by Scott Rylan Powell and Gerry J. Elman†
In New York City on October 20, 2009, the American Civil Liberties Union (“ACLU”) hosted a screening of In The Family, a documentary on the emotional turmoil experienced by people across the nation who carry certain mutations along the Breast Cancer 1 and 2 (“BRCA”) genes. Everyone has these genes, and as the name implies, the mutated forms are linked to an increased risk of breast cancer. And certain specific mutations of these genes indicate a high probability of developing ovarian and/or prostate cancer. These types of cancer, after developing in one organ, are prone to spreading throughout the body and killing the host.
The main focus of In The Family is that, once a woman learns that she carries any of the mutations, the only preventative step she can take is to have her breasts and ovaries surgically removed. Understandably, the women interviewed in the documentary struggled with the prospect of voluntarily excising these organs before cancer had even struck. Ones who chose the surgery had joined emotional support groups. Many of those who had chosen to forego surgery died after the cancer developed and spread throughout their bodies. All in all, the movie paints a gloomy picture, leaving the viewer desperately looking for a solution to end the trauma.
After the movie, the ACLU presented their solution: sue the U.S. Patent and Trademark Office, along with anyone associated with patents relating to the BRCA 1 and 2 genes. Representatives from the ACLU proudly announced that ACLU and Public Patent Foundation (“PubPat”)( lawyers, on behalf of a variety of plaintiffs including makers of home-brew genetic testing kits that infringe intellectual property rights, had already filed such a lawsuit.
If the connection between the problem and the proposed solution seems attenuated, that’s because it is. However, with gross oversimplification and some sleight-of-hand, the ACLU converted their emotionally-charged, if slightly-confounded, audience of laypeople into supporters of the ACLU/Pubpat’s lawsuit.
On May 12, 2009, lawyers for the ACLU and the Public Patent Foundation (“PubPat”), an organization affiliated with the Benjamin N. Cardozo School of Law, filed a federal lawsuit in the Southern District of New York against the U.S. Patent and Trademark Office, Myriad Genetics Inc., and directors of the University of Utah Research Foundation. Myriad Genetics (“Myriad”), portrayed as the archetypal evil corporation in the propaganda issued by the ACLU and PubPat, is a practitioner of a patent-protected test used to determine whether a person carries certain mutations of the breast cancer susceptibility genes. A number of patents are at issue in the case: US 5,693,473; US 5,709,999; US 5,710,001; US 5,747,282; US 5,753,441; US 5,837,492; and US 6,033,857. All of the patents are owned or co-owned by the University of Utah Research Foundation. Myriad is a co-owner of US 5,747,282 and is a licensee of the other patents.
Patents for Genes?
First some background: To provide a means for inventors to recover their research and development costs and to incentivize further innovation, Article I of United States Constitution grants patent holders a time-limited exclusive right to practice their invention. When the founding fathers drafted the Constitution, inventions were primarily mechanisms. Accordingly, whether a given area of technology qualifies as patent-eligible subject matter is a question that repeatedly appears as science and engineering branch out into new fields.
Fast-forward to 1972, when, having developed an oil-eating bacterium that would be particularly useful for cleaning up oil spills at sea, a scientist at General Electric Company, Ananda Chakrabarty, applied for a patent with claims to the microorganism itself. When the application was examined for patentability, Chakrabarty immediately encountered resistance at the U.S. Patent and Trademark Office (“PTO”). The government rejected the notion that a man-made microorganism could be patent-eligible subject matter. That began a struggle starting at the PTO, winding its way through appellate-level venues, and reaching its conclusion at the U.S. Supreme Court in 1980, when Chakrabarty’s bacterium was finally deemed to be patent-eligible. As a result, the doctrines of U.S. patent law were adjusted to recognize the patent-eligibility of biological entities generated through human ingenuity.
Such a change in perspective was timely, given that during the interim, molecular biologists had been hard at work developing improved techniques to splice together DNA fragments and arrive at previously-non-existent sequences. In short, U.S. patent law was seen as recalibrated to accommodate and support the burgeoning field of biotechnology.
Man-Made Molecules or Products of Nature?
The case strikes at the validity of any patent claims to polynucleotide molecules embodying naturally occurring genetic sequences, though “isolated” through a man-made process. The ACLU/PubPat arguments obscure the latter aspect by repeatedly stating in their complaint and through widely distributed propaganda that the patent claims are drawn to subject matter that is purely a product of nature. Whether it is through a misunderstanding of the science and U.S. patent law, or through intentional misrepresentation, the ACLU/PubPat’s efforts threaten to pull the rug out from under an entire biotech industry that has invested heavily in intellectual property and which is relying on the U.S. patent system in order to recover costs attendant to innovation. Whatever the underlying reasons for the ACLU/PubPat’s joint efforts in this regard, would-be infringers of the patents are all too happy to join the bandwagon. Indeed, one maker of a home-brew test for the BRCA mutations spoke at the New York City film screening to express her outrage at receiving a cease-and-desist letter for infringing the patents.
