Justia Drugs & Biotech Opinion Summaries

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

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

In 2003, the FDA granted Bayer approval to market vardenafil hydrochloride trihydrate to treat erectile dysfunction (ED) under the name Levitra. Vardenafil belongs to a class of ED drugs called phosphodiesterase inhibitors. When the FDA approved Levitra, two other phosphodiesterase inhibitors were already on the market: Pfizer launched Viagra in 1998, and Eli Lilly launched Cialis in 2003. Each is formulated as immediate-release tablets that are swallowed whole. Bayer’s 950 patent issued in 2013, claiming priority to 2005; it is directed to a formulation of vardenafil as “an uncoated tablet which disintegrates rapidly in the mouth,” vardenafil ODT, which Bayer markets as Staxyn. Watson filed an FDA Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Staxyn. Bayer alleged infringement. The Federal Circuit reversed the district court’s holding Watson failed to prove by clear and convincing evidence that two claims would have been obvious, 35 U.S.C. 103. The district court clearly erred in finding a skilled artisan would not have been motivated to use the claim elements to formulate an ED drug as a fast-dissolving tablet; the claims would have been obvious. View "Bayer Pharma AG v. Watson Laboratories, Inc." on Justia Law

Merck owns the 150 patent, which is directed to a process for preparing a stable formulation of ertapenem, an antibiotic compound, and claims a manufacturing process for a final formulation of the antibiotic that purportedly minimizes both dimerization and hydrolysis degradation pathways. Hospira notified Merck that it had filed an abbreviated new drug application, seeking FDA approval to engage in the commercial manufacture, use, or sale of generic versions of Merck’s Invanz® product, the principal component of which is the carbon dioxide adduct of ertapenem. Merck sued Hospira for infringement of two patents—the 150 patent and the 323 patent. The Federal Circuit affirmed a holding that certain claims of the 150 patent are invalid under 35 U.S.C. 103, for obviousness. It was reasonable for the district court to deduce from the evidence that the order and detail of the steps, if not already known, would have been discovered by routine experimentation while implementing known principles. View "Merck Sharp & Dohme Corp. v. Hospira, Inc." on Justia Law

Amgen’s patents relate to antibodies that help reduce low-density lipoprotein cholesterol (LDLC), or “bad cholesterol.” Typically, high LDL-C is treated using small molecules (statins), which sometimes have adverse side effects or cannot reduce a patient’s LDL-C to a healthy level, requiring an alternative treatment, such as a PCSK9 inhibitor. PCSK9 is a naturally occurring protein that binds to and causes the destruction of liver cell receptors (LDL-Rs) that are responsible for extracting LDLC from the bloodstream. Amgen began studying PCSK9 in 2005 and developed the drug Repatha™ with the active ingredient “evolocumab,” a monoclonal antibody that targets PCSK9 to prevent it from destroying LDL-R proteins.The FDA approved Repatha in 2015. In 2007, Appellants started exploring antibodies targeting PCSK9, resulting in the development of Praluent. Praluent's active ingredient is a monoclonal antibody that targets PCSK9 to prevent it from binding to and destroying LDL-R proteins. The LDL-R proteins then extract LDL-C, lowering overall LDL-C levels. In 2011, Appellants obtained a patent that claimed Praluent by its amino acid sequence. The FDA approved Praluent in 2015. Amgen sued Appellants. Appellants stipulated to infringement. The district court enjoined the sale of Praluent. The Federal Circuit reversed in part. The district court erred by excluding Appellants’ evidence regarding post-priority-date evidence of enablement and improperly instructed the jury on written description. View "Amgen Inc. v. Sanofi" on Justia Law

Dr. David Jang, M.D., is the named inventor of the patent, which is directed to a coronary stent. Jang assigned the patent to BSC. BSC agreed to pay a royalty if it ever produced a product that would infringe the patent. Jang sued, based on BSC’s “Express stent.” BSC sought ex parte reexamination, then sought to include invalidity defenses in Jang’s suit. The district court denied the motion, deeming invalidity defenses “irrelevant” as to whether BSC owed royalties for past sales. The Patent and Trademark Office subsequently cancelled the asserted claims as unpatentable. The court denied BSC’s motion in limine to preclude Jang from presenting a doctrine of equivalents theory, finding that Jang’s experts sufficiently explained his doctrine of equivalents theory in their expert reports. The jury ultimately found no literal infringement, but found infringement under the doctrine of equivalents. Following through on its earlier decision, the district court conducted an evidentiary hearing on ensnarement. Concluding that Jang did not meet his burden of persuasion, which includes providing a proper hypothetical claim that does not ensnare the prior art, the district court vacated the jury verdict and entered judgment of non-infringement. The Federal Circuit affirmed the entry of judgment of non-infringement. View "Jang v. Boston Scientific Corp." on Justia Law