A California federal judge on Tuesday denied a bid made by Celgene Corp. to halve the time period covered by a whistleblower’s False Claims Act suit over alleged off-label marketing of cancer drugs Thalomid and Revlimid and related kickbacks to doctors.
The U.S. Food and Drug Administration's warning letters this week went out to a salsa maker for failing to ensure the proper acidity of its products, a company that sells a supplement purporting to aid concussion recovery and a dairy farm in Arizona that sold a cow on antibiotics for slaughter.
MedTel24 Inc. has been found in contempt after a Pennsylvania federal judge said the heart monitoring company clearly violated his order in a patent suit and is still using the infringing software.
A California woman is suing the maker of a metal-on-metal hip replacement system she claims was defective and caused pain, inflammation and permanent injury during the nine years it was implanted in her body, according to a complaint filed in California district court Tuesday.
A man who sued Stryker Corp. after his toe implants broke urged the Fifth Circuit on Monday to stand by its 2-1 ruling sending the claims to state court and to ignore the manufacturer's argument that the ruling encourages abuse of the Louisiana Medical Malpractice Act.
GlaxoSmithKline and Teva told a New Jersey federal court on Monday that they plan to ask the U.S. Supreme Court to review whether a pay-for-delay class action against them should be nixed because their settlement over Lamictal patents didn't involve a cash payment.
Hi-Tech Pharmaceuticals Inc. on Monday once again asked a Georgia federal judge to remove himself from a case the Federal Trade Commission is bringing against the company over dietary supplement labels, claiming a fair verdict isn’t possible when the judge has seen privileged communications.
Canadian generics maker Apotex Inc. fired back in Florida federal court Monday with counterclaims accusing Amgen Inc. of filing sham litigation alleging Apotex infringed two patents for blockbuster biologic Neulasta.
Johnson & Johnson recently convinced a Pennsylvania federal jury that over-the-counter Children's Motrin didn't cause a child to develop the life-threatening skin condition Stevens-Johnson Syndrome, a win that attorneys say will help the pharmaceutical giant try more cases involving patients who took a little longer to develop the condition.
A California federal judge on Monday granted Allergan Inc.’s motion for summary judgment in a $600 million breach-of-contract lawsuit over Botox, holding that the pharmaceutical giant does not have to pay Miotox certain royalties under the terms of a license agreement.
A New York federal judge has ruled that collective notice will be provided to female employees accusing Forest Laboratories Inc. of gender bias who worked for the company as a sales representative as of May 22, 2012, rejecting the plaintiffs’ argument that notice should extend 10 months earlier.
Astellas Pharma US LLC pressed the First Circuit Monday to nix a ruling certifying a class of indirect purchasers who claim the drugmaker improperly delayed generic competition for the immunosuppressant drug Prograf, arguing it would be an impossible task to weed out the class members who can’t actually prove they were injured.
A Texas appellate court on Friday stood by its reinstatement of a $1.875 million arbitration award in a dispute over patent licensing for technology used to treat excessive human growth hormone, despite a biotech firm's argument that the arbitrators exceeded a contractual limit on damages.
The completion of the Trans-Pacific Partnership talks on Monday stands as a landmark achievement for the 12 nations party to the accord, but various concessions on issues like agriculture and intellectual property that made the TPP possible may also be the biggest obstacle to its final passage by lawmakers.
A Massachusetts federal judge on Monday divvied out more than $8 million in expenses for a settlement reached between Nexium buyers and Teva Pharmaceutical Industries Ltd., but agreed to hold off on approving fees for AstraZeneca PLC and Ranbaxy Inc. following their win in a multidistrict litigation pay-for-delay trial brought by the same buyers.
Activist investor Engaged Capital said Monday that heart pump maker HeartWare International should drop its bid to purchase Valtech Cardio in a cash and stock deal worth as much as $857.8 million, and should consider selling itself instead.
The U.S. Supreme Court on Monday declined to hear W.L. Gore & Associate Inc.’s $1 billion case over a blood vessel graft patent, which questioned whether an exclusive patent license could be transferred through verbal or implied contract, instead of in writing.
