Thursday, August 27, 2009

ACLU Moves for Summary Judgment in Case Challenging Patentability of Gene-Based Inventions

The ACLU has filed a motion for summary judgment asking a district court to invalidate many of Myriad Genetics’ patent claims directed towards the BRCA1 and BRCA2 breast cancer genes. The challenged claims are directed to isolated DNA molecules having the sequence of naturally occurring wild type and mutant forms of the genes, and towards methods of identifying mutations in the genes and/or correlating the existence of mutations with a predisposition for cancer. This lawsuit was discussed in an earlier post. Documents that have been filed in connection with the case can be found here, and in particular the motion for summary judgment can be found here.

In its brief, the ACLU argues that isolated naturally occurring DNA molecules, and cDNA molecules corresponding in structure to naturally occurring genes and messenger RNA, are unpatentable natural phenomena. This goes against the patent office’ longtime policy of allowing patents claiming isolated forms of genes and other naturally occurring molecules, based on the rationale that isolation from the cellular milieu constitutes sufficient human intervention to render the molecules patentable. The ACLU cites a number of cases predating Diamond v. Chakrabary which arguably support the proposition that the mere isolation of a natural occurring product is insufficient to render it patentable, and argues that Myriad’s gene patents preempt a natural phenomenon by effectively covering any use of the claimed naturally occurring genes.

ACLU make similar arguments with respect to method claims, arguing that owing to the breadth of the claims they effectively monopolize laws of nature and abstract ideas.

ACLU also makes constitutional arguments. For example, it alleges that genes embody information, and thus broad restrictions on the use of genes is tantamount to a restriction on thought and speech in violation of the First Amendment. They also point to Article 1, Section 8, Clause 8, the so-called "intellectual property clause," which provides Congress with the authority to grant inventors exclusive rights in their discoveries for the purpose of promoting the progress of science and useful arts, and argue that gene patents in fact impede rather than promote the advancement of science and medicine.

Many of the ACLU’s arguments are based on assertions that Myriad has employed its patents in a manner that harms the public interest, by blocking research, limiting patient options, preventing patients from getting second opinions, etc.

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

Sunday, August 23, 2009

New Book Perpetuates Popular Misperceptions Surrounding Gene Patents

I was recently invited to review a book entitled "Who Owns You? The Corporate Gold Rush to Patent Your Genes" for the Notre Dame Philosophical Review, an online publication. My review is available here.

Based on the title, I had some idea of where the book was going, but was frankly shocked by the gross misstatements of patent law, particularly with respect to so-called "gene patents." For example, at one point he states that one who has "successfully filed a patent over a non-engineered sheep gene [suddenly becomes] the owner of at least a part of every new and existing sheep in the world." Later he argues that gene patents "might be an affront to individual liberty and equality" because patent owners "have rights over parts of ourselves over which we as possessors of those parts have no particular rights." He goes on to conclude that "having babies would actually technically violate a patent if that baby carries a patented gene given it is the result of an unauthorized reproduction." He then asserts that "technically, each of us carrying a gene that has been patented runs the risk of making unauthorized reproductions simply by virtue of reproducing. When we passed that gene onto our progeny we have technically violated the patent."

All of these scenarios would indeed raise serious ethical concerns if they had any basis in reality, but in fact all are mere figments of the author's imagination resulting from his profound misunderstanding of patent law. I would guess that most readers of this blog recognize how badly this book mischaracterizes the nature of gene patents. Unfortunately, with celebrities like Michael Crichton making similar assertions, these alarmist and irrational fears surrounding gene patents have been adopted by some members of Congress, as exemplified by the bill introduced a couple years ago by Congressman Becerra to outlaw gene patents (H.R. 977, 110th Congress (2007)).

The author of the book, David Koepsell, has posted his response to my review, which questioned my motives based on my past employment in the biotechnology industry but failed to identify any substantive errors in my attempt to correct his misstatements of law.

The author's response to my book review seems to have generated more controversy than the review itself, as exemplified by this blog post by a law professor at the University Chicago.

The book was also panned by Patent Doc Kevin Noonan last June (I published my review prior to seeing Kevin's take on the book).

Friday, August 21, 2009

Federal Circuit to Rehear Ariad En Banc

Today the Federal Circuit vacated the panel's decision in the case of Ariad Pharmaceuticals v Eli Lilly, and granted Ariad’s petition for rehearing en banc. The parties are requested to file new briefs addressing (1) whether 35 USC 112, paragraph 1, contains a written description requirements separate from enablement requirement; and (2) if a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

The order is available here.

The Ariad case was discussed in an earlier post, and has important implications for the biotechnology industry. Prior to Regents of the University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the written description requirement was used solely to prevent patent applicants from amending or adding new claims encompassing subject matter not adequately disclosed in the patent application is filed. In UC v. Lilly, a panel of the Federal Circuit led by Judge Lourie established a new form of the written description requirement that applies to originally filed claims, and which functions very much like the enablement requirement. I have argued that this new form of the written description requirement, which I call Lilly written description (LWD), is essentially redundant with the enablement requirement, and should be abolished. Other academics, and some judges on the Federal Circuit, notably Judge Rader, have expressed a similar opinion.

This will be the first opportunity for the en banc court to address the viability and scope of LWD - it will be a case worth watching.

Wednesday, August 19, 2009

Law Professors Debate Bilski

Two law professors, both with substantial practical patent law experience, recently debated Bilski.

Michael Risch, Associate Professor of Law at the West Virginia University School of Law, takes the position that essentially any applied, non-abstract invention should be considered patentable so long as it meets various patentability requirements such as novelty, nonobviousness, utility and enablement. In his view, the doctine of patent eligibility at issue in Bilski should not function as a substantial bar to patentability so long as the invention is applied and satisfies the other requirements of patentability. I generally share this view with Professor Risch.

Joshua Sarnoff, Professor of the Practice of Law at American University’s Washington College of Law, sees the matter quite differently, and argues that the doctrine of patent eligibility should serve as a meaningful limitation to patentability, preventing the patenting of certain non-technological inventions regardless of their utility and nonobviousness.

During their debate, the professors discuss the significance of a number of arguably inconsistent historical cases dealing with the issue of patent eligibility. A podcast of the debate, which was moderated by Adam Mossoff, Associate Professor at George Mason University School of Law, can be found here.

Monday, August 3, 2009

Bilski and Biotechnology: An Update

A host of amicus briefs critical of the Federal Circuit's "machine-transformation" test for patent eligibility, as recently set forth in the court's en banc Bilski decision, will be filed this week with the US Supreme Court. Some of these briefs reflect concerns of biotechnology industry, particulary with respect to patentability of diagnostics and personalized medicine, I will post some of these briefs as they become available to me. Briefs supporting affirmance of Bilski will be filed later this summer.

In the meantime, those interested in some of my thoughts on the subject might want to check out an article I recently posted on SSRN, you should be able to access it at, but if you have problems please let me know and I will get you a copy.

My blog is back

For those who might be wondering, my blog was taken down for a few days due to Google robots identifying it as "having the characteristics of a spam blog." (I assume based on number of links to other sites) I have apparently succeeded in convincing a human at Google to reconsider, thanks to readers who gave me a heads up that my site had been shut down.