The Impact on Women's Health Claims
November 9, 2022
The Marker/Start Israel
What can we learn from recent cases concerning the written description requirement? A few practical tips follow this cautionary tale from Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323 (Fed. Cir. 2021), in which Dr. Reddy’s Laboratories successfully challenged claims of U.S. Patent No. 9,687,454. Id. at 1324-25. The patent at issue is directed to oral, mucoadhesive films that dissolve and release therapeutic agents to combat opioid dependence. Id. at 1323-26. Each challenged claim included a weight percentage value or range element for a constituent water-soluble polymeric matrix. Id. at 1325-26. DRL contended that these elements lacked written description support in the parent application to which the patent claimed priority. Id.
The Patent Trial and Appeal Board held that the parent application adequately supported the claimed weight percentage value, but not the claimed weight percentage ranges. Id. at 1326. The Federal Circuit agreed. The Court concluded that the parent application failed to explicitly disclose the claimed ranges or, for some claims, even the endpoints of the ranges. Id. at 1328-29. It further noted that the parent application stated that “any desired level of . . . polymer” could be used in the film and disclosed embodiments with weight percentages outside the claimed ranges, which would lead a skilled artisan to conclude that the inventors did not possess the claimed subject matter as of the parent application’s filing date. Id. at 1329. Finally, the Court acknowledged that tables in the parent application disclosed weight percentages of film sample components that, when aggregated, yielded weight percentage values within the claimed ranges. Id. However, it held that this could not support claiming the ranges because a skilled artisan would have merely been “invit[ed] to go on a hunting expedition to patch together after the fact a synthetic definition of an invention” by “cobbling together [these] numbers.” Id.
Each woman is different. Each patient is different. To be useful, then, each invention in the women’s health arena—whether a new medication, a new treatment, a new dosing regimen, a new procedure, or a new medical device—must account for these differences. Many of these inventions do so by incorporating ranges in which they are most effectively practiced.
As a simplified example, imagine a pharmaceutical research team has developed a new dosing regimen for a hypothetical oral treatment for cervical cancer. To maximize the regimen’s practical potential, the team may attempt to account for differences in cancer severity (e.g., cancer stage and the presence of metastases). The team may thus make the following findings:
Accordingly, the team may decide that the new dosing regimen for the treatment should take place over a period of thirty to ninety days. In doing so, the team has incorporated a range into the new dosing regimen.
Unfortunately, the Federal Circuit has made claiming these kinds of inventions more difficult by significantly tightening the written description requirement for claims including closed ranges: it now demands explicit disclosure of (possibly identical) closed ranges in associated specifications. While it remains to be seen whether other Federal Circuit panels enforce this stricter written description requirement in future cases, at this stage inventors, applicants, and practitioners—particularly in women’s health research and development fields—would do well to follow it.
Accordingly, we present five practical tips for drafting patent applications in the women’s health space in light of this precedent:
Keeping these tips in mind should help you avoid Indivior’s pitfalls and protect closed ranges in your claims from attacks under the 35 U.S.C. § 112(a) written description requirement.
Originally printed in The Maker on November 18th, 2022. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
Workshop
Life Sciences Workshop: Updates and Key Trends in Pharmaceutical and Biotechnology IP Law
May 2, 2024
Cambridge
At the PTAB Blog
IPR and PGR Statistics for Final Written Decisions Issued in February 2024
April 16, 2024
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.