Justia Drugs & Biotech Opinion Summaries

Index and Gilead were developing drugs for treating the hepatitis C virus (HCV). Idenix alleged that the imminent FDA approval, and launch, of Gilead’s HCV treatment drug sofosbuvir would infringe Idenix’s 597 patent. After a jury trial, Gilead stipulated to infringement under the district court’s claim construction but argued that the patent was invalid for failure to meet the written description and enablement requirements. The jury found for Idenix, upheld the patent and awarded damages. The district court denied Gilead’s motion with respect to written description but granted judgment as a matter of law on enablement, holding the 597 patent invalid. The Federal Circuit affirmed as to non-enablement and held that the patent is also invalid for lack of written description. Although the level of skill in the art is high, the patent does not provide enough meaningful guidance or working examples, across the full scope of the claim, to allow a person of ordinary skill in the art to determine which nucleosides would be effective against HCV without extensive screening. The immense breadth of screening required amounts to "undue experimentation." Given the conspicuous absence of that compound, a person of ordinary skill in the art would not “visualize or recognize the members of the genus” as including 2'-fluoro-down, and the specification could not demonstrate that the inventor had possession of that embodiment at the time of filing. View "Idenix Pharmaceuticals LLC v. Gilead Sciences Inc." on Justia Law

Horizon’s patents generally relate to methods and compositions for treating osteoarthritis and share a substantially similar specification; there are method-of-use patents and formulation patents. Both groups of patents are listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for Horizon’s PENNSAID® 2% product, a nonsteroidal anti-inflammatory drug (NSAID) and the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees. Prior art, PENNSAID® 1.5%, also treats osteoarthritis knee pain but differs from PENNSAID® 2% both in the formulation and recommended dosage. Actavis sought to market a generic version of PENNSAID 2% and filed an Abbreviated New Drug Application (ANDA) with certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV), stating that the patents-at-issue were invalid or would not be infringed by Actavis’s generic product. Horizon filed an infringement suit under 35 U.S.C. 271(e)(2)(A). The Federal Circuit affirmed findings of invalidity and noninfringement, upholding claim construction that the terms “impurity A”; “degrades at less than 1% over 6 months”; and “consisting essentially of” are indefinite. Actavis’s ANDA label did not induce infringement of the method-of-use patent. View "HZNP Medicines LLC v. Actavis Laboratories UT, Inc." on Justia Law

Non-small cell lung cancer (NSCLC) was the leading cause of cancer deaths in 2000. The standard for treating NSCLC was chemotherapy, which ameliorated some lung cancer-related symptoms, but was limited in use due to toxicity. In response to a need for a therapy that would effective and well-tolerated, investigators pursued targeted therapies as alternatives to chemotherapy. A great majority of alternative therapies for NSCLC failed in clinical trials. One compound that ultimately gained FDA approval was erlotinib. OSI markets erlotinib under the name Tarceva®, which is covered by the 221 patent, which issued in 2005. On inter partes review, the Patent Board found certain claims unpatentable under 35 U.S.C. 103, in light of prior art and the 10-K disclosure filed by OSI with the Securities and Exchange Commission. The Federal Circuit reversed. Substantial evidence did not support the Board’s finding that the asserted combinations of prior art or prior art and the 10-K disclosures each would have provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal. View "OSI Pharmaceuticals, LLC v. Apotex Inc" on Justia Law

Allergan’s patents, entitled “Combination of Brimonidine and Timolol for Topical Ophthalmic Use,” the Patents-in-Suit share a common specification that relates “to the topical ophthalmic use of brimonidine in combination with timolol . . . for treatment of glaucoma or ocular hypertension.” Allergan sued Sandoz, asserting that Sandoz’s Abbreviated New Drug Application (ANDA) for a generic version of Allergan’s ophthalmic drug Combigan® infringed those patents. The district court granted Allergan a preliminary injunction. The Federal Circuit affirmed, limiting a number of “wherein” clauses in the patents. Both Allergan and the Examiner explicitly relied on the “wherein” clauses to distinguish the claimed methods over the prior art during prosecution. The “wherein” clauses were neither unnecessary nor irrelevant. View "Allergan Sales, LLC v. Sandoz, Inc." on Justia Law

Arthrex’s 541 patent describes a surgical suture anchor used to reattach soft tissue to bone. The disclosed “fully threaded suture anchor” includes “an eyelet shield that is molded into the distal part of the biodegradable suture anchor.” In an inter partes review, the Patent Trial and Appeal Board ruled two claims invalid. In doing so, the Board employed different language than Smith & Nephew, Inc.’s petition to explain why a person of ordinary skill in the art would have been motivated to combine the teachings of the prior art. The Federal Circuit affirmed. The Board’s minor variation in wording does not violate the safeguards of the Administrative Procedure Act and did not deprive Arthrex of an opportunity to be heard. The Board’s findings have substantial evidence support, its claim constructions are correct, and Arthrex has not articulated a cognizable constitutional challenge to inter partes review for its patent. View "Arthrex, Inc. v. Smith & Nephew, Inc." on Justia Law

