The U.S. Food and Drug Administration answered drugmakers’ questions Wednesday about how to maintain data from drug tests and the manufacturing floor, following an uptick in violations of federal information retention standards.
The Eighth Circuit on Wednesday summarily shot down a New York pharmacy’s bid to revive its breach of contract and antitrust suit against Express Scripts Holding Co.
A Delaware federal jury found Tuesday that Edwards Lifesciences Corp. damaged Boston Scientific SciMed Inc. to the tune of $35.4 million by infringing a heart valve patent, while rejecting claims that Boston Scientific infringed three Edwards patents.
A liquidating trustee of bankrupt mining company IMMC Corp. asked the full Third Circuit Wednesday to revisit its precedential November decision that a Delaware bankruptcy court lacked jurisdiction to transfer his $250 million adversary proceeding to Pennsylvania district court, arguing that the ruling contravened U.S. Supreme Court precedent along with the applicable law.
The U.S. Food and Drug Administration’s leader on Wednesday said that tougher enforcement is coming in early 2019 for bogus claims or shoddy manufacturing involving stem cell therapies, dietary supplements and compounded drugs.
Online retailer 1-800 Contacts Inc. has asked the Federal Trade Commission to stay part of its recent ruling knocking out more than a dozen of the lensmaker’s marketing agreements, saying the decision goes too far and blocks the company from enforcing its own trademarks and keeping up with competitors.
Teva Pharmaceuticals USA Inc. scored a win on Wednesday when the Federal Circuit affirmed an Eastern District of Texas ruling that the generics maker did not infringe Allergan USA’s patent for the ulcerative colitis drug Delzicol, paving the way for Teva to get approval on the generic version of the drug.
A European court on Wednesday reduced a fine by €102.67 million ($116.73 million) that enforcers levied against pharmaceutical company Servier over allegations it reached several anti-competitive agreements to delay cheaper versions of blood pressure medicine perindopril, but rejected appeals of fines from most of the other companies involved.
Biopharmaceutical company Synergy Pharmaceuticals Inc. filed for Chapter 11 in New York bankruptcy court on Wednesday, with plans to shrug off its $130 million debt load by selling itself to Bausch Health Companies Inc. for an opening bid of roughly $200 million.
The federal government has weighed in on a whistleblower suit accusing Bayer Corp. of paying kickbacks to get doctors to use a surgery drug called Trasylol, saying the company can still be held liable under the False Claims Act even though the government pays for the drugs as part of a bundle rather than individually.
A California biotech entrepreneur avoided jail time Wednesday for lying to the U.S. Securities and Exchange Commission, receiving five months' home confinement and up to five years' probation from a Massachusetts federal judge on a conviction stemming from a pump-and-dump scheme.
Lori Cohen, co-chair of Greenberg Traurig’s global litigation practice and chair of the firm's trial practice group, spearheaded big wins for life sciences clients in the past year, including the Seventh Circuit's rejection of state lawsuits in national litigation over eye drop doses, earning her a spot among Law360's 2018 Life Sciences MVPs.
Hospira has urged the Federal Circuit to toss a $70 million jury verdict finding its biosimilar version of Amgen Inc.’s blockbuster anemia treatment Epogen infringed an Amgen patent, arguing its drug production was protected by a safe harbor for companies seeking federal approval for biosimilar products.
The Federal Circuit on Monday affirmed Stryker Corp.’s $248 million win in a surgical tool patent dispute that had previously gone to the U.S. Supreme Court as part of a case that set a new and more relaxed standard for awarding enhanced damages in patent suits.
A California-based dental products maker has added to its expanding intellectual property battle with a Danish rival over patents covering intraoral scanners and related equipment, filing two complaints Tuesday in Delaware federal court and one complaint Monday at the U.S. International Trade Commission.
Weighing in on venue rules in patent infringement disputes, nonprofit Washington Legal Foundation urged the full Federal Circuit on Monday to rehear arguments by Eli Lilly and Co. that a Cialis dispute resulting in a $20 million verdict against the pharma giant shouldn’t have been litigated in East Texas.
An accountant found guilty of helping a venture capitalist siphon $18 million from a fund through false tax returns has told a California federal court he should serve no time behind bars despite prosecutors' request for a "significant" prison sentence.
Investors suing ImmunoCellular Therapeutics Ltd. over an alleged illegal stock promotion scheme asked a California federal judge Monday to preliminarily approve a $1.1 million settlement nearly equal to the company's entire market capitalization.
A California federal judge overseeing allegations that Hoffmann La-Roche Inc.'s anti-malarial drug neurologically harmed a Navy veteran has sent the case back to state court, ruling there wasn't federal diversity jurisdiction because the company's principal place of business is in California, not New Jersey.
GNC knocked down a proposed securities class action accusing the retailer of misleading investors about nutrition supplements that contained unlawful ingredients after the Third Circuit found Tuesday that the plaintiffs have not sufficiently alleged that company executives were knowingly or recklessly deceptive.
Many law firms have tickets or luxury suites at sporting events to host clients and prospects. Matthew Prinn of RFP Advisory Group and Matt Ansis of TicketManager discuss some of the ways that firms can use those tickets effectively.
A recent opinion from the American Bar Association provides useful guidance on attorneys’ obligations to guard against cyberattacks, protect electronic client information and respond if an attack occurs, says Joshua Bevitz of Newmeyer & Dillion LLP.
The U.S. Food and Drug Administration wants to "modernize" the approval process for medical devices based on older products by encouraging developers to use more modern devices as predicates. This does not mean older devices are unsafe, but the negative implication seems undeniable, say Patricia Kaufman and Joel Schwartz of Stinson Leonard Street LLP.
Two recent decisions from the Federal Circuit — Novartis AG v. Ezra Ventures and Novartis Pharmaceuticals v. Breckenridge Pharmaceutical — clarify the law of "obviousness-type double patenting" and give certainty to biopharmaceutical patent owners, say Irena Royzman and Andrew Cohen of Patterson Belknap Webb & Tyler LLP.
Opening comments by parties in mediation that are made with the proper content and tone can diffuse pent-up emotion and pave the way for a successful resolution. But an opening presentation can do more harm than good if delivered the wrong way, say Jann Johnson and William Haddad of ADR Systems LLC.
If implemented, the U.S. Food and Drug Administration's proposed framework for regulating prescription drug-use-related software would likely mean that pharmaceutical companies will need to exert more control over certain software applications and be more involved in software update processes, say attorneys at Ropes & Gray LLP.
Local patent rules in the Eastern District of Texas and Northern District of California don’t squarely address the issue of what must be disclosed during claim-construction discovery in order to rely on expert declarations. But thanks to the corpus of post-Teva decisions a clearer picture has emerged, says Ken Fung of Fisch Sigler LLP.
In the second installment of this three-part legislative preview, Rich Ehisen of State Net Capitol Journal examines a number of issues that should keep state lawmakers occupied next year.
The U.S. Supreme Court recently agreed to hear Cochise Consultancy v. United States ex rel. Hunt, which deepened the circuit split over how the False Claims Act’s statute of limitations applies in certain qui tam actions. The decision should bring sorely needed clarity, say Matthew Curley and Scott Gallisdorfer of Bass Berry & Sims PLC.
During U.S. Supreme Court oral arguments in Helsinn Healthcare v. Teva Pharmaceuticals, the justices’ focus on the statutory language, and the relative lack of focus on the specific facts of the case, suggest they may address the meaning of the America Invents Act language broadly, say Michael Pomianek and Michelle Nyein of Wolf Greenfield & Sacks PC.