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Life Sciences
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December 3, 2012
Heart Docs Hit Forest Labs With Class Action Over Junk Faxes
A Missouri cardiology practice has accused a Forest Laboratories Inc. unit of sending junk faxes advertising a blood pressure drug in violation of the Telephone Consumer Protection Act, according to a proposed class action removed to federal court Friday.
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December 3, 2012
Endo Claims Opana Generic Versions Ripe For Misuse, Abuse
Endo Pharmaceuticals Inc. on Friday urged a judge to force the U.S. Food and Drug Administration to determine whether the drugmaker voluntarily yanked the original version of its Opana ER painkiller from the market over tampering and abuse concerns and to suspend approval of nontamper-resistant generic versions.
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November 30, 2012
Takeda Hits Lupin With IP Suit Over Acid Reflux Drug
Takeda Pharmaceutical Co. Ltd. on Thursday accused generic-drug maker Lupin Ltd. and a U.S. subsidiary of infringing four of its patents in a suit New Jersey that marks the company's latest attempt to protect the acid reflux drug Prevacid.
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November 29, 2012
GSK Hit With Suit Over Avodart's Prostate Cancer Risks
GlaxoSmithKline PLC was hit with a product liability suit in Pennsylvania state court Wednesday claiming the pharmaceutical giant concealed or downplayed the potentially life-threatening side effects of its prostate drug Avodart, which the plaintiff claims caused him to develop prostate cancer.
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November 29, 2012
Ex-Baseball Player Indicted For Insider Trading On Abbot Buy
A California federal grand jury on Wednesday indicted former Baltimore Orioles third baseman Doug DeCinces and three others on insider trading charges for allegedly using nonpublic information about Abbott Laboratories' takeover of a medical device company to purchase stock.
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November 29, 2012
St. Jude's Rival Says Co. Flouted Heart Monitor Patent
Medical supplier Body Science LLC launched its latest patent infringement suit Tuesday alleging that rival St. Jude Medical Inc.'s pacemakers and other wireless medical monitoring devices violated patented Body Science technology.
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November 29, 2012
Bayer Targets Lupin Over Generic Natazia
Bayer Pharma AG on Wednesday hit Lupin Ltd. with a patent infringement suit in Delaware federal court, seeking to block the India-based drugmaker's plans to market a generic version of its birth control pill Natazia.
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November 27, 2012
DaVita Hit With FCA Suit Over Alleged Medicare Violations
DaVita Inc. has been hit with a False Claims Act suit by a former patient claiming the kidney care provider took tens of millions of dollars from Medicare and Medicaid but violated those programs' regulations by failing to ensure the safety of its patients with the required nurse-to-patient ratio.
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November 26, 2012
BioMimetic Investor Says $380M Buyout Deal Doesn't Cut It
A BioMimetic Therapeutics Inc. investor launched a putative class action Wednesday protesting the orthopedic therapy company's planned $380 million buyout by Wright Medical Technology Inc., claiming the deal greatly undervalues a company on the verge of a major breakthrough.
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November 26, 2012
GlycoBioSciences Says Skin Ointment Infringed 2 Patents
A Canadian pharmaceutical company hit dermatology drugmaker Innocutis Holdings LLC with a patent infringement suit Sunday, claiming the company's Bionect skin irritation ointment violated two patents.
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November 21, 2012
Investors Say Pfizer Destroyed Files On Celebrex, Bextra
Pfizer Inc. destroyed or concealed millions of pages of documents in hopes of undermining a securities class action over risks of arthritis drugs Celebrex and Bextra and should be sanctioned, investors told a New York federal judge Friday.
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November 21, 2012
Eisai Says Zurich Policy Covers Off-Label FCA Suit
Eisai Inc. sued Zurich American Insurance Co. in New Jersey federal court Tuesday to snag more than $5 million in coverage for a former employee's False Claims Act suit claiming the company pushed off-label uses for its drug.
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November 21, 2012
Millennium Sues Generic-Drug Maker Over Velcade Plans
Millennium Pharmaceuticals Inc. sued Accord Healthcare Inc. and its parent company Intas Biopharmaceuticals Ltd. in Delaware federal court Tuesday, seeking to block their plans to produce a generic version of the chemotherapy drug Velcade.
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November 20, 2012
Apotex Targets Exclusivity Period In Generic Benicar Suit
Apotex Inc. slapped Daiichi Sankyo Co. Ltd. with a patent suit in Illinois on Tuesday, seeking a noninfringement ruling which Apotex said could strip Mylan Laboratories Ltd. of exclusive rights to market a generic version of the hypertension drug Benicar.
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November 20, 2012
SAC Manager Arrested In $276M Insider Trading Case
A former portfolio manager for SAC Capital Advisors LP was arrested Tuesday and charged with insider trading involving a treatment for Alzheimer's disease that allegedly netted the hedge fund about $276 million, a new record, according to prosecutors.
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November 16, 2012
Investors Opt Out Of Pfizer Securities Fraud Class Action
A group of investors opted out of a securities fraud class action against Pfizer Inc. and filed its own suit Thursday in New York federal court alleging the pharmaceutical giant concealed heart attack risks linked to arthritis drugs Celebrex and Bextra.
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November 16, 2012
Investors Sue Heart-Device Co. Over DOJ Mislabeling Fallout
A pair of Abiomed Inc. investors sued the cardiac-device maker in Massachusetts federal court Friday, claiming the company lied about a U.S. Food and Drug Administration investigation into ad campaigns for one of its products, which artificially inflated stock values before they plummeted as word of the probe got out.
