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

Sunovion owns the rights to the patent, which is directed to pharmaceutical compositions of the single-enantiomer drug eszopiclone, the active ingredient in the chiral drug marketed as a sleep medication with the brand name Lunesta®. The district court held, on summary judgment, that Dr. Reddy’s Laboratories did not infringe certain claims in that patent. The Federal Circuit reversed. Although the district court did not err in construing the claim term “essentially free” as containing less than 0.25 percent levorotatory isomer, Sunovion was entitled to a judgment of infringement as a matter of law under 35 U.S.C. 271(e)(2)(A). A generic manufacturer’s “certification” pledging not to infringe cannot override the conclusion that when a drug manufacturer seeks FDA approval to market a generic compound within the scope of a valid patent, it is an infringement as a matter of law. View "Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc." on Justia Law

The patents at issue relate to methods and devices for sealing a vascular puncture, which occurs when a medical procedure requires a puncture through the skin and into a vein or artery to insert a medical device, such as a catheter, into a patient’s vasculature. After such a procedure, the medical professional typically removes the medical device from the vasculature. Prior to development of the technology at issue, the medical professional was then required to apply external pressure to the puncture site until clotting occurred, sometimes for an extended period of time. This caused discomfort and increased the recovery time. The Janzen and Fowler patents disclose methods and devices for sealing a vascular puncture to improve patient recovery. The district court held that the safe-harbor provision of 35 U.S.C. 121 protects the Janzen patent from invalidity due to double-patenting; construed key terms in the Janzen patent; and found that the Fowler patents were not invalid for obviousness. The Federal Circuit reversed the safe harbor ruling, which rendered the rulings regarding the claim constructions moot, and affirmed that the Fowler patents are nonobvious and not shown to be invalid. View "St. Jude Med., Inc. v. Access Closure, Inc." on Justia Law

Bayer’s patent concerns genetically modifying plants to confer resistance to a common herbicide (2,4-D) by inserting a particular DNA segment into plant cells, which reproduce to create new cells that contain that gene. Those cells produce an enzyme that catalyzes a biochemical reaction with 2,4-D in which the herbicide is broken down into something harmless to the plant. A plant with the gene survives 2,4-D application while surrounding weeds do not. At the time of the patent application, the inventors had sequenced one gene coding for one enzyme, using a test supposedly capable of finding other, similar genes. In writing the application, they claimed a broad category based on the function of the particular enzyme, defining the category by using a term with established scientific meaning. Years before the patent issued, experiments showed that the term did not apply to the particular enzyme whose gene was sequenced, but Bayer did not change its claim language. When Bayer sued Dow for infringement, Bayer recognized that the term’s established scientific meaning, did not cover the accused product, which was, itself, different from the enzyme whose gene Bayer’s inventors had sequenced. Bayer argued for broad functional claim construction. The district court entered summary judgment of noninfringement, citing particularly the great breadth of the asserted functional construction. The Federal Circuit affirmed. View "Bayer CropScience AG v. Dow AgroSciences, LLC" on Justia Law

SkinMedica owns the 494 and 746 patents, which relate to methods for producing pharmaceutical compositions containing “novel conditioned cell culture medium compositions ... [and] uses for the[m].” Skinmedica filed a patent infringement suit against Histogen for producing dermatological products according to methods covered by the claims of those patents. The district court entered summary judgment of noninfringement after construing the phrase “culturing ... cells in three-dimensions” as “growing ... cells in three dimensions (excluding growing in monolayers or on microcarrier beads).” The Federal Circuit affirmed. View "SkinMedica Inc v. Histogen Inc" on Justia Law

