process for preparing ISB by reacting isoleuco acid with silver oxide in a polar solvent, followed by reaction with a sodium solution. In response to Aurobindo’s FDA application to market a generic version of Myland’s drug, Lymphazurin®, Apricore and Myland obtained a preliminary injunction precluding Aurobindo from making, using, selling, offering to sell, and importing the accused ISB product that allegedly infringes the patents. The Federal Circuit affirmed. While the district court’s “equivalents analysis” was deficient and there remains a substantial question concerning infringement, so that the court’s grant of a preliminary injunction based on the process patents constituted an abuse of discretion, the injunction stands under the 050 patent. View "Mylan Institutional LLC v. Aurobindo Pharma Ltd." on Justia Law

The Leahy-Smith America Invents Act did not change the statutory meaning of “on sale” under 35 U.S.C. 102, in a case involving patents that were ready for patenting and subject to an invalidating contract for sale prior to the critical date of January 30, 2002. Teva had invoked the provision as a defense in a suit charging infringement based on Teva’s filing of an Abbreviated New Drug Application (ANDA). The district court upheld, as valid, Helsinn’s patents, directed to intravenous formulations of palonosetron for reducing chemotherapy-induced nausea and vomiting, and rejected Teva’s “on sale” defense. In reversing, the Federal Circuit noted that the invention worked for its intended purpose, that the evidence that the formulation was ready for patenting was “overwhelming,” and that there was no tenable argument that, before the critical date, Helsinn was unable to file a patent application that met the requirements of 35 U.S.C. 112. The district court clearly erred by applying too demanding a standard. The completion of Phase III studies and final FDA approval are not pre-requisites for the invention here to be ready for patenting. View "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc." on Justia Law