Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Paragraph IV Cases
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Purdue Pharm. Products v. TWI Pharms., No. 12-5311 (D.N.J.) by Alex Menchaca In an opinion last week, the U.S. District Court for the District of New Jersey stymied what appears to be an attempt by Purdue Pharma to prevent TWi Pharmaceuticals from obtaining a final judgment of noninfringement of all four Orange Book-listed patents on Intermezzo®…
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Pfizer Inc. et al. v. Teva Pharms. USA et al., No. 2012-1576 (Fed. Cir.) Teva and several other generic pharmaceutical companies each submitted an ANDA seeking approval to market a generic version of Lyrica, for treating seizures and pain. In a unanimous decision last Thursday, the Federal Circuit affirmed the judgment of the U.S. District…
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Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc., IPR2013-00368, IPR2013-00371, IPR2013-00372 (PTAB) by Robert F. Kappers The U.S. Patent Trial and Appeal Board issued a trio of related decisions on December 17, 2013, each instituting inter partes review of one of three related patents on once-daily formulations of tetracycline. On June 20, 2013, Amneal Pharmaceuticals filed…
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Galderma Labs., L.P. et al. v. Tolmar, Inc., No. 2013-1034 (Fed. Cir.) by Dunstan H. Barnes On December 11, 2013, a three-judge Federal Circuit panel struck down the asserted claims of five patents belonging to Galderma Laboratories for being invalid as obvious. In Judge Sharon Prost's opinion for the court, joined by Judge…
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Cadence Pharms., Inc. v. Exela Scis., LLC, No. 11-733-LPS (D. Del.) by Dunstan H. Barnes On November 22, 2013, the U.S. District Court for the District of Delaware issued a Final Judgment and Permanent Injunction barring Exela from manufacturing a generic version of OFIRMEV®, which is an injectable liquid acetaminophen composition. Judge Leonard Stark…
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Pfizer Inc. v. Sandoz Inc., No. 12-654-GMS-MPT (D. Del.) by Malaika D. Tyson Undue delay that resulted in prejudice to Pfizer coupled with failure to demonstrate good cause are some of the reasons why on November 4, 2013, Magistrate Judge Mary Pat Thynge issued a report and recommendation denying Sandoz’s motion to amend its…
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Pronova Biopharma Norge v. Teva Pharms., No. 2012-1498 (Fed. Cir.) by Aaron F. Barkoff It is not unusual for a defendant in an ANDA case to assert invalidity due to prior public use, but it is rare that such a defense succeeds. In a unanimous decision last week, the Federal Circuit held the asserted claims of…
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Novo Nordisk v. Caraco Pharm. Labs., No. 2011-1223 (Fed. Cir.) In its third trip to the Federal Circuit, the court on Tuesday affirmed a decision holding claim 4 of Novo's U.S. Patent No. 6,677,358 invalid as obvious. Claim 4 of the '358 patent, listed in the Orange Book for PRANDIN (repaglinide) tablets, is directed to "[a] method…
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Endo Pharmaceuticals v. Mylan, No. 11-220-GMS (D. Del.) In an opinion filed on Monday, the U.S. District Court for the District of Delaware granted leave to Endo Pharmaceuticals to file an amended complaint to correct a defective initial complaint. In doing so, the court found that Endo's first complaint, while defective, properly triggered a statutory thirty-month…
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Merck Sharp & Dohme Corp. v. Sandoz Inc., No. 12-3289 (D.N.J. 2013) by Katherine H. Johnson In an opinion issued earlier this month, Defendants moved to dismiss for lack of subject matter jurisdiction with respect to one of two asserted patents in a lawsuit involving generic versions of EMEND (fosaprepitant dimeglumine) for injection. Merck…
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