A Paris appeals court has upheld a €40.6 million ($49.7 million) antitrust fine against Sanofi SA for campaigning to discourage doctors and pharmacists from prescribing or substituting generic versions of its former blockbuster blood thinner Plavix.
The U.S. Food and Drug Administration said Monday that a recent court defeat won’t stop it from withholding exclusivity for new orphan drugs that are essentially the same as previously approved medications, a surprising stance that experts say all but guarantees future litigation.
The U.S. Securities and Exchange Commission on Monday hit two Chilean businessmen, including an ex-board member of CFR Pharmaceuticals SA, with a New York federal suit alleging they made $10.6 million by trading on insider information in Abbott Laboratories' $3.3 billion takeover of CFR.
The U.S. Federal Trade Commission on Monday issued a report finding that the number of potentially anti-competitive patent settlements over the past fiscal year between branded pharmaceutical companies and generic-drug makers dropped significantly from the previous record high filed two years ago.
The U.S. Securities and Exchange Commission in California federal court on Monday accused a Newport Beach-based attorney of trading on inside information he learned from a pharmaceutical company he was representing, ordering him and his wife to pay a combined $90,000 in disgorgement and fines.
A group of Nexium buyers told the First Circuit on Friday that they didn't oppose AstraZeneca AB's bid to dismiss its class certification challenge in a pay-for-delay suit over the heartburn drug but warned that the drugmaker's claim that the suit was wrapped up was "mere gamesmanship."
The Federal Trade Commission on Monday cleared Eli Lilly & Co.'s $5.4 billion acquisition of Novartis AG's animal health unit on the condition that Eli Lilly shed Novartis' heartworm treatment product line.
Attorneys for a plaintiff suing Daiichi Sankyo Inc. and Forest Laboratories Inc. over side effects of the blood pressure drug Benicar have asked the U.S. Judicial Panel on Multidistrict Litigation to consolidate suits over the drug in Ohio, arguing the majority of cases to date have been filed there.
Amazon.com Inc. has hit back at allegations that it turns a blind eye to third parties selling weight loss supplements containing a dangerous and prohibited ingredient on its site, saying that a putative class of consumers is attempting to usurp the government’s powers by forcing it to notify purchasers that it had pulled the products.
The Patent Trial and Appeal Board has ruled that Warsaw Orthopedic Inc.’s patent on a spinal implant device is invalid as obvious, handing a win in an America Invents Act review proceeding to petitioner NuVasive Inc., which was accused of infringing the patent.
Propelled by their strongest start since the financial crisis, a strong run in the back half of 2014 cemented a turnaround for the deal-making marketplace driven by rising confidence and renewed boldness. Here, in the second of a two-part series, Law360 looks back on a handful of plays that defined an active back half.
A California federal judge has denied class certification in a suit alleging that Eli Lilly & Co. downplayed the withdrawal risks of its antidepressant drug Cymbalta, saying that the plaintiffs’ damages model was flawed because of complicating factors in the prescription drug market.
Johnson & Johnson will pay $125 million, and potentially $575 million more if certain goals are met, to help develop a drug treating blood cancers through a collaboration announced Monday with its subsidiary Janssen Biotech Inc. and clinical stage company MacroGenics Inc.
The University of Connecticut Health Center will be forced to turn over the names of researchers who failed to follow animal welfare protocols after a state judge overturned an administrative court’s decision that the researchers could face harm from animal rights activists.
A Florida federal judge on Friday told attorney Mitchell J. Stein his court won’t “simply change its mind” about a 17-year sentence leveled against the attorney for participating in former NFL player Willie Gault’s scheme to inflate heart-monitoring company Signalife Inc.'s stock.
A Delaware bankruptcy judge threw out Derma Pen LLC’s Chapter 11 case Friday, ruling there was no evidence the skin treatment seller was in financial distress when it filed and that its petition was simply a tactic to disrupt a lawsuit over ownership of the trademark for its primary products.
Venture capital-backed drug company Ascendis Pharma, a Danish developer of treatments for human growth hormone deficiency, filed Thursday for an $86.25 million initial public offering in the U.S., marking the latest biotech to seek public markets amid a robust climate.
