Justia Drugs & Biotech 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

Novozymes’s 723 patent, entitled “Alpha-Amylase Mutants with Altered Properties,” relates to recombinant enzyme technology. Enzymes are proteins that catalyze biochemical reactions; they facilitate molecular processes that would not occur or would occur more slowly in their absence. The 723 patent claims particular modified enzymes with improved function and stability under certain conditions. Novozymes sued DuPont, alleging infringement. DuPont counterclaimed, seeking a declaratory judgment of invalidity for failing to satisfy enablement and written description requirements of 35 U.S.C. 112. The district court granted Novozymes summary judgment on the issue of infringement and denied DuPont summary judgment of invalidity. A jury concluded that the claims were not invalid and awarded infringement damages of more than $18 million, but the district court granted DuPont’s post-trial motion for judgment as a matter of law that the claims are invalid for failure to satisfy the written description requirement. The Federal Circuit affirmed. To actually possess the variant enzymes claimed in the patent would require Novozymes to confirm its predictions by actually making and testing individual variants or at least identifying subclasses of variants that could be expected to possess the claimed properties, which it did not do before filing its 2000 application. View "Novozymes A/S v. DuPont Nutrition Biosciences, APS" on Justia Law

The 096 application states that “[p]athologies of the gastrointestinal (GI) tract may exist for a variety of reasons such as bleeding, lesions, angiodisplasia, Crohn’s disease, polyps, celiac disorders, and others.” It can be difficult to detect the pathologies, although the majority of pathologies result in changes of color and/or texture of the inner surface of the GI tract and may be due to bleeding. The 096 application is directed to a system for detection of blood within a body lumen, such as the esophagus, and includes a swallowable capsule having an in-vivo imager for obtaining images from within the body lumen. An examiner rejected the claims (35 U.S.C. 103) as obvious over several prior art references. The Board of Patent Appeals and Interferences and Federal Circuit affirmed. View "In re: Adler" on Justia Law

Synthes owns a patent, issued in 2006, directed to a system for repairing fractures in long bones, such as the femur, using a bone plate along the outside of the fractured bone, attached by anchors inserted through predrilled holes in the plate and then into the bone. The Patent and Trademark Office granted Smith & Nephew’s 2009 reexamination request and rejected all 55 claims of the patent as obvious based on prior art. The Board of Patent Appeals upheld the rejections of 31 of the claims, but reversed the rejections of 24. The Federal Circuit reversed, holding that Smith & Nephew met its burden of showing that the claims at issue would have been obvious. The patentability of the invention turns on the structure of the holes, not the special nature of the non-locking screws. The conical, partially threaded holes were well known in the art, as was the advantage of adding more of them to the head of a bone plate in place of unthreaded holes. The screws and the holes perform a conventional, expected function in securing the plate. View "Smith & Nephew, Inc. v. Rea" on Justia Law

In 2003, Fresenius, a manufacturer of hemodialysis machines sought declaratory judgments of invalidity and non-infringement with respect to Baxter’s 434 patent, covering a dialysis machine with an integrated touch screen interface. Baxter counterclaimed for infringement. The Federal Circuit affirmed a determination that the claims at issue were not invalid, but remanded for reconsideration of an injunction and post-verdict damages. While the appeal was pending, the United States Patent and Trademark Office completed reexamination of the patent and determined that all asserted claims were invalid. The Federal Circuit affirmed. Meanwhile the district court entered judgment against Fresenius in the infringement proceedings. The Federal Circuit vacated; in light of the cancellation of the asserted claims and the fact that the infringement suit remains pending, Baxter no longer has a cause of action. View "Fresenius USA, Inc. v. Baxter Int'l, Inc." on Justia Law

This case involved disputes over licensing agreements for, inter alia, the RS 3400 blood irradiation device. At issue was whether the Federal Circuit has exclusive jurisdiction to hear an appeal of a breach of contract claim that would require the resolution of a claim of patent infringement for the complainant to succeed. The court concluded that it did not have appellate jurisdiction and resolved dispositive issues in favor of Rad Source, leaving a single dispositive issue for certification: When a licensee enters into a contract to transfer all of its interests in a license agreement for an entire term of a license agreement, save one day, but remains liable to the licensor under the license agreement, is the contract an assignment of the license agreement, or is the contract a sublicense?View "MDS (Canada) Inc., et al. v. Rad Source Technologies, Inc." on Justia Law

Wyeth’s patents relate to the use of rapamycin for treatment and prevention of restenosis, the renarrowing of an artery. To open a blocked artery, a doctor guides a balloon catheter to the site of accumulated plaque and inflates the balloon to crush the plaque. As the balloon inflates it may cause injury to the arterial wall that leads to restenosis. The claims recite a method of treating or preventing “restenosis ... which comprises administering an antirestenosis effective amount of rapamycin.” In general, “rapamycin” may refer to a class of compounds; the parties agree that the specification discloses only one rapamycin species, sirolimus. In Wyeth’s infringement action, the district court adopted Wyeth’s proposed construction of “rapamycin,” but entered summary judgment, finding the patents invalid for nonenablement. The Federal Circuit affirmed, finding that the specification does not enable one of ordinary skill to practice the asserted claims without undue experimentation. View "Wyeth & Cordis Corp. v. Abbott Labs." 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