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Silence May Be Sufficient Written Description Disclosure for Negative Limitation

Addressing the issue of written description in a Hatch-Waxman litigation, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the patent adequately described the claimed daily dose and...more

Article III Standing Required to Appeal Final Decisions by the PTAB

Addressing the issue of Article III standing in an appeal of an inter partes review (IPR) decision, the US Court of Appeals for the Federal Circuit dismissed the appeal because the party appealing failed to establish an...more

Prima Facie Obviousness Established Where Claimed pH Range Overlaps with Prior Art Range for Similar Compounds

The US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment that found a patent was not obvious because the claimed pH range would not have been obvious-to-try despite overlapping ranges...more

Obviousness Reversed for Clear Error in Factual Findings on Combination of References

The US Court of Appeals for the Federal Circuit reversed a district court’s judgment that the challenged claims were invalid for obviousness. The Court also vacated judgments in separate actions that had been entered based on...more

ANDA Update - March 2017 Volume 3, Number 1

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Declaratory Judgment of Non-Infringement of a Disclaimed Patent Warranted in Hatch-Waxman - Apotex Inc. v. Daiichi Sankyo, Inc.

Addressing the issue of subject matter jurisdiction in Hatch-Waxman litigation, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s dismissal for lack of case or controversy of an action seeking...more

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