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18 August 2016AmericasPat Carson and Mira Atanassova Mulvaney

Biomedical patents: the quest for balance

The trend of frequent challenges to patent eligibility started with the US Supreme Court’s decision in Bilski v Kappos in 2010. Noting that “business method patents were rarely issued until modern times”, that “some business method patents raise special problems in terms of vagueness and suspect validity”, and that “[i]f a high enough bar is not set when considering [business method patents], patent examiners and courts could be flooded with claims that would put a chill on creative endeavour and dynamic change”, the court in Bilski endeavoured to set the “high enough bar” that it deemed necessary to preserve the stated purpose of the Patent Act in the business method context.

Although Bilski was singularly focused on business methods, its application has not been so limited. Patent eligibility challenges have arisen in a wide variety of subject areas, including in the context of biomedical patents, yielding several additional trips to the Supreme Court. Indeed, some commentators have suggested that medical diagnostic and treatment patents have become particularly vulnerable to §101 challenges.

The Supreme Court decided the first post-Bilski biomedical patent eligibility case, Mayo v Prometheus, only a year after Bilski. At issue in Mayo were patents concerning the use of thiopurine drugs in the treatment of autoimmune diseases, claiming that concentrations in a patient’s blood of certain metabolites correlated with either ineffective or potentially harmful drug dosage levels.  The court struck down the claims at issue, articulating a new framework for §101 analysis.

A year later, the court considered the patent eligibility of DNA. In Association for Molecular Pathology v Myriad Genetics, the court found that segments of naturally occurring DNA are not patent-eligible, while synthetically created DNA segments that are structurally distinct from naturally occurring DNA are patent-eligible, even though they contain the same coding information as naturally occurring DNA.

Since Bilski, the US Court of Appeals for the Federal Circuit has ruled on a number of §101 challenges to biomedical patents, and has frequently struck down claims directed to abstract ideas or laws of nature. A noteworthy example of the Federal Circuit’s approach is Ariosa Diagnostics v Sequenom. In Ariosa, the court struck down claims directed to certain methods of using cell-free foetal DNA (cffDNA) in non-invasive prenatal testing.

“The ever-increasing amount of guidance from courts and the USPTO will allow practitioners to navigate eligibility challenges during patent prosecution by, for example, focusing on claims directed to applications.”

Despite agreeing that the claimed method “reflects a significant human contribution in [combining] man-made tools of biotechnology in a new way that revolutioniz ed prenatal care”, the panel was compelled to follow the Mayo test, ultimately finding that the method at issue “amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA” that do not provide an “inventive concept” sufficient to render the claims patent-eligible.

Although Supreme Court review has been sought in some of these cases, including in Ariosa, the court has declined to revisit the issue after Myriad.

Better results

District courts have been kinder to biomedical patents, declining to invalidate claims of biomedical patents under §101 about 60% of the time. But it remains to be seen whether these outcomes are driven by procedural posture or by substantive analysis. In particular, many of the district court challenges declining to invalidate claims under §101 have arisen in the context of motions to dismiss or motions for judgment on the pleadings. Noting that patents are statutorily presumed valid, courts have declined to invalidate claims at the outset of the case without a fully developed record. How those claims are addressed at later stages of the case remains to be seen.

Responding to developing case law, in 2014 the US Patent and Trademark Office (USPTO) issued guidance to assist examiners in making determinations on subject matter eligibility. The 2014 guidance sets forth a two-part test for determining subject matter eligibility and provides case-derived nature-based product examples explaining, for instance, the USPTO’s approach to claims directed to pharmaceutical compositions, methods of treatment, purified proteins, genetically modified bacteria, bacterial mixtures, nucleic acids, antibodies and cells.

A 2016 update provides further examples of subject matter eligibility specific to the life sciences, addressing matters such as vaccines, diagnosing and treating claims, and claims directed to screening for gene alterations.

As the biomedical field continues to progress, §101 challenges to biomedical patents will undoubtedly continue, particularly in light of the Federal Circuit’s recent record and given the fact that the USPTO’s practice pre-Mayo was to grant patents on technologies such as isolated genes that courts have since expressly held not to be patent-eligible.

Going forward—although the Supreme Court has said that patentability should not depend on the skill of the drafter—the ever-increasing amount of guidance from courts and the USPTO will allow practitioners to navigate eligibility challenges during patent prosecution by, for example, focusing on claims directed to applications of the technologies in question and including elements that clearly distinguish them from pre-existing technologies and their uses. This may also become easier as the technology develops and more and new useful applications are found.

One thing seems clear. Although the Mayo and Myriad decisions have brought §101 challenges to the forefront in the biomedical patent context, they do not signal the end of biomedical patents. Rather, as courts grapple with the complex and ever-evolving technology and as practitioners learn to navigate the guidance provided by the courts and the USPTO, a balance is again likely to emerge.

Pat Carson is a partner in the New York office of  Kirkland & Ellis. She can be contacted at:

Mira Atanassova Mulvaney is an associate in the New York office of Kirkland & Ellis. She can be contacted at:

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