Justia Drugs & Biotech Opinion Summaries

The patents involve topical compositions for protecting pets from fleas and ticks. The 940 patent, now expired, claimed fipronil for pest control by direct toxicity. Merial, as exclusive licensee, developed compositions sold as Frontline. Merial also devised compositions, covered by the 329 patent, combining fipronil with an insect growth regulator, sold as Frontline Plus, the leading flea and tick treatment. In 2007 Merial sued Cipla and other internet retailers, alleging infringement. No defendant responded. The district court found that the patents were not invalid, that Cipla had infringed each patent, and entered a permanent injunction barring Cipla from directly or indirectly infringing the patents. In 2008 Cipla filed an informal communication, not intended to constitute an appearance, denying infringing or having any presence in the U.S., and requesting dismissal. The district court entered final judgment. Velcera, led by former Merial executives, engaged with Cipla to develop, test, manufacture, and distribute products to compete with Merial. Both Velcera and Cipla entered into development and supply agreements with various companies. In 2011, they began selling PetArmor Plus. The district court held Velcera and Cipla in contempt. The Federal Circuit affirmed, rejecting challenges to jurisdiction and to the contempt order’s application to Velcera. View "Merial, Ltd. v. Cipla, Ltd." on Justia Law

The patent is entitled “Ultra High Molecular Weight Polyethylene Molded Article for Artificial Joints and Method of Preparing the Same.” The examiner rejected a reissue application as obvious, finding that it would have been obvious to a person of ordinary skill in the art to use cross-linked UHMWPE in the method of making the UHMWPE products disclosed by a reference, given the teaching of another reference that cross-linking prior to compression deformation results in improved transparency, an increased melting point, and excellent dimensional stability. The examiner further found that one of ordinary skill in the art would have had a reasonable expectation of success in obtaining those enhanced properties by combining the techniques taught by the two references. The Board affirmed, rejecting an argument that there would have been no motivation to combine the teachings because the references are directed to different products. The Federal Circuit affirmed. View "In Re: Hyon" on Justia Law

The FDA last approved a typical antipsychotic in 1975. Despite drawbacks, typical antipsychotics are still used to treat schizophrenia. In the early 1960s, researchers discovered clozapine, the first "atypical" antipsychotic, useful for treating both positive and negative symptoms. Clozapine had serious potential side effects and was withdrawn from clinical trials. The FDA approved no new antipsychotic drugs between 1976 and 1989, finally approving clozapine in 1990, only for certain patients, subject to blood testing. The FDA approved risperidone, an atypical antipsychotic, in 1994, and, since then, has approved seven other atypical antipsychotics, including aripiprazole. These are as effective as typical antipsychotics for treating positive symptoms, while also treating negative symptoms and causing fewer side effects than clozapine. Every approved atypical antipsychotic has chemical structure related either to clozapine or risperidone, except aripiprazole, the active ingredient in "Abilify," marketed by plaintiff for treatment of schizophrenia, bipolar disorder, irritability associated with pediatric autistic disorder, and as add-on treatment for depression. Anticipating expiration of the patent, companies submitted FDA Abbreviated New Drug Applications for approval of generic aripiprazole. The district court ruled in favor of plaintiff on patent infringement, 35 U.S.C. 103. The Federal Circuit affirmed, rejecting claims of obviousness and of nonstatutory double patenting. View "Otsuka Pharm. Co., Ltd. v. Sandoz, Inc." on Justia Law

This case involved a type of patent litigation settlement known as a "pay for delay" or "reverse payment" agreement. In this type of settlement, a patent holder paid the allegedly infringing generic drug company to delay entering the market until a specified date, thereby protecting the patent monopoly against a judgment that the patent was invalid or would not be infringed by the generic competitor. This case began when the FTC filed a complaint in district court alleging that the reverse payment settlements between the holder of a drug patent and two generic manufacturers of the drug were unfair restraints on trade that violated federal antitrust laws. The court's precedent established the rule that, absent sham litigation or fraud in obtaining the patent, a reverse payment settlement was immune from antitrust attack so long as its anticompetitive effects fell within the scope of the exclusionary potential of the patent. The court rejected the FTC's claims to the contrary and affirmed the judgment. View "FTC v. Watson Pharmaceuticals, Inc., et al." 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

Plaintiff's 561 and 512 pharmaceutical patents for "Taxotere" are related to administration of the chemotherapy cancer drug docetaxel (a successor to the cancer drug paclitaxel, covered by a now-expired patent). To stabilize the perfusion and delay precipitation, the cancer drugs are mixed with additives like surfactants and ethanol. Prior art used the surfactant Cremophor, but it was known to trigger serious allergic reactions. The 561 and 512 patents relate to using surfactants other than Cremophor and decreasing the amount of ethanol to reduce alcohol intoxication and anaphylactic effects in patients. After defendants applied for FDA approval to market generic versions of Taxotere, plaintiff claimed infringement, 35 U.S.C. 271(e). The district court found certain claims invalid for obviousness and that the patents were unenforceable for inequitable conduct. The Federal Circuit affirmed, concluding that withheld references to prior art were material View "Aventis Pharma S.A. v. Hospira, Inc." on Justia Law

In 1996, RG, exclusive licensee of a German patent and corresponding patents in the U.S., Europe, and Japan relating to genetic identification, entered into a license agreement with Promega, granting Promega certain licenses. The agreement included a clause, providing that “all controversies or disputes arising out of or relating to this Agreement, or relating to the breach thereof, shall be resolved by arbitration” and prohibited assignment without consent. Assignments were approved in 2001 and 2003; a subsequent assignment from IP to LT was not approved. In 2008 LT believed that Promega was paying less than required royalties. Negotiations failed and LT demanded arbitration. Promega sought a declaratory judgment of non-arbitrability, alleging infringement of five patents and contenting that rights under the 1996 agreement had never been assigned to LT. IP then moved to compel arbitration. The district court ordered arbitration, finding that IP was the assignee, remained in existence, and that it was irrelevant that Promega alleged that IP was merely a puppet of LT. The Federal Circuit affirmed.View "Promega Corp. v. Life Tech. Corp." on Justia Law

The patent describes an infusion system used to meter and deliver fluids from multiple sources into a patient's body. Different fluids may be discharged at different rates using a central control device. Ergo sued CareFusion for infringement of several of the patent's claims; the parties stipulated that several terms were means-plus-function terms, including the terms "programmable control means" and "control means." The parties agreed that the analysis for both terms is the same and that the function for the terms is "controlling the adjusting means." The district court held that the "control means" terms are indefinite for failure to disclose corresponding structure. The Federal Circuit affirmed. View "Ergo Licensing, LLC v. CareFusion 303, Inc." 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

The technology involves prosthetic vascular grafts, fabricated from highly-expanded polytetrafluoroethylene, and used to bypass or replace blood vessels to assure adequate and balanced blood flow to particular parts of the body. The 135 patent application was filed in 1974, but the patent did not issue until 2002. The district court found that the patent had been willfully infringed and was not invalid for improper inventorship, anticipation, obviousness, or lack of written description, and awarded enhanced damages, attorneys' fees and costs, and an ongoing royalty. The Federal Circuit affirmed, finding substantial evidence to support the jury verdict. View "Bard Peripheral Vascular, Inc. v. W.L. Gore & Assocs., Inc." on Justia Law