Justia Drugs & Biotech Opinion Summaries

Helsinn makes a treatment for chemotherapy-induced nausea using the chemical palonosetron. While developing that product, Helsinn granted another company the right to market a 0.25 mg dose of palonosetron in the United States; that company was required to keep proprietary information confidential. Nearly two years later, in 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Helsinn filed four patent applications that claimed priority to the 2003 date. Helsinn’s fourth application, filed in 2013 (the 219 patent), is covered by the Leahy-Smith America Invents Act (AIA). In 2011, Teva sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued for infringement. Teva countered that the 219 patent was invalid under the “on sale” provision of the AIA, which precludes a person from obtaining a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention,” 35 U.S.C. 102(a)(1), arguing the 0.25 mg dose was “on sale” more than one year before Helsinn filed the 2003 application.The Federal Circuit held, and the Supreme Court unanimously agreed, that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements. A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under section 102(a). The patent statute in force immediately before the AIA included an on-sale bar. Supreme Court and Federal Circuit precedent interpreting that provision indicated that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. The Court applied the presumption that when Congress reenacted the “on sale” language in the AIA, it adopted earlier judicial constructions. View "Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

The Ninth Circuit affirmed the district court's grant of summary judgment for defendants, makers of vitamin E supplements, in an action alleging that the labels on the supplements violated California laws against false advertising. The panel held that section 343-1(a)(5) of the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempts state law requirements for claims about dietary supplements that differ from the FDCA's requirements. In this case, the panel held that section 343-1(a)(5) preempted most of plaintiff's claims.The panel held that because the FDCA and California law have the same labeling requirement with respect to failing to disclose an increased risk of death, section 343-1(a)(5) did not preempt this part of plaintiff's action. The panel held that the record lacked evidence that vitamin E supplements were actually harmful, as opposed to simply useless at reducing all-cause mortality (which they did not claim to reduce). Therefore, there was no genuine issue of material fact as to whether defendants' immune-health structure/function claim was misleading. View "Dachauer v. NBTY, Inc." on Justia Law

Plaintiff filed suit against pharmaceutical companies, alleging that they were liable for substantial gambling and other financial losses that resulted from obsessive compulsive behavior, a side effect of taking a dopamine agonist called Mirapex for his Parkinson's disease. The Eighth Circuit affirmed the district court's grant of summary judgment dismissing all claims as barred by the applicable California statute of limitations. The court rejected plaintiff's contention that the statute should be tolled because he was insane when the cause of action accrued; rejected plaintiff's contention that each ingestion of the drug gave rise to a separate and distinct claim under the continuing violations doctrine; and held that the district court did not abuse its discretion in denying a motion to stay defendants' motion for summary judgment. View "Mancini v. Boehringer Ingelheim Pharmaceuticals" on Justia Law

Hi-Tech filed suit alleging that the label of a protein-powder supplement distributed by HBS misled customers about the quantity and quality of protein in each serving, violating both the Georgia Uniform Deceptive Trade Practices Act and the federal Lanham Act. The district court dismissed the complaint.The Eleventh Circuit affirmed the district court's dismissal of the state law claim because it was preempted by the Food, Drug, and Cosmetics Act (FDCA). However, the court reversed the district court's dismissal of the Lanham Act claim, and rejected HBS's arguments that the FDCA barred the claim under the Lanham Act. In this case, Hi-Tech's Lanham Act claim would only require a court to determine whether the protein-content representations on the HexaPro label were misleading to consumers in the context of the label's failure to specify the sources of the nitrogen measured by the federal test. Therefore, this inquiry would not require a court to interpret or apply the FDCA to determine whether or not the marketing of the supplement was deceptive. View "Hi-Tech Pharmaceuticals, Inc. v. HBS International Corp." on Justia Law

In late 2015, Mississippi filed a complaint against fifteen pharmaceutical manufacturers and their affiliates (“Defendants”). In this interlocutory appeal, the issue this case presented for the Mississippi Supreme Court's review centered on whether the location of a foreign corporation’s registered agent was relevant when determining the appropriate venue for an action. The Supreme Court found that the adoption of the Registered Agents Act (“RAA”) made the location of a corporation’s registered agent irrelevant for purposes of venue. View "Purdue Pharma L.P. v. Mississippi" on Justia Law

The First Circuit reversed the district court’s certification of a class of all purchasers of Asacol, including purchasers who had not suffered any injury attributable to Defendants’ allegedly anticompetitive behavior, holding that the district court’s approach to certifying a class was at odds with both Supreme Court precedent and the law of this circuit.Drug manufacturer Warner Chilcott Limited’s coordinated withdrawal and entry of two drugs, Asacol and the similar drug called Delzicol, precluded generic manufacturers from introducing a generic version of Asacol, which would have provided a lower-cost alternative to Warner’s drugs, Delzicol and Asacol HD. Plaintiffs filed a class action alleging violations of the consumer protection and antitrust laws of twenty-five states and the District of Columbia. The district court certified a class of all Asacol purchasers who subsequently purchased Delzicol or Asacol HD in one of those twenty-six jurisdictions, finding that while ten percent of the class had not suffered any injury, those uninjured class members could be removed in a proceeding conducted by a claims administrator. The First Circuit reversed, holding that where injury-in-fact is a required element of an antitrust action, a class cannot be certified based on an expectation that the defendant will have no opportunity to press at trial genuine challenges to allegations of injury-in-fact. View "Teamsters Union 25 Health Services & Insurance Plan v. Warner Chilcott Limited" on Justia Law

