Category Archives: Written Description Requirements (WDR)

Novartis v. Accord – No Limits on Negative Limitations?

A split panel of Judges O’Malley, Linn and Moore (dissenting) affirmed a district court ruling that the claims of U.S. Pat. No. 9,187,405 met the written description requirement (WDR) of s. 112(a). Novartis Pharmaceuticals v. Accord Healthcare Inc., Appeal No. … Continue reading

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Biogen v. Mylan – Therapeutic v. Clinical Efficacy – What is Required by the Written Description Requirement?

In Biogen v. Mylan, Appeal No. 2020-1933 (Fed. Cir., November 30, 2021), a divided panel of Judges O’Malley, Reyna and Hughes affirmed a district court’s ruling that Biogen’s U.S. Pat. No. 8,399,514 is invalid for failing to meet the written … Continue reading

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Indivior v. Dr. Reddy’s Laboratory – Homeless on the Range

In Indivior v. Dr. Reddy’s Laboratory (“DRL”), Appeal  nos. 2020-2073, -2142 (Fed. Cir., November 24, 2021) a split panel (Lourie [writing] and Dyk, with Linn concurring in part and dissenting in part) affirmed a Board decision that claims 1-5 and … Continue reading

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Biogen v. Mylan: When Does a Specification Fail to Describe a Newly-Presented Claim?

The disclosure requirements that will meet the written description requirement of s. 112(1) had a fairly mundane priority policing role prior to the expansion of the importance of the requirement in the biotech cases leading up to the en banc … Continue reading

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