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Life Sciences
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May 14, 2013
2nd Circ. Upholds Standard For SEC Debarment Of Officers
The Second Circuit on Tuesday upheld an 18-year-old precedent for determining when the U.S. Securities and Exchange Commission may bar a fraud defendant from serving as an officer or director of a public company, affirming a former Takeda Pharmaceuticals International Inc. executive’s ouster.
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May 14, 2013
Sanofi Fined $53M In France Over Generic Plavix Smears
France’s antitrust regulator has fined Sanofi SA €40.6 million ($52.7 million) after ruling the drugmaker had engaged in a campaign to discourage doctors and pharmacists from prescribing or substituting generic versions of its former blockbuster blood thinner Plavix, the watchdog announced Tuesday.
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May 14, 2013
Shook Hardy Lands Stradley Ronon Life Sciences Whiz
Shook Hardy & Bacon LLP has hired the former head of Stradley Ronon Stevens & Young LLP’s life sciences regulatory and compliance practice group who specializes in food and drug oversight and product liability to join its Philadelphia office as a partner, the firm announced Monday.
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May 13, 2013
Kasowitz Lures Fish & Richardson IP Atty In Silicon Valley
After four intellectual property attorneys from Kasowitz Benson Torres & Friedman LLP recently jumped to Latham & Watkins LLP, Kasowitz enlisted a patent litigator from Fish & Richardson PC with experience representing tech and pharmaceutical firms to head up its Silicon Valley office, the firm told Law360 on Monday.
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May 13, 2013
AstraZeneca Sues Actavis Over Planned Generic Vimovo
AstraZeneca AB sued Actavis Inc. in New Jersey federal court Friday to block the generic-drug maker from selling a version of the arthritis drug Vimovo.
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May 13, 2013
NJ Court Won't Revive Sun Pharma's Contract Breach Suit
Sun Pharmaceuticals Inc. on Monday failed to reanimate a breach of contract suit against a New Jersey drug research firm after a state appellate court affirmed a trial judge's ruling that there was no evidence of bad faith in a botched deal between the companies.
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May 13, 2013
CR Bard Pays $48M To Settle FCA, Kickback Claims
C.R. Bard Inc. will hand over approximately $48.3 million to the federal government to settle whistleblower allegations that it filed false Medicare claims and paid hospitals various kickbacks to use its brachytherapy seeds for prostate cancer treatment, the U.S. Department of Justice announced Monday.
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May 13, 2013
CVS, Cardinal Health Returned Opened Drugs, Savient Says
Savient Pharmaceuticals Inc. has hit CVS Caremark Corp. and Cardinal Health Inc. with a nearly $1.4 million breach of contract lawsuit in New Jersey over CVS' alleged attempts to return hundreds of opened or partial bottles of the specialty biopharmaceutical company's drugs through Cardinal for credit.
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May 13, 2013
Teva Defends IP Suit Over Generic MS Drug Research
Teva Pharmaceuticals Ltd. on Monday defended its patent suit over rival Sandoz Inc.’s attempt to develop a generic version of its multiple sclerosis drug Copaxone, saying legal safe harbors that protect generic development do not apply in this case.
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May 13, 2013
Novartis Tells High Court State Punitive Awards Are Illegal
Novartis Pharmaceuticals Corp. is continuing its appeal of a $1.2 million verdict all the way to the U.S. Supreme Court, claiming that the family of a deceased woman who was allegedly disfigured by the bone drugs Aredia and Zometa is not eligible to receive punitive damages.
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May 13, 2013
AGs Urge FDA To Warn Of Newborn Opioid Withdrawal
Forty-three attorneys general on Monday told the head of the Food and Drug Administration that the FDA should require black-box warnings on opioid painkillers alerting pregnant mothers to the risk that their babies could suffer withdrawal from the painkillers after birth.
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May 13, 2013
Thermo Fisher Hid Mexico Plant's Cartel Woes, OpenGate Says
OpenGate Capital LLC sued lab equipment maker Thermo Fisher Scientific Inc. in California federal court Friday, claiming Thermo Fisher sold a lab workstations unit to the private equity firm last year without disclosing that its Mexico plant was under near-constant siege from drug cartels.
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May 13, 2013
Nobel Biocare $1.3M Dental Impact Settlement Stalls
A proposed settlement to resolve a $450 million federal lawsuit accusing Nobel Biocare Holding AG of misrepresenting a dental implant dentists said caused bone and gum problems stalled at a hearing in California Monday when a dispute arose over whether the settlement forms break the law.
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May 13, 2013
Ranbaxy Pays Record $500M To End Tainted Drug Claims
Ranbaxy Laboratories Ltd. will pay $350 million to settle a Maryland whistleblower False Claims Act suit over selling allegedly adulterated drugs to several government health care programs, plus an additional $150 million after pleading guilty to related felony charges, the U.S. Department of Justice announced Monday.
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May 13, 2013
Vitamin C Classes Blast Bid To Nix $153M Antitrust Verdict
The class alleging North China Pharmaceutical Group Corp. and its vitamin C unit fixed prices pushed back Friday against NCPG’s bid to dismiss the suit in New York federal court and toss a recent $153 million damages award, saying China didn’t compel the companies’ illegal conduct.
