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: Validity–Section 112
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By: Rocco Screnci Ben recently covered Astellas Pharma, Inc. v. Sandoz Inc., in which the Federal Circuit vacated a district court decision for violating the principle of party presentation. 117 F.4th 1371 (Fed. Cir. 2024). Today’s post focuses on some interesting procedural issues that have since developed on remand. By way of background, the district…
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CAFC holds that later-developed antibody species may be evidence that a claimed antibody genus is invalid for lack of written description, and casts doubt on the “antibody exception” Amgen Inc. v. Sanofi, No. 2017-1480 (Fed. Cir. October 5, 2017) by Christopher P. Singer, Ph.D. In a precedential opinion yesterday, the Federal Circuit refined the manner…
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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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Cephalon, Inc. v. Watson Pharms., Inc., No. 2011-1325 (Fed. Cir. 2013) by Katherine H. Johnson In Cephalon v. Watson, decided earlier this month, the Federal Circuit reversed a finding of invalidity for lack of enablement where the factual record of undue experimentation was insufficient. The patented invention involved methods of oral mucosal administration…
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On Friday morning, the USPTO pre-published its proposed rule changes implementing the provisions of the America Invents Act that convert the U.S. patent system from a "first to invent" to a "first inventor to file" system. The proposed rules (available here) were scheduled to be published in the Federal Register on Monday, but were withdrawn…
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Bone Care Int'l v. Roxane Labs., No. 09-cv-285 (GMS) (D. Del.) In an opinion this past Monday, the U.S. District Court for the District of Delaware found in favor of Genzyme and against ANDA applicants Roxane, Sandoz, and Anchen in the paragraph IV litigation concerning HECTOROL (doxercalciferol), Genzyme's drug for the treatment of secondary hyperparathyroidism…
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