Justia Drugs & Biotech Opinion Summaries

Tranexamic acid, the active ingredient in Ferring’s patented product, is used to treat heavy menstrual bleeding (menorrhagia) in women. Tranexamic acid has been widely used in an immediate release formulation for more than 30 years to treat menorrhagia in other countries. Ferring developed a tranexamic acid formulation with fewer gastrointestinal side effects than the immediate release version used abroad, but with the same benefits, by creating a formulation with a tranexamic acid release rate that matched the rate of absorption in the gastrointestinal tract. Ferring’s commercial product is known as Lysteda. In 2004, the FDA approved a fast-track designation for approval of Lysteda, and the Lysteda New Drug Application was approved in 2009 as the first tranexamic acid drug approved for use in the U.S. Apotex sought to market a generic version of Lysted that would avoid infringement of Ferring’s patent applications, but that would be bioequivalent to Lysteda, by altering the rate of absorption. Ferring then sued Apotex for infringement. The district court dismissed after Apotex amended its Abbreviated new Drug ApplicationView "Ferring B.V. v. Watson Labs, Inc., FL" on Justia Law

The Kennedy patents cover a popular treatment for rheumatoid arthritis: a combination therapy of a disease-modifying antirheumatic drug and an antibody. The 766 patent expired in October 2012; the 422 patent will expire in August 2018. In 2002, AbbVie1 obtained a license to the 766 patent. Thereafter, AbbVie obtained FDA approval to sell Humira, an anti-TNFα antibody, for use either alone or in combination with methotrexate to treat rheumatoid arthritis. AbbVie paid Kennedy more than $100 million in royalties for AbbVie’s U.S. sales of Humira. When the 442 patent issued in 2010, Kennedy demanded that AbbVie secure an additional license for that patent in order to continue sales of Humira. Kennedy conceded that the 766 patent encompasses the same inventive subject matter as the 442 patent, but contended that the 442 patent was nonetheless patentable because the 766 patent claims a “broad genus” of methods for treating rheumatoid arthritis, whereas the 442 patent claims a “narrower species” of those treatment methods with unexpected results. AbbVie obtained a declaratory judgment that claims of the 442 patent were invalid over the 766 patent for obviousness-type double patenting. The Federal Circuit affirmed.View "AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust" on Justia Law

Payne sued Novartis for failing to warn her doctor that two of the drugs it manufactures, Aredia and Zometa, could cause serious damage to a patient’s jaw bones. The drugs are given intravenously, most often to patients with cancerous conditions, and are effective in preventing pathological fractures and other bone pains. Payne took both in 1999-2001 and had to have part of her jaw removed in 2007 because of osteonecrosis, which results in the gums being eaten away until the bone is exposed The connection between the drugs and the condition began to come to light to the medical community in the early 2000’s. The district court entered summary judgment for Novartis. The Sixth Circuit reversed. Under Tennessee law, the question of whether Novartis’s failure to warn was a cause of Payne’s injuries is for a jury to determine. Payne’s testimony, combined with that of her doctor, could establish a sufficient causal link between Novartis’s failure to warn and Payne’s jaw death. A reasonable jury could conclude that Payne would not have taken Aredia or Zometa had her doctor warned her of the risk View "Payne v. Novartis Pharm. Corp." on Justia Law

Apotex’s 556 patent, titled “Pharmaceutical Compositions Comprising Moexipril Magnesium,” issued in 2004, from an application that claims priority to a Canadian application filed in 2000. The patent is directed to manufacture of moexipril tablets, an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension. Like other ACE inhibitors, Moexipril and its acid addition salts are susceptible to degradation and instability. To improve stability, the 556 patent discloses tablets consisting mostly of moexipril magnesium obtained by reacting moexipril or its acid addition salts with an alkaline magnesium compound. Several methods for stabilizing ACE inhibitors were known in the prior art. UCB’s accused products, Univasc and Uniretic, moexipril tablets, sold in the U.S. since 1995 and 1997, respectively, are prior art. In allowing the claims of the 556 patent over findings of obviousness, the examiner stated: prior art teaches that only a portion of drug (if any) may be converted to the alkaline salt and that the stable product results entirely or primarily not from conversion to alkaline salts, but from stabilization of the moexipril hydrochloride by the presence of the alkaline stabilizing compound in the final product. In 2012 Apotex accused UCB of infringement. The district court ruled that the 556 patent was unenforceable due to the inventor’s inequitable conduct before the PTO in concealing his knowledge and misrepresenting the nature of Univasc and the prior art and submitting results of experiments that he never conducted. The Federal Circuit affirmed, upholding the finding of inequitable conduct.View "Apotex Inc. v. UCB, Inc." on Justia Law

