A Massachusetts federal judge refused Thursday to let Nexium buyers get a second crack at their pay-for-delay suit against AstraZeneca PLC and Ranbaxy Inc., saying the plaintiffs' claim for how new evidence would let them prove their case at trial was "at least a couple of bridges too far."
A growing number of life sciences companies are locking down crossover financing rounds shortly before kicking off their initial public offering plans, a move that’s helping to fuel strong listings in the space, experts say.
At least two new plaintiffs filed complaints Wednesday in Pennsylvania federal court accusing Bayer Corp. and Merck & Co. Inc. of downplaying the risk of permanent nerve damage posed by the antibiotic Avelox and promoting the drug for minor conditions that can be treated with safer medications.
The U.S. Patent and Trademark Office issued interim guidance Thursday to its 2014 memo to examiners concerning how to determine subject matter eligibility under federal patent law, in light of the recent Alice, Mayo and Myriad Supreme Court decisions.
Novartis Pharmaceuticals Corp. told a Massachusetts federal judge to dismiss a proposed class action that claims the company illegally withheld generic versions of a leukemia drug from consumers, saying the plaintiffs lack standing to sue and have failed to state a claim.
AbbVie Inc. told the Delaware Supreme Court late Wednesday that the Chancery Court was right to toss shareholders' records demands investigating the failed $55 billion merger with Shire PLC, which fell apart amid an Obama administration crackdown on tax-driven inversions, arguing there was no proper purpose for the probe.
Medical device maker NuVasive Inc. will pay $13.5 million to resolve whistleblower allegations that it violated the False Claims Act by promoting off-label uses of spinal fusion products for Medicare patients and dispensing kickbacks through a supposedly independent medical society, the U.S. Department of Justice said Thursday.
Bio-Rad Laboratories Inc. told a California federal court Tuesday that its general counsel was fired because of “abusive and damaging conduct,” not because he reported his suspicion that company brass were bribing Chinese officials as alleged in the legal officer’s retaliation lawsuit.
A host of business leaders on Thursday lobbied a U.S. Senate committee for relief from high corporate tax rates, saying the current system pressures them to relocate overseas and makes their companies vulnerable to buyouts by foreign rivals.
An attorney who was forced to bow out of litigation over the diet drug Fen-Phen when he developed amnesia can present to a jury his claim that his former firm underpaid him for his work, the Utah Supreme Court ruled Tuesday, reversing a trial court’s decision.
GlaxoSmithKline LLC asked the Third Circuit on Wednesday to uphold a Pennsylvania court's finding that Hagens Berman Sobol Shapiro LLP's last client standing in litigation over the 1950s morning sickness drug Thalidomide was too late in bringing her suit, after the firm was previously sanctioned over obviously time-barred claims.
Actavis Inc. on Tuesday asked a New York federal judge overseeing Endo Pharmaceuticals Inc.’s case accusing it and several other generics manufacturers of infringing its patent for painkiller Opana ER to disregard a U.S. Patent and Trademark Office decision upholding Endo’s patent, arguing the administrative ruling has no bearing on the pending civil case.
Over three years, Medicare contractors overpaid providers at least $35.8 million for outpatient drugs, according to a U.S. Department of Health and Human Services’ Office of the Inspector General report released Wednesday.
The Patent Trial and Appeal Board instituted inter partes review Tuesday of four Jazz Pharmaceuticals Inc. patents for the narcolepsy drug Xyrem, the same patents it previously refused to review under a different America Invents Act program.
Novartis AG has sold three midstage clinical drugs to a newly formed U.K.-based pharmaceutical company in exchange for equity, the pharmaceutical giant announced on Wednesday.
The U.S. Department of Justice on Wednesday sought a criminal contempt finding against the operator of an online herbal supplement store in Montana federal court, alleging he’s continued to sell products falsely professing to cure serious diseases despite two court orders to shut his business down.