A Texas state court jury on Monday cleared Johnson & Johnson of liability in the first trial over the company's Prosima pelvic mesh device, rejecting claims the device was defectively designed and that the company didn't adequately warn consumers about the risks involved.
AbbVie Inc. has improperly clawed back documents in a pay-for-delay suit over testosterone replacement treatment AndroGel and wrongly told the court that certain documents are privileged, the Federal Trade Commission told a Pennsylvania federal judge Friday.
Bristol-Myers Squibb Co. on Monday agreed to pay $14 million to settle allegations by the U.S. Securities and Exchange Commission that its representatives in China bribed state-owned and state-controlled hospitals to boost prescription sales.
Given the times we live in, it is almost inevitable that everyone will, sooner or later, need to consult with legal counsel. With that in mind, I thought it might be interesting to discuss a few things that clients just won't tell their lawyers, says Francis Drelling, general counsel of Specialty Restaurants Corp.
The logic behind the Seventh Circuit's explicit break with its sister courts in Mullins v. Direct Digital LLC over the “heightened” ascertainability requirement is predicated largely on its view that the preservation of consumer class actions involving low-cost products is a policy imperative that outweighs manageability and fairness concerns, says Geoffrey Wyatt of Skadden Arps Slate Meagher & Flom LLP.
The ruling in the NJOY Inc. Consumer Class Action Litigation and a recently proposed rule by the U.S. Food and Drug Administration indicate that e-cigarette advertising claims that suggest or emphasize specific chemical, physical and toxicological effects may be subject to increased scrutiny, say Eric Heyer and Neelam Gill of Thompson Hine LLP.
M&A activity in the specialty pharmacy sector has been quite active, as witnessed by a number of key recent deals spread across different players, including large pharmacy providers and big-box retailers. Although increased valuations are expected to follow, opportunities remain for private equity sponsors able to understand the complex regulatory framework, say attorneys with McGuireWoods LLP.
The Federal Circuit’s decisions this year in Gilead v. Natco Pharma and G.D. Searle v. Lupin Pharmaceuticals show that obviousness-type double-patenting remains an effective mechanism to protect the public from patentees gaining unjustified patent term extensions by filing duplicative patents having different expiration dates, say attorneys with Axinn Veltrop & Harkrider LLP.
Unilateral drug price increases alone — when not done by agreement or through collusion with competitors — are almost never actionable under U.S. antitrust law. As long as Turing Pharmaceuticals AG acted alone in raising Daraprim's price, it would be highly unlikely to face any antitrust claim or criminal antitrust penalties, say attorneys at Wilson Sonsini Goodrich & Rosati PC.
Ten years after the Judicial Panel on Multidistrict Litigation created the Guidant Corp. Implantable Defibrillators Products Liability MDL and assigned it to Judge Donovan Frank in the District of Minnesota, the litigation’s key players returned to Minnesota to reflect on the lessons learned. See what the judges, lien administrator, and plaintiffs and defense counsel had to say.
A number of recent court decisions have highlighted important gaps and a lack of consensus between key EU member states on the law regarding infringement of second medical use patents. The rulings also demonstrate how differences in the drug dispensing and reimbursement systems between different EU countries can influence the nature of the relief available, say attorneys with Jones Day.
What aspects of the patent exhaustion doctrine does the Federal Circuit’s recent holding in JVC Kenwood Corp. v. Nero Inc. develop, and how far does it move the mile marker? Far from a drive, Judge Pauline Newman’s opinion represents a carefully coordinated pick-and-roll, says Gino Cheng of Winston & Strawn LLP.
This summer saw a number of reports of alleged cybersecurity breaches in Internet-connected devices. Given the interconnectedness of products and the fact that manufacturers do not have end-to-end control of device networks, in-house counsel should craft a checklist to defend against security breach claims, regulatory violation allegations, or injury or damage lawsuits, say attorneys at Reed Smith LLP.