Justia Drugs & Biotech Opinion Summaries

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

Amphastar Pharmaceuticals Inc. and its wholly owned subsidiary (collectively, Amphastar) and Sandoz Inc. were competitors in the U.S. market for generic enoxaparin, an anticoagulant. Momenta Pharmaceuticals Inc. served as Sandoz’s contract laboratory. Amphastar filed a complaint alleging antitrust violations by Sandoz and Momenta based on Defendants’ alleged misrepresentations to the United States Pharmacopeial Convention, a private standard-setting organization charged with ensuring the quality of drugs. Defendants brought an infringement suit against Amphastar, resulting in a temporary restraining order (TRO) and preliminary injunction prohibiting Amphastar from selling enoxaparin. The preliminary injunction was later vacated, but it did prevent Amphastar from selling its generic enoxaparin for approximately three months. Amphastar then filed this suit under the Sherman Act seeking damages for lost profits during the pendency of the TRO and injunction. The district court dismissed the complaint under the Noerr-Pennington doctrine, which immunizes good-faith petition of government entities from antitrust liability. The First Circuit reversed, holding that the district court erred in applying Noerr-Pennington. Remanded for the district court to consider Defendants’ other arguments in the first instance. View "Amphastar Pharmaceuticals, Inc v. Momenta Pharmaceuticals, Inc." 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

This case involved disputes over licensing agreements for, inter alia, the RS 3400 blood irradiation device. At issue was whether the Federal Circuit has exclusive jurisdiction to hear an appeal of a breach of contract claim that would require the resolution of a claim of patent infringement for the complainant to succeed. The court concluded that it did not have appellate jurisdiction and resolved dispositive issues in favor of Rad Source, leaving a single dispositive issue for certification: When a licensee enters into a contract to transfer all of its interests in a license agreement for an entire term of a license agreement, save one day, but remains liable to the licensor under the license agreement, is the contract an assignment of the license agreement, or is the contract a sublicense?View "MDS (Canada) Inc., et al. v. Rad Source Technologies, Inc." on Justia Law

Proveris owns the 400 patent, for a mechanism to evaluate aerosol spray plumes. The apparatus evaluates delivery of drugs by inhalers or nasal sprays, by triggering a spray and collecting data on the plume with an illumination device and an imaging device. Innova made and sold the Optical Spray Analyzer (OSA). Proveris sued, alleging that OSA infringed the 400 patent. Innova conceded infringement of certain claims (including claim 3), but disputed infringement of others. The district court ruled in favor of Proveris on invalidity. A jury found that Innova did not infringe the disputed claims and that no damages had been proven. Based on the conceded infringement, the district court enjoined Innova from making or selling OSA. Innova modified OSA and began selling the new Aerosol Drug Spray Analyzer (ADSA). Proveris filed a contempt motion. Innova argued that OSA allowed a user to identify what range of images he wanted to analyze before activating the spray, while ADSA requires the user to first activate the spray and later determine what he wants to analyze. The district court ruled that, because Innova could have raised claim construction issues in the underlying infringement action, the court would not construe claim 3; Innova could not raise new invalidity arguments in contempt proceedings. The court entered a contempt order against Innova, found that the violation had been willful, and ordered disgorgement of profits. The Federal Circuit vacated, holding that the court erred in failing to construe the disputed claim language. View "Proveris Scientific Corp. v. Innovasystems, Inc." on Justia Law

The patents at issue relate to methods and devices for sealing a vascular puncture, which occurs when a medical procedure requires a puncture through the skin and into a vein or artery to insert a medical device, such as a catheter, into a patient’s vasculature. After such a procedure, the medical professional typically removes the medical device from the vasculature. Prior to development of the technology at issue, the medical professional was then required to apply external pressure to the puncture site until clotting occurred, sometimes for an extended period of time. This caused discomfort and increased the recovery time. The Janzen and Fowler patents disclose methods and devices for sealing a vascular puncture to improve patient recovery. The district court held that the safe-harbor provision of 35 U.S.C. 121 protects the Janzen patent from invalidity due to double-patenting; construed key terms in the Janzen patent; and found that the Fowler patents were not invalid for obviousness. The Federal Circuit reversed the safe harbor ruling, which rendered the rulings regarding the claim constructions moot, and affirmed that the Fowler patents are nonobvious and not shown to be invalid. View "St. Jude Med., Inc. v. Access Closure, Inc." on Justia Law

Bayer’s patent concerns genetically modifying plants to confer resistance to a common herbicide (2,4-D) by inserting a particular DNA segment into plant cells, which reproduce to create new cells that contain that gene. Those cells produce an enzyme that catalyzes a biochemical reaction with 2,4-D in which the herbicide is broken down into something harmless to the plant. A plant with the gene survives 2,4-D application while surrounding weeds do not. At the time of the patent application, the inventors had sequenced one gene coding for one enzyme, using a test supposedly capable of finding other, similar genes. In writing the application, they claimed a broad category based on the function of the particular enzyme, defining the category by using a term with established scientific meaning. Years before the patent issued, experiments showed that the term did not apply to the particular enzyme whose gene was sequenced, but Bayer did not change its claim language. When Bayer sued Dow for infringement, Bayer recognized that the term’s established scientific meaning, did not cover the accused product, which was, itself, different from the enzyme whose gene Bayer’s inventors had sequenced. Bayer argued for broad functional claim construction. The district court entered summary judgment of noninfringement, citing particularly the great breadth of the asserted functional construction. The Federal Circuit affirmed. View "Bayer CropScience AG v. Dow AgroSciences, LLC" on Justia Law

Once the FDA has approved a brand manufacturer's drug, another company could seek permission to market a generic version pursuant to legislation known as the Hatch-Waxman Amendments. See Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585. The relevant statute at issue in this case provided that a generic company "may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted... under [two statutory subsections] on the ground that the patent does not claim... an approved method of using the drug." 117 Stat. 2452, 21 U.S.C. 355(j)(5)(C)(ii)(I). At issue in this case was whether Congress had authorized a generic company to challenge a use code's accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit. The Court held that a generic manufacturer could employ this provision to force correction of a use code that inaccurately described the brand's patent as covering a particular method of using the drug in question. Therefore, the Court reversed the judgment of the Federal Circuit. View "Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S" on Justia Law

The patent claims at issue covered processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level was too low or too high. The claims purported to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage would be ineffective or induce harmful side-effects. At issue was whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. The Court concluded that they have not done so and that therefore the processes were not patentable. The steps in the claimed processes involved well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. Therefore, the Court reversed the judgment of the Federal Circuit. View "Mayo Collaborative Services v. Prometheus Laboratories, Inc." on Justia Law