Tyco owns patents directed to temazepam, a drug used to treat insomnia and marketed under the brand name Restoril. The patents claim 7.5 mg formulations of temazepam having a specific surface area between 0.65 and 1.1 square meters per gram (m2/g). Specific surface area is a measure of the surface area of a drug per unit of weight. Generally, as chunks of drug material are ground down into smaller particles, the specific surface area increases because more of the drug is exposed to the surrounding environment. Mutual filed an Abbreviated New Drug Application (ANDA) with the FDA, seeking approval to manufacture and sell a generic 7.5 mg version of temazepam. The ANDA represented that its product would have a specific surface area of not less than 2.2 m2/g and included a certification representing that the generic drug was not protected by a U.S. patent (21 U.S.C. 355(j)(2)(A)(vii)). Mutual sent Tyco a “paragraph IV certification letter” claiming that the product would not infringe because its specific surface area would not fall within the 0.65-1.1 m2/g range claimed by the temazepam patents. Tyco filed an infringement action, 35 U.S.C. 271(e)(2)(A). Mutual raised antitrust counterclaims. The district court granted summary judgment of noninfringement. Tyco filed a citizen petition, urging the FDA to change the criteria for evaluating the bioequivalence of proposed generic temazepam products in order to “help ensure therapeutic equivalence.” The FDA approved Mutual’s ANDA; months later it denied the petition. The court granted summary judgment to Tyco on the antitrust counterclaims. The Federal Circuit court vacated the summary judgment that Tyco’s infringement claims were not a sham and the summary judgment that Tyco’s citizen petition was not a sham. View "Tyco Healthcare Grp. v. Mut. Pharm. Co" on Justia Law

Bristol-Myers Squibb (BMS) was sued in a coordinated proceeding before the San Francisco Superior Court for alleged defects in Plavix, a drug BMS manufactures and sells throughout the country. BMS moved below to quash service of the summons regarding the complaints concerning plaintiffs who are not California residents, for lack of personal jurisdiction. The trial court denied BMS’s motion, finding that California had general jurisdiction over BMS, and did not address the issue of specific jurisdiction. Following the U.S. Supreme Court’s ruling in Daimler AG v. Bauman (2014) which limited the application of general jurisdiction under the Fourteenth Amendment, the California Supreme Court remanded to the court of appeals, which affirmed denial of the motion to quash. California does not have general jurisdiction over BMS in this case, but, applying the International Shoe Co. v. Washington test of “fair play and substantial justice,” the court reasoned that BMS has engaged in substantial, continuous economic activity in California, including the sale of more than a billion dollars of Plavix to Californians. That activity is substantially connected to claims by non-residents, which are based on the same alleged wrongs as those alleged by California-resident plaintiffs. BMS has not established that it would be unreasonable to assert jurisdiction over it. View "Bristol-Myers Squibb Co. v. Superior Court" on Justia Law

Gnosis appealed the district court's entry of judgment in favor of Merck on its Lanham Act, 15 U.S.C. 1125(a), false advertising and contributory false advertising claims; award to Merck of damages, attorneys' fees and costs, and prejudgment interest; and order that Gnosis engage in a corrective advertising campaign. Merck had filed suit against Gnosis, claiming misleading advertising in connection with its use of the pure Isomer Product chemical name and properties in its marketing materials for Extrafolate. At issue on appeal was the court's false advertising jurisprudence. The court concluded that where, as here, the parties operate in the context of a two-player market and literal falsity and deliberate deception have been proved, it is appropriate to utilize legal presumptions of consumer confusion and injury for the purposes of finding liability in a false advertising case brought under the Lanham Act; in a case where willful deception is proved, a presumption of injury may be used to award a plaintiff damages in the form of defendant's profits, and may, in circumstances such as those presented here, warrant enhanced damages; and, therefore, the court affirmed the judgment of the district court. View "Merck Eprova AG v. Gnosis S.P.A." on Justia Law

