A recent ruling that GlaxoSmithKline PLC faces liability for the suicide of a Reed Smith LLP partner who took a generic version of its antidepressant Paxil sets forth a powerful strategy for plaintiffs to use negligence claims to go after brand-name drugmakers, who have long evaded liability for their generic counterparts.
To shut down a pay-for-delay class action against Pfizer Inc.'s King Pharmaceuticals Inc. and generic-drug maker Mutual Pharmaceutical Co. Inc., attorneys from Kaye Scholer LLP and Munger Tolles & Olson LLP had to figure out how to explain why the U.S. drug distribution system didn't fit the traditional antitrust class certification model. For the defense team, that meant leading with a complex economic story and trusting the judge to come along for the ride.
Baxter International Inc. has asked the U.S. Supreme Court to review a Federal Circuit decision voiding its $23.5 million award against Fresenius USA Inc. based on a patent’s cancellation by the U.S. Patent and Trademark Office, arguing the judgment weakens the stability of the patent system.
The Obama administration’s epic retreat from a major overhaul of Medicare Part D was a cautionary tale for regulators who float grand plans without first getting buy-in from corporations and beneficiaries, according to experts who say the changes nonetheless could return in retooled forms and shake up business for drugmakers, pharmacies and insurers.
The Federal Trade Commission said Monday it has the authority to issue reporting requirements that impact just the pharmaceutical industry, and asked a Washington, D.C., federal judge to rule in its favor in a dispute over patent licenses with the Pharmaceutical Research and Manufacturers of America.
A New Jersey jury on Tuesday awarded at retrial over $1.5 million to a woman who developed a form of inflammatory bowel disease after taking Hoffman-LaRoche Inc.’s acne drug Accutane, representing the plaintiff's second victory, with her earlier verdict having been overturned on appeal.
The Federal Circuit ruled Tuesday that Medtronic Inc. had not infringed defibrillator patents held by Boston Scientific Corp., applying the U.S. Supreme Court’s finding that patent owners bear the burden of proof when a licensee files a suit alleging invalidity and noninfringement.
Teva Pharmaceuticals USA Inc. will pay the U.S. Department of Justice and the state of Illinois $27.6 million for allegedly paying a doctor to push prescriptions of a risky antipsychotic drug used to treat schizophrenia to patients, the DOJ announced Tuesday.
Successfully handling high-profile matters, with and against so many well-known insurance coverage professionals, offered me a chance to break into, then gain prominence and respect in, an industry dominated by men, says Sherilyn Pastor, leader of McCarter & English LLP's insurance coverage group and a member of the firm's executive committee.
When you are in the middle of a trial or a large transaction and have missed one too many soccer games, it is easy to say you must make a change. But the best thing to do is to get through the madness, and then re-evaluate your personal and professional balance, says Heidi Goldstein, leader of Thompson Hine LLP's women's initiative.
A Utah federal judge on Monday halted Myriad Genetics Inc.'s quest to block sales of Ambry Genetics Corp. cancer-testing products it claims infringe several of its patents, including five tackled in a landmark U.S. Supreme Court decision last year, ruling that Ambry had raised sufficient questions about the patents' validity.
A Pennsylvania federal judge refused Monday to dismiss GlaxoSmithKline LLC's lawsuit accusing Teva Pharmaceuticals USA Inc. of falsely advertising a generic antidepressant as equivalent to GSK's brand-name version, saying it was not preempted by a past U.S. Food and Drug Administration finding.
The Federal Circuit handed a win to biotechnology company Promega Corp. on Monday when it affirmed a lower court’s finding that claims in a patent asserted by Life Technologies Corp. over a method for fluorescence-based DNA analysis were invalid.
In a petition delayed pending a full Ninth Circuit rehearing, Teva Pharmaceuticals Inc. has asked the U.S. Supreme Court to consider whether suits can be removed to federal court under the Class Action Fairness Act if the plaintiffs want to coordinate them before one judge but have not asked for a joint trial.
Bowing to widespread outcry, federal regulators on Monday abandoned several controversial Medicare Part D proposals, including plans to end guaranteed access to certain drugs and cap the number of prescription drug plans that insurance companies offer.
A California federal judge on Friday refused to dismiss Genetic Technologies Ltd.’s allegations that Agilent Technologies Inc. sold a DNA-testing device that infringes GT's genetic analysis patent, ruling the patent did not merely cover a law of nature.
