35 U.S.C. §101 and Medical Diagnostics

U.S. Patent and Trademark Office Biotechnology, Chemical and Pharmaceutical Partnership Meeting

During yesterday’s USPTO Biotechnology, Chemical and Pharmaceutical Partnership Meeting, the USPTO addressed two priorities of the USPTO Strategic Plan 2018-2022:

                                (1) optimize patent quality and timeliness; and

                                (2) issue highly reliable patents. 

Under Secretary Andrei Iancu’s specific priorities are to address subject matter eligibility under 35 U.S.C. §101 and improve the search capabilities of the agency, finding the most relevant prior art early in prosecution.  This includes testing new semi-automated tools for data mining in specific technology areas.

While new guidelines for rejections under 35 U.S.C. §101 were released January 4, 2019, these changes do not address the problems with rejections in the life sciences.   There is also still a question as to whether the Federal Circuit will agree with these new guidelines.

Current strategies for overcoming 35 U.S.C. §101 frequently do not work well for research institutions and cutting edge life science technologies.  For example, many diseases do not yet have treatments and therefore claims that include both a diagnostic step and  a treatment step, which would be patent eligible, as illustrated by Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018) (and as covered by our earlier post here), are not possible. 

As summarized by Kathleen Chaffee, PhD, Washington University in St. Louis, Office of Technology Management, known strategies to overcome 35 U.S.C. §101 rejections in life sciences typically don’t work because:

o   Academics use conventional methods in the discovery of a new invention to ensure their experiments are reproducible or can be validated

o   Academics typically rely on industry to move research/commercialize

o   Commercial engagement typically occurs after patent filing

o   Unnecessarily adding unconventional steps to satisfy an eligibility requirement render claims commercially less valuable

o   Additional steps reciting elements (e.g., comparing, diagnosing), often necessary to satisfy 35 U.S.C. §102 and §103, can trigger a 35 U.S.C. §101 rejection

Dr. Chaffee went on to enumerate a number of potentially impactful diagnostics that Washington University in St. Louis has abandoned due to problems with 35 U.S.C. §101.  For example:

o   Bacterial Vaginosis Diagnostics –discovered a new enzyme to predict adverse  pregnancy outcomes, preterm birth, infertility

o   Alzheimer’s Disease Diagnostics

 o   Diagnostics for autism, diabetes, lysosomal storage diseases, autoimmune conditions,  allergy, infection, arthritis, inflammatory disease, kidney disease, skin disease, heart disease, cancer, neurodegenerative diseases, etc.

Diagnostics also remain risky ventures for potential commercial partners of educational/research institutions.  The uncertainty regarding their patentability/validity inhibits commercial development and practical exploitation of potentially important discoveries.  Diagnostic claims are being dissected and overgeneralized into foundational laws of nature or natural phenomenon and restated at a high level of generalization so as to be regarded as conventionally known techniques.

In 2015, the White House launched a precision medicine initiative.  Rising health care costs are under constant scrutiny.   Diagnosing by exclusion can be an expensive and time consuming undertaking and frequently leads to delayed intervention and poorer clinical outcomes.  However, diagnostics inform treatment and drive personalized medicine.  They improve clinical outcomes and decision making, decreasing costs and benefiting patients.  As Dr. Chaffee observed, diagnostics frequently represent cutting edge applications in science and biotechnology.  They are ‘useful Arts’ that the patent system is supposed to be promoting and securing for public use and benefit. However, the issue with 35 U.S.C. §101 is something that will probably have to be addressed through legislative change.

On April 17, 2019, U.S. Senators Chris Coons and Thom Tillis and Representatives Doug Collins, Hank Johnson, and Steve Stivers released a framework for 35 U.S.C. §101 reform.  They suggested a “practical application” test to ensure that statutorily ineligible subject matter is construed narrowly.  But it remains unclear what “integrated into a practical application” would mean for a diagnostic invention.  Do they only apply to method claims or would formulations also be considered practical applications?  Is diagnosing a specific disease a practical application of the discovery of the underlying natural phenomenon?  Current case law would suggest not.

The Supreme Court is considering petitions for certiorari in decisions generally viewed as favorable to patent holders and has asked the Solicitor General to submit a brief in both Berkheimer v. HP Inc., 881F.3d1360 (Fed. Cir. 2018) and the Vanda decision.  In the meantime, many potentially game changing diagnostics and treatment opportunities are being abandoned due to the continued uncertainty.