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…patent.” Teva’s complaint and motion for preliminary injunction requests that the court enter an injunction compelling FDA to relist the ‘952 patent and restore the company’s Paragraph IV certification, declare…
…spare you all of the details of the case. Instead, we will focus on FDA’s Letter Decision. But first, some quick facts . . . . Hi-Tech submitted the first…
…either party to the action failed to reasonably cooperate in expediting the action . . . .” FDC Act § 505(j)(5)(B)(iii) (emphasis added). Since the enactment of the Hatch-Waxman Amendments…
By Jennifer B. Davis & John R. Fleder – In a March 17, 2009 opinion in United States ex rel Roop v. Hypoguard USA, Inc., the United States Court of…
…instant case, the Court finds nothing equivalent to Apotex’s stipulation to the infringement and validity of the [relevant] patent. . . . Here, . . . Dey has not stipulated…
By Kurt R. Karst – We recently reported on a Complaint and a Motion for Preliminary Injunction Teva Pharmaceuticals USA, Inc. (“Teva”) filed in the U.S. District Court for the…
…Teva Pharmaceuticals USA, Inc. (“Teva”) filed a Complaint and a Motion for Preliminary Injunctive Relief against FDA concerning 180-day exclusivity forfeiture for generic versions of Merck & Co., Inc.’s (“Merck’s”)…
…hired a compliance officer to insure that the company remained in compliance with the consent decree. Lane Labs also offered two experts who testified that the company had competent and…
…for discounts (United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ)). Just one day after issuing her opinion in the Omnicare case, Judge Zobel used similar…
…FDA forfeiture decision. But that’s the topic of today’s post . . . a recent and interesting case concerning generic ACTONEL (risedronate sodium) Tablets approved under NDA No. 020835. And…
…big firm experience, including litigation experience, and a federal judicial clerkship. E-discovery expertise is a bonus. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please…
…academic credentials and strong communication and writing skills. Candidates should send their curriculum vitae, transcript, and a writing sample to Jeffrey N. Wasserstein (jwasserstein@hpm.com). HP&M is an equal opportunity employer. …
…be desirable. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Jeffrey N. Wasserstein (jnw@hpm.com). …
…are required. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Jeffrey N. Wasserstein (jnw@hpm.com)….
…are required. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Jeffrey N. Wasserstein (jnw@hpm.com)….