Previous Paragraph IV Certification Does Not Foreclose Institution of IPR

A recent decision by the PTAB highlights two unsuccessful arguments by a patent owner attempting to prevent institution of an IPR. Petitioner, Johnson Matthey Inc. and two others, filed an IPR petition against U.S. Pat. No. 8,129,431 (“the ‘431 patent”). The patent relates to an aqueous liquid preparation named Prolensa, consisting of essentially two components: […]

PTAB’s Institution of IPR Not Sufficient for District Court to Reconsider Grant of Preliminary Injunction

A recent District of New Jersey case highlights the importance of presenting evidence in federal district court in addition to presenting it in proceedings before the PTAB. New Jersey District Court Judge Hochberg recently held that the PTAB’s institution of an IPR was not a basis to reconsider the court’s order granting plaintiff a preliminary […]

Sandoz’s Remodulin Label Carve-Out Found Not to Infringe Method Claims

In United Therapeutics Corp. v. Sandoz, Inc., Judge Peter G. Sheridan of the District of New Jersey ruled that Sandoz’s proposed label for a generic version of UTC’s anti-hypertensive Remodulin (treprostinil sodium) injection did not induce infringement of various UTC method patent claims.  (Civil Action No. 3:13-cv-1617-PGS-LHG, Dkt. No. 364).  As a way to reduce […]

Off-Label Use Cannot Save Generic From Contributory Infringement Where Method In Label Infringes

In Depomed Inc. v. Actavis Elizabeth LLC, et al., the District of New Jersey blocked Actavis from producing and selling generic gabapentin once-daily tablets. Actavis filed an ANDA for approval to market a generic version of Depomed’s timed release Gralise®, a once-a-day gabapentin treatment for post-herpetic neuralgia (PHN), or nerve pain due to shingles. Following […]

Federal Circuit Affirms Holding of Inequitable Conduct, Dooming Apotex Patent

In Apotex, Inc. v. UCB, Inc. the Federal Circuit affirmed the Southern District of Florida’s holding that Apotex’s patent (U.S. Patent No. 6,767,556) is unenforceable for inequitable conduct.  This marks a rare instance of success for the defense after the Federal Circuit’s Therasense decision raised the bar on the materiality and intent requirements necessary to […]

Both Braintree Labs and Novel Labs Petition for the Federal Circuit En Banc Rehearing

We discussed Braintree Labs v. Novel Labs in a previous post.  In the panel decision, Judge Prost, with Judge Dyk joining, found the term “a patient” in Braintree’s Suprep colon cleanser patent to mean a general class of persons, i.e., a patient population.  Accordingly, the panel vacated and remanded the infringement ruling relying on erroneous […]

The Federal Circuit Finds Functionally-Based Genus Claims to Be Invalid for Lack of Written Description

A recent Federal Circuit case shows that broad, functionally-defined genus claims are susceptible to written-description invalidity challenges.  In AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. et al., the Federal Circuit affirmed a jury verdict invalidating a patent, finding that there was substantial evidence to conclude that the claims failed to meet the Patent […]

Obviousness holding reinforces the importance of claim scope

Last week, in Allergan Inc. v. Apotex Inc., a panel of the Federal Circuit reversed a finding from the Middle District of North Carolina that patents covering Allergan’s Latisse® (bimatoprost ophthalmic solution) were not invalid for obviousness.  In doing so, the Federal Circuit reinforced the principle that the obviousness analysis, including secondary considerations of nonobviousness, […]

Supreme Court Eases Federal Circuit’s “Insolubly Ambiguous” Test For Indefiniteness Defense

This morning, in Nautilus, Inc. v. Biosig Instruments, Inc., the Supreme Court rejected the Federal Circuit’s formulation of the definiteness requirement under 35 U.S.C. § 112, para. 2.  Under the now-abandoned iteration of the definiteness test, claims were deemed to have satisfied the statutory requirement so long as they were “amenable to construction” and “not insolubly […]