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|Payers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars|
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
July 22, 2014, previously published on July 2014Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...
|Federal Circuit Holds That Even Functional Claims Require Structural Fence Posts|
Courtenay C. Brinckerhoff, Jacob D. Moore; Foley & Lardner LLP;
July 17, 2014, previously published on July 11, 2014In AbbVie Deutschland Gmbh v. Janssen Biotech, Inc., the Federal Circuit affirmed the district court decision that found AbbVie’s patents directed to anti-IL-12 antibodies invalid for lack of adequate written description. As between the parties, this decision leaves Centocor free to market...
|USPTO Asks for Patent Subject Matter Eligibility Comments by July 31, 2014|
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
July 8, 2014, previously published on June 30, 2014In a June 30, 2014 Federal Register notice, the USPTO requested public comments by July 31, 2014 on patent subject matter eligibility under the recent Supreme Court decision in Alice Corporation Pty. Ltd. v. CLS Bank International and on the USPTO’s March 4, 2014 “Guidance For...
|Insurers Singing the Blues After District Court Denies Motion to Dismiss in Lawsuit Accusing Blue Cross/Blue Shield of Conspiring to Limit Competition|
Robert B. Craig; Taft Stettinius & Hollister LLP;
July 8, 2014, previously published on June 27, 2014The multidistrict class action litigation challenging an alleged horizontal market allocation by Blue Cross/Blue Shield Association and nearly 40 Blue Cross/Blue Shield Plans around the country will proceed to discovery after a federal judge in Alabama recently denied the defendants’ motion...
|District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers|
Benjamin R. Dryden, Alan D. Rutenberg; Foley & Lardner LLP;
July 7, 2014, previously published on June 26, 2014A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We explained these Hart-Scott Rodino rules back in November...
|Is the DOJ FCPA Enforcement Hegemony Dead?|
Alexandra M. Gorman, Michael K. Loucks; Skadden, Arps, Slate, Meagher & Flom LLP;
July 3, 2014, previously published on June 26, 2014For nearly 15 years, the United States has had the worldwide corruption enforcement stage to itself, reaping billions of dollars in fines and settlement payments from companies that have acknowledged engaging in bribery in foreign countries. That monopoly, however, may soon end. In a report...
|First-Half Activity Energizes US Capital Markets in 2014|
David J. Goldschmidt, Stacy J. Kanter, Phyllis G. Korff, Michael J. Zeidel; Skadden, Arps, Slate, Meagher & Flom LLP;
July 3, 2014, previously published on June 26, 2014The U.S. equity and debt markets experienced a strong first half of the year. In the first quarter, the U.S. IPO market was the busiest since 2000, more than doubling the number of IPOs from the same period last year. The second quarter was nearly as active, bringing the year-to-date total to 134...
|How the Supreme Court Decision in Alice Corp. v. CLS Bank Undermines the USPTO Subject Matter Eligibility Guidance|
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
June 30, 2014, previously published on June 24, 2014On June 19, 2014, the Supreme Court issued its decision in Alice Corp. v. CLS Bank International, finding that patents directed to “a computer-implemented scheme for mitigating ‘settlement risk’” were invalid as being drawn to a patent-ineligible abstract idea. Although the...
|OSHA Issues Brochure on Safe Patient Handling in Nursing Homes|
Marilyn Robertson; Husch Blackwell LLP;
June 26, 2014, previously published on June 17, 2014The U.S. Occupational Safety and Health Administration (OSHA) recently published a new brochure titled “Safe Patient Handling: Preventing Musculoskeletal Disorders in Nursing Homes.” In the brochure, OSHA recommends strategies to reduce musculoskeletal disorders (MSDs) in nursing homes....
|HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect|
Ellyn L. Sternfield; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 23, 2014, previously published on June 18, 2014In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B Program operations.