Nalpropion markets Contrave® for weight management in overweight or obese adults, with three Orange Book-listed patents. The 626 patent is drawn to a method for treating overweight or obesity comprising diagnosing an individual as suffering from overweight or obesity by body mass index, administering bupropion in an amount effective to induce weight loss, and administering naltrexone in an amount effective to enhance the weight loss activity of bupropion. The 195 patent is also directed to methods of treating overweight or obesity, but the claims are drawn to specific dosages of sustained-release naltrexone and bupropion that achieve a specific dissolution profile. The 111 patent is directed to a composition of sustained-release bupropion and naltrexone for affecting weight loss. Actavis filed an abbreviated new drug application seeking to enter the market with a generic version of Contrave® before the expiration of those patents. Nalpropion alleged infringement; Actavis brought invalidity counterclaims. The district court held each claim not invalid and infringed. The Federal Circuit affirmed in part, rejecting Actavis’s argument that a claim of the 195 patent lacked adequate written description support because its claimed dissolution profile was achieved using one method but the specification discloses data obtained using another method. The court reversed with respect to the 626 patent; it would have been obvious for a person of skill to combine bupropion and naltrexone for treating overweight and obesity because both drugs were known to cause weight loss. View "Nalpropian Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc." on Justia Law

Sanofi’s 170 and 592 patents respectively claim the compound cabazitaxel and methods of using it. Sanofi markets cabazitaxel under the trade name Jevtana® to treat certain drug-resistant prostate cancers. Both patents are listed in the Orange Book as covering cabazitaxel. Cabazitaxel belongs to a family of compounds called taxanes and is the third and most recent taxane drug to gain FDA approval. The others are paclitaxel, approved in 1992, and docetaxel, approved in 1996. Defendants filed Abbreviated New Drug Applications to market generic versions of cabazitaxel before the expiration of the patents, prompting Sanofi to sue for infringement. Defendants sought a declaration of invalidity. The district court found claims 7, 11, 14–16, and 26 of the 592 patent invalid as obvious and claims 1 and 2 of the 170 patent not invalid as obvious. The Federal Circuit vacated as to claims 7, 11, 14–16, and 26 of the 592 patent because there was no case or controversy with respect to those claims when the district court issued its decision. Sanofi’s disclaimer of the disclaimed claims mooted any controversy over them. The court affirmed that the 170 patent is not invalid as obvious over docetaxel. View "Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC" on Justia Law

Lilly markets the compound pemetrexed in the form of a disodium salt as Alimta®, which is indicated, both alone and in combination with other active agents, for treating certain types of non-small cell lung cancer and mesothelioma. Patent disputes about Alimta® reach back more than a decade. DRL, Hospira, and Actavis submitted New Drug Applications (NDA) under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(b)(2), relying on Lilly’s clinical data for pemetrexed disodium but each seeks to market different pemetrexed salts. The district court concluded that the NDA submission infringed the 209 patent under 35 U.S.C. 271(e)(2) and prohibited FDA approval of the products at issue until the expiration of that patent. The Federal Circuit reversed in part. The finding of literal infringement in the Hospira Decision was clearly erroneous in light of the court’s claim construction of “administration of pemetrexed disodium.” The court otherwise affirmed the infringement holding; the district court did not err in its application of the doctrine of equivalents in either decision. View "Eli Lilly and Co. v. Hospira, Inc." on Justia Law

Anjinomoto’s 655 patent claims E. coli bacteria that have been genetically engineered to increase their production of aromatic L-amino acids, such as L-tryptophan, during fermentation, as well as methods of producing aromatic L-amino acids using such bacteria. Ajinomoto filed a complaint against CJ with the International Trade Commission, alleging that CJ was importing certain products that infringed the patent. CJ used several strains of E. coli to produce L-tryptophan products, which it then imported into the United States. The Commission determined that CJ’s earlier strains did not infringe but that CJ’s two later strains did, and that the relevant claim of the 655 patent is not invalid for lack of an adequate written description. The Federal Circuit affirmed, upholding the Commission’s construction of “replacing the native promoter . . . with a more potent promoter.” The court rejected CJ’s claim of prosecution history estoppel and held that the 655 patent expressly provides four examples of “more potent promoters,” so that the Commission supportably found that a skilled artisan could make relatively predictable changes to the native promoter to arrive at a more potent promoter. View "Ajinomoto Co., Inc. v. International Trade Commission" on Justia Law

A teratogen is an agent known to disturb the development of an embryo or fetus. Teratogenic drugs, such as thalidomide, can cause birth defects or other abnormalities following fetal exposure during pregnancy. Celgene’s 501 and 720 patents are generally directed to methods for safely distributing teratogenic or other potentially hazardous drugs while avoiding exposure to a fetus to avoid adverse side effects of the drug. The patents describe the System for Thalidomide Education and Prescription Safety that compiles information about patients and prescribers to prevent the prescription from being filled before appropriate counseling. The Coalition for Affordable Drugs (CFAD) sought inter partes review. The Patent Trial and Appeal Board determined that all of the claims of the 501 patent and multiple claims of the 720 patent were obvious. The Federal Circuit affirmed and held that the retroactive application of IPR proceedings to pre-Leahy-Smith America Invents Act, 125 Stat. 284-341, patents is not an unconstitutional taking under the Fifth Amendment. IPRs do not differ sufficiently from the PTO reconsideration avenues available when the patents here were issued to constitute a taking. View "Celgene Corp. v. Peter" on Justia Law