Justia Drugs & Biotech Opinion Summaries

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

An antibody is a protein that binds to a foreign substance, called an antigen, to facilitate its removal from the body, and is useful in treating diseases. AbbVie owns patents directed to genetically engineered fully human antibodies that bind to and neutralize the activity of human interleukin 12 (IL-12), a signaling protein secreted by the human body, the overproduction of which can cause psoriasis and rheumatoid arthritis. Because the human body does not typically make antibodies to neutralize its own proteins, it does not produce IL-12 antibodies naturally. Antibodies from a non-human species can cause adverse immune reactions in humans. The AbbVie patents share the same written description and claim priority from a provisional application filed in 1999; they describe the amino acid sequence of about 300 antibodies having a range of IL-12 binding affinities. AbbVie sued for infringement and the defendants sought interference review under 35 U.S.C. 146. The district court entered judgments of invalidity in both the infringement and the interference actions. The Federal Circuit affirmed; all of the asserted claims are invalid for failing to satisfy the written description requirement. View "AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc." on Justia Law

In 1957, the FDA approved propoxyphene for the treatment of mild to moderate pain, under the trade name Darvon. In 1972, the manufacturer obtained FDA approval to market another product combining propoxyphene with acetaminophen, under the name Darvocet. Because the new drug application (NDA) process is onerous, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, (Hatch-Waxman Act) to make available more low cost generic drugs. Generic drugs require an abbreviated new drug application (ANDA) showing that the drug is equivalent to and that labeling proposed is the same approved for the brand-name drug. Several companies obtained approval to market generic versions of Darvon and Darvocet. Complaints about perceived risks associated with propoxyphene began in 1978; eventually the United Kingdom withdrew it from the market. Two FDA advisory committees recommended withdrawal from the market, but the FDA ordered the NDA holder to change the label to include “Black Box” warnings and to undertake a clinical trial to assess the risks of a particular cardiac complication. In 2010, the FDA determined that the risks of propoxyphene outweighed its benefits and ordered its removal from the market. Plaintiffs in 68 consolidated cases alleged that they ingested propoxyphene products prior to its withdrawal and that manufacturers continued marketing propoxyphene after they knew or should have known that risks exceeded benefits. The district court dismissed. The Sixth Circuit affirmed, except with respect to one plaintiff.View "Germain v. Teva Pharm, USA, Inc" on Justia Law

BMS owns the 244 patent and markets a drug for the treatment of hepatitis B. Claim 8 of the patent is directed to a nucleoside analog composed of two regions: a carbocyclic ring and a guanine base. Nucleoside analogs are manmade compounds designed to mimic the activity of natural nucleosides, the building blocks of DNA and RNA. These compounds are modified slightly from their natural counterparts to interfere with the replication of viral DNA—which means that they can serve as possible antiviral compounds. Claim 8 covers one such compound, entecavir. BMS markets entecavir as a treatment for hepatitis B, under the trade name Baraclude®. In an infringement case, the district court found claim 8 invalid as obvious. The Federal Circuit affirmed, noting that three other drugs for treating hepatitis B were invented before the filing date of entecavir; that the three drugs also gained FDA approval before entecavir; and that entecavir’s inventors did not know about its hepatitis B properties until four years after the filing date, and by then the first FDA-approved hepatitis B treatment was launched. View "Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc." on Justia Law