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Life Sciences
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April 23, 2013
Pfizer Escapes Shareholder Suit Over Wyeth Alzheimer's Drug
A New Jersey federal judge on Monday threw out an amended shareholder class action contending Pfizer Inc. deceived investors about the efficacy of Wyeth Inc.'s Alzheimer’s drug bapineuzumab, finding the plaintiffs had not sufficiently alleged that Wyeth's statements about the drug were affirmatively false.
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April 23, 2013
Allergan, Duke Block Lash-Growth Generics
A North Carolina federal judge on Tuesday granted a permanent injunction to Allergan Inc. and Duke University against several planned generic versions of eyelash growth stimulant Latisse after previously finding the proposed drugs infringed on two patents, disregarding the protests of the generic-drug makers.
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April 22, 2013
Promega Denied Do-Over On $52M Gene-Testing Patent Verdict
A Wisconsin federal judge on Monday denied Promega Corp.’s bid for a new trial in its patent infringement suit over gene-testing technology after a $52 million jury verdict for Promega was vacated, saying Promega had already “forfeited” the argument.
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April 22, 2013
Merck's NuvaRing Win Puts Pressure On MDL Plaintiffs
A New Jersey state judge on Thursday tossed seven bellwether cases over injuries allegedly caused by a Merck & Co. Inc. subsidiary's NuvaRing contraceptive, a devastating ruling that will force plaintiffs in upcoming multidistrict litigation to retool their argument on how the drug harmed them.
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April 22, 2013
Justices Let Hearing-Aid Makers' $31M Patent Judgment Stand
The U.S. Supreme Court declined Monday to hear an appeal of a Federal Circuit decision upholding a jury's $31 million verdict against William Demant Holding A/S and Widex A/S for allegedly infringing an Energy Transportation Group patent for technology that reduces hearing-aid feedback.
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April 19, 2013
Sanofi Can't Duck Amphastar's FCA Suit Over Lovenox
A California federal judge on Friday denied Sanofi-Aventis SA's latest bid to toss rival Amphastar Pharmaceuticals Inc.'s False Claims Act suit alleging it fraudulently inflated the price of its Lovenox anti-coagulant drug.
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April 19, 2013
Shire Settles Patent Row With Sandoz Over Generic Intuniv
Pharmaceuticals manufacturer Shire PLC has settled its patent infringement claims against Sandoz Inc. over the company’s attempt to develop a generic form of Intuniv, an attention deficit hyperactivity disorder drug, according to an order issued Thursday by a Colorado federal judge.
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April 19, 2013
Ingredient Maker Escapes Liability In Drug Recall Suit
NuSil Technology LLC on Thursday escaped Guardian Drug Co.'s bid for partial indemnity in Prestige Brands Inc.'s suit over Guardian's alleged contract breach for failing to cover losses stemming from several drug recalls, after a New York federal judge ruled that NuSil had no responsibility to indemnify Guardian.
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April 18, 2013
J&J Win Highlights FDA's Impact On Hip Implant Cases
After a costly loss in its first trial, Johnson & Johnson subsidiary DePuy Inc. this week managed to even its record in metal-on-metal implant cases, and attorneys say a crucial difference was the company's ability to tell jurors that the U.S. Food and Drug Administration had cleared the device.
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April 18, 2013
UK Appeals Court Sends Singulair Arguments To EU Court
Sigma Pharmaceuticals PLC's appeal of a ruling that it violated European patent laws by importing Merck & Co. Inc.’s asthma drug Singulair from Poland to the U.K. cannot be decided until the Court of Justice interprets parts of EU law central to the dispute, a U.K. court said Thursday.
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April 18, 2013
Galderma Must Pay Oracea Fees To NYU During Appeal
A New York federal judge ruled Wednesday that Galderma Laboratories Inc. will have to keep paying royalties to New York University for the patents behind rosacea treatment Oracea while the school appeals a decision that found the patents invalid.
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April 17, 2013
5th Circ. Quashes Generic Reglan Failure-To-Warn Suit
The Fifth Circuit refused Wednesday to resurrect failure-to-warn claims against three generic-drug makers, ruling that the companies had no duty to issue a warning about health risks linked to the anti-nausea drug metoclopramide because of brand-name manufacturer inaction.
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April 16, 2013
Amgen To Pay $25M To Escape Anemia Drug Kickback Suit
Amgen Inc., which pled guilty in December to misbranding its Aranesp anemia drug, will pay $24.9 million to settle a whistleblower suit alleging it paid kickbacks to pharmacy providers to promote the drug among Medicare and Medicaid patients, the U.S. Department of Justice said Tuesday.
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April 16, 2013
GSK Backed By Fed. Circ. In Leukemia Drug Patent Suit
The Federal Circuit on Tuesday determined that GlaxoSmithKline LLC's leukemia drug Arzerra doesn't infringe a Biogen Idec Inc. and Genentech Inc. patent covering an antibody therapy.
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April 16, 2013
Bayer's Yaz Patent Claims Are Invalid, Fed. Circ. Says
The Federal Circuit said Tuesday that two claims in Bayer HealthCare Pharmaceuticals Inc.'s patent for its Yaz contraceptive were invalid because they are obvious, siding with generic-drug makers that the company had accused of patent infringement and overturning the trial court’s decision in the case.
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April 15, 2013
11th Circ. Revives FTC False Ad Claim Over Supplements
The Eleventh Circuit on Monday refused to revive most of the Federal Trade Commission's claims accusing dietary supplement maker Garden of Life Inc. of violating an injunction that barred it from making misrepresentations in its advertisements, but remanded one claim tied to an ad for a calcium product.