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November 16, 2012
Endo Targets Sandoz, Impex Over Generic Versions Of Opana
Endo Pharmaceuticals on Wednesday sued generic-drug makers Sandoz Inc. and Impax Laboratories Inc., alleging that they infringed patents covering a version of its Opana ER painkiller, the company's latest attempt to keep copycat versions of the drug from coming to market.
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November 15, 2012
Psychiatrist Took Kickbacks From Teva, FCA Suit Says
The federal government launched a civil False Claims Act suit against a Chicago psychiatrist on Thursday alleging that he raked in kickbacks from drug companies including Teva Pharmaceuticals Inc. and submitted 190,000 false claims to Medicaid and Medicare while treating nursing home patients.
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November 15, 2012
FDA Approved Possibly Harmful Generic Acetadote, Suit Says
Cumberland Pharmaceuticals Inc. on Tuesday moved to block the U.S. Food and Drug Administration's approval of InnoPharma Inc.'s generic version of Cumberland's acetaminophen-overdose treatment Acetadote, claiming the approval could put potentially harmful versions of the drug on the market.
Expert Analysis
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Successful Life Science Collaborations Require Flexibility
The life sciences companies that get the most value out of collaborative relationships are the ones that continue to pay attention to the parties’ strategic objectives long after the ink on the contract is dry, that maintain regular, open dialog at the senior-most levels of the organization, and that aren’t afraid to put the contract aside and think about new and better ways to achieve individual and collective goals — even if it means completely restructuring the relationship, say Gerald Quirk and David Wittenberg of Choate Hall & Stewart LLP.
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How EPA Will Clean Things Up In 2013
In 2013, we expect to see significant changes in the areas of waste and contamination, including vapor intrusion, waste management and cleanup, brownfields and issues related to real estate purchases. Out of several relevant cases, it will be interesting to watch Soco West v. U.S. Environmental Protection Agency, which challenges a unilateral Resource Conservation and Recovery Act compliance order, say attorneys with McGuireWoods LLP.
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Look Out For Possible Changes In Energy Drink Industry
Following demands for tougher oversight of energy drinks, the U.S. Food and Drug Administration responded recently that it had no immediate plans to change any relevant laws. If the FDA follows the Canadian authorities' lead on regulating energy drinks, it likely will not introduce any age-related bans but may only change some labeling laws, say Daragh Hoey of Fulbright & Jaworski LLP and Martha Healey of Norton Rose LLP.
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Things To Keep In Mind When Marking Your Pot
With the recent passage of Colorado and Washington voter initiatives, a new marijuana economy is emerging — one in which adults can walk into retail stores and buy locally grown pot that is licensed, taxed and regulated by the state. As entrepreneurs seek to tap into what could prove a multibillion-dollar market, they need to act quickly to secure their branding strategies with proper trademark protections, say attorneys with Stoel Rives LLP.
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No Touch Up On 'Natural' Beauty By Calif. Court
In the recent ruling of Astiana v. Hain Celestial Group Inc., the U.S. District Court for the Northern District of California dismissed a putative class action alleging that cosmetics manufacturers' "natural" labels were misleading. The opinion reinvigorates a judicial approach that could even the balance between plaintiffs and defendants in such class action, says William Dance of Tucker Ellis LLP.
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Divergent Approaches To Claim Construction
Differing opinions on claim construction at the Federal Circuit have left patentees uncertain as to what really is the magic formula for understanding the scope of their own inventions. Unfortunately, the U.S. Supreme Court’s recent denial of certiorari in Retractable Technologies v. Becton Dickenson and Company is allowing one of the most vexing conundrums in patent litigation to persist, say Alexander Long and Limor Rabie of Latham & Watkins LLP.
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Senate's Pay-For-Delay Bill Would Weaken Drug Patents
Several U.S. senators recently introduced the Preserve Access to Affordable Generics Act, which would expand Federal Trade Commission powers and alter the legal test governing drug patent settlements. If enacted, the law would gut patent rights in a sector where innovation is vital to human health and welfare. The statutory presumption of patent validity would effectively disappear, say attorneys with Dechert LLP.
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A Food Industry Issue Menu For 2013: Part 1
This year is sure to bring a number of significant changes to the food and beverage industry, especially given the 2012 election results and the continued momentum of several hot topics from 2012 that attracted the attention of government officials, agencies and the general public. Food labeling, food safety and taxes on sweetened beverages are a few areas in which we expect to see such changes, say attorneys with McGuireWoods LLP and McGuireWoods Consulting LLC.
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Primary Jurisdiction May Be Useful In Food Labeling Cases
In recent years, there has been a growing number of consumer fraud class actions brought against the manufacturers of regulated products. The recent case Taradejna v. General Mills Inc. reminds defense attorneys everywhere that when defending claims involving regulated products, it is well worth considering whether the doctrine of primary jurisdiction should result in the dismissal of the plaintiff’s claim, says Brendan Krasinski of Alston & Bird LLP.
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Ready Or Not, Final Compliance Guidelines Are Here
There are no more excuses for failing to adopt a comprehensive compliance program — the Centers for Medicare and Medicaid Services has issued a set of final compliance program guidelines applicable to sponsors, which serves as an important road map to health care providers for the development and refinement of compliance programs, say attorneys with Blank Rome LLP.