Troubled Indian drug manufacturer Wockhardt Ltd. found itself on Wednesday in regulatory hot water once again, as the U.S. Food and Drug Administration issued an alert restricting the import of various human and animal drugs from one of its top production facilities.
The Wisconsin Alumni Research Foundation and a consumer group challenging its patent on stem cells recently sparred over whether the group has standing at the Federal Circuit, raising an issue that could limit the ability some patent challengers have to appeal decisions by the U.S. Patent and Trademark Office.
Abbott Laboratories Inc. has been hit with a lawsuit alleging it overcharged the nonprofit AIDS Healthcare Foundation by at least $2 million for Kaletra and Norvir, the HIV drugs it owns and markets.
Novartis Pharmaceuticals Corp. hit Accord Healthcare Inc. with a patent infringement lawsuit in New Jersey federal court on Tuesday, saying Accord asked the U.S. Food and Drug Administration to approve generic versions of Novartis’ bone drug Zometa prior to the expiration of a patent that protects it.
The U.S. Trade Representative's office said Wednesday it will seek a “flexible” approach to pharmaceutical intellectual property provisions in the Trans-Pacific Partnership, attempting to allow access to lifesaving medicine while also retaining incentives for new drugs to be developed.
A Staten Island man recently hit Rite Aid Corp. with a proposed class action in New York federal court, alleging the pharmacy chain falsely advertises that its store-brand glucosamine and chondroitin supplements can ease arthritis symptoms, despite overwhelming scientific evidence to the contrary.
Drugstore chain CVS Caremark Corp. will put up $2.1 billion for the private equity-backed infusion unit of Apria Healthcare Group Inc. in a move that will help flesh out its specialty pharmacy offerings and drive new growth, CVS said Wednesday.
South Korea-based biotherapeutics and contract research company SillaJen Inc. will acquire San Francisco clinical-stage biotechnology firm Jennerex Inc. for about $150 million, SillaJen said Tuesday, in a merger that would bring together two companies that have previously partnered in the quest against cancer.
The fate of the Affordable Care Act’s contraception mandate now rests with the U.S. Supreme Court, but access to birth control could end up a mere subplot if the justices hand down a sweeping decision recognizing corporate religious rights, something that could weaken federal laws and build on the landmark Citizens United decision, experts say.
A New Jersey federal judge on Tuesday declined to split into two phases any such trial in Depomed Inc.’s suit alleging Purdue Pharma LP's pain reliever OxyContin infringed on three of its patents for extended-release drug technology, saying bifurcation isn’t warranted.
A California federal judge sanctioned dental implant company Implant Direct Mfg. LLC for destroying evidence in rival Zest IP Holdings LLC's patent infringement case, saying Monday that he would warn the jury about missing emails and order Implant Direct to pay Zest's attorneys' fees.
Public policy groups warned the Ninth Circuit Friday that a California state law requiring drugmakers to pay for the environmentally safe disposal of unused drugs could force jurisdictions to foot cleanup costs for other communities.
The widow of a Bristol-Myers Squibb Co. employee filed a putative class action against the company Tuesday, accusing it of taking out a $6 million insurance policy against her husband without his knowledge or consent.
The European Medicines Agency and Pfizer Ltd., Novartis Pharma AG and other drugmakers joined an initiative Tuesday designed to create a continentwide framework for assessing the benefits and drawbacks of vaccines after they have been approved for use.
Myriad Genetics Inc. on Monday accused genetic testing company Invitae Corp. of infringing on patents related to cancer-testing, marking the latest front in a growing legal battle that has ensnared four other companies.
A New York federal judge on Tuesday refused to toss a $153.3 million award against Hebei Welcome Pharmaceutical Co. Ltd. and North China Pharmaceutical Group Corp. in a class action over vitamin C price-fixing claims, finding a jury wasn't improperly blocked from evidence.
Blackstone and Goldman Sachs bowed out of the chase for a bundle of nearly 1,500 Spanish rental properties, while RBS is nearing a deal that would spin off an investment unit as part of its plan to get rid of noncore operations and comply with new regulations.
