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

Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law

Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law

By 2000, Altaire was manufacturing R-phenylephrine hydrochloride products, used to dilate patients’ pupils. In 2011, Altaire and Paragon agreed to pursue FDA approval. Paragon submitted a new drug application (NDA). The FDA recommended that Paragon consider adding a chiral purity test. Altaire measured the optical rotation of Lots 11578 and 11582, 2.5% and 10% phenylephrine hydrochloride ophthalmic solution products. Paragon submitted a supplementary NDA, which was FDA-approved. Altaire also conducted high-performance liquid chromatography testing on the two lots (TMQC-247). Paragon proposed an amendment to the Agreement to address filing a patent application. Altaire responded that: “the formulation, processes[,] and controls ... were developed solely by [Altaire’s Chief Executive] … and are . . . the proprietary and confidential information of Altaire”; the Agreement “does not contemplate ... a patent application.” Paragon did not respond but filed a patent application, entitled “Methods and Compositions of Stable Phenylephrine Formulations.” While the application was being prosecuted, Paragon requested “all the work [Altaire] ha[s] on chiral purity” for its annual FDA report. Altaire provided a report. Altaire later sued, alleging that Paragon breached a nondisclosure agreement; Paragon counterclaimed. Altaire sought a declaratory judgment of invalidity of the patent and sought post-grant review, arguing that the Asserted Claims would have been obvious over Lots #11578 and #11581. The Patent Board rejected the argument. The Federal Circuit reversed. The Board erred in refusing to consider a declaration by Altaire’s Chief Executive concerning the TMQC-247 and optical rotation test data. View "Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc." on Justia Law

Merck's patents claim classes of compounds, identified by structural formulas, and the administration of therapeutically effective amounts of such compounds for treating Hepatitis C. Gilead developed its own Hepatitis C treatments, marketed as Solvadi® and Harvoni®, based on the compound sofosbuvir. Gilead sought a declaratory judgment that Merck’s patents were invalid and that Gilead was not infringing. Merck counterclaimed for infringement. Gilead stipulated to infringement based on the court’s claim construction, which was not appealed. A jury trial was held on Gilead’s challenges to the patents as invalid for lack of both an adequate written description and enablement of the asserted claims, and Gilead’s defense that Merck did not actually invent the subject matter but derived it from another inventor, employed by Gilead’s predecessor. The jury ruled for Merck but the district court ruled for Gilead, finding pre-litigation business misconduct and litigation misconduct attributable to Merck, and barred Merck from asserting the patents against Gilead. The court awarded attorney’s fees, relying on the finding of unclean hands. The Federal Circuit affirmed the judgment based on unclean hands. The district court found, with adequate evidentiary support, two related forms of pre-litigation business misconduct attributable to Merck. The court noted clear violations of a “firewall” understanding between Gilead’s predecessor and Merck, with a direct connection to the ultimate patent litigation. View "Gilead Sciences, Inc. v. Merck & Co., Inc." on Justia Law

Stereochemistry is the study of a molecule’s three-dimensional structure. Stereoisomers are molecules with the same chemical formula and structure but different three-dimensional configurations. Enantiomers, non-superimposable mirror images of one another, often have identical physical properties, such as density and boiling point, but can exhibit different pharmacological properties in the human body. Sumitomo’s 372 patent relates generally to “novel imide compounds and their acid addition salts” that are useful as antipsychotic agents. The patent discloses and claims more than one billion compounds, some of which have stereo and optical isomers. Lurasidone, the (–)-enantiomer of an imide compound covered by the patent, is the active ingredient in Sunovion’s schizophrenia and bipolar depression drug LATUDA®. After Emcure filed Abbreviated New Drug Applications with the FDA, seeking approval to market generic versions of LATUDA®, Sumitomo sued for infringement. The claim construction question centered on what combination of enantiomers claim 14 encompassed. The Federal Circuit rejected Sumitomo’s attempt to “import limitations from the specification into the claim” and affirmed the district court, holding that the patent covers at least the specific orientation depicted in the claim, which is the active pharmaceutical ingredient in each party’s commercial product. View "Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Ltd." on Justia Law

