Justia Drugs & Biotech Opinion Summaries

Oxycodone hydrochloride—the active pharmaceutical ingredient (API) in OxyContin®—is an opioid analgesic used to treat moderate to severe pain. In 2014 the FDA became concerned about 14-hydroxycodeinone, which belongs to a class of potentially dangerous compounds known as alpha, beta unsaturated ketones (ABUKs), and mandated that oxycodone hydrochloride manufacturers either provide evidence that the 14-hydroxy levels in their formulations were safe or reduce the amount of 14-hydroxy to less than 10 ppm. Purdue’s four low-ABUK patents recite an improved formulation of oxycodone hydrochloride, describing an oxycodone salt with extremely low levels of ABUKS. In 2011, Purdue sued Teva for infringement of the low-ABUK patents in response to Teva’s filing of an abbreviated new drug application (ANDA) seeking FDA approval to market generic versions of Reformulated OxyContin®. Purdue later filed similar lawsuits against others. In consolidated cases, the district court found that the asserted claims were infringed by Teva’s proposed generic product, but also held that all of the claims were invalid as anticipated by or obvious over the prior art. The Federal Circuit affirmed, finding claims obvious in light of prior art, 35 U.S.C. 103(a). View "Purdue Pharma L.P. v. Epic Pharma, LLC" on Justia Law

Relators filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729 et seq., against Purdue, alleging that the company was involved in a fraudulent scheme regarding the equianalgesic ratio of OxyContin. The court declined realtors' invitation to read United States ex rel. Siller v. Becton Dickinson & Co., so as to render it internally inconsistent and at odds with the public disclosure bar’s purpose. Indeed, by foreshadowing the court’s conclusion in this case, Siller itself eschews the interpretation relators urge. Here, relators’ claims are based on facts their counsel learned in the course of making the prior public disclosure of Purdue’s allegedly fraudulent scheme. The court held, consistent with its reasoning in Siller and the public disclosure bar’s purpose, that the district court correctly dismissed the relators’ suit. View "United States ex rel. May v. Purdue Pharma L.P." on Justia Law

In 2010, the City of Eastport learned that Husson University would no longer lease seventeen acres of publicly owned oceanfront property after the 2011-12 school year. In 2011, the City Council voted to accept an offer by First Perry Realty, LLC and CPM Constructors to purchase the property for $300,000. Phyllis Bradbury and David Gholson brought this action seeking declaratory and equitable relief that would prevent the sale of the City property, arguing that the sale of the property was not “advertised” within the meaning of the Eastport City Charter then in effect. The superior court denied relief. The Supreme Judicial Court affirmed, holding that the City Council took adequate measures to publicly advertise the sale of the property. View "Bradbury v. City of Eastport" on Justia Law

Plaintiff was diagnosed with drug-induced lupus, allegedly a side effect from using Solodyn, a treatment for acne. Plaintiff sued Medicis Pharmaceutical Corporation, which manufactures and distributes Solodyn, alleging that Medicis knowingly represented and omitted material facts in connection with the sale or advertisement of Solodyn in violation of the Consumer Fraud Act (CFA). Plaintiff also alleged that Medicis failed to adequately warn her of the consequences of the long-term use of Solodyn. The superior court granted Medicis’s motion to dismiss. At issue on appeal was the learned intermediary doctrine (LID), under which a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the class of persons who may prescribe or administer the product. The Supreme Court reversed the superior court’s order dismissing Plaintiff’s complaint, holding (1) the LID does not prevent Plaintiff from suing Medicis; (2) Plaintiff alleged sufficient facts to survive Medicis’s motion to dismiss with regard to her products liability claim; and (3) the CFA applies to prescription pharmaceuticals, and therefore, Plaintiff alleged an actionable claim under the CFA. View "Watts v. Medicis Pharmaceutical Corp." on Justia Law

After Congress directed the FDA to establish a twelve-member Tobacco Products Scientific Advisory Committee to, among other things, report on the safety of menthol cigarettes, plaintiffs filed suit claiming that the FDA appointed to the Committee three members with pecuniary interests hostile to their products, in violation of relevant conflict-of-interests statutes and regulations, and that these appointments injured plaintiffs. Plaintiffs claim that the FDA’s appointments of these Committee members caused them three injuries: (1) an increased risk that the FDA will regulate menthol tobacco products adversely to plaintiffs’ interests; (2) access by the challenged Committee members to plaintiffs’ confidential information, with a probability of their using the information to plaintiffs’ detriment; and (3) the shaping of the menthol report to support the challenged members’ consulting and expert witness businesses, with injuries flowing both from the report itself and from its use as support for their expert testimony and consulting. The court concluded that plaintiffs' alleged injuries are too remote and uncertain. Because the alleged injuries are insufficiently imminent to confer standing, the court vacated the district court's grant of summary judgment for lack of jurisdiction and dissolved the district court's injunction barring the use of the menthol report and ordering the reconstitution of the Committee. View "R.J. Reynolds Tobacco Co. v. FDA" on Justia Law

