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

Posted on December 2, 2021 by Warren Woessner

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.

Continue reading →

Posted in Written Description Requirements (WDR) | Tagged | Leave a comment

Strathclyde v. Clear-Vu – A Class in Obviousness

Posted on November 17, 2021 by Warren Woessner

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.

Continue reading →

Posted in Obviousness | Tagged , | Leave a comment

Inequitable Conduct Lives! Therasense Update and Refresher

Posted on October 27, 2021 by Warren Woessner

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 – dfields@aipla.org.

Posted in Inequitable Conduct/Rule 56 | Tagged , | Leave a comment

CareDx v. Natera – Are Processing Steps Known to the Art Always “Conventional”?

Posted on October 15, 2021 by Warren Woessner

In CareDx (Stanford U.) v. Natera Civ. Action No. 19-0567-CFC-CJB Consolidated (Sept. 28, 2021, D. Delaware), Judge Connolly ruled that the diagnostic method claimed in U. S. Pat. No. 8,703,652 and two others was a patent-ineligible natural phenomenon. The method is based upon the known correlation between the presence of donor-specific cell-free DNA (cfDNA) in a transplant recipient’s tissue and transplant rejection. Since the correlation was known, CareDx was left to argue that the improvement in sensitivity provided by the combination of known steps—which improvement was even recited in claim 1—was sufficient to satisfy the Mayo/Alice test for patent eligibility. However, by now we know that even discovery of a natural correlation and the discovery of its utility as a diagnostic is not enough to satisfy the requirement for the further “inventive concept” required by Step 2 of the Mayo/Alice test.

Continue reading →

Posted in Patent Eligible Subject Matter | Tagged , | Leave a comment