Justia Drugs & Biotech Opinion Summaries

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

Plaintiff and others sought and received LASIK eye surgery with a Nidek EC-5000 Excimer Laser System ("Laser") to correct farsightedness. Plaintiff, on behalf of himself and a class of similarly situated individuals, claimed that, had they known that the FDA had not approved the Laser for this use, they would not have consented to the surgeries. The court held that the complaint did not state a claim under the California Protection of Human Subjects in Medical Experimentation Act, Cal. Health & Saf. Code 24171 et seq., because the surgeries were not "medical experiments" subject to the protection of the Act. Plaintiff did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (CLRA), Cal. Civ. Code 1750 et seq., and his other substantive claim was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq. Plaintiff's common-law fraud by omission claim was expressly preempted by the preemption provision in the Medical Device Amendments. Even if it were not, it was impliedly preempted because it amounted to an attempt to privately enforce the FDCA. Accordingly, the court affirmed the dismissal of the complaint. View "Perez, et al v. Nidek Co., Ltd., et al" on Justia Law

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