Hardin suffered complete blindness and permanent, severe and painful scarring after she took Lamotrigine, the generic form of the medication Lamictal. Hardin sued the prescribing physician, the manufacturer, the store where she bought the prescription (Safeway), WKH, which produced the drug information pamphlet (monograph), and PDX, a software provider that distributes drug information to pharmacy customers. Unlike physician package inserts and patient medication guides, which are FDA-mandated, WKH monographs are not regulated or reviewed by the FDA, but are produced as part of a self-regulating action plan required under 110 Stat. 1593. The WKH monograph was the only information received by Hardin when she first filled her prescription for Lamictal. The abbreviated warning used by Safeway and provided to Hardin omitted the “Black Box” warning: “BEFORE USING THIS MEDICINE” that stated: “SERIOUS AND SOMETIMES FATAL RASHES HAVE OCCURRED RARELY WITH THE USE OF THIS MEDICINE. Hardin says that had she been provided this warning, she would not have taken the medication. WKH moved to strike Hardin’s claims against it under Code of Civil Procedure section 425.16, the “anti-SLAPP” (Strategic Lawsuit Against Public Participation ) statute.. The trial court ruled that WKH’s production of drug monographs was protected speech concerning a public issue or an issue of public interest and that Hardin had no probability of prevailing because she could not establish that WKH owed her any duty. The court denied PDX’s motion to strike, finding that the activity underlying PDX’s alleged liability was the reprogramming of its software to permit Safeway to give customers an abbreviated, five-section monograph that omitted warnings instead of the full eight-section version that included those warnings. The court of appeal affirmed. View "Hardin v. PDX, Inc." on Justia Law

Plaintiff filed a products liability suit against generic and brand-name manufacturers of the prescription drug metoclopramide, alleging that her long-term use of generic metoclopramide caused her to develop tardive dyskinesia and that manufacturers provided misleading and inadequate warnings. The court affirmed the district court's judgment on the pleadings for the generic manufactures under Rule 12(c) on plaintiff's failure-to-warn, design-defect, and express-warranty claims because the claims were preempted by federal law; affirmed the dismissal of plaintiff's claims against the brand-name manufacturers under Rule 12(b)(6) because the claims were barred by Louisiana state law where plaintiff never ingested Reglan manufactured by brand-name manufacturers; even if Louisiana law did not apply, plaintiff has not established that name-brand defendants owed her a duty of care; and denied plaintiff leave to amend her complaint. Accordingly, the court affirmed the judgment of the district court. View "Johnson v. Teva Pharmaceuticals USA, Inc., et al." on Justia Law

The funds filed suit alleging that, among other things, the pharmacies engaged in fraudulent, misleading, or deceptive practices in connection with the sale of merchandise by failing to pass on the funds the entire difference between the acquisition cost of the generic prescription drug dispensed and its brand name equivalent as required by Minn. Stat. 151.121, subd. 4. The district court granted the pharmacies's Rule 12 motion to dismiss the complaint. The court held that section 151.21, subd. 4 does not create a private cause of action in favor of union-sponsored health and welfare benefit funds against pharmacies for failing to pass on the difference between the acquisition cost of brand name drugs and substituted generic prescription drugs; an omission-based consumer fraud claim is actionable under Minn. Stat. 325F.69, subd. 1 when special circumstances exist that trigger a legal or equitable duty to disclose the omitted facts; the amended complaint did not allege facts that would trigger a legal or equitable duty for the pharmacies to disclose prescription-drug acquisition costs; and, therefore, the complaint failed to state a claim upon which relief can be granted under Minn. Stat. 325F.69, subd. 1. Accordingly, the court affirmed in part and reversed in part. View "Graphic Communications Local 1B, et al. v. CVS Caremark Corp., et al." on Justia Law