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?
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- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Paragraph IV Cases
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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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In re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 09-MD-2118-SLR (D. Del.) Under 35 U.S.C. § 285, a court may, in "exceptional cases," award attorney fees to the prevailing party. In an Order filed on January 12th, the district court presiding over the ANDA litigation involving AMRIX granted Anchen's motion for attorney fees, concluding that…
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Warner Chilcott Labs. v. Mylan Pharms. Inc., No. 2011-1611 (Fed. Cir.) An interesting development in ANDA litigation this year has been the increasing frequency with which district courts have granted preliminary injunctions or temporary restraining orders against ANDA filers–even, in some cases, after the district court has found after a full trial that the patents…
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Leo Pharma A/S v. Tolmar, Inc., No. 10-269-SLR (D. Del.) LEO Pharma A/S sued Tolmar, Inc. in the District of Delaware for patent infringement under 35 U.S.C. § 271(e)(2) after Tolmar submitted an ANDA for a generic version of DOVONEX, certifying that a certain LEO Pharma patent is invalid or would not be infringed by…
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Unigene Labs and Upsher-Smith v. Apotex, No. 2010-1006 (Fed. Cir. 2011) In a decision yesterday, the Federal Circuit affirmed a district court opinion granting Unigene's motion for summary judgment that claim 19 of U.S. Patent No. RE40,812 is not invalid for obviousness. Claim 19 of the '812 patent covers the pharmaceutical formulation of FORTICAL (calcitonin…
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Mitsubishi Chemical Corp. v. Barr Labs., No. 2010-1432 (Fed. Cir. 2011) Mitsubishi Chemical owns U.S. Patent No. 5,214,052, which claims a "method for dissolving an arginineamide, comprising dissolving [argatroban] and/or its salt in a solvent containing ethanol, water and a saccharide"; and a "pharmaceutical composition for injection, comprising [argatroban] and/or its salt together with ethanol,…
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Duramed Pharms., Inc. v. Paddock Labs., Inc., No. 2010-1419 (Fed. Cir. 2011) by Scott P. McBride CENESTIN is a conjugated estrogen pharmaceutical composition used to reduce the symptoms of menopause. In a 3-0 decision last week, the Federal Circuit affirmed that Paddock's generic version of CENESTIN would not infringe U.S. Patent No. 5,908,638, directed to…
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Tyco Healthcare Group LP v. Mutual Pharm. Co., No. 2010-1513 (Fed. Cir. 2011) by Scott P. McBride RESTORIL (temazepam) is a hypnotic (sleep-inducing) drug marketed for the treatment of insomnia. In a decision last month, the Federal Circuit affirmed the invalidity of two claims of U.S. Patent No. 5,211,954 directed to temazepam formulations. Claim 1 recites:…
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In Re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, No. 2011–1399 (Fed. Cir. 2011) This case has an unusual history. Here is a brief summary of recent events: April 8: U.S. District Court for the District of Delaware enjoins Mylan from launching its generic AMRIX until the court issues its opinion on the patent infringement and validity issues in…
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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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