Thursday, August 27, 2009

A Review of Some of the Amici Briefs Filed in Bilski

In earlier posts (here and here, for example), I have argued that recent developments will in the doctrine of patent eligibility, particularly LabCorp, Prometheus and Bilski, threaten to seriously undermine the ability of patents to adequately protect innovations in personalized medicine and diagnostics. The Supreme Court has agreed to hear Bilski, a case that arose out of the patent office's rejection of patent claims attempting to broadly encompass methods of hedging risk, but which resulted in a Federal Circuit decisions that has serious potential for unintentionally adversely impacting biotechnology. In view of the importance of the case for the biotechnology industry, particularly companies working in the area of personalized medicine, it is no surprise that a number of amicus briefs have been filed arguing that the machine- transformation test set forth by the Federal Circuit in Bilski is ill-suited and potentially quite harmful to the life sciences and the development of personalized medicine. I have posted a few of the briefs below, along with a brief filed by a number of law and business professors that does not focus on biotechnology but to which I added my signature.

The following is a brief synthesis of some of the main points made in these briefs:

The machine-or-transformation test, as articulated by the Federal Circuit in Bilski, threatens to preclude the availability of adequate patent protection for many important innovations in biotechnology, particularly those relating to personalized medicine.

Innovation in personalized medicine has already provided substantial benefit to patients, and promises to play an increasingly important role in improving health care, which will have clinical benefits for patients, as well as reducing the cost of health care and expediting marketing approval for innovative life-saving technologies. For example, Genomic Health, Inc. has developed a test for identifying breast cancer patients likely to experience a recurrence of the disease, and whether that patient will benefit from adding chemotherapy to hormonal therapy. Monogram Biosciences has developed a test for identifying breast cancer patients likely to respond to trastuzumab (Herceptin). These processes are at the front- end of the healing process, but nevertheless will play an integral role in the development of the next generation of therapeutics, and require incentives for innovation just like back-end technologies such as drugs and methods of treatment.

The diagnostic and personalized medicine innovations implicated by Bilski are technically difficult and expensive, requiring significant investment of time and capital. For example, Monogram Biosciences and Genomic Health, Inc. explain that thousands of hours of research by highly trained scientists were required to develop their respective products. Effective patent protection is necessary to incentivize it is important new area of innovation.

The patent eligibility doctrine should be interpreted in a dynamic fashion so as to effectively encompass newly emerging fields of technology, consistent with the famous statement by the US Supreme Court that "anything under the sun that is made by man” is eligible for patent protection, so long as it meets the other requirements of patentability such as novelty and nonobviousness.

The doctrine of patent eligibility generally should not play a dominant role in policing the availability of patent protection, or patent scope. Instead, doctrines such as requirements of novelty, nonobviousness and enablement are sufficient and more appropriate safeguards against the issuance of unworthy patents.

Although the machine-or-transformation test might be useful in some contexts in determining the patent eligibility of a claim, particularly in non-biotechnology contexts, it should not be treated as the sole test for all processes, and it can be particularly inappropriate for inventions relating to biotechnology and personalized medicine.

[W]hatever merit there may be to using the machine-or-transformation test as one means to choose one process claim's patent-eligibility, this Court should make clear that it is not requiring satisfaction of that test as the only test for a diagnostic-process claim to be patent eligible; that narrow question should at the very least be reserved for a case that squarely involves such patent claims and raises such issues.(Novartis brief)

The proper test, consistent with Supreme Court precedent, should focus on whether the claim encompasses an abstract idea (patent ineligible) or an applied use of an idea (patent eligible). The application of an idea or discovery in a useful process should generally be patent eligible, and the scope of patent coverage should not be limited to processes employing a specific machine or physical transformation step.

The machine-or-transformation test, as articulated in Bilski, threatens not only to preclude patenting of future innovations in the areas of diagnostics and personalized medicine, but calls into question the validity of many important issued patents. Examples of specific patents implicated by Bilski are provided in the Caris Diagnostics brief. The Caris Diagnostics brief provides a specific example of a pending diagnostic method application recently rejected by the patent office under Bilski. These patents are clearly directed towards innovations providing substantial real-world benefits to patients, but which arguably lack sufficient involvement of a specific machine or transformation to satisfy the Bilski test.

BIO argues that the court should set aside the so-called "preemption" and "extra-solution activity" test for patent eligibility. Some case law would suggest that a claim that wholly preempts a fundamental principle is patent ineligible. BIO argues that while it is impermissible to claim a fundamental principle per se, an inventor should be able to broadly claim applications of the principle, and the scope of this exclusionary right should be constrained by the prior art and the disclosure requirements of section 112, not the patent eligibility doctrine. The "extra-solution activity" test improperly invites the court to dissect the claim and ignore certain claim language, instead of focusing on the claim as a whole.

In order to satisfy the machine-or- transformation test, inventors might be forced to specifically recite a specific machine or transformation in their claims, which would render the claims unduly susceptible to circumvention by design around. For example, BIO points out that for algorithm improvements it may be impossible to find a linking “machine” that isn't conventional or easy to design around. If the claim recites a general purpose computer, for example, it might fail to satisfy the Bilski requirement of a "particular machine," but recitation of a specific machine runs a high risk of design around by a competitor using a different machine to achieve the same result. Likewise, it might be impossible to effectively explain a diagnostic or personalized medicine invention without explicitly reciting a treatment or diagnosis step. The fact that diagnosis or treatment is typically performed by a health care provider, rather than the competitor in the market the patent owner would like to block, raises a number of significant practical issues that could preclude the patent owner from effectively enforcing the patent.

The Bilski test would disproportionately impact universities and nonprofits

Technology transfer by university's and non-profit research institutions depends almost entirely on the underlying patent position for further investment and commercial a station that provides to partners and licensees. Given that most university generated inventions are embryonic in nature and require significant effort and investment to develop a product, any uncertainty that accompanies the patent and its scope and validity increase the likelihood that the technology will not be developed and decreases the chances that the public will benefit from the taxpayers investment in the research that led to the patented technology. (BIO brief)

Links to Briefs

Law and Business Professor Supporting Neither Party

Biotechnology Industry Organization (BIO), Advanced Medical Technology Association, Wisconsin Alumni Research Foundation (WARF) and the Regents of the University of California


Monogram Biosciences and Genomic Health, Inc.

Caris Diagnostics

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