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Lilly Targets Actavis In Latest Cymbalta Patent Suit

Wednesday, Nov 19, 2008

Eli Lilly and Co. added a fifth generic drugmaker to its bid to block competing versions of its antidepressant Cymbalta Tuesday, suing Actavis Elizabeth LLC over a patent for the blockbuster drug less than a week after filing four similar suits.

FDA Opens 3 Offices In China

Wednesday, Nov 19, 2008

The U.S. Food and Drug Administration opened three inspection offices in China on Wednesday, taking the first steps to expand its oversight abroad in response to a long list of foreign food and drug recalls in the past year.

USPTO Works Record Number Of Patent Apps In FY08

Wednesday, Nov 19, 2008

The U.S. Patent and Trademark Office examined the highest number of applications in history in fiscal year 2008, increasing production of patents by an additional 14 percent from the year before, the agency said in its annual review.

'Straw Dogs' Unlikely To Doom Obama AG Nominee

Wednesday, Nov 19, 2008

Political experts and politicians alike said Wednesday that, while likely attorney general nominee Eric Holder's controversial role in the Clinton-era pardon of a convicted financier whose wife gave money to Democrats might cause political fireworks, it was unlikely to derail a confirmation.

Nevada Sues Wyeth, Pfizer Over Hormone Drugs

Wednesday, Nov 19, 2008

The state of Nevada has filed a lawsuit accusing Wyeth and Pfizer Inc. of misrepresenting the benefits of popular hormone therapy treatments such as Prempro and Provera and downplaying the risks of cancer and other ailments associated with the drugs.

Boehringer Sues To Block Norbrook's Generic Metacam

Wednesday, Nov 19, 2008

Boehringer Ingelheim Pharma GmbH & Co. KG has unleashed a lawsuit alleging veterinary pharmaceutical company Norbrook Laboratories Ltd. infringed a patent for Metacam when seeking regulatory approval for a generic version of the canine anti-inflammatory drug.

FDA Seeks Panel Expert Review Of Antibiotic

Tuesday, Nov 18, 2008

An experimental antibiotic developed by drugmaker Theravance Inc. to treat complicated skin infections may cause possible kidney damage, birth defects and death, according to the U.S. Food and Drug Administration's review of the drug.

Women Attorneys Still Earn Less Than Men: Survey

Tuesday, Nov 18, 2008

Women attorneys at the largest U.S. law firms continue to earn less than their male counterparts at every stage of practice and are markedly underrepresented in the leadership ranks, according to a survey published Monday by the National Association of Women Lawyers.

3rd-Party Funding Fuels European Litigation Growth

Tuesday, Nov 18, 2008

Third-party financing of litigation and an increasing acceptance of class action lawsuits in European courts have opened companies there up to litigation risks similar to those in the United States, a major British insurance firm reports.

GSK Wins Bid To Boot Paxil Suicide Suit

Tuesday, Nov 18, 2008

A Pennsylvania judge has thrown out a product liability case accusing GlaxoSmithKline PLC of failing to include specific warnings about an increased risk of suicide associated with its antidepressant Paxil after finding that the claims were barred by the state's statute of limitations.

Teamwork, Turf Wars For State AGs Under Obama

Tuesday, Nov 18, 2008

With a newly minted administration under President-elect Barack Obama set to sweep into Washington promising more regulation and increased enforcement actions in several sectors, is the era of the crusading state attorney general over? Not necessarily, according to attorneys who monitor federal regulations.

Jury Tags J&J Units To Pay $16M For Pain Patch Death

Tuesday, Nov 18, 2008

An Illinois state jury has reportedly decided that the surviving family members of a woman who died after using a Duragesic-brand pain-killing skin patch manufactured by two Johnson & Johnson subsidiaries should receive $16.6 million.

5th Circ. Rebuffs Insurers In Vioxx Settlement

Tuesday, Nov 18, 2008

An appeals court has affirmed the denial of preliminary injunctions in a lawsuit brought by numerous insurance companies against the administrators of the $4.85 billion Vioxx settlement.

Alpharma Sues Purdue Over Painkiller Mktg. Rights

Tuesday, Nov 18, 2008

Alpharma Inc. has filed a preemptive lawsuit against Purdue Pharma LP, the makers of Oxycontin, over the right to market ALO-01, an opioid painkiller with less potential for abuse.

Cadwalader Looks To Demote Managing Partner

Tuesday, Nov 18, 2008

Bracing for a sharp decline in profits, partners at Cadwalader Wickersham & Taft LLP are reportedly planning to vote for the firm’s managing partner and former chairman to step down from the management committee.

