Justia Drugs & Biotech Opinion Summaries

Plaintiffs filed suit under federal securities laws and state blue sky laws, alleging that Sanofi made materially false or misleading statements regarding its breakthrough drug, Lemtrada, designed to treat multiple sclerosis. The district court granted defendants' motion to dismiss for failure to state a claim. The court agreed with the district court's reasoning and holding. The court writes principally to examine the impact of the Supreme Court’s decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, decided after the district court rendered its decision. Given the sophistication of the investors here, the FDA’s public preference for double‐blind studies, and the absence of a conflict between defendants’ statements and the FDA’s comments, the court concluded that no reasonable investor would have been misled by defendants’ optimistic statements regarding the approval and launch of Lemtrada. Issuers must be forthright with their investors, but securities law does not impose on them an obligation to disclose every piece of information in their possession. As Omnicare instructs, issuers need not disclose a piece of information merely because it cuts against their projections. Accordingly, the court affirmed the judgment. View "In re Sanofi Sec. Litig." on Justia Law

The underlying coverage dispute arose from the supplying of a defective ingredient for incorporation into Wisconsin Pharmacal Company (Pharmacal) probiotic supplement tablets. Pharmacal brought this action against Jeneil Biotech, Inc. and Nebraska Cultures of California, Inc. (the Insureds) and the Netherlands Insurance Company and Evanston Insurance Company (the Insurers), alleging numerous tort and contract claims. The Insurers moved for summary judgment, arguing that their respective insurance policies did not cover any damages that arose out of the causes of action against the Insureds. The circuit court granted the Insurers’ motions for summary judgment, determining that the facts of this case did not trigger the Insurers’ duties to defend. The court of appeals reversed, concluding that the policies provided coverage. The Supreme Court reversed, holding that there was no “property damage” caused by an “occurrence” in this case, and even if there were, certain exclusions in both policies applied to negate coverage. View "Wis. Pharmacal Co., LLC v. Neb. Cultures of Cal., Inc." on Justia Law

Warner Chilcott, a brand-name drug manufacturer that owns the patent covering Loestrin 24 Fe, and Watson Pharmaceuticals, Inc., which sought to introduce a generic version of Loestrin 24, entered into a settlement agreement wherein Watson agreed to delay entry of its generic version of Loestrin 24 in exchange for favorable side deals. Thereafter, Lupin Pharmaceuticals, Inc. announced that it would introduce a generic version of Loestrin 24. Warner and Lupin settled on terms similar to those between Warner and Watson. Two putative classes of plaintiffs brought antitrust claims that the settlement agreements were violations of the Sherman Act and constituted illegal restrains on trade under FTC v. Actavis. At issue in this case was whether such settlement agreements are subject to federal antitrust scrutiny where they do not involve reverse payments in pure cash form. The district court dismissed, concluding that Actavis applies only to monetary reverse payments and that Plaintiffs had alleged the existence of non-cash reverse payments only. The First Circuit vacated and remanded, holding that the district court erred in determining that non-monetary reverse payments do not fall under the scope of Actavis. Remanded. View "In re Loestrin 24 FE Antitrust Litig." on Justia Law

OWW owns patents directed to cushioning devices that fit over the residual stumps of amputated limbs to make the use of prosthetics more comfortable. OWW has asserted its patents against Alps in several actions, including one filed in 2004 concerning devices consisting of stretchable synthetic fabric, coated with a gel on only the side touching the body, to reduce skin irritation, while the dry side allows free interaction with the prosthesis. After the court issued a claim construction order, Alps filed two successive ex parte reexamination proceedings before the Patent and Trademark Office. The examiner rejected the claims of the patent for obviousness. The Board of Patent Appeals and Interferences reversed, but the court granted Alps summary judgment of invalidity as to all asserted claims. The Federal Circuit remanded. Following remand, the Federal Circuit affirmed findings of inequitable conduct in the second reexamination, but not in the first. OWW executive Colvin was aware that OWW’s reexamination counsel represented to the Board that testimony by Alps’s witness (Comtesse) was uncorroborated; that Colvin was aware of materials that corroborated Comtesse’s testimony; and that Colvin failed to correct counsel’s misrepresentations. Based on that inequitable conduct finding, the patent is unenforceable and the case was exceptional, justifying a fee award against OWW. View "Ohio Willow Wood Co. v. Alps S., LLC" on Justia Law

AngioScore sells angioplasty balloon catheters (AngioSculpt), designed to open arterial blockages. Three AngioScore patents each list three inventors, but none lists Lotan as an inventor. TriReme is a competitor of AngioScore. Apparently concerned that AngioScore might charge TriReme with infringement, TriReme sought to acquire an interest in the AngioScore patents from Dr. Lotan, who performed consulting services for AngioScore. Lotan granted TriReme an exclusive license to “any and all legal and equitable rights” he held in the AngioScore patents. Lotan claimed that his inventive contribution arose from his work in connection with the development of the AngioSculpt catheters in 2003, which is reflected in the AngioScore patents. AngioScore’s defense was based on a 2003 consulting contract between AngioScore and Lotan. AngioScore asserts that it acquired rights to all inventive work completed by Lotan. TriReme brought suit for correction of inventorship, 35 U.S.C. 256. The district court dismissed, finding that TriReme lacked standing. The Federal Circuit reversed and remanded for consideration of whether Lotan’s continued work on AngioSculpt after the contract’s effective date came within the contract’s language. View "TriReme Med., LLC v. Angioscore, Inc." on Justia Law

Samuel’s 575 patent, filed in 1997, claims inventions in the field of intraluminal stent technology. One type of intraluminal stent is a vascular stent. Vascular stents are used to treat medical conditions wherein a vascular wall is unduly constricted, as in the case of vascular stenosis, or unduly enlarged, as in the case of aneurysm. Either of these medical conditions poses an unacceptable risk of insufficient blood flow or vascular rupture. The 575 patent generally claims intraluminal stents that can be affixed to a vascular wall via the use of “an inflatable and deflatable cuff” without penetrating the vessel wall. In a 2013 infringement suit, defendant TriVascular filed a petition for inter partes review. The Patent Trial and Appeal Board found that TriVascular failed to demonstrate that the challenged claims were unpatentable over the applied art; adopted Samuels’ construction of “inflatable protrusions,” as “protrusions that are themselves inflatable, i.e., expandable by being filled with fluid;” and concluded that the 575 patent’s “inflatable protrusions” were not disclosed by the prior art. The Federal Circuit affirmed. View "Trivascular, Inc. v. Samuels" on Justia Law

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