Justia Drugs & Biotech Opinion Summaries

The patent claims methods for preparing multi-cryopreserved hepatocytes (a type of liver cell), used for evaluating drug candidates. The owner claimed infringement and obtained a preliminary injunction. The Federal Circuit affirmed. The district court acted within its discretion in finding likelihood of success on the merits, considering defenses of non-infringement, obviousness, written description, and inequitable conduct. The court considered and properly addressed the public's interest in obtaining an adequate supply of pooled multi-cryopreserved hepatocyte products. View "Celsis In Vitro, Inc. v. Cellzdirect, Inc." on Justia Law

The 2006 patent, entitled "Surgical Devices Having a Polymeric Material with a Therapeutic Agent and Methods for Making Same" and the 2007 patent, entitled "Surgical Devices Containing a Heat Bondable Material with a Therapeutic Agent" have identical specifications and are directed to a surgical implant in which a polymeric material is bonded by heat to an expandable implant, where the polymer includes a therapeutic agent such as an antibiotic. The owner of the patents sued. The district court made a finding of noninfringement. The Federal Circuit affirmed the finding and construction of the term "bonded." The district court then declared the case exceptional under 35 U.S.C. 285 and awarded defendant attorney and expert witness fees totaling $4,683,653.03. The Federal Circuit affirmed. The district court opinion indicates its finding that plaintiff acted in bad faith in filing a baseless infringement action and continuing to pursue it despite no evidence of infringement and engaged in vexatious and unjustified litigation conduct that unnecessarily prolonged the proceedings and forced defendant to incur substantial expenses. View "MarcTec, LLC v. Johnson & Johnson" on Justia Law

In the first appeal in a case regarding clopidogrel bisulfate tablets, sold by plaintiff under the brand name Plavix®, the Federal Circuit affirmed the district court's grant of a preliminary injunction concerning defendants' generic product. In the second appeal, the court affirmed a judgment that the patent-in-suit is not invalid, was infringed, and not unenforceable. The district court then awarded prejudgment interest and denied defendants' motion for leave to file a supplemental answer, affirmative defenses, and counterclaims pleading patent misuse and breach of contract. The Federal Circuit reversed in part. The district court erred by awarding prejudgment interest in addition to actual damages specified in a settlement agreement. The court affirmed the district court’s holding that defendant is jointly and severally liable for all damages and denial of defendant's motion. View "Sanofi-Aventis v. Apotex" on Justia Law

The patents at issue relate to balloon-expandable stents, used to treat occluded blood vessels. Following a remand, the district court found that defendants did not literally infringe the patents and rejected claims that the patents were invalid for lack of description or due to inequitable conduct. The Federal Circuit affirmed. Based on the court's proper clarification of its construction of the term "undulating," there was not substantial evidence to support a finding of infringement, nor was there substantial evidence of inequitable conduct. View "Cordis Corp. v. Boston Scientific Corp." on Justia Law

The district court granted summary judgment that all of the claims in plaintiff's patents were ineligible under 35 U.S.C. 101, which excludes from patentability "laws of nature, natural phenomena, and abstract ideas" because they were directed to the "abstract idea" that there is a relation between the infant immunization schedule for infectious diseases and the later occurrence of chronic immune-mediated (non-infectious) disorders. The Supreme Court vacated the Sixth Circuit's 2008 decision. On remand the Federal Circuit affirmed with respect to one patent's ineligibility, but vacated a portion of the judgment granted under the "safe harbor" provision of 35 U.S.C. 271(e)(1). One set of claims did not include putting knowledge to practical use, but was directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases. Others require the further act of immunization in accordance with a lower-risk schedule, moving from abstract scientific principle to specific application. View "Classen Immunotherapies, Inc. v. Biogen Idec" on Justia Law

Plaintiff owns a patent on an FDA-approved (21 U.S.C. 355(b)(2) ) pharmaceutical nasal spray Fortical, used to treat osteoporsis, with the active ingredient salmon calcitonin. In its FDA filing, plaintiff identified the drug as bioidentical to Miacalcin. Defendant filed an Abbreviated New Drug Application with the FDA, stating intent to make, use, offer to sell, sell, and/or import a generic version of Fortical product before the expiration of plaintiff's patent. Plaintiff claimed infringement. Defendant alleged invalidity under 35 U.S.C. 101, 102, 103,and 112, noninfringement and inequitable conduct in failure to disclose an allegedly material piece of prior art and making allegedly misleading statements during patent prosecution. The district court found that the patent would not have been obvious at the time of invention, denied defendant's motion to breach the attorney-client privilege under the crime-fraud exception, and determined that defendant had waived several counter-claims. The Federal Circuit affirmed. Even accepting that there was a design need and market pressure to develop a pharmaceutical formulation bioequivalent to Miacalcin, there was no evidence that the claim would be an obvious solution to those motivations.View "Unigene Labs, Inc. v. Apotex, Inc." on Justia Law

Plaintiff, a pharmaceutical company, owns a patent that claims conjugated estrogen pharmaceutical compositions for use in hormone replacement therapies. Plaintiff alleged infringement of the patent based on defendant's Abbreviated New Drug Application for a generic version of plaintiff's hormone replacement therapy product, arguing the doctrine of equivalents. The district court entered summary judgment for defendant. The Federal Circuit affirmed. Plaintiff failed to rebut the presumption of prosecution history estoppel based on unforeseeability. The doctrine of prosecution history estoppel prevents a patent owner from recapturing, through the doctrine of equivalents, subject matter surrendered to acquire the patent. Because plaintiff narrowed the scope of the patent's claims in response to a prior art rejection, a presumption of prosecution history estoppel applies. View "Duramed Pharm., Inc. v. Paddock Labs, Inc." on Justia Law