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Life Sciences
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May 21, 2013
Novo To Lay Down $700M For Antibiotics Specialist Xellia
Novo A/S, the holding company for Danish drugmaker Novo Nordisk A/S, has agreed to purchase majority venture capital-owned Norwegian antibiotic drug specialist Xellia Pharmaceuticals A/S for $700 million, the companies announced Tuesday.
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May 21, 2013
Herbalife Preys On Latinos, Nonprofit Tells FTC
A nonprofit on Monday urged the Federal Trade Commission to investigate Herbalife Ltd., claiming its vitamin distribution network — famously called the world’s “best-managed pyramid scheme” by activist investor Bill Ackman — preys on Latinos.
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May 21, 2013
Jury Convicts Atty Over Stock Fraud Scheme With Ex-NFLer
A Florida jury on Monday convicted a California attorney of conspiring with former NFL player Willie Gault and others to artificially inflate a heart-monitoring device company's stock through a series of fraudulent schemes.
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May 21, 2013
Herbalife Taps PwC As Auditor After KPMG Insider Scandal
Herbalife Ltd. said Tuesday it had chosen PricewaterhouseCoopers LLP as its auditor, replacing KPMG LLP after a partner at the firm was charged in early April with leaking confidential information about Herbalife and other clients to a friend who traded on the tips.
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May 21, 2013
Whistleblower Takes Takeda FCA Case To Supreme Court
A Takeda Pharmaceuticals North America Inc. sales leader has asked the U.S. Supreme Court to revive his whistleblower suit accusing the company of defrauding Medicare by overbilling for stomach acid drug prescriptions, arguing that it meets False Claims Act qualifications.
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May 21, 2013
Boehringer, Hospira Products Adulterated, FDA Warns
The U.S. Food and Drug Administration on Tuesday released warning letters it sent to generic-drug maker Hospira Inc. and German pharmaceutical company Boehringer-Ingelheim Pharma GmbH & Co. KG warning the companies of several products that are considered adulterated due to inadequate manufacturing processes.
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May 21, 2013
Deals Rumor Mill: Dish, Alere, Raytheon
Dish Network's chairman served up a $2 billion offer for wireless spectrum controlled by bankrupt LightSquared, while an activist investor is ratcheting up pressure on multibillion-dollar life sciences firm Alere to seek out a buyer.
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May 21, 2013
Reps. Urge Delay Of Medicare Competitive Bidding Program
Medicare should delay its controversial expansion of competitive bidding for durable medical equipment because unlicensed contractors have infiltrated the program and are greatly distorting prices, two congressmen wrote in a letter released Monday.
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May 21, 2013
Judge Disqualifies Whistleblowers' Attys In Kinetic FCA Suit
A California federal judge Monday disqualified the lawyers for whistleblowers accusing medical device maker Kinetic Concepts Inc. of violating the False Claims Act by falsely billing Medicare, ruling the attorneys knowingly and improperly used privileged documents in their clients’ pleadings.
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May 20, 2013
Pfizer Can't Shake Skelaxin Pay-For-Delay MDL
A federal judge on Monday refused to dismiss multidistrict litigation accusing Pfizer Inc.'s King Pharmaceuticals Inc. and Mutual Pharmaceutical Co. Inc. of keeping generic versions of the muscle relaxer Skelaxin off the market, finding Rite Aid Corp. and others had plausibly alleged a conspiracy.
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May 20, 2013
High Court Could Put Patent Burden Of Proof On Licensees
The U.S. Supreme Court could establish clear rules on whether patent owners always have the burden of proving infringement, having agreed Monday to hear Medtronic Inc.'s appeal of a ruling that the burden falls on license holders when a patentee is barred from alleging infringement, attorneys say.
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May 20, 2013
Fighting Agencies May Be Tougher After High Court Ruling
The U.S. Supreme Court's Monday ruling in favor of the Federal Communications Commission, which held that courts should apply a deferential standard of review when federal agencies interpret the limits of their own authority, may make it tougher for regulated businesses to fight agency actions, attorneys say.
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May 20, 2013
High Court's Atty Fee Ruling May Spur More Vaccine Claims
The U.S. Supreme Court ruled Monday that attorneys can still recover fees and costs for vaccine injury claims that a government compensation program determines to be time-barred, a decision that will make lawyers more likely to take calculated gambles on cases with timeliness concerns.
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May 20, 2013
Plan B Ruling Shouldn't Be Stayed, 2nd Circ. Told
Reproductive health advocates on Monday urged the Second Circuit not to delay a court order that Plan B and other emergency birth control pills be made available over the counter without age restrictions, saying a New York federal judge acted reasonably to address political obstructionism.
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May 20, 2013
FDA Airs Safety Concerns About Merck Insomnia Drug
The U.S. Food and Drug Administration on Monday released a clinical study of Merck & Co. Inc. insomnia drug suvorexant revealing some troubling side effects, including suicidal behavior and impaired driving performance.
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May 20, 2013
Fed. Circ. Revives 5 Mylan Drug Patents In Sunovion Row
The Federal Circuit on Monday threw out a ruling that five Mylan Inc. patents covering treatments for chronic pulmonary obstructive disease were invalid, reviving claims that Sunovion Pharmaceuticals Inc.'s drug Brovana infringed the patents.
