Justia Drugs & Biotech Opinion Summaries

The University of Minnesota owns the 281 and 291 patents, which are directed to “septal occluders,” medical devices for repairing holes in the septum of the heart, using a catheter threaded through a vein. The University accused AGA of infringing both patents. AGA’s accused septal occluders are one-piece devices made from tubes of wire mesh. After claim construction, the district court granted summary judgment that the 291 patent was not infringed and that the asserted claims of the 281 patent were invalid as anticipated. The Federal Circuit affirmed. The district court properly construed the terms “affixed” and “conjoint” to conclude that the 291 patent requires two physically separate disks. View "Regents of the Univ. of MN v. AGA Med.Corp." on Justia Law

Piperidine derivatives are commonly used as active ingredients in antihistamines. D’Ambra, AMRI’s president, found the prior art processes for making piperidine derivatives inefficient and overcame the deficiencies by synthesizing piperidine derivatives using piperidine and cyclopropylketone (CPK) intermediates at an earlier stage in the reaction. The processes developed by Dr. D’Ambra have the stated advantage of more readily separating out a substantially pure piperidine derivative end product, if desired. Sanofi-Aventis, the exclusive licensee of AMRI’s 703 patent, uses the processes to produce large quantities of fexofenadine, which is the active ingredient in its antihistamines marketed under the brand name Allegra® and Allegra-D® 24 Hour. The parties stipulated to a noninfringement judgment following the district court’s Markman opinion, which consolidated numerous patent infringement cases and construed terms of the 703 patent, among others. The Federal Circuit reversed and remanded, holding that the district court erred in construing “substantially pure.” View "Aventis Pharma, Inc. v. Amino Chem., Ltd." on Justia Law

Sunovion and Dey plaintiffs were simultaneously developing pharmaceutical products to treat chronic obstructive pulmonary disease by storing the compound formoterol in an aqueous solution and administering it through a nebulizer. Sunovion filed a patent application, followed by an application to test its products in human subjects. It then received a patent and held clinical trials, before ultimately releasing a commercial product. Dey likewise filed a series of patent applications, received several patents, ran human subject trials, and released a commercial product. Dey’s patent applications were filed after Sunovion’s, and its patents were issued after consideration of Sunovion’s patent. When Dey sued Sunovion for patent infringement, the district court held that some of Dey’s patents were invalid because a Sunovion clinical trial in which Sunovion tested its own product constituted anticipated Dey’s inventions and a prior public use within the meaning of 35 U.S.C. 102(b). The Federal Circuit reversed. Sunovion has not shown that it is entitled to summary judgment based on its assertion that its use of formulations meeting the limitations of Dey’s later-issued patents constituted a public use of Dey’s inventions within the meaning of section 102(b). View "Dey,L.P. v. Sunovion Pharma, Inc." on Justia Law

In 1985, Behringwerke filed a U.S. patent application directed to the use of DNA sequences (enhancers) identified in human cytomegalovirus. An enhancer, when introduced into a cell that produces a drug, can enable the cell to produce the drug at a much higher rate. In 1992, Behringwerke and Genentech entered into a licensing agreement related to enhancers that matured into the patents-in-suit; for fixed annual payments, Genentech could practice the patents for research purposes. Genentech was to pay a royalty on sales of commercially marketable goods incorporating a “Licensed Product.” The Agreement, governed by German law, required that disputes be settled by arbitration. Behringwerke sold its pharmaceutical business to Sanofi, but the Agreement and patent rights stayed with Hoechst; both are German entities. In 2008, Sanofi sued Genentech for infringement based on sales of the allegedly infringing drugs Rituxan and Avastin, which Genentech had not identified as licensed products. Hoechst demanded arbitration before a European arbitrator. The district court found no infringement. The Federal Circuit affirmed. Arbitration continued. On remand, Genentech sought to enjoin Sanofi from continuing the foreign arbitration. The district court denied the motion, finding that Hoechst is a party to the arbitration, but not a party to the litigation and that an injunction would frustrate policies favoring enforcement of forum selection clauses, and would not be in the interest of international comity. The arbitrator determined that German substantive law, not U.S. patent law, would be used, that a drug could be a licensed article even though it did not contain the patented enhancers, if those enhancers were used in its manufacture, and that Genentech was liable for damages. The Federal Circuit affirmed that Genentech was not entitled to an injunction. View "Sanofi-Aventis Deutschland, GMBH v. Genentech, Inc." on Justia Law

Combigan®, used to treat glaucoma, is a combination of the well-known alpha2-agonist Alphagan® and the well-known beta-blocker Timoptic® and contains the preservative benzalkonium chloride, which is widely-used in ophthalmic formulations. Allergan holds four patents related to Combigan®. The asserted claims are directed to a composition of 0.2% brimonidine and 0.5% timolol, expressed in different ways, some claims are directed to a fixed combination, others are directed to a method of treatment by administering the composition twice daily, and others are directed to packaging material indicating that twice daily administration of the composition is useful for treating glaucoma or ocular hypertension. Defendants submitted to the U.S. Food and Drug Administration an Abbreviated New Drug Application, seeking approval to market a generic version of Combigan®. Allergan sued under 35 U.S.C. 271(e)(2)(A), claiming infringement of Allergan’s four Orange Book-listed patents. Prior to trial, but after claim construction, the district court granted summary judgment of non-infringement as to certain claims, the court then found each asserted claim not invalid. The Federal Circuit affirmed in part and reversed in part, finding the district court erred in finding certain claims not invalid as obvious. Defendants, however, failed to prove that another claim would have been obvious. View "Allergan, Inc. v. Sandoz, Inc." on Justia Law