The Ninth Circuit reversed the dismissal of an action alleging California consumer claims against MusclePharm Corporation, a manufacturer of nutritional supplements. The complaint alleged that MusclePharm made false or misleading statements about the protein in one of its products.The Ninth Circuit held that the Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations concerned only the calculation and disclosure of protein amount; the FDCA preempted a state-law misbranding theory premised on the supplement's use of nitrogen-spiking agents to inflate the measurement of protein for the nutrition panel; but the FDCA did not preempt a state-law misbranding theory premised on the label's allegedly false or misleading implication that the supplement's protein came entirely from two specifically named, genuine protein sources. In this case, plaintiff's claims were not preempted to the extent they arose under this theory. View "Durnford v. MusclePharm Corp." on Justia Law

This appeal arose from 532 product-liability claims filed against Hoffmann-La Roche Inc. and Roche Laboratories Inc. (collectively Roche), corporations with their principal places of business in New Jersey. Roche developed, manufactured, marketed, and labeled Accutane, a prescription medication for the treatment of severe and persistent cases of acne. Plaintiffs alleged Accutane caused them to contract inflammatory bowel disease (IBD) and that Roche failed to give adequate label warnings to advise them of the known risks of the medication. At issue for the New Jersey Supreme Court was : (1) what law governed whether Roche’s label warnings were adequate (the law of each of the 45 jurisdictions in which plaintiffs were prescribed and took Accutane or the law of New Jersey where the 532 cases are consolidated); and (2) the adequacy of the label warnings for the period after April 2002. The Court found that because Roche’s warnings received the approval of the FDA, they enjoyed a “rebuttable presumption” of adequacy under New Jersey’s Products Liability Act (PLA). The Court reversed all cases in which the Appellate Division reinstated plaintiffs’ actions against Roche. "New Jersey has the most significant interests, given the consolidation of the 532 cases for MCL purposes. New Jersey’s interest in consistent, fair, and reliable outcomes cannot be achieved by applying a diverse quilt of laws to so many cases that share common issues of fact. Plaintiffs have not overcome the PLA’s presumption of adequacy for medication warnings approved by the FDA. As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD." As a result, the 532 failure-to-warn cases brought by plaintiffs against Roche were dismissed. View "Accutane Litigation" on Justia Law

Esperion has never generated any revenue, relying solely upon investor funding. Esperion’s sole focus is the development of ETC-1002, a first-in-class oral medication for lowering LDL “bad cholesterol,” a significant risk factor in cardiovascular disease. Esperion hopes to market ETC-1002 as an alternative treatment for statin-intolerant patients and as an add-on for patients are unable to reach their recommended levels using statins alone. In 2015, Esperion had completed several clinical studies and reported that ETC-1002 was well-tolerated and demonstrated significant average LDL-cholesterol reductions. After a meeting with FDA officials regarding Phase 3 of the approval process, Esperion published a press release, stating that “[b]ased upon feedback from the FDA, approval of ETC-1002 in [specific] patient populations will not require the completion of a cardiovascular outcomes trial,” with cautionary language, suggesting that “Esperion may need to change the design of its Phase 3 program once final minutes from the FDA meeting are received.” Market reaction was mostly positive. Following its receipt of the final FDA minutes, Esperion published another press release, indicating that the “FDA has encouraged the Company to initiate a cardiovascular outcomes trial promptly.” Esperion’s stock dropped 48% the next day. Plaintiffs, the purchasers of Esperion common stock between the two press releases, brought a class action under sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and SEC Rule 10b-5. The Sixth Circuit reversed the district court holding that Plaintiffs failed to adequately plead a strong inference that Esperion’s CEO willfully or recklessly made misleading statements. Plaintiffs adequately alleged scienter. View "Dougherty v. Esperion Therapeutics, Inc." on Justia Law

Acorda’s patents claim the administration of a medication containing the active ingredient 4- aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. Acorda holds an FDA-approved New Drug Application and markets, under the name “Ampyra®,” 10 milligram 4-AP sustained-release tablets for twice-daily oral administration and holds an exclusive license to the earlier, broader “Elan patent,” which is listed in the FDA Orange Book for Ampyra with the Acorda patents, and claims methods of treating patients having certain conditions, including multiple sclerosis, by administering a drug containing a sustained-release formulation of any of certain agents, including 4-AP. Defendants sought FDA approval to market generic versions of Ampyra. In Acorda's infringement suit, the district court held that the asserted claims in the Acorda patents are invalid for obviousness but upheld the Elan patent and enjoined infringement of that patent until it expired in July 2018. The Federal Circuit affirmed that the asserted Acorda patent claims are invalid, discounting the weight of Acorda’s evidence of commercial success, failure of others, and long-felt but unmet need. The court noted the Elan patent issued in 1996 and was licensed exclusively to Acorda in 1997 for spinal cord injury and in 1998 for multiple sclerosis treatment, which blocked others from domestic marketing without risk of infringement and deterred other entities from investing in research whose reward depended on marketing a drug like Ampyra. View "Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc." on Justia Law