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

Dutasteride is useful in the treatment of androgen responsive diseases. Androgens are a class of hormones; testosterone is the major circulating androgen. Androgens are implicated in diseases including benign prostatic hyperplasia, prostate cancer, acne, male pattern baldness and hirsutism. In some target tissues, including prostate and skin tissue, testosterone produces certain effects by first being converted to dihydrotestosterone. Dutasteride inhibits the enzymes that catalyze the conversion, mitigating some of testosterone’s physiological effects. GSK markets Avodart® and Jalyn™, which contain dutasteride and are FDA-approved to treat benign prostatic hyperplasia. GSK’s patent covers dutasteride and any “pharmaceutically acceptable solvate thereof.” Defendants filed Abbreviated New Drug Applications under 21 U.S.C. 355(j), seeking FDA approval to market generic versions of the drugs. As authorized by 35 U.S.C. 271(e)(2), GSK sued for infringement. Defendants stipulated to infringement, but alleged that the asserted claims were invalid for anticipation, lack of utility, lack of enablement, and inadequacy of the written description. The district court construed “solvate” (of dutasteride), acknowledging considerable extrinsic evidence that, in the pharmaceutical field, “solvate” is limited to crystalline complexes, no matter how created, but concluded that the specification of this particular patent directly contradicted any such narrow usage. The Federal Circuit affirmed without addressing claim construction because no matter which construction is adopted, the term “solvate” involves no performance propertyView "GlaxoSmithKline LLC v. Banner Pharmacaps, Inc." on Justia Law

Takeda owns patents that claim the formulation for the brand-name drug Prevacid® SoluTab,™ which contains the active ingredient lansoprazole, a proton pump inhibitor used to treat acid reflux. It is the only proton pump inhibitor available as an orally disintegrable tablet. A patient allows the tablet to disintegrate in his mouth, leaving behind thousands of granules which the patient swallows. The stated objective of the 994 patent is a formulation with granules small enough to avoid a feeling of roughness in the patient’s mouth upon disintegration. In 2010, Zydus filed an abbreviated new drug application (ANDA) with the FDA, seeking to manufacture a generic version of Prevacid® SoluTab.™ Takeda filed suit, alleging that the ANDA product infringed claims of several patents. Only claim 1 of the 994 patent remains at issue. Zydus counterclaimed, alleging that claim 1 was invalid for failure to comply with 35 U.S.C. 112. The district court construed the claim term “fine granules having an average particle diameter of 400 μm or less,” accepting Takeda’s argument that the term should be construed to include a deviation of ±10%, based on a “universally accepted” 10% standard of error for particle size measurements. The Federal Circuit reversed the finding of infringement and found no invalidity. View "Takeda Pharm. Co., Ltd. v. Zydus Pharm. USA, Inc." on Justia Law

Proveris owns the 400 patent, for a mechanism to evaluate aerosol spray plumes. The apparatus evaluates delivery of drugs by inhalers or nasal sprays, by triggering a spray and collecting data on the plume with an illumination device and an imaging device. Innova made and sold the Optical Spray Analyzer (OSA). Proveris sued, alleging that OSA infringed the 400 patent. Innova conceded infringement of certain claims (including claim 3), but disputed infringement of others. The district court ruled in favor of Proveris on invalidity. A jury found that Innova did not infringe the disputed claims and that no damages had been proven. Based on the conceded infringement, the district court enjoined Innova from making or selling OSA. Innova modified OSA and began selling the new Aerosol Drug Spray Analyzer (ADSA). Proveris filed a contempt motion. Innova argued that OSA allowed a user to identify what range of images he wanted to analyze before activating the spray, while ADSA requires the user to first activate the spray and later determine what he wants to analyze. The district court ruled that, because Innova could have raised claim construction issues in the underlying infringement action, the court would not construe claim 3; Innova could not raise new invalidity arguments in contempt proceedings. The court entered a contempt order against Innova, found that the violation had been willful, and ordered disgorgement of profits. The Federal Circuit vacated, holding that the court erred in failing to construe the disputed claim language. View "Proveris Scientific Corp. v. Innovasystems, Inc." on Justia Law

The products at issue in this appeal are formulations of Athena’s RevitaLash, all of which contain a prostaglandin derivative as an active ingredient. The FDA has not taken enforcement action against, or otherwise regulated, the products. Allergan sells a product called Latisse, which also contains a prostaglandin derivative. Latisse is an FDA-approved prescription drug used for the treatment of a condition that affects eyelash growth. Allergan sued Athena for patent infringement and a violation of the Unfair Competition Law (UCL), California Business and Professions Code 17200 by violating California’s Health and Safety Code 1115501 by “marketing, selling, and distributing [its] hair and/or eyelash growth products without [a new drug] application approved by the FDA or California State Department of Health Services.” The district court rejected Athena’s claim that the Federal Food, Drug, and Cosmetic Act preempts Allergan’s UCL claim and granted Allergan an injunction on its claim that the products at issue qualify as new drugs that lack the requisite approval. The Federal Circuit vacated and remanded. The FDCA did not preempt Allergan’s UCL claim and there is no genuine dispute that the products are drugs under California law, but the injunction was overbroad. View "Allergan, Inc. v. Athena Cosmetics, Inc." on Justia Law

