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 Clozapine had serious potential side effects and was withdrawn from clinical trials.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

Landmark invented an LED billboard and retained Kohler to file a patent application. Kohler filed the 096 application. USPTO indicated that the application contained multiple inventions. Kohler pursued two claims and withdrew others, intending that withdrawn claims would be pursued in divisional applications, to benefit from the 096 filing date. Kohler submitted an incomplete (916) divisional application, not using a postcard receipt to enable prompt notification of deficiencies. Months later, PTO issued notice of incomplete application. Kohler had changed firms. The anniversary of the 096 application’s publication passed; the 096 application became prior art against the 916 application under 35 U.S.C. 102(b). The attorneys did not immediately notify Landmark. Their petition to grant the 916 application an earlier filing date was dismissed. Landmark eventually filed suit alleging malpractice, negligence, and breach of fiduciary duty and reached a partial settlement. The state court dismissed remaining claims for lack of subject matter jurisdiction. Landmark filed the same claims in federal court, adding claims for breach of contract and fraud. The district court dismissed all except the fraud claim under a one-year limitations period and later dismissed the fraud claim under a three-year limitations period. The Federal Circuit reversed. Under California equitable tolling law, the state law fraud claim was timely filed. View "Landmark Screens, L.L.C. v. Morgan, Lewis & Bockius, L.L.P" 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

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