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
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Declaratory Judgment Jurisdiction
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Apotex Inc. v. Daiichi Sankyo, Inc., Nos. 2014-1282, 2014-1291 (Fed. Cir. Mar. 31, 2015) by Dunstan H. Barnes Apotex, Inc. sued Daiichi Sankyo Co., Ltd. and Daiichi Sankyo, Inc. in the United States District Court for the Northern District of Illinois for a declaratory judgment of non-infringement of a Daiichi-owned, but Daiichi-disclaimed, patent,…
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Celltrion Healthcare v. Janssen Biotech, No. 14-11613 (D. Mass.) by Sandra A. Frantzen As we previously reported, Celltrion filed a Complaint for Declaratory Judgment against Janssen Biotech on March 31, seeking a declaration of invalidity and unenforceability of three Janssen patents. In its complaint, Celltrion alleged that Remsima®, a biosimilar version of Janssen's Remicade®…
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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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Sandoz v. Amgen and Hoffman-La Roche, No. 13-204 (N.D. Cal.) by Aaron F. Barkoff In what appears to be the first court decision interpreting the patent litigation provisions of the BPCIA (the "Biosimilar Act"), the U.S. District Court for the Northern District of California granted Amgen's motion to dismiss Sandoz's declaratory judgment complaint concerning…
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Cephalon v. Sandoz, No. 11-821-SLR (D. Del.) In January 2010, Sandoz sent a Paragraph IV notice letter to Cephalon in connection with its ANDA for a generic version of Cephalon's FENTORA (fentanyl citrate) buccal tablets. Cephalon responded by filing suit against Sandoz under 35 USC § 271(e)(2), alleging infringement of U.S. Patent Nos. 6,200,604 and…
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Medeva Pharma Suisse v. Par Pharmaceutical, No. 2011–1391 (Fed. Cir. 2011) In an Order issued today, the Federal Circuit denied Medeva's motion to dismiss Par's appeal of a decision from the U.S. District Court for the District of New Jersey that dismissed Par's declaratory judgment claim in paragraph IV litigation involving ASACOL (mesalamine). Medeva had…
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Eisai v. Teva Pharms. USA, No. 10-1070 (U.S. 2011) In a little-noticed decision two weeks ago, the Supreme Court vacated the Federal Circuit's decision in Teva v. Eisai and remanded the case with instructions to dismiss it as moot. The Court's decision (found on the Order List of June 13) is significant in that it vacates a…
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Teva Pharms. USA v. Eisai et al., No. 2009-1593 (Fed. Cir. 2010) In a 3-0 decision last week, the Federal Circuit held that Teva has standing to challenge four of Eisai’s Orange Book-listed patents on Aricept (donepezil)–notwithstanding that Eisai statutorily disclaimed two of the patents and granted Teva covenants not to sue on the others. The Federal…
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Pfizer Inc. et al. v. Apotex Inc. et al., No. 08-7231 (N.D. Ill. 2010) The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case,…
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Merck & Co. v. Apotex, No. 2008-1133 (Fed. Cir. 2008) In 2005, Hi-Tech Pharmacal became the first company to file a paragraph IV certification relating to Merck's glaucoma drugs Trusopt and Cosopt. Hi-Tech filed paragraph IV certifications with respect to all three of the Orange Book-listed patents for these drugs: U.S. Patent Nos. 4,797,413; 6,248,735;…
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