Institut Pasteur owns three U.S. patents, which claim methods and tools for the site-directed insertion of genes into eukaryotic chromosomes. Precision requested inter partes reexamination of each. A Patent and Trademark Office examiner rejected a number of Pasteur’s claims for obviousness, under 35 U.S.C. 103.The Patent Trial and Appeal Board affirmed the rejections, concluding that the claimed inventions were obvious extensions of two prior-art references disclosing similar methods of targeting non-chromosomal DNA in prokaryotic cells. With respect to one patent, the Federal Circuit dismissed Pasteur’s appeal as moot, because Pasteur presented only substantively amended claims and amended claims cannot be entered after the patent has expired. With respect to another patent, the court reversed the Board’s conclusion as unsupported by substantial evidence and containing an erroneous obviousness analysis, including improper discounting of Pasteur’s objective indicia of non-obviousness. The court vacated the Board’s decision on the third patent and remanded for consideration of what motivation, if any, a skilled artisan at the relevant time would have had to pursue the claimed invention. View "Institut Pasteur & Universite v. Focarino" on Justia Law

Tolmar’s filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Differin® Gel, 0.3%, a topical medication containing 0.3% by weight adapalene approved for the treatment of acne. Galderma sued Tolmar, alleging that Tolmar’s ANDA product infringed its patents. The district court ruled against Tolmar, finding the Galderma patents not invalidity for obviousness under 35 U.S.C.103. The Federal Circuit reversed, after examining prior art. While the comparable tolerability of 0.1% and 0.3% adapalene was unexpected in view of the prior art, a skilled artisan would have expected that tripling the concentration of adapalene would have resulted in a clinically significant increase in side effects, so the result does not constitute an unexpected result that is probative of nonobviousness. The commercial success of Differin® is of “minimal probative value.” View "Galderma Labs, L.P. v. Tolmar, Inc." on Justia Law

OWW owns related patents directed to cushioning devices that fit over the residual stumps of amputated limbs to make the use of prosthetics more comfortable. Some of the patents have been asserted in patent infringement suits and many have been involved in reexamination proceedings before the Patent and Trademark Office. OWW sued Alps for infringement of the 237 patent, entitled “Gel and Cushioning Devices,” lists Kania as the sole inventor and has an application date of 1996. The district court issued its claim construction order. Alps subsequently initiated the first of two consecutive ex parte reexaminations of the 237 patent. After a stay was lifted, the district court granted summary judgment to Alps, finding certain claims invalid due to the collateral estoppel effect of parallel litigation and other claims invalid for obviousness. The district court also granted OWW summary judgment of no inequitable conduct. The Federal Circuit affirmed on the issues of collateral estoppel and obviousness, but reversed and remanded on the issue of inequitable conduct. Issues of material fact regarding whether OWW committed inequitable conduct during the reexamination proceedings by withholding information preclude summary judgment.View "Ohio Willow Wood Co. v. ALPS South, LLC" on Justia Law

IL-13 is a regulatory molecule called a cytokine. Cytokines interact with cytokine receptors located on target cells. Sanofi and Pfizer were conducting research, for therapeutic and diagnostic purposes, and each discovered and filed patent applications directed to the polynucleotide encoding the IL-13 protein binding chain. The patent is awarded to the first applicant to conceive and reduce to practice the invention represented by an interference count, in accordance with Patent and Trademark Office (PTO) rules. Sanofi had a December 6, 1995 priority date. Pfizer’s filing date was March 1, 1996; Pfizer bore the burden of proving a date of conception earlier than Sanofi’s date. Pfizer presented evidence that it had isolated and identified the desired cDNA before that date, but, due to sequencing errors, did not then have a completely accurate analysis of the entire nucleotide sequence. The PTO Board found that Pfizer had “the claimed polynucleotide in hand with some additional identifying information including at least a partial sequence,” and ruled that Pfizer “established conception and actual reduction to practice of a polynucleotide within the scope of count 3” before the Sanofi date. The Federal Circuit affirmed; possession and appreciation of the actual isolated DNA is dispositive for priority of conception for an interference count directed to isolated DNA.View "Sanofi-Aventis v. Pfizer, Inc." on Justia Law

The patent concerns blood glucose monitoring systems, used by individuals with diabetes. Such systems typically consist of an electrochemical meter and disposable test strips onto which the user places a drop of blood. The strip contains “working electrodes” or “reference electrodes,” that connect to the meter during operation. Each working electrode is coated with an enzyme and a mediator. The enzyme reacts with glucose in the blood sample, releasing electrons. The mediator then transfers those electrons to the working electrode, which is connected to the meter, which measures the resulting electric current to determine blood glucose level. Meters and test strips of this general design became available in the 1980s. LifeScan’s patent claims to improve earlier systems with a method of comparing measurements from separate working electrodes. Significant differences in the readings of the working electrodes indicate problems such as inadequate sample volume or manufacturing defects, and the readings are to be discarded. A reference electrode on the strip serves as a common reference for both working electrodes. LifeScan manufactures such a system, the “OneTouch Ultra” and claimed infringement by defendant. The district court found likely infringement and entered an injunction. The Federal Circuit reversed, finding that defendant established a patent exhaustion defense. View "Lifescan Scotland, Ltd. v. Shasta Tech., LLC" on Justia Law

Synthes filed suit, alleging that SK’s M6-C and M6-L intervertebral implants infringed claims of a Synthes patent that is directed to an “Intervertebral Implant,” a prosthetic device designed to replace a diseased or degenerated disc located between adjacent vertebrae of the human spine. The Synthes patent originated from a German language Patent Cooperation Treaty application filed in 2003. The asserted claims were added by amendment in 2008. A jury found that SK’s implants did not infringe the asserted claims and that the claims were invalid for lack of written description. The Federal Circuit affirmed both the finding of invalidity and the district court’s denial of SK’s request for attorneys’ fees.View "Synthes USA LLV v. Spinal Kintetics, Inc." on Justia Law