A pair of Republican senators on Monday urged a government watchdog to investigate claims that pharmaceutical companies paid to attend private meetings between the U.S. Food and Drug Administration and medical professionals to influence the approval of controversial opioid painkiller Zohydro ER.
A Johnson & Johnson unit on Thursday agreed to pay $5.9 million to resolve a suit brought by Montana's attorney general claiming the company promoted its antipsychotic drug Risperdal as safe despite knowing it posed risks of health problems including diabetes.
The Eighth Circuit on Monday upheld a victory for Eli Lilly & Co. in a lawsuit claiming it failed to adequately warn of the risks of long-term use of the antipsychotic drug Zyprexa, backing a lower court's exclusion of expert testimony.
GlaxoSmithKline PLC has bumped up its stake in its Indian pharmaceuticals subsidiary GlaxoSmithKline Pharmaceuticals Ltd., revealing Sunday that it spent 64 billion rupees ($1.05 billion) to increase its clout in a market expected to see significant growth.
While it appears likely that manufacturers will follow GlaxoSmithKline PLC’s lead in ending physician promotional activity, it remains much less clear whether the elimination of these arrangements will reduce or eliminate bias, or reduce health care costs. And the elimination of a relatively low-cost but effective means of promotion and education via experienced clinician speakers may do more harm than good, says Christine Savage of Choate Hall & Stewart LLP.
Recent decisions by the Federal Circuit and the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board offer further incentive for generic litigants to seek an inter partes review as a complement — or even alternative — to district courts for challenging Orange Book patents, say attorneys with Sterne Kessler Goldstein & Fox PLLC.
In recognition of the increasingly important role of fixed-combination drugs for treating chronic diseases such as heart disease, cancer and diabetes, the U.S. Food and Drug Administration has proposed guidance that significantly departs from its historical interpretation of the "new chemical entity" exclusivity provision. It will be interesting to follow the debate that ensues regarding the NCE status of combinations of a new drug with a previously approved drug, say attorneys at Jones Day LLP.
Unfortunately, the U.S. Patent and Trademark Office's recent memorandum to its patent examiners outlining patent eligibility under Section 101 was not subject to public notice or comment. The memorandum is flawed and, as written, may result in flawed examination of patent applications, says David Gass of Marshall Gerstein & Borun LLP.
The D.C. Circuit recently upheld a district court's ruling that autologous stem cells are a medical procedure subject to regulation by the U.S. Food and Drug Administration under the Federal Drug and Cosmetic Act and Public Health and Safety Act. The decision will further embolden the FDA to regulate stem cell therapies, so industry would be well advised to prepare for greater regulatory scrutiny, says Stacie Ropka of Axinn Veltrop & Harkrider LLP.
Most notable about China's most recent conditional merger approval decision were the faster speed of the review and the Ministry of Commerce's increased use of economic analysis. The decision on Thermo Fisher Scientific Inc.'s acquisition of Life Technologies Corp. also highlights MOFCOM's willingness to impose remedies that go beyond what other jurisdictions require, say attorneys with Jones Day.
Cloud users must know how to use the cloud responsibly to prevent later difficulties with document production. When negotiating a cloud service agreement, users should look for certain services that will prove useful when responding to discovery requests, such as comprehensive search options, instant suspension of the auto-delete function, and preservation of metadata and embedded data, say attorneys with Sidley Austin LLP.
The U.S. Supreme Court has agreed to review the Sixth Circuit’s decision in Indiana State District Council of Laborers v. Omnicare Inc., which parts ways with the Second, Third and Ninth circuits and holds that “subjective falsity” is not required for opinion-based Section 11 claims. Although the circuit split is hogging all the attention, everyone seems to be overlooking the fact that the Sixth Circuit in Omnicare ignored its own precedent, says Drew Dropkin of King & Spalding LLP.
The U.S. Department of Health and Human Services recently issued a report on the 340B Drug Discount Program to gain a better understanding of how contract pharmacy arrangements operate. While the report does not provide any recommendations in response to the inconsistencies in contract pharmacy arrangement operations, covered entities should develop policies and protocols for performing self-audits and explore the availability of independent auditing services, say attorneys at Epstein Becker & Green PC.
Although the U.S. Food and Drug Administration's recently issued draft guidance begins to shed light on the FDA’s views regarding the custom device exemption from premarket approval, a number of key open questions remain, and the exemption likely will continue to be rarely used, say Scott Danzis and Melissa Whittingham of Covington & Burling LLP.