Application of Section 101 in Life Sciences Patents: Leveraging Revised USPTO Guidelines, Recent Decisions

Seven plus years after Mayo, subject-matter eligibility under 35 U.S.C. Section 101 remains a major hurdle in the life sciences. In particular, the personalized medicine and diagnostics industries have been hard hit with hurdles in district and federal courts, as well as in the USPTO. There have been several recent developments, including new guidelines and cases, that impact the life sciences field. For example, the USPTO issued new patent application examination guidelines with respect to subject-matter eligibility under 35 U.S.C. Section 101, which went into effect Jan. 7, 2019, and in April, the Federal Circuit in Cleveland Clinic v. True Health Diagnostics, No. 18-1218 (Fed. Cir. Apr. 1, 2019), declined to follow such guidance when assessing Mayo-type detecting claims ("While we greatly respect the PTO's expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance.")

To say that the courts have struggled applying Section 101, particularly in the life sciences, is an understatement. While the courts have consistently found certain diagnostic claims ineligible under the Mayo and Alice framework, other diagnostic-like claims that don't reach as far as explicitly reciting diagnostic or correlating language have received mixed reviews. While method of treatment claims have fared better at the Federal Circuit, the Supreme Court is teed up to decide Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc., after requesting the Solicitor General to file a brief in this case in March 2019.

Listen as our authoritative panel of patent attorneys examines the current landscape of patent subject matter eligibility under 35 U.S.C. Section 101 and new developments for the life sciences, including revised guidelines recently announced by the USPTO, recent cases decided by the Federal Circuit, and developments at the Supreme Court in the cases of HP Inc. v. Berkheimer and Vanda v. West-Ward. The panelists will discuss the implications of these developments on prosecution and litigation, as well as prospects for reform through legislation, jurisprudence or administrative efforts.

1. Recent life sciences decisions
2. Practical applications: prosecution guidance
3. Practical applications: litigation and diligence guidance
4. Legislative updates

The panel will review these and other relevant issues:

• How are the courts applying the framework for patent eligibility created in Alice in life sciences cases?
• How can patent counsel meet the requirements under Section 101 in patent applications for life sciences inventions?
• What steps should patent counsel take to minimize the likelihood of 101 rejections with life sciences patent applications?