Justia Drugs & Biotech Opinion Summaries

1999, Drs. Dawson and Bowman submitted the patent application that led to the issuance of the two patents at issue, which concern a method for topically treating and preventing infections of the eye. They claim to overcome difficulties in existing methods through a process for topically applying an azalide antibiotic to the eye. Both patents are entitled “Topical Treatment or Prevention of Ocular Infections.” In 2007, in order to provoke an interference, UCSF filed a patent application that named Dr. Dawson as the sole inventor and generally copied the specification and claims from the patents. Dr. Dawson declined to join UCSF’s submission. The Patent and Trademark Office’s Board of Patent Appeals and Interferences found that Dr. Dawson did not conceive of the claimed inventions by himself prior to his collaboration with Dr. Bowman. The Federal Circuit affirmed, noting that, apart from reduction to practice, conception requires that the inventor know how his “definite and permanent idea of the complete and operative invention ... is hereafter to be applied in practice.” View "Dawson v. Dawson & Bowman" on Justia Law

This case stemmed from Cytori's application to the FDA to market two new medical devices, the Celution 700 and the StemSource 900. Two devices that use adipose tissue as a source of stem cells that could later be used in lab analysis or, potentially, in regenerative medicine. The FDA concluded that the Celution and the StemSource were not substantially similar to devices on the market that extract stem cells from blood or bone marrow. Thus, the FDA ruled that Cytori must go through an extensive premarket approval process for new medical devices, rather than go through the streamlined premarket notification process for new devices that would be substantially equivalent to another device already on the market. Cytori appealed. As a preliminary matter, the court concluded that it was the proper forum for direct review of the FDA's substantial equivalence determination. On the merits, the court concluded that the FDA reasonably concluded and reasonably explained, for purposes of the Administrative Procedures Act, 5 U.S.C. 500 et seq., that the Celution and StemSource did not meet either the "intended use" requirement or the "technological characteristics" requirement for a substantial equivalence determination. View "Cytori Therapeutics, Inc. v. FDA" on Justia Law

This case involved a confidential document called the Project Tulip Financial Analysis (Tulip FA), which projected profits, as well as discussed the appropriate terms and benefits from a settlement, involving Solvay's highly lucrative patent on AndroGel, a topical testosterone gel. Solvay subsequently appealed the district court's decision to modify an earlier protective order and unseal the Tulip FA. The court affirmed the district court's judgment, concluding that the district court did not abuse its considerable discretion to modify its own protective order. The district court found that the passage of time had altered the balance enough so that the value of public access to the Tulip FA exceeded the value of confidentiality to Solvay. The court also vacated the stay entered by a panel of the court. View "Federal Trade Commission v. AbbVie Products LLC" on Justia Law

Fulgenzi was prescribed the generic drug metoclopramide (FDA approved in 1980), sold originally under the brand name Reglan, a drug approved for short-term treatment of patients suffering from gastroesophageal reflux disease. In her suit, claiming failure to adequately warn of risks, she alleged that taking the drug caused her to develop tardive dyskinesia, an often-irreversible neurological disorder that causes involuntary movements, especially of the lower face. In 2009, the Supreme Court held that with respect to branded drug manufacturers, state failure-to-warn suits were not preempted by the federal Food Drug and Cosmetic Act , 21 U.S.C. 301. In 2011 the Court held that such suits could not go forward against generic drug manufacturers, as it is impossible to comply simultaneously with their state duty to adequately warn and their federal duty of sameness (federal law requires generic drug labels to be the same as their branded counterpart). The district court dismissed. The Sixth Circuit reversed, noting that after the branded-drug manufacturer of metoclopramide strengthened warnings on its label, the generic manufacturer failed to update its label as required by federal law, rendering compliance with both federal and state duties no longer impossible. View "Fulgenzi v. PLIVA, Inc." on Justia Law