The European Commission has cleared drugmaker Mylan NV to acquire Irish pharmaceutical company Perrigo Co. PLC, Mylan announced Wednesday, bringing it a step closer to closing the $35.6 billion hostile bid, which Perrigo rejected earlier this year.
Celgene Corp. filed on Tuesday a motion for sanctions against an organization tied to hedge fund manager Kyle Bass, arguing the group’s challenge to Celgene’s drug patents is an abuse of the American Invents Act review program.
Johnson & Johnson Inc. and subsidiary Janssen Pharmaceuticals Inc. removed a suit to Oklahoma federal court in which the Cherokee Nation claims that the companies misbranded its anti-psychotic Risperdal and failed to disclose the drug's risk to the elderly.
A New Jersey judge departed from his predecessor in dismissing hundreds of suits in the consolidated Accutane litigation, General Motors Co. secured a Chapter 11 shield from certain ignition switch liability suits, and asbestos plaintiffs in New York City won a decision that will aid their fight for punitive damages. Here, Law360 looks at the year's most significant product liability cases so far.
At the heart of the dispute in Amarin Pharma Inc. v. U.S. Food and Drug Administration before the Southern District of New York is the complaint that the federal government cannot prosecute the simple promotion of a drug’s off-label use because such an interpretation raises First Amendment concerns, says Emily Pincow of Weil Gotshal & Manges LLP.
While the U.K. Competition and Markets Authority's decision to close its investigation into loyalty-inducing discounts offered by a pharmaceutical firm suggests a continuing reluctance to devote resources to complex abuse of dominance probes, the fact that the CMA investigated this for a year, together with the more active enforcement by other European competition authorities, shows that firms that may be dominant cannot afford to ... (continued)
The U.S. Food and Drug Administration should be releasing initial policy positions soon on nonproprietary naming for biological products. Joanne Hawana of Mintz Levin Cohn Ferris Glovsky and Popeo PC examines both sides of the debate.
Manipulating gender disparity in the service of hawking a flawed investment product does nothing but trivialize a serious and important issue. The tortured logic in Burford Capital LLC’s recent plug for third-party litigation financing is nothing more than a marketing ploy to boost revenues, says Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform.
A Third Circuit decision in IP theft case Aleynikov v. Goldman Sachs Group Inc. and the Delaware Chancery Court’s ruling in insider trading suit Holley v. Nipro Diagnostics Inc. have raised important issues regarding fee advancement bylaws. For one, a litigant will not be considered an “officer” simply based on his or her title, say attorneys with Katten Muchin Rosenman LLP.
By clarifying the standard against which patent definiteness is evaluated, the U.S. Supreme Court in Nautilus has articulated the role of reasonable certainty in patent claim construction. While there is no bright-line test to define reasonable certainty, the concept of reasonableness itself is well accepted as the basis of the common law system, say Neil Steinkamp and Robert Levine of Stout Risius Ross Inc.
Fisher and Romaine’s well-known article, “Janis Joplin’s Yearbook and the Theory of Damages,” argues that commercial damages should be measured as of the time the challenged act occurred, an approach that has generally been favored. However, their argument is somewhat contrived, says Paul Godek, principal at MiCRA and a former economic adviser at the Federal Trade Commission.
The lack of unanimity, combined with the exceptional importance of this decision to the biopharmaceutical industry suggests that one or both litigants may seek en banc rehearing, say Dr. Paul Calvo and Timothy Shea Jr. of Sterne Kessler Goldstein & Fox PLLC.
In the United States, many patent claims related to personalized medicine are being challenged based on patentable subject matter, whereas in Europe, most claims are questioned based on novelty and inventive step, says Gabriela Coman of Dickstein Shapiro LLP.
Understanding how the U.S. Federal Drug Administration regulates antibody drug conjugates and how regulatory data exclusivity will likely be awarded for different types of ADCs is of critical importance to life science companies that are developing these new types of innovative and targeted biopharmaceuticals, say Charles Lyon and Robert Sahr at Choate Hall & Stewart LLP.