Justia Drugs & Biotech Opinion Summaries

A.S., who suffers from a congenital birth defect, and his mother, Miller, who ingested Paxil while pregnant, sued GSK in the Philadelphia County Court, alleging that all parties were citizens of Pennsylvania. GSK removed the case based upon diversity. On plaintiffs’ motion, the case was consolidated with other Paxil cases before a district court judge who had previously held that GSK was a citizen of Pennsylvania and who remanded A.S.’s case and the other consolidated cases to state court. The case returned to state court on January 4, 2012. On June 7, 2013, the Third Circuit issued its opinion in Johnson, which held that GSK was a citizen of Delaware. Less than 30 days after the Johnson decision, GSK filed a second notice of removal in A.S.’s case and in eight other cases with the same procedural posture. The district court denied the motion and certified its order for interlocutory review. The Third Circuit directed remand to state court, holding that the second removal request was untimely under 28 U.S.C. 1446(b) because there had been a final order. View "A.S. v. SmithKline Beecham Corp" on Justia Law

Plaintiffs, non-profit organizations representing the manufacturers and distributors of pharmaceutical products, filed suit challenging the Alameda County Safe Drug Disposal Ordinance, which requires that prescription drug manufacturers, who either sell, offer for sale, or distribute "Covered Drugs" in Alameda, operate and finance a "Product Stewardship Program." The court concluded that the Ordinance, both on its face and in effect, does not discriminate because it applies to all manufacturers that make their drugs available in Alameda County - without respect to the geographic location of the manufacturer; the Ordinance does not directly regulate interstate commerce where it does not control conduct beyond the boundaries of the county; under the balancing test in Pike v. Bruce Church, Inc., the court concluded that, without any evidence that the Ordinance will affect the interstate flow of goods, the Ordinance does not substantially burden interstate commerce; and therefore, the Ordinance does not violate the dormant Commerce Clause. Accordingly, the court affirmed the district court's grant of summary judgment to defendants. View "PRMA v. County of Alameda" on Justia Law

In 2008, ReGen Biologics, manufacturer of the Collagen Scaffold, obtained FDA approval to market the device. After allegations that improper political pressure tainted the clearance process, the FDA conducted an internal investigation and concluded that some procedural irregularities had occurred during the agency's review of the device. Asserting its inherent reconsideration authority, the agency reevaluated the scaffold and concluded that it had erred in allowing the device to be sold. The FDA issued an order rescinding its clearance decision. ReGen immediately pulled the scaffold from the market and subsequently filed for bankruptcy. ReGen and its successor in interest, Ivy, filed suit challenging the FDA's decision to rescind and the district court granted summary judgment for the agency. The court reversed, concluding that the FDA did not follow the proper statutory procedure for reclassifying a device. Rescinding its determination had the effect of putting the device into Class III, and thus required completion of the extensive pre-market approval process before the scaffold could be marketed again. Accordingly, the court vacated and remanded for further proceedings. View "Ivy Sports Medicine, LLC v. Sebelius, et al." on Justia Law

Ferring and Watson market competing prescription progesterone products. Progesterone plays a key role in helping women become pregnant and maintain pregnancies by preparing and maintaining the uterine lining to support the embryo during early pregnancy. Historically, women have received progesterone through intramuscular shots, which are not FDA-approved and which patients consider painful. Both companies manufacture a product that administers progesterone to women through vaginal inserts rather than shots. Ferring’s product, Endometrin, is delivered in capsule form. Watson’s product, Crinone, is a gel delivered via applicator. Ferring unsuccessfully sought a preliminary injunction under the Lanham Act, based on two presentations made by Watson in 2012 to healthcare professionals concerning Crinone. Watson’s consultant, Dr. Silverberg made statements concerning a “Black Box” warning on Endometrin’s package insert; a patient preference survey comparing the products; and Endometrin’s effectiveness in women over the age 35. Silverberg was alerted to the inaccuracy of his statement about a Black Box warning after the first webcast and certified to Ferring and to the court that he would not repeat the statement. The district court held that Ferring failed to demonstrate irreparable harm. The Third Circuit affirmed, citing Supreme Court holdings that a party bringing a claim under the Lanham Act is not entitled to a presumption of irreparable harm when seeking a preliminary injunction and must demonstrate that irreparable harm is likely. View "Ferring Pharm. Inc. v. Watson Pharm., Inc." on Justia Law

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