Justia Drugs & Biotech Opinion Summaries

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 Clozapine had serious potential side effects and was withdrawn from clinical trials.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

A brand-name company seeking FDA new drug approval must submit information about patents for which a claim of infringement could reasonably be asserted, 21 U.S.C. 355(b)(1), for publication in the Orange Book. A generic company may seek FDA approval using abbreviated new drug application (ANDA), including, for each patent in the Orange Book, certification that approval is not sought until the patent expires or paragraph IV certification that such patent is invalid or will not be infringed. If an ANDA contains only paragraph IV certifications, it may be approved unless the holder sues for patent infringement within 45 days. The first generic company to file an ANDA containing paragraph IV certification receives a 180-day exclusivity period from the date of its first commercial marketing. The period can be forfeited by failure to launch after final judgment of noninfringement or invalidity. An ANDA filer, not sued within 45 days, can seek declaratory judgment under 28 U.S.C. 2201. Plaintiffs obtained declaratory judgment that a generic pharmaceutical did not infringe defendant's patent. The Federal Circuit affirmed, rejecting a challenge to the district court’s jurisdiction, based on a covenant not to sue contained in an earlier settlement between the parties.View "Dey Pharma, LP v. Sunovion Pharm., Inc." on Justia Law

Plaintiffs are the owner of the patents, which cover a modified-release dosage form of skeletal muscle relaxants (793) and a method of relieving muscle spasms with the formulation disclosed in the 793 patent, and the exclusive licensee of the patents. The district court found the patents invalid as obvious, but enjoined defendants from launching their generic product, pending appeal. The Federal Circuit reversed. The district court failed to consider the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed drug formulation and, therefore, erred when it assessed the importance of the teachings of the prior art to the obviousness analysis. The court rejected defendants' alternate argument that the patents were invalid for failure to disclose the best mode (35 U.S.C. 112), stating that the evidence supported a finding that the patents enable one of ordinary skill in the art to practice the inventor's preferred dew points.View "In re Cyclobenzaprine Hydrochloride Extended Release Casule Patent Litigation" 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