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 description requirement [WDR] of s. 112(a).  Judges Reyna and Hughes were the majority, while Judge O’Malley penned an 11-page dissent.

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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 7-14 were invalid. Indivior had issued these claims in U. S. Pt. No. 9,687,454 out of one of a long chain of continuations. However, it had added two ranges to the claims directed to an “oral, self-supporting, mucoadhesive film”. One “new claim” (1) added the element that the film comprised “about 40 wt % to about 60 wt % of a water soluble polymeric matrix.” The other claims in suit added the element that the film comprises about 48.2 wt % to about 58.6 wt % of the water soluble polymeric matrix.

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Strathclyde v. Clear-Vu – A Class in Obviousness

In fact, it was Clear-Vu that got “schooled” in the law of obviousness, but this case would be a good teaching—or review—article for anyone on this subject. I admit, it was refreshing to re-read some of the classic quotes from Fed. Cir. panels that set the standards for s. 103 inquiries. I know that patent eligibility and even s. 112(1) are the hot topics of the day. This decision by Judges Reyna, Cleavinger and Stoll (writing)  felt like encountering the ghost of s. 103 past—when the entire IP world seemed like a friendlier place.

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Inequitable Conduct Lives! Therasense Update and Refresher

On November 3 at 12:30 EST, I will be participating in an AIPLA webinar with Prof. David Hricik (Mercer College of Law) and William Covey, Director of the OED at the USPTO. We will present:

Inequitable Conduct Lives!

This presentation will provide information of use to old pros and new practitioners. The panelists will provide an overview of the ethical obligations of practice as well as the substantive law of inequitable conduct and related disciplinary matters, including several recent cases finding inequitable conduct despite the barriers created in 2011 by Therasense.  It will also provide practical procedures and practices to avoid creating a record that leads to inequitable conduct and for more compact prosecution.

To register, visit the AIPLA website. For further information contact Dominique Fields at AIPLA –

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