The Right to Exclude after eBay v. MercExchange
Moreover, the thrust of the ACLU/PubPat’s case is misguided. In 2006, the Supreme Court issued a decision in eBay Inc. v. MercExchange, L.L.C., which reinterpreted one of the fundamental principles of U.S. patent law.  Prior to the decision, a patent was understood to give its owner an automatic ability to enjoin others from practicing the patented invention, absent exceptional circumstances. Indeed, the Patent Act states that “patents shall have the attributes of personal property,” including “the right to exclude others from making, using, offering for sale, or selling the invention.” The availability of an injunction against patent infringement differed from most other areas of federal law, where a four-factor test is utilized to carefully weigh the pros and cons of granting this extraordinary type of relief instead of money damages. The test requires the plaintiff to show (1) that it has suffered an irreparable injury; (2) that remedies available at law are inadequate to compensate for that injury; (3) that considering the balance of hardships between the plaintiff and defendant, a remedy in equity (such an injunction) is warranted; and (4) that the public interest would not be disserved by a permanent injunction.
In the case of eBay v. MercExchange, this reinterpretation of patent law allowed eBay and its customers to continue using the “buy it now” feature of eBay’s online auction system, even though MercExchange owned a patent covering that functionality.
As a result of the Supreme Court’s holding that the same four-factor test also applies for injunctions against infringement of U.S. patents, the public interest is now a relevant consideration in whether a court would enjoin a patent infringer to altogether stop practicing the invention or instead hold that the infringer should just compensate the patent holder with money, rather as if it were a licensee of the patent.
The ACLU/PubPat lawyers justify their case by arguing that since a patent gives the patent holder the right to exclude all others from practicing the invention, members of the public are prevented from getting the test for BRCA mutations from anyone but Myriad. The lawyers argue that, in order for members of the public to have the option of getting a second opinion on whether their BRCA genes contain the mutations indicative of breast, ovarian, or prostate cancer, the patents must be deemed invalid.
Yet, since the day eBay v. MercExchange was decided, the public interest is a factor to be carefully weighed before a court grants a patent holder an injunction to prevent others from practicing an invention recited in a patent claim. If the goal is to ensure the availability of health care that includes widely available genetic tests, there is no need to challenge the patentability of molecules embodying isolated genetic sequences. Instead, the same ends of enabling other entities to perform the BRCA gene tests could be achieved simply through licensing the patents to others. And if as seems to be the case, the owners of the pertinent patents are unwilling to license them to others, the courts are now open to considering the public policy arguments that weigh in favor allowing others to pay monetary damages, equivalent in effect to licensing royalties, instead of enjoining others from performing the tests.
The Research Exception to Patent Infringement
Another assertion that the ACLU/PubPat lawyers make is that research that could lead to developments of cures for cancer resulting from mutations along the BRCA genes is stifled because the act of researching the genes would constitute infringement of the BRCA patent claims. However, U.S. patent law provides an exception to patent infringement for research and development efforts that could lead to such a cure. Title 35, section 271(e)(1) of the United States Code states, in pertinent part:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
The Supreme Court visited this topic in the case of Merck KGaA v. Integra Lifesciences I, Ltd. and helped further define the metes and bounds of this statutory exception to patent infringement. In that case, the Supreme Court said that (1) experimentation on drugs that are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the FDA can still fall within the protection of 35 U.S.C. §271(e)(1). In other words, if an entity, such as a research physician or hospital, is developing a drug that will cure or treat cancer caused by mutations along the BRCA genes, then it is reasonable to expect that entity will be submitting information about the drug to the FDA in the future. Correspondingly, the entity would be protected under 35 U.S.C. §271(e)(1) and free to use the isolated genetic sequences recited in the claims of the BRCA patents for research and experimentation. According to Merck v. Integra Lifesciences, even if the experiments are not ultimately submitted to the FDA, perhaps because further testing revealed that the drug is ineffective, there is still no infringement.
Accordingly, the ACLU/PubPat’s tearful assertion that research into treatments and cures for breast and ovarian cancer is inhibited by the BRCA patents has little merit. Their tears are crocodile tears, unnecessarily shed but to gather support from lay people for their assault on the protections fostered by U.S. patent system.
The Claims in Question
Perhaps the most glaring disconnect between the ACLU’s statements and reality is the nature of certain patent claims that the ACLU seek to invalidate. The ACLU argue that the patent claims in dispute fall outside the scope of statutory subject matter, defined in a 35 U.S.C. §101 as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” The ACLU assert that the claims recite products of nature, a class that has been judicially recognized as falling outside the scope of statutory subject matter. A quick look at the challenged patent claims reveals that they are directed to isolated DNA sequences of BRCA. Isolation is a process that must be carried out by a person or machine. In other words, for an isolated sequence of BRCA to exist, there must be human intervention. As the Supreme Court said in Chakrabarty, “non-naturally occurring manufacture or composition of matter – a product of human ingenuity” is patent-eligible subject matter. The claims in question, reproduced below, all recite “isolated” as a limitation, thereby excluding naturally occurring compositions of matter from their scope:
U.S. Patent 5,693,473
Claim 1: An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.
(b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385;
U.S. Patent 5,747,282
Claim 1: An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
Claim 2: The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
(c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.