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April 15, 2013
High Court Won't Mull Double Avandia Damages For Insurers
The U.S. Supreme Court refused Monday to review a decision allowing Humana Inc. to seek double damages from GlaxoSmithKline PLC in a putative class action over costs for Medicare patients allegedly harmed by diabetes drug Avandia, despite GSK’s argument that the remedy shouldn't be available to private insurers.
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April 12, 2013
DC Circ. Won't Kill FTC Bid For Boehringer Deal Docs
The D.C. Circuit on Friday refused to dismiss the Federal Trade Commission’s bid to force Boehringer Ingelheim Pharmaceuticals Inc. to turn over allegedly privileged documents on patent settlements with Barr Pharmaceuticals Inc., ruling the agency’s appeal was legitimate.
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April 11, 2013
Biolitec Held In Contempt Over Merger In AngioDynamics Row
A Massachusetts federal judge on Thursday granted medical device manufacturer AngioDynamics Inc.’s emergency motion for contempt against specialty laser firm Biolitec AG and Biomed Technology Holdings Co. for allegedly violating a preliminary injunction in an intellectual property indemnification suit by completing the downstream merger of Biolitec into its Austrian subsidiary.
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April 11, 2013
Chinese Co. Wants $153M Award Vacated In Vitamin C MDL
North China Pharmaceutical Group Corp. on Thursday asked a New York federal judge to vacate a recent $153 million award and dismiss multidistrict antitrust litigation alleging illegal collusion in China's vitamin C industry, claiming that only NCPG's indirectly owned subsidiary was involved in the scheme.
Expert Analysis
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Manufacturers, Be Sure To Read These Tea Leaves
The Northern District of California opinion in Ries v. AriZona Beverages USA LLC serves as a reminder that while defeating class certification is critical, it is equally important to establish an evidentiary record focused on defeating the merits of plaintiffs’ claims. It also suggests that defendants may remain well-poised to prevail despite a negative class certification order if they are armed with expert testimony, say attorneys with Alston & Bird LLP.
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Post-Merck Debate Over Research Exemption For Infringement
A review of Federal Circuit and district court decisions following the U.S. Supreme Court's ruling in Merck KGaA v. Integra LifeSciences I Ltd. can guide patent holders and would-be infringers in analyzing whether the use of research tools and other activities are exempt from infringement under the Hatch-Waxman Act, say Patrick Gattari and Nicole Grimm of McDonnell Boehnen Hulbert & Berghoff LLP.
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Sound The Alarm: Uninjured Plaintiffs Now Have Standing
The recent Second Circuit decision in National Resources Defense Council v. U.S. Food and Drug Administration sets a concrete example of the potential of Administrative Procedure Act actions involving products that are not yet proven harmful, sounding a warning alarm for regulatory agencies and manufacturers, says Jesse Morris of Weil Gotshal & Manges LLP.
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Va. Takes The Lead In Biosimilar Substitution Law
Recently, Virginia Gov. Bob McDonnell signed into law the nation’s first state law concerning substitution of biosimilars. The law’s requirements that pharmacists give notice of substitution to prescribers and of retail costs to patients differ significantly from the state’s existing law applicable to substitution of small-molecule drugs, say attorneys with Ropes & Gray LLP.
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Beware Pharmacy Record-Keeping Violations
CVS Pharmacy Inc. recently agreed to pay $11 million to the federal government to resolve allegations of deficient record-keeping in regard to prescriptions for controlled substances. Although the allegations involved several CVS pharmacies in Oklahoma, the deficiencies noted have application to all pharmacies, says Ronald Friedman, a shareholder with Lane Powell PC and former federal prosecutor.
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Preemption Of Research Has No Place In Gene Patent Case
In urging the U.S. Supreme Court to find that gene patents are ineligible for patent protection, the Association for Molecular Pathology relied heavily on the argument that patents inhibit research. The court should disregard that argument, and the evidence supporting it, as equivocal and misguided because it misdirects the debate on gene patents away from the fundamental question of patent eligibility, say attorneys with RatnerPrestia.
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Let's Fix The Patent-Specific Preliminary Injunction Test
It is critically important to biopharmaceutical companies, in particular, that the district courts and the Federal Circuit apply the right preliminary injunction standard. But they do not. They apply a patent-specific standard. That standard is harder for a movant to meet, and it directly conflicts with U.S. Supreme Court preliminary injunction jurisprudence, says Vernon Winters of Sidley Austin LLP.
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Inside The FTC's Take On Generic Access To Branded Drugs
The Federal Trade Commission has entered previously uncharted ground by filing an amicus brief in Actelion Pharmaceuticals Ltd. v. Apotex Inc., which addresses a branded pharmaceutical company's restrictions on the sale and distribution of branded drugs to generics. The regulatory background is an important part of why the FTC is weighing in to what otherwise would appear to be a simple private dispute, says David Leichtman of Robins Kaplan Miller & Ciresi LLP.
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A Narrow Exception To The Mensing Preemption Defense
In Fulgenzi v. Pliva Inc., the Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Manufacturers cannot simply cite Pliva v. Mensing and rely on a preemption defense, but must show diligence and timeliness in keeping their labels up to date, say attorneys with Morrison & Foerster LLP.
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No Defense Reimbursement For Insurers In Wash.
In Washington state, insurance carriers are between a rock and a hard place with an anvil overhead. The rock: coverage by waiver or estoppel if rights are not reserved. The hard place: the inability to obtain reimbursement for providing a prophylactic defense. The anvil: potential bad faith liability. In light of National Surety Corp. v. Immunex Corp., that seems to be where the Washington State Supreme Court wants them, says Louis Castoria of Wilson Elser Moskowitz Edelman & Dicker LLP.