The European Union's antitrust watchdog on Tuesday announced its approval of Thermo Fisher Scientific Inc.’s $13.6 billion acquisition of Life Technologies Corp., after the buyer agreed to divest three units to ease concerns about the merged entity cornering the markets for some supplies to medical laboratories.
Pennsylvania product liability law permitting unlimited punitive damages controls three suits alleging Novartis Pharmaceuticals Corp.’s bone drug Zometa caused jaw injuries, a federal judge said Friday, denying the drugmaker’s attempt to apply softer New Jersey law.
Travelers Indemnity Co. on Monday asked a federal judge not to toss its $47 million lawsuit claiming it overpaid Pfizer Inc. for the epilepsy drug Neurontin due to the drugmaker’s anti-competitive efforts and aggressive marketing of off-label uses, saying its claims are not time-barred.
Sometimes — as in the Arizona immigration case — the preemption question before the U.S. Supreme Court is about state legislation, and whether the state has power to legislate in an area that is already governed by federal law. But lately the question has been more often about litigation, and whether federal law prevents plaintiffs from bringing state law claims, says Jason Steed of Bell Nunnally & Martin LLP.
While the effect of California's new legislation amending Proposition 65 remains to be seen, the food and beverage industry should see some relief from Proposition 65 litigation and bounty-hunter settlements. The new legislation may also pave the way for other industries in California to seek similar protections, say Sophia Belloli and Eric Junginger of Hanson Bridgett LLP.
At first glance, the Federal Circuit's recent decision in Leo Pharmaceutical Products Ltd. v. Rea appears to reflect a narrower approach to the “sufficient reason” to combine prior art references as established by the U.S. Supreme Court's ruling in KSR Int'l Co. v. Teleflex Inc. On closer analysis, however, this decision is in accord with KSR, say attorneys with Alston & Bird LLP.
According to its recent guidance, the U.S. Food and Drug Administration will now oversee mobile medical applications that could pose a risk to a patient's safety if they were not to function as intended. Manufacturers should review the steps to determine whether their product is subject to such oversight and act accordingly when the FDA plans to focus on it, say Jennifer Hennessy and Lisa Davis of Quarles & Brady LLP.
While reliance on outside counsel will continue, only 13 percent of companies recently surveyed indicated that increasing the use of outside counsel was of high importance in addressing increases in legal demand. The trend, more notably since the economic crisis of the late 2000s, has been on rigorous management of outside counsel costs — 95 percent of survey participants said they are taking measures to reduce outside counsel spending, says Lauren Chung of HBR Consulting LLC.
The False Claims Act is both less effective than it could be at reducing fraud and too often a spur for frivolous litigation and coercive out-of-court settlements. We propose a package of reforms designed to improve the FCA’s effectiveness as an anti-fraud tool by encouraging companies to adopt rigorous compliance programs designed to prevent fraud before it happens, say David Ogden and Jonathan Cedarbaum of WilmerHale.
In McPhee v. DePuy Orthopedics, a Pennsylvania district court cited Riegel v. Medtronic and — no surprise here — found that state law premarket approval claims are preempted if they impose requirements on medical device manufacturers that are different from federal regulations. Express warranty claims in the Third Circuit, however, are governed by Michael v. Shiley, a pre-Riegel decision holding that federal law does not preempt such claims, says Michelle Hart Yeary of Dechert LLP.
It has been 20 years in the making, but a new regulatory scheme is quickly moving into force, which may impact the development of, and intellectual property rights surrounding, an array of products, including pharmaceuticals, biotech products, agricultural products, nutritionals, supplements, cosmetics, perfumes and fragrances and industrial enzymes, says Bruce Manheim of WilmerHale.
As health care companies contemplate how to best leverage text messaging, information security should remain a key focus in light of recent upticks in mobile device data breaches and a concomitant rise in Health Insurance Portability and Accountability Act enforcement, say Alaap Shah and Ali Lakhani of Epstein Becker Green PC.
In light of the recent trial against MicroAire Surgical Instruments LLC, which had purchased assets from Coapt Systems, it is recommended that practitioners defending a claim of alter ego and/or successor liability strongly consider a bench trial on these issues as a means of resolving the case early, says Frederick Ufkes of Hinshaw & Culbertson LLP.