Month: May 2007
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American Conference Institute will hold the 2nd west coast edition of its popular "Maximizing Pharmaceutical Patent Life Cycles" conference next week in San Francisco (at the beautiful Mark Hopkins hotel). ACI calls this "the only Hatch-Waxman conference specifically designed for the biopharmaceutical industry." According to ACI, the conference will "bring the biopharmaceutical industry the critical…
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Guest Post by Prof. Christopher M. Holman, UMKC School of Law In my view, the Solicitor General was correct in recommending denial of certiorari in Joblove, but erred in its characterization of the majority opinion. For example, the Solicitor General’s brief implies that at the time of the settlement the parties intended…
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Via the Antitrust Review and Pharmalot, the Solicitor General has recommended that the Supreme Court deny certiorari in Joblove v. Barr Labs, the most recent “reverse payments” case to be appealed to the Court. Last year, the Solicitor General advised the Court not to take the FTC v. Schering case. At the time, many observers…
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Merck & Co. v. Apotex, No. 06-230 (D. Del. 2007) Last month (as we reported then), the U.S. District Court for the District of Delaware granted Merck’s motion to dismiss the patent suit Merck filed against Apotex concerning generic Fosamax. The court indicated at the time that an opinion would "follow at the court’s earliest…
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Pfizer v. Apotex, No. 2006-1261 (Fed. Cir. 2007) This afternoon, the Federal Circuit denied Pfizer’s petition for rehearing and rehearing en banc of Pfizer v. Apotex, in which the court invalidated claims 1-3 of Pfizer’s U.S. Patent No. 4,879,303. The ‘303 patent covers amlodipine besylate, the active ingredient in Norvasc. Three of the twelve judges…
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Novartis v. Teva, No. 04-4473 (D.N.J. 2007) More drama involving amlodipine–this time with Lotrel (made by Novartis), rather than Norvasc (made by Pfizer). Lotrel contains a combination of two active ingredients–amlodipine besylate and benazepril–whereas Norvasc contains only one. Both drugs are indicated for the treatment of high blood pressure and both are blockbusters. Teva announced…
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In a May 14 Order, the district court in D.C. denied all motions for reconsideration of its April 30 decision on Norvasc pediatric and 180-day exclusivity. FDA Law Blog has all the reconsideration briefs. Apotex and Mylan have now appealed to the D.C. Circuit. The In Vivo Blog reports that "Democratic and Republican staffers involved…
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Eisai v. Dr. Reddy’s and Teva, Nos. 03-9053 and 03-9223 (S.D.N.Y. 2007) Eisai owns U.S. Patent No. 5,045,552, which claims the chemical compound rabeprazole sodium, the active ingredient in Eisai’s blockbuster proton-pump inhibitor Aciphex. Dr. Reddy’s, Teva and Mylan filed ANDAs for generic Aciphex with paragraph IV certifications to the ‘552 patent. Aciphex has annual…
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Janssen Pharmaceutica et al. v. Mylan Pharms., No. 07-1021 (Fed. Cir. 2007) Last Thursday, the Federal Circuit heard oral arguments in Mylan’s appeal of a district court decision upholding the validity of Janssen Pharmaceutica’s patent on Risperdal (risperidone), an antipsychotic medication with over $2 billion in annual U.S. sales. On Friday, the Federal Circuit affirmed…
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Guest Post by Prof. Christopher M. Holman, UMKC School of Law Much of the current discussion surrounding the proposed follow-on biologics bills assumes that a “statutory path” is necessary before FDA can implement an abbreviated biologics license application (BLA) process for biotechnology-derived therapeutic proteins. In fact, FDA probably already has the authority…
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