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

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

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

In 1990 Novo began experimenting with the drug repaglinide in monotherapy treatement of Type II diabetes, conducted a study to determine whether repaglinide might be more effective in combination with metformin, and concluded that the combination obtained fasting plasma glucose levels more than eight times lower than typically achieved by metformin alone. Novo filed a provisional patent application for the combination in 1997. The examiner rejected the initial application as obvious. In its fifth response, Novo included the Sturis report, concluding that the combination has synergistic properties in type 2 diabetic human patients. The examiner withdrew her rejection, based solely upon the Sturis declarations and reconsideration of the synergistic effects. The 358 patent issued in 2004. In 2005, pursuant to the Hatch-Waxman Act, Caraco filed an Abbreviated New Drug Application requesting FDA approval to sell a generic version of repaglinide, and certifying that the 358 patent was invalid or would not be infringed. Novo responded with an infringement lawsuit. The district court held that claim 4 of the patent was invalid because of obviousness and that the patent was not enforceable because of inequitable conduct. The Federal Circuit affirmed with respect to obviousness but reversed with respect to inequitable conduct. View "Novo Nordisk A/S v. Caraco Pharma. Labs., Ltd." on Justia Law

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