Tag Archives: Written Description Requirements

Novartis v. Accord Redux – Panel 2 Reverses Panel 1

To save me a lot of typing, please read my post of January 10, 2022, summarizing the first Panel’s holding in Novartis Pharmaceutical v Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir., 2022). The panel in that decision was Judges … Continue reading

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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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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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