Hill filed a successful drug application with the FDA for a corticosteroid called "Derma-Smoothe." The FDA later approved three abbreviated new drug applications submitted by Identi for generic versions of Hill's products. Hill sued the FDA arguing that the FDA's approval of Identi's products was arbitrary and capricious under the Administrative Procedures Act (APA), 5 U.S.C. 500 et seq. The district court granted summary judgment to the FDA and Hill appealed. The court held that the district court did not abuse its discretion in refusing to consider 21 extra-record declarations; Hill's arguments challenging the FDA's decision to grant bioequivalence waivers to Identi have no merit; and the court rejected Hill's argument that the FDA should not have approved Identi's drugs because Identi did not use the same labeling as Hill. Accordingly, the court held that the FDA's actions were not arbitrary and capricious, and affirmed the district court's grant of summary judgment. View "Hill Dermaceuticals, Inc. v. FDA, et al" on Justia Law

The patent examiner rejected all of the inventors’ pending claims in an application entitled “Enzyme-Mediated Modification of Fibrin for Tissue Engineering,” filed in 2003, relating generally to the field of tissue repair and regeneration, and more specifically to matrices containing bidomain peptides or proteins. The examiner found obviousness-type double patenting over several patents. The Board of Patent Appeals and Interferences affirmed. The Federal Circuit affirmed; tO'Mahe Board did not err in concluding that the pending claims were barred under the doctrine of obviousness-type double patenting. View "In re Hubbell" on Justia Law

DHS sued VHS for misappropriation of trade secrets, breach of contract, and trademark violations. DHS engaged VHS to market and sell the drug Provasca. After that relationship ended, VHS began to manufacture, market, and sell Arterosil, a product similar in many respects to Provasca. The court held that the district court granted DHS's request for a preliminary injunction after making sufficient findings of fact to support each element of the analysis and applying the correct legal standard to those facts. Therefore, the court affirmed the district court's grant of the preliminary injunction in full and lifted the stay of the injunction. The court remanded and directed the district court to expedite the trial on the permanent injunction and to attempt to narrow the breadth of its preliminary injunction. View "Daniels Health Sciences, L.L.C v. Vascular Health Sciences, L.L.C." on Justia Law

The patents relate to a method of drug delivery via the mucous membrane lining or mucosa in the oral cavity. The oral mucosal route provides direct access to the bloodstream without having to travel through the gastrointestinal tract, which allows the drug to avoid the “first pass effect,” the percentage of drug lost to metabolization in the liver. Drug delivery across the oral mucosa potentially provides patients with rapid onset of action at a lower dosage. The patents disclose use of effervescent agents used as penetration enhancers, which influence drug absorption across the buccal, sublingual and gingival mucosae and use of an additional pH adjusting substance in combination with an effervescent agent for promoting the absorption. Watson filed an Abbreviated New Drug Application for a generic version of FENTORA®. In response, Cephalon instituted a patent infringement suit. The district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. The Federal Circuit reversed on the issue of enablement, holding that Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. The court upheld the noninfringement finding. View "Cephalon, Inc. v. Watson Pharm., Inc. " on Justia Law

Plaintiff brought a putative class action against defendants, alleging that defendants violated Section 10(b) and Section 20(a) of the Securities and Exchange Act of 1934, 15 U.S.C. 78u-4(b)(2)(A), by issuing a misleading press release concerning the results of a clinical trial for a drug called bapineuzumab. Plaintiff appealed from the district court's dismissal of his amended complaint with prejudice for failure to state a cause of action under Rule 12(b)(6) and denying leave to amend. The court concluded that, in the context of the full presentation of the details surrounding the study of the drug, nothing omitted from the press release rendered it false or misleading to a reasonable investor. Moreover, the court held that plaintiff offered insufficient additional allegations to cure this deficiency. Accordingly, the court affirmed the judgment of the district court. View "Kleinman v. Elan Corp., PLC" on Justia Law

Plaintiff appealed from the district court's grant of summary judgment in favor of Merck and the dismissal of her products liability claim for failure to provide an adequate warning regarding the risks associated with Fosamax. Fosamax has allegedly been linked to osteonecrosis of the jaw and plaintiff claimed that Merck should have known of a possible link between the drug and the condition. At issue was whether the district court erred in granting Merck's summary judgment motion after discrediting expert testimony from plaintiff's treating physician. Because the physician's expert testimony contained contradictions that were unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and were central to plaintiff's failure-to-warn claim, the court held that the district court did not err in determining that there was no genuine dispute of material fact raised by the later testimony. View "In Re: Fosamax Products Liability Litigation" on Justia Law