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…was adopted by unanimous consent. As we previously reported, the amendment makes significant changes to the version of S. 369 Sen. Kohl introduced earlier this year. The new version of…
…Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), in which the D.C. Circuit was convinced by Teva’s structural argument that the patent delisting counterclaim provision at…
…protect the nation’s young people. Failure to respond to this letter may result in FDA taking action to enforce the premarket authorities in the TCA . . . . FDA…
…U.S. Senate incorporated H.R. 3605 as an amendment to S. 1538, which became Pub. L. No. 98-417 (the Hatch-Waxman Amendments). The PTE provisions in H.R. 3605 mirrored previous legislation introduced…
…public health goals, including the reduction of. . . poor nutrition.” Section 4201 provides for the award of grants to State agencies and community-based organizations for the conduct of “community…
…time is received on the same calendar day. . . . Second, the FDA was conducting business after 4:30 p.m. on December 15,2000, and any other time it takes action….
…to Gilead Sciences Inc. (“Gilead”) “based on the apparent ineligibility of U.S. Patent No. RE 44,599 [and U.S. Patent No. RE 44,638] for [PTE] request under 35 U.S.C. § 156.”…
…also been proposed. Sen. Herb Kohl (D-WI) filed an amendment (SA 2862) concerning so-called “pay-for-delay” settlements. The amendment is almost identical to the substitute amendment to S. 369, the Preserve Access…
…recently ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange Book-listed patent use code for a patent (U.S. Patent No. 6,677,358 (“the ’358 patent”)) on…
…46-49 for Sen. Kohl’s remarks.) Under the version of S. 369 Sen. Kohl introduced in February 2009, it would be unlawful for a person, in connection with the sale of…
…than unapproved drugs. The Sentencing Commission did not adopt FDA’s proposal. Thus, despite the distinction between misbranded and unapproved drugs, the court (seemingly incorrectly), applied the comment concerning unapproved drugs…
…heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated August 13, 2009 did not come until more than 6 years after the date of…
…(including flavors, ingredients, etc.); Sale and distribution of tobacco products; Manufacturing restrictions and facilities controls; and Other. Information that FDA receives in response to its request could well help the…
…U.S. Constitution prohibits the government from relying upon a company press release and related communications alleged to be part of the wire fraud and misbranding that the defendant reportedly committed. …
…to each other . . . . GSK’s decision to submit such patents to FDA for Orange Book listing could be a creative way of pushing the Agency to more…