Figueroa received the flu vaccine in 2008. Within 20 days, he developed numbness in his face, impaired speech, and weakness. He was diagnosed with Guillain-Barré Syndrome, a sometimes fatal nervous system disorder. Because GBS is not listed on the Vaccine Injury Table, 42 U.S.C. 300aa-14(a), it requires proof of causation, although flu vaccine GBS cases have been compensated under the National Childhood Vaccine Injury Act. Figueroa had 36 months from the onset of symptoms to file a petition under the Act (until November, 2011), but, in 2010, he died of pancreatic cancer. His widow timely sought compensation for the vaccine-related neurological injuries suffered prior to his death. A special master dismissed, reasoning that because Figueroa had died of pancreatic cancer, a non-vaccine-related cause, Ms. Figueroa lacked standing to seek injury compensation. The Court of Federal Claims affirmed. The Federal Circuit reversed, interpreting a section that provides: “any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine ... may ... file a petition for compensation,” 42 U.S.C. 300aa-11(b)(1)(A) View "Figueroa v. Sec'y of Health & Human Servs." on Justia Law

The 753 patent is directed to a heart rate monitor that purports to improve upon the prior art by effectively eliminating noise signals during the process of detecting a user’s heart rate. According to the patent, prior art monitors did not eliminate signals given off by skeletal muscles (EMG signals), which are brought about when users move their arms or squeeze the monitor with their fingers. Biosig, the assignee of the 753 patent, brought a patent infringement action against Nautilus. After claim construction of the disputed term ”space relationship,” the district court declared the patent invalid. The Federal Circuit reversed and remanded, finding the claims at issue not invalid for indefiniteness. View "Biosig Instruments, Inc. v. Nautilus, Inc." on Justia Law

In the mid-1990s, Biogen scientists discovered that patients with Chronic Lymphocytic Leukemia could be treated using anti-CD20 antibodies like Biogen’s Rituxan. Biogen obtained the 612 patent covering a method for treating patients with CLL involving administering a therapeutically effective amount of the anti-CD20 antibody, entitled “Treatment of Hematologic Malignancies Associated with Circulating Tumor Cells Using Chimeric Anti-CD20 Antibody.” The patent was not limited to any particular type of antiCD20 antibody. In 2002, GSK and Genmab developed a breakthrough anti-CD20 antibody, Arzerra, which is distinctly different from Rituxan in several respects. Unlike Rituxan, which is a chimeric antibody, Arzerra is a fully human antibody, with less risk that the body will reject it and it can bind longer, giving the antibody more time to kill the target B cell. In 2010, Biogen sued GSK for infringement. The district court applied a construction of “anti-CD20 antibody” that narrowed the term based on prosecution history disclaimer. Under that construction, Biogen stipulated that it could not prove infringement and appealed the claim construction. The Federal Circuit affirmed; the district court did not err in finding a clear and unmistakable disclaimer. View "Biogen Idec, Inc. v. GlaxoSmithKline, LLC" on Justia Law

First introduced in 1960, combined oral contraceptive (COC) “birth control pills,” deliver synthetic hormones that regulate the natural ovarian cycle and prevent pregnancy. Bayer filed an application directed to a low-dose, extended-regimen COC in 1993, which eventually led to the 564 patent. Bayer received final approval to market YAZ in the U.S. in 2006. Defendants filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market generic versions of YAZ, with certifications asserting that the 564 patent is invalid (21 U.S.C. 355(j)(2)(A)(vii)(IV). Bayer responded with patent infringement actions. The district court entered summary judgment that the patent’s claims are not invalid for obviousness in view of numerous cited prior art references. The Federal Circuit reversed, finding that Bayer did not present evidence that overcomes the plain disclosures and express motivation to combine those disclosures in the prior art. View "Bayer Healthcare Pharma, Inc. v. Watson Pharma, Inc." on Justia Law

Saffran is the owner and sole named inventor of the 760 patent, entitled “Method and Apparatus for Managing Macromolecular Distribution,” which concerns “treatment of injured tissues within human or animal bodies, specifically ... the way injured tissues are joined and the way macromolecules are directed to promote healing.” The patent discloses methods and devices for treating injured tissues by sequestering particles and macromolecules in a defined space using a selectively permeable barrier. The specification primarily describes the invention in terms of a strategy for treating serious bone fractures, known as complex or comminuted fractures, where the bone has been shattered into numerous fragments. The district court held Cordis liable for infringing multiple claims of the patent. The Federal Circuit reversed, holding that the district court erroneously construed the “device” and “release means” limitations of the asserted claims. View "Saffran v. Johnson & Johnson" on Justia Law