A federal judge has allowed Mylan Pharmaceuticals Inc. to file an interlocutory appeal to the Federal Circuit of his decision that the company is subject to jurisdiction in Delaware in a suit over generic versions of AstraZeneca AB drugs, saying the case raises a novel issue in Hatch-Waxman law.
K&L Gates LLP has lured a transaction pro away from her role as LipoScience Inc.'s general counsel to work as a mergers and acquisitions partner in its Raleigh, North Carolina, office, the firm said Monday.
A Texas federal judge denied Retractable Technologies Inc.'s attempt to add a charge of monopoly power to a jury's 2013 verdict against Becton Dickinson and Co., saying that Becton's declining 50 percent market share constituted a "proper basis" justifying the jury's conclusion that it lacked monopoly standing.
In 2014, courts and regulators ultimately left unresolved critical underlying issues in product liability law with potentially substantial legal repercussions, particularly in the areas of class certification and liability for food product and medical device defects, say attorneys at Nutter McClennen & Fish LLP.
The rule of thumb that can be gleaned from this year’s case law is that parties should address the use of technology-assisted review early on in the discovery process since a failure to do so may later be used against them, says Gabriela Baron of Xerox Litigation Services.
Despite the government continuously sending signals that it approves of gainsharing, such arrangements are illegal for both hospitals and physicians and yet, given the past and current position of the U.S. Department of Health and Human Services' Office of Inspector General, the office is highly unlikely to take enforcement action against a gainsharing arrangement with safeguards, says Norman Tabler Jr. of Faegre Baker Daniels LLP.
Though the U.S. Supreme Court in Actavis provided a general framework for lower courts to utilize in evaluating reverse payment cases, it expressly deferred to lower courts the task of “structuring” the rule-of-reason analysis announced in the case. Over the last year, trial courts have taken divergent views, says Jonathan Watkins of Zelle Hofmann Voelbel & Mason LLP.
The Mayo-Myriad-Alice trilogy of U.S. Supreme Court decisions is impacting many much less controversial patents. Denying patent protection to treatments for cancer, AIDs and tuberculosis because they are based on unpatentable concepts is unwise, if not dangerous, say Bernard Chao, an assistant professor at the University of Denver Sturm College of Law, and Lane Womack, an attorney at Kilpatrick Townsend & Stockton LLP.
The bad news coming out of the European Pro Bono Summit in November was the rising toll of heavy cuts to public legal aid in England. From this crossroad, there is a lot to be learned about the relationship between public and private assistance, the direction of legal help for the poor in the EU, and whether the American legal aid/pro bono experience offers a road map for what’s next in Europe, says Kevin Curnin of the Association ... (continued)
While many biotech founders and investors believe their scientific efforts will generate substantial value, big pharma is often unwilling to pay significant sums to acquire products before significant derisking is undertaken — to bridge this gap, big pharma and early-stage biotech companies have turned to option deals to accomplish their respective goals, says Brian Goldstein of Choate Hall & Stewart LLP.
This year, the Federal Circuit agreed to reconsider its decision narrowing Section 337’s applicability to induced infringement, as the U.S. International Trade Commission held onto its jurisdiction over standard-essential patents and confirmed its ability to reach digital imports. Meanwhile, the ITC took steps toward better exclusion order enforcement, even as it stayed a remedial order pending appeal for the first time, says Shara... (continued)
The Seventh Circuit's recent rejection of a class action settlement in Pearson v. NBTY Inc. highlights the important role objectors play in policing the adequacy of class action settlements and provides guidance to lawyers crafting such settlements as well as to district courts charged with reviewing them, says Rhonda Wasserman of the University of Pittsburgh School of Law.
The first wave of appeals from the U.S. Patent and Trademark Office’s final written decisions in inter partes review, covered business method review and post-grant review proceedings are just starting to reach the Federal Circuit. The court issued several opinions in 2014 that are important to practitioners in this area, say Russell Cass and Raquel Rodriguez of Sidley Austin LLP.