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May 20, 2013
Fed. Circ. Flips Noninfringement Judgment In Allegra IP Row
Aventis Pharmaceuticals Inc. and Albany Molecular Research Inc. on Monday convinced the Federal Circuit to reverse a noninfringement judgment over an Albany Molecular patent covering processes used to make a purer form of a key ingredient in allergy medication, including Sanofi-Aventis U.S.'s Allegra.
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May 20, 2013
Agencies Deserve Deference On Jurisdiction, Justices Say
The U.S. Supreme Court ruled Monday that courts should apply a deferential standard of review toward a federal agency's definition of its own jurisdiction, siding with the Federal Communications Commission in a fight with local government agencies over zoning rules for wireless facilities.
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May 20, 2013
Zydus Defends Obvious Challenge In Zegerid Patent Row
Zydus Pharmaceuticals USA Inc., which was sued in New Jersey federal court for developing a generic version of the heartburn drug Zegerid, said on Friday that a Federal Circuit decision in a parallel case doesn't preclude it from arguing that a Santarus Inc. patent Zydus allegedly infringes is obvious.
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May 20, 2013
Dental-Care Company Infringes Crest Patents, P&G Says
The Procter & Gamble Co. filed a suit Monday in Ohio federal court alleging that CAO Group Inc. had violated three of the personal-hygiene and cleaning-product giant's patents for its teeth-whitening product Crest Whitestrips.
Expert Analysis
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5 Reasons For Optimism In The Venture Capital Community
Not every company can be the next Facebook. But thankfully, for many startups, generating one billion users is not the end goal, nor should it be. Enter “narrowcasting” — one of a few reasons to be optimistic about venture capital, despite the first quarter of 2013 being the slowest for fundraising since 2002, says David Kaufman of Thompson Coburn LLP.
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Preparing A Successful Daubert Motion
When preparing a Daubert motion, one of the things practitioners should remember is that there is no better way to succeed than to demonstrate to the trial judge that the challenged expert's own testimony has demonstrated that his methodology is deficient, says William Martin of Haight Brown & Bonesteel LLP.
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Lessons From Philips FCPA Settlement Over Polish Bribes
While Poland has not received particular Foreign Corrupt Practices Act enforcement focus over the years, the U.S. Securities and Exchange Commission's recent order against Koninklijke Philips Electronics NV over Polish bribes underscores the fact that, in given circumstances, any country can present high corruption risk, say attorneys with Fulbright & Jaworski LLP.
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How HIPAA Marketing And Sale Provisions May Apply To You
In light of the Health Insurance Portability and Accountability Act's new requirements on the use of personal health information for marketing and sale purposes, it is important to note that not just covered entities but also advertisers, data aggregators, market researchers and others who want access to PHI will be impacted, say attorneys with Duane Morris LLP.
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EU's New Package Of Consumer Product Safety Rules
The European Commission has put forward a new set of measures to provide more consistency in European Union legislation on consumer product and market surveillance. It is likely that manufacturers, importers and distributors will find additional obligations relating to labeling, product identification and corrective actions imposed as a result of the new rules, say attorneys with Morrison & Foerster LLP.
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Pharma IP Rights In China: Avoiding The Antitrust Pitfalls
China's recent draft guidelines are a welcome development in providing insight on the interaction between intellectual property rights and the Chinese Anti-Monopoly Law. Although the guidelines bear some similarities with the approach adopted in other jurisdictions, including the EU, there are aspects that are troubling for the pharmaceutical sector, say Suzanne Rab, an EU competition attorney, and Jet Zhisong Deng of T&D Associates.
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It’s My Expert, And I’ll Call Her If I Want To
The recent decision in Washington v. Perez is a useful reminder that defense counsel must remain mindful during opening statement and cross-examination that it may later decide not to call certain experts. Fortunately, this decision clarifies that New Jersey appellate courts recognize that the defense is entitled to change strategy as the case progresses, says Adam Tolin of Weil Gotshal & Manges LLP.
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Caronia And Harkonen — Lessons For The Gov't
After U.S. v. Caronia and U.S. v. Harkonen, there can be little question that the landscape has shifted — securing a final conviction in a misbranding case, based not on a false or misleading label on the drug but rather on oral statements made in promoting the drug for a nonapproved use, is, at best, a difficult quagmire for the government, say attorneys with Skadden Arps Slate Meagher & Flom LLP.
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OIG's Alert Has Broad Implications With A Hint Of Warning
Recently, the Office of the Inspector General of the U.S. Department of Health and Human Services issued a special fraud alert on physician-owned distributorships, an entity that has been under ongoing controversy. While focusing on PODs, the alert makes some statements that have broader implications in the industry, reminding it of significant OIG positions, say attorneys with Ropes & Gray LLP.
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An Update On Daubert And Class Certification
The U.S. Supreme Court’s decision in Comcast v. Behrend clearly endorses an in-depth analysis of plaintiffs’ class action theories at the class certification stage even where the merits are implicated. This suggests that the court may favor a full Daubert analysis with regard to experts’ class certification opinions, say attorneys with Skadden Arps Slate Meagher & Flom LLP.