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May 13, 2013
Fired Exec Says Research Firm Illegally Tracked Applicants
A former executive for ReSearch Pharmaceutical Services Inc. contends the pharmaceutical research company illegally fired him for objecting to its practice of tracking job applicants' religion, sexual orientation and other personal details, according to a lawsuit filed Wednesday in Pennsylvania federal court.
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May 13, 2013
Elan's $1B Royalty Buy Beefs Up Hostile Takeover Defense
Elan Corp. PLC said Monday that it will pay drugmaker Theravance Inc. $1 billion for the rights to future royalty payments, proving to shareholders it can pull off big deals — the key to its defense against a looming $5.7 billion hostile bid.
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May 10, 2013
Actavis, Warner Chilcott In Merger Talks
Actavis Inc. and Warner Chilcott PLC confirmed Friday that they are in talks about a possible merger, one that would create a trans-Atlantic generic drug maker with $20 billion in combined market value and a trove of valuable drugs.
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May 10, 2013
Drug Cos. See Path To Legal Off-Label Marketing
The drug industry is using a Second Circuit ruling that blocked the U.S. Food and Drug Administration from prosecuting a salesman for promoting a drug for off-label uses to push the agency to adopt regulations that would allow for truthful off-label marketing, hoping the change would significantly boost drug sales.
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May 10, 2013
Star Scientific Shareholders Sue Over Drug Claims
Star Scientific and its board of directors Thursday were slapped with a derivative shareholder action in Virginia federal court alleging the company falsely linked John Hopkins University to one of its clinical tests and delayed releasing information about a federal investigation of the company.
Expert Analysis
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Breaking Down The Bartlett Oral Argument
Given Justice Elena Kagan’s remark that this case is within the four corners of Mensing and the discomfort demonstrated by the other justices with Bartlett’s position, it seems unlikely that the First Circuit decision in Mutual Pharmaceuticals v. Bartlett will stand, say attorneys with Morrison & Foerster LLP.
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The Supreme Court Is Paying Attention To Patent Law Again
Justice Stephen Breyer had put the legal field on notice that the U.S. Supreme Court was paying attention to patent eligibility in Lab. Corp. in 2006 — well before seemingly eliminating medical diagnostic patents with Prometheus. With Myriad V to be heard this term, the Supreme Court may further impact the future of patents supporting this field, as it addresses the patentability of isolated DNA sequences, say John Cox and Joseph Vandegrift of Alston & Bird LLP.
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Reading The Labels Of Par And Harkonen
Following the Second Circuit’s ruling in U.S. v. Caronia, two recent developments, the Par Pharmaceutical Companies Inc. settlement and the Ninth Circuit's affirmation of Scott Harkonen's conviction, demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under the federal Food, Drug and Cosmetic Act, say attorneys with King & Spalding LLP.
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5 Things To Know About Oral Argument In FTC V. Actavis
On March 25, the U.S. Supreme Court heard oral argument in Federal Trade Commission v. Actavis Inc. The justices appeared likely to issue a narrow ruling, not a broad one that would satisfy the FTC or fully resolve all the issues in the "pay-for-delay" area, say Thane Scott and Hill Wellford of Bingham McCutchen LLP.
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Litigation Support At A Crossroads
Despite recession-driven cost pressures that have resulted in the downsizing of nonlawyer personnel at law firms, many litigation support departments are growing. In a recent survey, half of respondents indicated that their function has grown in size in the past three years, and more than half of respondents indicated that current staffing levels are inadequate for the projected needs of the coming year, say experts at Epiq Systems and Georgetown University Law Center.
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The Business End Of Supreme Court's Current Term
This term marks a continuation of the Roberts court trend of close attention to business issues. From affirmative action and class actions to tort litigation, government enforcement and intellectual property, almost one half of this term’s argued cases are of interest to the business community, say Cliff Sloan and David Foster of Skadden Arps Slate Meagher & Flom LLP.
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What Food Cos. Can Learn From Horses And Peanuts
As of late, two big stories have made headlines in the food industry: the horse meat scandal in Europe and the indictment against the Peanut Corp. of America on a salmonella outbreak. Both cases warrant close examination to understand how quickly a company can become ensnared in a public relations nightmare and how to handle an investigation once it starts, say attorneys with Davis Wright Tremaine LLP.
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Supreme Court Tames Class Action Frankenstein's Monster
The unanimous U.S. Supreme Court decision in Standard Fire Insurance Co. v. Knowles will be praised by class action defense counsel as comporting with the congressional intent of the Class Action Fairness Act and ramifying the pleading strategies used by putative class representatives to maximize the litigation leverage of the "Frankenstein's monster" created by class actions, say attorneys with Fulbright & Jaworski LLP.
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Delaware Rethinks Reverse Triangular Mergers
Meso Scale Diagnostics v. Roche Diagnostics, a case of first impression in Delaware, will likely be viewed with relief by corporate practitioners because it both resolves the ambiguity created by an earlier ruling in this same case and because it sits in stark conflict with two previous federal district court opinions in California and New Jersey, say attorneys with Ropes & Gray LLP.
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In Re Hubbell Puts Inventors At A Disadvantage
Obviousness-type double patenting usually arises between commonly owned patents or patent applications. While the U.S. Patent and Trademark Office has interpreted the judicially created doctrine as pertaining when there is common or overlapping inventorship, without regard to common ownership, the Federal Circuit had not upheld that interpretation of the doctrine until recently in In re Hubbell, says Courtenay Brinckerhoff of Foley & Lardner LLP