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Life Sciences
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May 21, 2013
Biotech Exec Indicted On Charges He Stole Investor Funds
A businessman whom New Jersey securities regulators sued for allegedly running a $9.5 million investment scam has been indicted on charges that he pilfered more than $230,000 from his biotechnology and medical device companies, the state attorney general announced Tuesday.
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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.
Expert Analysis
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Digging Into The Duty To Mine Big Data
Data mining has led, and will lead to, startling discoveries in the sciences. In the law, it may well lead to startling liabilities, especially if defendants are made to pay for harms foreseeable only by the most powerful software available, says David Oliver of Vorys Sater Seymour and Pease LLP.
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High Court Takes On Declaratory Judgment Burden Of Proof
With the U.S. Supreme Court granting certiorari in Medtronic Inc. v. Boston Scientific Corp., it will help clarify who bears the burden of proof in a declaratory judgment action. If the court affirms the Federal Circuit, the traditional patent law for this type of controversy will be turned on its head, requiring a licensee to disprove infringement, says Shashank Upadhye of Seyfarth Shaw LLP.
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Rise Of The Machines — Predictive Coding Goes Mainstream
The pros of using predictive coding far outweigh the cons. Given the heavy pressure on law firms and in-house counsel to reduce discovery costs, as well as the Justice Department's recent stance on the subject, it appears predictive coding will continue to emerge from the obscure world of legal technology to the mainstream of legal practice, say Michael Moscato and Myles Bartley of Curtis Mallet-Prevost Colt & Mosle LLP.
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The Growing Problem Of Fishy Labeling
As evidenced by a recent study conducted by Oceana, mislabeled seafood appears to be a widespread problem that can adversely affect both the public interest and individual consumers’ wallets, health and socially responsible purchasing precepts, say attorneys with Arnold & Porter LLP.
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K-V Case Tests Limits Of ITC Jurisdiction
As illustrated by the recent K-V Pharmaceutical Co. case, the U.S. International Trade Commission will likely closely review complaints that could usurp the power of another federal agency and potentially undermine that agency's application of its own rules, say Eric Fues and Mareesa Frederick of Finnegan Henderson Farabow Garrett & Dunner LLP.
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Get Ready For Stricter RMP Enforcement
The recent $4 million settlement by Tyson Foods Inc. represents one of the largest penalties for a stand-alone risk management program enforcement case since the provision was added to the Clean Air Act in 1990. This case also exemplifies the U.S. Environmental Protection Agency’s increasing focus on RMP compliance and its intention to seek ever-larger penalties for RMP violations, say attorneys with Kilpatrick Townsend Stockton LLP.
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Dissecting The Rules Of Generic Drug User Fee Amendments
The Generic Drug User Fee Amendments, a part of the U.S. Food and Drug Administration Safety and Innovation Act, have changed the practice of generic drug sponsors in a multitude of ways. These requirements should be top of mind for abbreviated new drug application filers because they may ultimately impact a generic applicant’s eligibility for the coveted six-month marketing exclusivity, says Suchira Ghosh of Axinn Veltrop & Harkrider LLP.
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E-Discovery In The Cloud: Who Can Get Your Data?
Many lawyers are asking whether placing electronically stored information in the cloud could inadvertently waive the attorney-client privilege and whether the government or a civil litigant could obtain ESI directly from a cloud service provider. In answering these questions, there are a number of aspects of the cloud worth considering, say Timothy Broas and Matthew Saxon of Winston & Strawn LLP.
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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.