GENEWATCH
 
THE DANGER OF THE BROAD BRUSH
By Christopher M. Holman
 

In considering the policy implications of Association for Molecular Pathology v. United States Patent and Trademark Office (the Myriad decision),1 it is important to bear in mind that much more is at stake than the specific patents targeted for invalidation by the plaintiffs in the case (the ACLU and Public Patent Foundation, referred to collectively herein as the ACLU). The ACLU has garnered compelling emotional capital by stressing the alleged detrimental impact of the challenged BRCA patents on patients suffering from, or at risk of developing, breast cancer. More particularly, much of the criticism has focused on the alleged overly aggressive patent enforcement practices of the patent owner Myriad Genetics. But instead of mounting a legal challenge to these particular patents, or to Myriad's patent enforcement practices, the ACLU has launched a broadside attack that threatens to render a huge swath of biotechnology inventions ineligible for patent protection, particularly inventions relating to genetic discoveries. If the Federal Circuit affirms the Myriad decision on appeal, it could cause substantial collateral damage to future innovation in genetic diagnostic testing, personalized medicine, and biotechnology in general.

Because of the potential for substantial unintended negative consequences, Robert Cook-Deegan and I have submitted an amici curiae brief with the Federal Circuit that supports neither party, but urges the Federal Circuit to reverse the lower court's decision finding the claims at issue patent ineligible.2 Dr. Cook-Deegan directs the Center for Public Genomics at Duke University, which conducted eight case studies of the impact of so-called "gene patents" on genetic diagnostic testing that were commissioned by the U.S. Secretary's Committee for Genetics, Health and Society and published in April 2010. We have both devoted much of our scholarship to the study of human gene patents and their role in biotechnology and genetic testing. Dr. Cook-Deegan and I do not always see eye to eye when it comes to questions of gene patent policy-he is generally more skeptical of the value of gene patents in the context of genetic testing, and more apprehensive about the potential negative impact of gene patents on future availability of genetic diagnostic testing. Nonetheless, we both agree that the approach taken by the ACLU and the district court could substantially harm innovation in biotechnology by broadly rendering genetic and biopharmaceutical inventions ineligible for patent protection, regardless of their usefulness and nonobviousness, and thought it important to voice our concerns to the Federal Circuit. In this article, I summarize some of the points made in our brief.

The Role of Gene Patents in Incentivizing Investment in Biotechnology

The U.S. Patent and Trademark Office has a long-standing policy of permitting gene patents, and has issued thousands over a period extending back more than 30 years. The biotechnology industry has benefited greatly from this policy, and gene patents have played a critical role in incentivizing the sizable investment necessary to develop and secure marketing approval for life-saving biotechnology products, as noted in two authoritative reports from the Congressional Office of Technology Assessment published in 1984 and 1991.3

Although the current controversy involves genetic diagnostic testing, historically the most important role of gene patents has been their use in providing protection for biologic drugs. For various reasons, it can be difficult to effectively patent a recombinant protein itself, and biologic innovators have relied heavily on patents directed towards the genetic sequences used in the production of human protein therapeutics. In effect, biotechnology gene patents play a role analogous to that of drug patents in the traditional pharmaceutical industry. Indeed, a 2009 report issued by the Federal Trade Commission concluded that gene patents have provided the "fuel" for the "R&D engine" bringing biologic drugs to patients.4

Gene patents have been more controversial in Europe, but there too the debate has been resolved in favor of gene patents. Indeed, Myriad's European patents directed towards the BRCA genes were found valid after being challenged in opposition proceedings in the European patent office. Ironically, many of these issued European patent claims would appear to be patent ineligible under the district court's decision. If affirmed on appeal, the Myriad decision would cause U.S. patent law to diverge from European law with respect to this important class of patents.

Insufficient Evidence of Harm That Would Justify Broad, Subject Matter-based Invalidation of Gene Patents

Initially, much of the concern over gene patents was based on a fear that they would create a "patent thicket" that would impede biomedical research. However, after more than a decade it is becoming increasingly apparent that the feared patent thicket for the most part failed to materialize, at least in noncommercial, academic research.

DNA hybridization array technologies, as exemplified by the Affymetrix gene chip and Illumina bead arrays, were thought to be particularly threatened by the human gene patent thicket. After all, these products can involve the use of DNA molecules representing many thousands of genes in a single array, and it was assumed that with so many issued gene patents it would be prohibitively burdensome to obtain licenses or patent clearance to make or use the arrays. In fact, however, it appears that hybridization array technology has never been the subject of a patent infringement lawsuit involving a gene patent (although they have generated copious patent litigation involving non-gene patents).

Today, most of the angst over gene patent centers around the potential negative effect on genetic diagnostic testing. The recently released Revised Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (the SACGHS Report),5 for example, identifies a potential for a substantial negative impact of gene patents on genetic diagnostic testing, but concludes that there is currently no conclusive evidence establishing that gene patents have had a net negative effect on the availability of genetic testing services.

Critics of gene patents, and Myriad's BRCA patents in particular, have alleged that gene patents unduly raise the cost of genetic diagnostic testing. However, SACGHS looked for evidence that patent-based exclusivity resulted in higher costs for genetic testing services and was unable to document any consistent effect. In fact, the SACGHS Report states that one "surprising finding from the case studies" was that the price of Myriad's BRCA test is "actually quite comparable to the price of other full-sequence tests done ... at both nonprofit and for-profit testing laboratories."