Stereochemistry is the study of a molecule’s three-dimensional structure. Stereoisomers are molecules with the same chemical formula and structure but different three-dimensional configurations. Enantiomers, non-superimposable mirror images of one another, often have identical physical properties, such as density and boiling point, but can exhibit different pharmacological properties in the human body. Sumitomo’s 372 patent relates generally to “novel imide compounds and their acid addition salts” that are useful as antipsychotic agents. The patent discloses and claims more than one billion compounds, some of which have stereo and optical isomers. Lurasidone, the (–)-enantiomer of an imide compound covered by the patent, is the active ingredient in Sunovion’s schizophrenia and bipolar depression drug LATUDA®. After Emcure filed Abbreviated New Drug Applications with the FDA, seeking approval to market generic versions of LATUDA®, Sumitomo sued for infringement. The claim construction question centered on what combination of enantiomers claim 14 encompassed. The Federal Circuit rejected Sumitomo’s attempt to “import limitations from the specification into the claim” and affirmed the district court, holding that the patent covers at least the specific orientation depicted in the claim, which is the active pharmaceutical ingredient in each party’s commercial product. View "Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Ltd." on Justia Law

Vanda had an exclusive license to the now-expired 198 patent and owns the 610 patent, relating to treatment of schizophrenia with iloperidone wherein the dosage range is based on the patient’s genotype. Vanda owns the New Drug Application for Fanapt® (iloperidone), an atypical antipsychotic approved by the FDA in 2009 under 21 U.S.C. 355(b) and based on the invention disclosed in the 610 patent, which reduces the side effects, enabling safer treatment of schizophrenia. The 198 and 610 patents are listed in connection with Fanapt® in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, (Orange Book). In 2013, West-Ward filed an Abbreviated New Drug Application (ANDA) seeking approval to commercially manufacture, use, offer to sell, and sell a generic version of Fanapt® for the treatment of schizophrenia (21 U.S.C. 355(j)). At that time, the 610 patent had not yet issued and only the 198 patent was listed in the Orange Book. The ANDA contained a Paragraph IV certification that the 198 patent was invalid and/or would not be infringed by West-Ward. The proposed ANDA label is substantially identical in all material respects to the Fanapt® label. The Federal Circuit affirmed a holding that the 610 patent is infringed and not invalid. View "Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International, Ltd." on Justia Law

Smith & Nephew’s patent relates to an endoscope and method to remove uterine tissue; it claims priority to an earlier-filed PCT application by the same inventor with a nearly identical specification. On inter partes review, the Patent Trial and Appeal Board found that S&N’s earlier-filed PCT application has sufficient written description to make it a priority document instead of an invalidating obviousness reference. The Federal Circuit affirmed. Substantial evidence supported the finding that the PCT application reasonably conveys to a person of ordinary skill that the inventor had possession of the “first channel having a light guide permanently affixed therein.” The court also upheld the Board’s definition of a person of ordinary skill in the art as a “degreed engineer having at least 5 years of experience designing and developing devices used in minimally invasive surgery (endoscopes, resectoscopes, shavers, tissue removal devices, etc.).” View "Hologic, Inc. v. Smith & Nephew, Inc." on Justia Law

Merck’s 353 patent claims mometasone furoate monohydrate, the active ingredient in Merck’s Nasonex® nasal product. Amneal submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration (FDA) seeking approval to market a generic mometasone furoate nasal spray. In Merck’s infringement suit, the district court found that Merck failed to prove that Amneal’s ANDA product will infringe. The Federal Circuit affirmed, upholding the district court’s refusal to require Amneal to produce additional samples of its ANDA product for testing before trial. The court rejected a claim that the noninfringement finding must be reversed because it was not based on Amneal’s final commercial product. The district court did not clearly err in finding that a Raman spectroscopy three-peak analysis was required to confirm the infringing form of mometasone furoate in Amneal’s product. Raman spectroscopy is a vibrational spectroscopy technique. A laser is used to generate a Raman spectrum, which indicates the vibrational modes of molecules and can be used to differentiate crystalline forms. View "Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC" on Justia Law

Sanofi’s patents describe and claim compositions and uses of the cardiovascular (antiarrhythmic) drug dronedarone. The 800 patent, which expires in 2019, claims pharmaceutical compositions containing dronedarone. The 167 patent, which expires in 2029, claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. In 2009, Sanofii received New Drug Application approval for 400 mg tablets of dronedarone, sold as Multaq®. Both patents are listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as patents claiming either Multaq® or a method of using Multaq®. Defendants, hoping to market generic versions of Multaq®, filed abbreviated new drug applications with the FDA, certifying under 21 U.S.C. 355(j)(2)(A)(vii)(IV), their beliefs that both patents were invalid and/or that the manufacture, use, and sale of the proposed generic drugs would not infringe either patent. Sanofi sued for infringement under 35 U.S.C. 271(e)(2)(A). The district court ruled, and the Federal Circuit affirmed, that as to the 167 patent, Sanofi proved that sale of the proposed generic drugs, with the proposed labels, would induce physicians to infringe, and defendants did not prove that any asserted claims were invalid for obviousness. As to the 800 patent, the courts rejected the non-infringement argument. View "Sanofi v. Watson Laboratories Inc." on Justia Law