Justia Drugs & Biotech Opinion Summaries

AndroGel is a testosterone replacement therapy that generated billions of dollars in sales. The Federal Trade Commission sued under Section 13(b) of the Federal Trade Commission Act, alleging that AndroGel’s patent owners filed sham patent infringement suits against Teva and Perrigo and entered into an anticompetitive reverse-payment agreement with Teva. The FTC accused the patent owners of trying to monopolize and restrain trade over AndroGel. The District Court dismissed the FTC’s claims to the extent they relied on a reverse-payment theory but found the owners liable for monopolization on a sham-litigation theory and ordered disgorgement of $448 million in ill-gotten profits. The court denied the FTC’s request for an injunction.The Third Circuit reversed in part, holding that the district court erred by rejecting the reverse-payment theory and in concluding the owners’ litigation against Teva was a sham. The court erred by ordering disgorgement because that remedy is unavailable under Section 13(b) of the FTC Act. The court affirmed in part. The district court correctly concluded that the Perrigo litigation was a sham and that the owners had monopoly power in the relevant market but did not show the monopolization entitles the FTC to any remedy. The court did not abuse its discretion in denying injunctive relief. View "Federal Trade Commission v. AbbVie Inc" on Justia Law

Biogen’s patent is directed to a method of treating a viral condition, a viral disease, cancers, or tumors, by the administration of a pharmaceutically effective amount of a recombinant polypeptide related to human interferon-β (IFN-β). Biogen sued Serono, alleging contributory and induced infringement of the patent by the sale and marketing in the U.S. of Rebif, a recombinant IFN-β product used for the treatment of Multiple Sclerosis. A jury found that the patent claims were anticipated by two references teaching the use of native IFN-β to treat viral diseases; that the asserted claims not invalid for lack of enablement or written description, or for obviousness; that patients and prescribers directly infringed the asserted claims; and that Serono contributorily infringed the claims but did not induce infringement thereof. The district court granted judgment as a matter of law of no anticipation in favor of Biogen and conditionally granted a new trial on anticipation; sustained the jury’s verdict of no invalidity based on written description or enablement; overturned the verdict of no induced infringement; sustained the verdict of contributory infringement; and held that the claims were not patent ineligible.The Federal Circuit reversed with respect to anticipation and the conditional grant of a new trial. A reasonable jury could find the claims of the patent anticipated on the record presented. The court remanded with instructions to reinstate the verdict of anticipation. View "Biogen MA Inc. v. EMD Serono, Inc." on Justia Law

Baxalta sued Genentech, asserting that Genentech’s Hemlibra® product used to treat the blood clotting disorder hemophilia infringes claims of its 590 patent. The 590 patent relates to preparations used to treat hemophilia patients who have developed factor VIII inhibitors. After the district court issued a claim construction order, construing the terms “antibody” and “antibody fragment,” the parties stipulated to non-infringement of the asserted claims. The Federal Circuit vacated, finding that the district court erred in construing the terms by selecting a narrower construction, which is inconsistent with the written description and the plain language of the claim. View "Baxalta Inc. v. Genentech, Inc." on Justia Law

Bio-Rad’s patents are directed to systems and methods for forming microscopic droplets (plugs) of fluids to perform biochemical reactions. Microfluidic systems—often called “labs-on-a-chip”—allow scientists to conduct microscale chemical and biological reactions. For example, the technology allows scientists to analyze and compare DNA, RNA, and proteins within large numbers of individual cells. This technology has applications in medical diagnostics and high-throughput screening. In an infringement suit, the jury found all three patents valid and willfully infringed and awarded damages of $23,930,716. The court granted Bio-Rad’s motion for a permanent injunction. The Federal Circuit affirmed the judgment of infringement of one patent (which covers all six accused products) and the entire damages award. Prosecution history estoppel does not apply and 10X’s challenges concerning the infringement under the doctrine of equivalents fail. The court reversed the district court’s construction of the asserted claims of two patents, vacated the judgment of infringement of those patents, and remanded for a new trial on the issue of whether 10X’s accused products infringe those patents under the proper claim construction. The court also vacated the injunction with respect to 10X’s Linked-Reads and CNV product lines. View "Bio-Rad Laboratories, Inc. v. 10X Genomics Inc." on Justia Law

Takeda sued Mylan for patent infringement based on Mylan’s Abbreviated New Drug Application (ANDA) for a generic version of Takeda’s Colcrys® version of the drug colchicine. The parties settled, entering into a License Agreement that allows Mylan to sell a generic colchicine product on a specified date or under circumstances defined in Section 1.2, which refers the date of a final court decision holding that all unexpired claims of the licensed patents that were asserted and adjudicated against a third party are not infringed, invalid, or unenforceable. The parties stipulated that Mylar's breach of Section 1.2 “would cause Takeda irreparable harm.”Takeda also sued Hikma based on Hikma’s FDA-approved colchicine product Mitigare®. The district court granted summary judgment of non-infringement. After Mylan launched its product, Takeda sued, alleging breach of contract and patent infringement.The Federal Circuit affirmed the denial of a preliminary injunction. Takeda failed to show it is likely to succeed on the merits or that it will suffer irreparable harm. Section 1.2(d) was triggered by the third-party litigation; all unexpired claims of the three patents that were “asserted and adjudicated” were held to be not infringed. An objective, reasonable third party would not read Section 1.2(d) to be limited to generic equivalents of Colcrys® excluding section 505(b)(2) products like Mitigare®. Because Takeda had not established that Mylan breached the Agreement, the irreparable harm stipulation did not apply. Money damages would remedy any harm Takeda would suffer as a result of Mylan launching its generic product. View "Takeda Pharmaceuticals U.S.A. v. Mylan Pharmaceuticals, Inc." on Justia Law

