Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Wake Forest is the owner of asserted patents, and KCI are the exclusive licensees of the patents, which claim methods and apparatuses for treating difficult-to-heal wounds by applying suction or negative pressure. In response to S&N’s 2008 announcement that it was launching a new foam-based negative pressure wound treatment product, Wake Forest and KCI asserted that S&N infringes two apparatus claims of the patent and induces infringement of four method claims. Rejecting the jury’s findings of non-obviousness, the district court found obviousness, based on prior art, and rejected infringement claims. The Federal Circuit reversed and remanded. The objective evidence strongly supported the jury’s findings under the first three Graham factors and cut against the view that the claimed inventions were an obvious combination of known elements from the prior art. View "Kinetic Concepts, Inc. v. Smith & Nephew, Inc." on Justia Law

Apotex submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of the anti-allergy eye drop Patanol. Alcon, which markets Patanol, sued Apotex for patent infringement under 35 U.S.C. 271(e)(2)(A). Alcon asserted claims 1-8 of the patent, which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Patanol. The district court held that claims would not have been obvious over the prior art and were not invalid. The Federal Circuit affirmed in part. Objective evidence indicated that claims 4 and 8 would not have been obvious. Patanol’s achieving nearly 70% market share within two years of its launch, demonstrates that “the commercial success was caused by the merits of the invention as distinct from the prior art.” The remaining claims were, however, obvious. A person of ordinary skill in the art at the time of invention would have been motivated to use olopatadine to treat human eye allergies as claimed for its established antihistaminic efficacy. View "Alcon Research, Ltd. v. Apotex, Inc." on Justia Law

Lovenox (enoxaparin) prevents blood clots. Enoxaparin is a version of heparin. Heparin molecules have considerable diversity in characteristics. Additional diversity is introduced when heparin is broken down, raising a problem with the FDA abbreviated new drug application (ANDA) process. ANDAs are used to obtain approval for a generic version of an existing drug and do not require extensive studies needed to initially prove the drug’s safety and efficacy. Aventis, which marketed Lovenox, asked the FDA to deny ANDA approval for a generic enoxaparin unless the applicant took certain steps. The FDA rejected Aventis’s arguments, stating that ANDA does not describe the information necessary to demonstrate that the active ingredient in the generic product is the same as the active ingredient in the reference drug. The FDA identified its own criteria for determining that generic enoxaparin has the same active ingredient as Lovenox. Amphastar was first to file an ANDA for generic enoxaparin and received FDA approval in2011. Momenta was first to bring generic enoxaparin to market, obtaining FDA approval more than a year earlier. Momenta alleged that Amphastar infringed its patent for analyzing heparin and obtained an injunction. The district court found that Amphastar’s quality control batch testing infringed the patent. The Federal Circuit vacated. The court applied an unduly narrow interpretation of the Hatch-Waxman safe harbor, 35 U.S.C. 271(e)(1).View "Momenta Pharma., Inc. v. Amphastar Pharma, Inc." on Justia Law

Lupin submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Fortamet, an extended-release tablet of metaformin hydrochloride. Shionogi, which markets Fortamet, sued Lupin for patent infringement under 35 U.S.C. 271(e)(2)(A) asserting, among others, the 866 patent), which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Fortamet. Lupin attempted to launch its generic Fortamet “at risk,”( without a final judgment on the merits in the litigation). Shionogi obtained a preliminary injunction. The Federal Circuit vacated and remanded. The district court incorrectly concluded that Lupin failed to raise a substantial question of validity regarding the asserted claims of the 866 patent, an abused its discretion by issuing a preliminary injunction. View "Sciele Pharma Inc. v. Lupin, Ltd." on Justia Law

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

Montgomery filed the 824 application in 2005, claiming priority to United Kingdom applications 9722026.3 (October 1997) and 9810855.8 (May 1998). The application is directed to inhibitors of the renin-angiotensin system (RAS), important in control of blood pressure and regulation of salt and water metabolism. The claims recite administering RAS inhibitors to patients diagnosed as in need of stroke treatment or prevention. The examiner rejected these claims as anticipated by each of prior art references. The Board of Patent Appeals and Interferences affirmed. The Federal Circuit affirmed. The contested claim elements were administration of ramipril, a known RAS inhibitor, to a patient diagnosed as in need of stroke treatment or prevention, where such administration is for treatment or prevention of stroke or its recurrence. Prior art discloses both requirements. View "In Re Montgomery" 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

Plaintiffs sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa, for injuries to their children allegedly caused by the Diptheria-Tetanus-acellular Pertussis vaccine. The children suffer a seizure disorder, known as Severe Myoclonic Epilepsy of Infancy. The same special master presided over both cases and determined that plaintiffs failed to show entitlement to compensation because evidence showed that a gene mutation present in both children was the sole cause of their injuries. The Court of Federal Claims affirmed. The Federal Circuit affirmed, noting considerable evidentiary support for the conclusion. View "Stone v. Sec'y of Health & Human Servs." on Justia Law

A drug manufacturer can obtain FDA permission to market a generic version of an approved drug by Abbreviated New Drug Application (ANDA), rather than full New Drug Application (NDA). It is an act of infringement to file an ANDA for a drug or use of the drug claimed in a patent, 35 U.S.C. 271(e)(2)(A). Every NDA must identify every patent that could reasonably be asserted in an infringement action, 21 U.S.C. 355(b)(1), for publication in the Orange Book. An ANDA for a generic drug must address each patent in the Orange Book that relates to that drug. For patents that will not expire prior to proposed marketing, the applicant can include a statement that the applicant is not seeking approval for the method of use claimed in the patent or can certify that the patent is invalid or will not be infringed. Bayer markets Yasmin, an oral contraceptive, approved by NDA in 2001. Defendants filed ANDAs to market generic versions and certified that three patents would not be infringed, arguing that their ANDAs related only to contraceptive use and not to claimed methods for treating hirsutism or acne or reducing water retention. The district court entered judgment of noninfringement. The Federal Circuit affirmed.View "Bayer Schering Pharma, AG v. Lupin, Ltd." on Justia Law