The FDA opened an investigation and sent warning letters to 1-800-GET-THIN and a few surgery centers in California, stating that the FDA believed 1-800-GET-THIN’s LapBand advertising violated the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., by not providing relevant risk information regarding the LapBand procedure. The district court subsequently granted the government’s ex parte motion to compel production of attorney-client documents. The court agreed with the Sixth Circuit and concluded that, while in camera review is not necessary to establish a prima facie case that the client was engaged in or planning a criminal or fraudulent scheme when it sought the advice of counsel to further the scheme, a district court must examine the individual documents themselves to determine that the specific attorney-client communications for which production is sought are sufficiently related to and were made in furtherance of the intended, or present, continuing illegality. Accordingly, the court vacated the order compelling production of all subpoenaed documents so the district court may examine the documents in camera to determine which specific documents contain communications in furtherance of the crime fraud exception to the attorney client privilege. View "United States v. Omidi" on Justia Law

Ethicon’s patent is directed to a surgical device used to staple, secure, and seal tissue that has been incised. As is commonly done during endoscopic procedures, a surgeon will insert the device into the patient and will pull a trigger to latch onto a desired tissue. Once attached, the surgeon will then pull another trigger, which causes a blade to move, cutting the desired tissue. Simultaneously, rows of staples on either side of the cutting blade are actuated against a staple forming surface, both securing and sealing the newly-cut tissue. The Patent Trial and Appeals Board granted inter partes review found all challenged claims invalid as obvious over the prior art. The Federal Circuit rejected an argument that the Board’s final decision is invalid because the same Board panel made both the decision to institute and the final decision and upheld the determination that the claims would have been obvious over prior art. View "Ethicon Endo-Surgery, Inc. v. Covidien, LP" on Justia Law

In 2005, Urbanski filed the 614 application, entitled “Protein and Fiber Hydrolysates” and is directed to a method of enzymatic hydrolysis of soy fiber, such that the product has a reduced water holding capacity suitable for use as food additives. The Patent Trial and Appeal Board affirmed the Examiner’s rejection of certain claims as unpatentable under 35 U.S.C. 103(a). The Federal Circuit affirmed, upholding the determination that the claims would have been obvious over cited references relating to enzymatic hydrolysis of dietary fibers, which are readily combinable. View "In re: Urbanski" on Justia Law

The Patent Trial and Appeal Board granted SAMSF’s motion to cancel certain claims prior to its review of SAMSF’s patents relating to administering the “natural” stereoisomer of 5-methyl-tetrahydrofolic acid (L-5-MTHF) and other vitamins to treat symptoms associated with folate deficiency, which causes health issues, including cardiovascular disease, neurological disorders, birth defects, and skeletal disorders. The Federal Circuit affirmed the Board’s conclusion of obviousness under 35 U.S.C. 103. The court prior rejected SAMSF’s arguments art taught away from its claimed use of a reduced folate to treat folate deficiency, and that objective indicia of non-obviousness further demonstrated the validity of its patents. Although the Board erred in its assessment of the evidence of licensing, its other factual findings were supported by substantial evidence. View "S. Ala. Med. Sci. Found. v. Gnosis, S.P.A." on Justia Law

At the request of Gnosis, the Patent Trial and Appeal Board instituted inter partes review of claims of Merck’s patent, which relates to methods of using folates to lower levels of homocysteine in the human body. Homocysteine is an amino acid that, when present in excessive quantities, can cause severe cardiovascular, ocular, neurological, and skeletal disorders. Merck filed a response and a motion to cancel claims 1–3, 5, 6, and 13, which the Board granted. The Board only reviewed the patentability of dependent claims 8, 9, 11, 12, 14, 15, and 19–22 and found them invalid for obviousness, 35 U.S.C. 103, in light of prior art. The Federal Circuit affirmed, finding that the Board’s factual findings to the contrary were supported by substantial evidence and rejecting Merck’s arguments that the prior art taught away from the claimed method and that objective indicia of non-obviousness further support the patentability of the claims. View "Merck & Cie v. Gnosis, S.P.A." on Justia Law