IBSA's patent, entitled “Pharmaceutical Formulations for Thyroid Hormones,” provides “pharmaceutical formulations based on thyroid hormones enabling a safe and stable oral administration in the framework of the strict therapeutic index prescribed in case of thyroid disorders.” It is listed in the FDA’s “Orange Book” for IBSA’s Tirosint® product, a soft gel capsule formulation containing the active ingredient levothyroxine sodium. Teva sought to market a generic version of Tirosint® and filed an Abbreviated New Drug Application (ANDA) that included a “Paragraph IV certification” that the 390 patent is invalid, unenforceable, or will not be infringed by Teva’s generic product. IBSA filed suit, alleging infringement.The Federal Circuit affirmed a holding that certain claims are invalid as indefinite under 35 U.S.C. 112. The intrinsic evidence fails to establish the boundaries of the claim term “half-liquid” and there was no clear error in the court’s determination that the extrinsic evidence does not supply “half-liquid” with a definite meaning under section 112. View "IBSA Institut Biochimique v. Teva Pharmaceuticals USA" on Justia Law

XY sued Trans Ova for infringement of seven patents relating to technology for sex selection of non-human mammals. Its 559 patent is titled “Enhancing Flow Cytometry Discrimination with Geometric Transformation.” Flow cytometers can be used as “high-speed jet-in-air sorters to discriminate particles and cells that are only subtly different.” The patent relates to “apparatus and methods for real-time discrimination of particles while being sorted by flow cytometry . . . resulting in enhanced discrimination between populations of particles” and “can be used to separate X from Y bearing sperm,” an application useful in animal husbandry to “guarantee[] the sex of offspring.”The district court found asserted claims 1–23 of the 559 patent-ineligible under 35 U.S.C. 101 and that XY’s patent-infringement allegations with respect to certain claims of other patents were claim-precluded based on a prior lawsuit filed by XY against Trans Ova. The Federal Circuit reversed. The asserted claims of the patent are directed to a patent-eligible improvement to a method of sorting particles using flow cytometry technology, not to an abstract idea. The district court did not apply the proper legal standard to its claim-preclusion analysis. The court vacated the claim-preclusion judgment. View "XY, LLC v. Trans Ova Genetics, LC" on Justia Law

Each patent at issue claims a method of treating cancer by administering antibodies targeting specific receptor-ligand interactions on T cells, which are responsible for processing information to develop an immune response in the body using receptors on their surfaces. The named inventor Dr. Honjo, a professor at Kyoto University, had shared information with Drs. Wood and Freeman until about 2001. In 2002, Honjo filed his patent application in Japan. Each patent at issue case claims priority from that patent application; none include Freeman and Wood as inventors.The Federal Circuit affirmed that Drs. Freeman and Wood should be deemed inventors of the subject matter of the patents alongside Dr. Honjo, 35 U.S.C. 116(a). The inventorship of a complex invention may depend on partial contributions to conception over time, and there is no principled reason to discount genuine contributions made by collaborators because portions of that work were published prior to conception for the benefit of the public. Earlier publication of an invention is obviously a potential hazard to patentability, but the publication of a portion of a complex invention does not necessarily defeat joint inventorship of that invention. View "Dana-Farber Cancer Institute v. Ono Pharmaceutical Co., Ltd." on Justia Law

Genentech manufactures and sells bevacizumab, a biological product used to treat certain types of cancer, under the name Avastin. Amgen filed a biologics license application, 42 U.S.C. 262(k) to market a biosimilar version of Avastin—Mvasi. Mvasi received FDA approval effective September 2017. In October, Amgen notified Genentech of its intent to commercially market Mvasi starting no earlier than 180 days from the date of the letter. In August 2018, Amgen filed a third supplement to its Mvasi application to add a manufacturing facility and a fourth supplement to change its drug label. By July 2019, Amgen decided it would commercially launch Mvasi, intending to market it immediately. Genentech filed motions, seeking to preclude Amgen from commercially marketing Mvasi until Amgen “provides notice of its intent to commercially market such product” pursuant to 42 U.S.C. 262(l)(8) and 180 days have elapsed,” arguing that Amgen’s third and fourth supplements resulted in new and distinct applications that require new notices. The Federal Circuit affirmed the denial of the motions, reasoning that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied Section 262(l)(8)(A)’s notice requirements. View "Genentech, Inc. v. Immunex Rhode Island Corp." on Justia Law

The patents at issue are directed to the fusion protein etanercept and methods of making the same. Etanercept is the active ingredient in Immunex’s biologic drug Enbrel®, which is primarily indicated for reducing the signs and symptoms of moderately to severely active rheumatoid arthritis, an autoimmune disorder. Sandoz filed an abbreviated Biologics License Application (aBLA), seeking approval to market Erelzi, a biosimilar version of Enbrel®. In a patent infringement suit under the Biologics Price Competition and Innovation Act, Sandoz stipulated to infringement of the asserted claims of the patents-in-suit. The district court held that Sandoz had failed to prove that the asserted claims of the patents-in-suit were invalid. The Federal Circuit affirmed, rejecting claims of obviousness-type double patenting; failure to meet the written description requirement; and obviousness. View "Immunex Corp v. Sandoz Inc." on Justia Law