More Targeted Approaches for Dealing with Problematic Gene Patents and Patent Enforcement Practices

The ACLU could have chosen a more targeted approach to address the perceived problems with the Myriad patent claims. For example, they argue that at the time Myriad identified and characterized the BRCA genes their existence was well-known, and it was inevitable that one of the multiple laboratories actively engaged in efforts to isolate and sequence the genes would have succeeded. In effect, they are arguing that the claimed inventions are obvious. But if that is the case, then the appropriate avenue for challenging the claims is the doctrine of nonobviousness, as set forth in Section 103 of the Patent Statute.6

The ACLU further alleges that the challenged patent claims are overly broad, completely blocking the ability of others to perform any sort of genetic testing, or to perform research, and even preventing doctors from communicating with their patients. In fact, this is probably a gross overstatement of the actual scope of coverage that would be afforded these claims if Myriad ever sought to enforce them in court. If a court were to interpret the claims as broadly as the ACLU suggests, there is good reason to believe at least some of the claims could be invalidated for lack of novelty or obviousness. More generally, the enablement and written description requirements as set forth in Section 112 are the appropriate doctrinal tools for challenging overly broad patent claims.7

Unfortunately, instead of using these more targeted approaches to challenge Myriad's patent claims, the ACLU has chosen to argue for a novel interpretation of the doctrine of patent eligibility which if embraced by the courts would not only invalidate the challenged claims, but would likely substantially restrict or even eliminate effective patent protection for gene-based inventions in general. Dr. Cook-Deegan and I argue in our brief that public policy would be better served by employing more conventional doctrines of patentability to challenge gene patent claims that appear overly broad, or which are directed towards allegedly obvious subject matter, thereby preserving the ability of true innovators to obtain patent claims of reasonable scope directed towards useful and nonobvious gene-based inventions.

Much of the concern relating to gene patents has more to do with the enforcement and business practices of gene patent owners than with the patents themselves. For example, there has been little criticism of gene patent owners who enforce their patents to protect an innovative biologic drug produced through recombinant expression of the patented gene. Given the high cost and risk associated with bringing a biologic to market, most would consider enforcement of gene patents in this context legitimate. In contrast, Myriad's use of gene patents to maintain market exclusivity over BRCA testing in the U.S. has been highly controversial. However, if society determines that the business and enforcement practices of certain gene patent owners is problematic in some contexts, it would be more appropriate to consider alternatives that more directly address these concerns, rather than the ACLU approach which would broadly preclude effective patent protection for DNA-based inventions in general.

For example, since the real concern with gene patents is the potential for restrictions on research and genetic testing, a more targeted approach could involve the creation of some sort of exclusion from infringement liability for those using patented genetic technology in research or genetic testing. This is the approach recommended in the SACGHS report, and could be accomplished by simply expanding the scope of a provision that already exists in the patent statute which shields healthcare providers from liability for acts of patent infringement occurring during the performance of "medical activities." Alternatively, if deemed necessary, other approaches such as compulsory licensing, invocation of march-in rights, and assertion of state sovereign immunity could be considered.8

Potential Unintended Negative Consequences for Biotechnology

Looking forward, companies focused on the development of pharmacogenetics and personalized medicine-technologies widely viewed as critical to the future of pharmaceutical development of healthcare-point to gene patents as critical for securing the funding necessary to bring these products to market. If the Federal Circuit affirms the Myriad decision, it could dramatically reduce the private incentive for investment in innovation in these and related fields. It could also undermine incentives for the development of new biologics, an increasingly important class of life-saving drugs.

Some would argue that gene patents are not required to promote innovation in genetic diagnostic testing, and this might be true with respect to patents on genes for Mendelian medical conditions, such as the BRCA genes. It does not follow, however, that publicly funded research will suffice to discover and develop the next generation of genetic testing technologies, particularly those involving more complex patterns of genetic variation involving a large number of genes dispersed throughout the genome, or identification of complex gene expression patterns. It also appears likely that at some point the FDA would take a more active role in regulating genetic diagnostic testing, and require a submission of data to demonstrate safety and efficacy, which could substantially increase the cost of commercializing new genetic diagnostic tests. These developments could render the availability of effective patent protection critical for incentivizing the necessary private investment to bring these technologies to fruition.                                                 

 

Christopher M. Holman, PhD, JD, is Associate Professor of Law at the University of Missouri-Kansas City School of Law.

 

 

1. Association for Molecular Pathology v. US Patent and Trademark Office, 702 F.Supp.2d 181 (SDNY 2010).

2. Brief of Amici Curiae Christopher M. Holman and Robert Cook-Deegan in Support of Neither Party, Association for Molecular Pathology v. US Patent and Trademark Office, United States Court of Appeals for the Federal Circuit Docket Number 2010-1406, available at https://docs.google.com/fileview?id=0B9_llJGo9WK0OWVkYjg3NjItYzRjYi00ODIyLWIyMjAtYmJkZDQxMGZmYTZi&hl=en&pli=1 (last visited December 2, 2010).

3. Commercial Biotechnology: An International Analysis (Washington, D. C.: U.S. Congress, Office of Technology Assessment, OTA-BA-218, January 1984); U.S. Congress, Office of Technology Assessment, Biotechnology in a Global Economy, OTA-BA-494 (Washington, DC: U.S. Government Printing Office, October 1991).

4. Emerging Healthcare Issues: Follow-On Biologic Drug Competition, Federal Trade Commission Report (June 2009).

5. Revised Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests (the SACGHS Report), available at http://oba.od.nih.gov/oba/SACGHS/SACGHS%20Patents%20Report%20Approved%202-5-20010.pdf (last visited December 2, 2010).

6. 35 USC 103.

7. 35 USC 112.

8. Joshua D. Sarnoff & Christopher M. Holman, "Recent Developments Affecting the Enforcement, Procurement, and Licensing of Research Tool Patents," 23 Berkeley Tech. L.J. 1299 (2008). 

 
 
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