Schering Sues Sun, Caraco Over New Clarinex Patent

Tuesday, Nov 18, 2008

Schering Corp. has accused Sun Pharmaceutical Industries Ltd. and Caraco Pharmaceutical Laboratories Ltd. of infringing its latest Clarinex patent more than two years after filing its original lawsuit seeking to block the two drug companies from producing a generic version of the blockbuster allergy treatment.

DOJ Subpoenas Medtronic Over Bone Graft Product

Tuesday, Nov 18, 2008

The U.S. Department of Justice is investigating Medtronic Inc. over the possible marketing of the medical company's spinal graft product for purposes that have not been approved by the U.S. Food and Drug Administration.

Eli Lilly Circles Wagons Around Cymbalta Patent

Tuesday, Nov 18, 2008

Eli Lilly and Co. has brought at least four lawsuits seeking to stop generic pharmaceutical companies from marketing copycat versions of the antidepressant Cymbalta.

Teva, Zydus Drop Some Claims In Coreg Patent Suit

Monday, Nov 17, 2008

Teva Pharmaceutical Industries Ltd. has agreed to drop two patents from an infringement suit against rivals Zydus Pharmaceuticals Inc. and Cadila Healthcare Ltd. over a patented process for making the key ingredient in the congestive heart treatment Coreg, but Zydus' invalidity and antitrust-related counterclaims for one of those patents remain in play.

DOJ Takes Aim At Actavis’ Drug-Making Practices

Monday, Nov 17, 2008

The U.S. Department of Justice has targeted two U.S. subsidiaries of Iceland-based generic-drug maker Actavis Group in a suit alleging that a series of regulatory inspections have turned up problems with company manufacturing practices.


Guest Columns

Quality Of Care Issues For Providers

Health care compliance, which has traditionally focused on compliance with laws and regulations and left quality issues to the quality assurance or improvement experts, has now started to encompass review of quality indicators, says Melissa M. Zambri of Hiscock & Barclay LLP.

Nursing Facility Transparency And Congress

For years, the long-term care community has supported the development of a nursing facility oversight system that is more objective, provides incentives for improvement, and better measures quality outcomes and processes. Congress has introduced two such bills this year, say Shirley Morrigan, Michael A. Okaty, Robert Slavkin and Lawrence W. Vernaglia of Foley & Lardner LLP.

Rule 502 And Electronic Discovery

Courts are approaching electronic discovery disputes with great hesitation and care – as they should. Yet, what constitutes a “reasonable step” under Federal Rule of Evidence 502 in the context of electronic keyword searches is still very much open to argument, say Linda E. B. Hansen and Anne F. Schubert of Foley & Lardner LLP.

Innovator's Guide To Navigating CMS

Medicare's guiding principle in making coverage determinations has always been the statutory requirement that precludes payment for items that are not “reasonable and necessary” for the diagnosis or treatment of illness or injury. Unfortunately, neither the statute nor the Medicare regulations define “reasonable or necessary,” say Judith A. Waltz and Alpana M. Kumar of Foley & Lardner LLP.

Why The Third Restatement Still Falls Short

Section 6(c) and its design defect standards simply do not resonate with courts that have grown accustomed to applying "comment k" on a case-by-case basis, say Stephen E. Scheve and Andrew J. Yoder of Baker Botts LLP.

Wyeth V. Levine In Light Of Merck's Vioxx Litigation

Understanding the reasoning of the Appellate Division of the New Jersey Court of Appeals in McDarby v. Merck & Co. Inc. may offer some insights as to how the Supreme Court may rule on the issue of preemption in Wyeth v. Levine, say David Molton, Steven B. Smith and David A. Abadir of Brown Rudnick LLP.

Rejecting Expansive FCA False Certification Theory

Because it found in Conner v. Salina Regional Health Center that Conner's allegations did not state a claim within the meaning of the Anti-Kickback Statute, the Tenth Circuit explicitly declined to reach the issue of whether a violation of that statute can support a cognizable False Claims Act allegation under an express false certification theory, say R. Christopher Cook and Nolan S. Young of Jones Day.

Mandatory Compliance With 'Voluntary' Codes

While the pharmaceutical and medical device industries have recognized the importance of voluntary compliance with industry codes in the past, state statutes and regulations incorporating the codes have transformed them from aspirational goals into minimum standards of conduct, say Erik Snapp and Monika Blacha of Winston & Strawn LLP.