Prior art concerning treatment of the skin disease, psoriasis, discloses a combination treatment of a vitamin D analog and a corticosteroid. Leo’s patent calls for simultaneous treatment with vitamin D and corticosteroids to heal psoriasis faster and more effectively; a storage-stable combination of vitamin D and corticosteroids in a single formulation did not exist in prior art because vitamin D and corticosteroids have different pH requirements for optimum stability. Because of the storage-stability problem, doctors had to prescribe a regimen that required patients to apply one drug in the morning and another at night, which caused patient compliance issues. Leo discovered that a new set of solvents, including polyoxypropylene 15 stearyl ether, solved the storage stability problem by allowing the vitamin D analog and corticosteroid to coexist in a single pharmaceutical product. The Board of Patent Appeals rejected several claims. The Federal Circuit reversed. The Board incorrectly construed the term “storage stable,” incorrectly found the claimed invention would have been obvious in view of prior art, and incorrectly weighed the objective indicia of nonobviousness. View "Leo Pharm. Prods., Ltd. v. Kappos" on Justia Law

Conventional tests for prenatal abnormalities caused by genetic abnormalities have relied on invasive and potentially risky techniques like amniocentesis to obtain fetal cells. As an alternative, scientists developed methods of analyzing DNA extracted from fetal cells floating in maternal blood to determine fetal abnormalities and other fetal traits. These methods require separating fluids from the cells and then discarding the fluids, either plasma or serum, and then separating fetal cells from the much more common maternal cells. The 540 patent discloses methods to identify fetal genetic defects by analyzing the fluid that had commonly been discarded as medical waste: maternal plasma or serum. The new tests presented fewer risks and a better rate of abnormality detection. Ariosa sought a declaratory judgment that it could use its Harmony test without infringing the 540 patent. The district court denied the patent holder’s motion for summary judgment. The Federal Circuit vacated and remanded, finding that the district court incorrectly interpreted the asserted claim terms “amplifying” and “paternally inherited nucleic acid” and improperly balanced factors regarding issuance of a preliminary injunction. View "Aria Diagnostics, Inc. v. Sequenom, Inc." on Justia Law

Rembrandt’s patent relates to contact lenses that have a highly wettable surface and are permeable to oxygen. The patent discloses a soft gas permeable lens with an acrylic layer on the surface of the lens body that increases the wettability and comfort of the contact lens. The district court held that Johnson & Johnson did not infringe the patent. The Federal Circuit affirmed. View "Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care, Inc." on Justia Law

Generic manufacturers submitted Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Copaxone®, a drug used in treating multiple sclerosis. Teva, which markets Copaxone®, sued the generic manufacturers for patent infringement under 35 U.S.C. 271(e)(2)(A). The patents at issue share a common specification and are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Copaxone®. The patents include claims reciting a product called copolymer-1 and recite two methods of making copolymer-1: one using statistical average measures and the other describing how many molecules in a polymer sample have molecular weights that fall within an arbitrarily set range. The district court found that various claims of the nine patents by Teva are infringed, based on holdings regarding indefiniteness, nonenablement, and obviousness. The Federal Circuit affirmed in part and reversed in part, holding that Group I claims are invalid for indefiniteness, but that Group II claims were not proven indefinite. The district court did not err in finding that the claims are infringed, and that the generic manufacturers failed to prove that the claims would have been obvious and are not enabled. View "Teva Pharm. USA, Inc. v. Sandoz, Inc." on Justia Law

The patent at issue concerns methods for preventing bovine mastitis, the inflammation of udder tissue in cows, and is entitled “Antiinfective free intramammary veterinary composition.” The summary of the invention describes how the composition employs a physical barrier within the teat canal to block introduction of mastitis-causing organisms without requiring use of antiinfectives such as antibiotics. A patent examiner rejected certain claims introduced in the context of ex parte reexamination. The Patent Trial and Appeal Board and Federal Circuit affirmed, finding that substantial evidence supported the Board’s finding that one claim failed the written description requirement because the disclosure did not “describe[] a formulation excluding a specific species of the anti-infective genus, while permitting others to be present.” View "In re: Bimeda Research & Dev. Ltd." 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