Justia Patents Opinion Summaries

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 Clozapine had serious potential side effects and was withdrawn from clinical trials.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

Plaintiff worked as an airplane mechanic, in the Navy and for several airlines. In the 1960s, he devised a tool that could reach deep inside airplane engines without disassembling external components. In 2000, a patent issued to plaintiff for the extended reach pliers, based on an application written and prosecuted by defendant. Danaher, a customer of plaintiff's business, subsequently developed its own version of the ERP and began competing against the device. Plaintiff sued for malpractice, alleging that the patent was so negligently drafted that it offered no meaningful protection against infringers. Its expert proposed alternate claim language that allegedly could have been enforced against Danaher. The district court granted defendant summary judgment, based on the element of causation. The Federal Circuit affirmed. Plaintiff did not raise a genuine dispute of material fact as to the patentability of its alternate claims. Plaintiff failed to raise a single material fact in dispute as to the nonobviousness of the proposed alternate claims. View "Minkin v. Gibbons, P.C." 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

In 1995, respondent filed a patent application covering 117 claims under the Patent Act of 1952, 35 U.S.C. 112. The patent examiner denied all of the claims for lack of an adequate written description. Respondent appealed to the Board of Patent Appeals and Interferences, pursuant to section 134 of the Act, which approved some claims but denied others. Pursuant to section 145 of the Act, respondent filed a civil action against the Director, but the district court declined to consider respondent's newly proffered written declaration in support of the adequacy of his description, thus limiting its review to the administrative record. On appeal, the Federal Circuit vacated the judgment. The Court held that there are no limitations on a patent applicant's ability to introduce new evidence in a section 145 proceeding beyond those already present in the Federal Rules of Evidence and the Federal Rules of Civil Procedure. If new evidence was presented on a disputed question of fact, the district court must make de novo factual findings that take account of both the new evidence and the administrative record before the Patent and Trade Office. Therefore, the Court affirmed the judgment of the Federal Circuit. View "Kappos v. Hyatt" 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

In 1999 Beasley filed a patent application for personalized postage stamps. In 2001 the PTO issued notice of allowance. Beasley then entered into a licensing agreement with Avery, specifying that Avery would assume responsibility for prosecution of the patent application and would pay patent prosecution expenses. Beasley appointed Renner to prosecute his application. A Renner attorney filed a supplemental information disclosure statement concerning prior art references. The PTO issued a second notice of allowance. Beasley transferred ownership USPPS. USPPS and Avery entered into an agreement. Later, the PTO vacated its notice of allowance and issued final rejections. Beasley and USPPS alleged that Avery mismanaged the application. Beasley’s suit for was dismissed for lack of standing. USPPS filed suit, alleging breach of fiduciary duty and fraud, based on Avery’s alleged representation that Beasley was the client of Renner. The district court granted summary judgment for defendants. The Fifth Circuit transferred to the Federal Circuit, finding that jurisdiction was based, in part, on 28 U.S.C. 1338 and that the alleged malpractice involves a question of patentability, even if no patent actually issued. The Federal Circuit affirmed, holding that it had jurisdiction and that the complaint was untimely. View "USPPS, Ltd. v. Avery Dennison Corp." 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

The patent involves screening devices used in the pulp and paper industry. According to the specification of the asserted patent, a persistent problem in the screening process is clogging of the openings in the screen resulting in reduced efficiency. The patent purports to include specially-designed screening devices that offer substantially increased efficiency and flow capacity. Submission for reissue in 2003 was initially rejected as anticipated by prior art 35 U.S.C. 102 (b). After the examiner withdrew the rejection, the patent-holder filed suit for infringement. The district court entered summary judgment of noninfringement and lack of willfulness. The Federal Circuit affirmed on willfulness, but reversed with respect to infringement, finding that the court erred in its construction of the term "perforated."View "Advanced Fiber Tech. Trust. v. J&L Fiber Serv., 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

Avery and 3M are competitors in the market for retroreflective sheeting technology, used in applications including road signs. In 2001, Avery sued 3M concerning patents not currently at issue; during the course of settlement discussions, 3M became aware that Avery was prosecuting reissue of the Heenan patents. Avery indicated that certain 3M sheeting products might infringe the patents and that licenses were available. 3M rejected the suggestion and asked for more information. Avery responded that it had performed an analysis of 3M’s product and would send claim charts, but never did so. The patents emerged from reissue 2009. n 2010 Avery filed another unrelated patent infringement claim and 3M filed with respect to the Heenan patents. 3M conceded that conversations prior to 2009 were covered by a confidentiality agreement that precluded their use as a basis to support a declaratory judgment action, then cancelled its declaratory judgments claims and refiled those claims separately (the current action). The district court dismissed for lack of subject matter jurisdiction. The Federal Circuit vacated, noting that the court would have jurisdiction under facts alleged by 3M and that the court did not resolve those factual issues. View "3M Co. v. Avery Dennison Corp." on Justia Law