Claim 5: An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
Claim 6: An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
Claim 7: An isolated DNA selected from the group consisting of:
(a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056;
U.S. Patent 5,837,492
Claim 1: An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.
Claim 6: An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer.
Claim 7: The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1.
The Bayh-Dole Act
As mentioned previously, the BRCA patents in dispute are owned in whole or in part by the University of Utah Research Foundation, with Myriad as a partial owner of one of them and a licensee of the remaining patents. In other words, even though the ACLU/PubPat lawyers portray Myriad Genetics as an evil corporation hoarding patents on naturally-occurring material, the reality is that the patents are by-and-large owned by the University of Utah, which is collecting fees from Myriad Genetics to practice the patents. The court complaint also briefly references the fact that the Trustees of the University of Pennsylvania have an ownership interest in two of the patents. To the lay person, it may seem odd that educational institutions, which on their face seem to support the free flow and sharing of knowledge, are actually building fences and toll-booths around the products of their research.
A patent portfolio can be a significant source of income for a university, biasing it towards a proprietary view of its research efforts instead of an open, socialistic approach. For example, the University of Utah Technology Commercialization Office reports that it received over $25 million in licensing income for 2008. The MIT Technology Licensing Office states that it granted 67 patent licenses and brought in $66.3 million in royalties in 2009. In universities, the old model of 1) research, then 2) publish has been replaced by 1) research, 2) apply for patent, and then 3) publish. The argument for the new process is that the revenue generated from licensing the resulting patents is necessary to fund further research. This appears to be a valid argument and would probably be agreeable to most lay people. What most lay people might not find agreeable is that their tax dollars are actually being appropriated to these institutions to help fund their research, the fruits of which the institutions are obtaining exclusive rights to.
The Bayh-Dole Act, passed by Congress in 1980, the same year as the aforementioned Chakrabarty decision, allows the recipient of government funding for research and development to hold sole title to the patents for any resulting inventions. In fact, the Bayh-Dole Act requires that an entity receiving government funds and obtaining title to any resulting inventions seek patent protection for and commercialize the inventions. Naturally, a university that intends to keep pace with its competition is going to take advantage of the government funds for research, and correspondingly, comply with the provisions of the Bayh-Dole Act. The result is that universities build up patent portfolios based on subject matter they might have simply published, if they were operating under the pre-Bayh-Dole model of 1) research, then 2) publish.
There are those who assert that the principles of the Bayh-Dole Act should be blunted when gene patents are involved. On February 5, 2010, a federal advisory committee to the Secretary of Health and Human Services approved a draft report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.
To head off the position expected of the SACGHS report, a press conference was convened by the Biotechnology Industry Organization (“BIO”) on February 4th. There former U.S. Senator Birch Bayh said that the legislation he had co-sponsored with former Senator Bob Dole came at a time when the federal government owned all the inventions that came from federally-funded research and U.S. innovation was stagnating and investment in R&D was not growing. He added that the Senate Judiciary Committee reported “that it could not find a single instance where the old policies had resulted in even one drug being developed when the government controlled the patent. We found numerous potentially helpful medical discoveries simply languishing on laboratory shelves, benefiting no one.”
“The American taxpayers had invested $30 billion in research and had received no return on investment,” Bayh added, pointing out that there needs to be incentives to get people and companies to invest in such ideas. “This incentive would not exist unless the investor has a right to the patent in which he’s investing.”
“Collaboration fostered by the Bayh-Dole Act and fueled by massive amounts of private investment means that research is translated into tangible medicines, diagnostic tests, and other healthcare-related products that save lives, improve diagnoses, and alleviate suffering for millions of people worldwide,” added BIO President and former Congressman Jim Greenwood. Although the SACGHS report indicates that gene patents and licensing practices have not had an adverse impact on patient access to genetic tests, the committee is nevertheless making recommendations that “would undermine the U.S. patent system and the Bayh-Dole technology transfer system that have served our nation so well,” he said.
SACGHS task force member Brian Stanton, Ph.D., a former biotechnology expert at the PTO and former director of the Division of Policy at the National Institutes of Health’s Office of Technology Transfer, said the report shows “no evidence of harm, and yet it still calls for changes.” One proposal under consideration has been exempt infringers of gene patents from liability. Acknowledging that the Task Force on Gene Patents and Licensing had identified isolated instances of harm that need to be addressed, it also determined that “the court systems and the systems of checks and balances that are built into the fabric of the patent system were more than capable of addressing problems on a case-by-case basis.” He pointed out that the SACGHS report includes a letter of dissent from the only three members of the full committee who have direct experience in business and law with respect to intellectual property and private sector development of products and services.
The ACLU/PubPat lawsuit exemplifies an oversimplified and ultimately incorrect view of the underlying facts and law. Their grandstanding threatens to sway public opinion in a direction that would reverse the advances fostered since 1980 by the U.S. patent system. It is of utmost importance that the defendants and the patent bar in general correct the ACLU/PubPat’s misrepresentations and reverse the damage that the ACLU has caused and prevent any further damage. Evidence of such damage due to misguided public opinion is in the SACGHS recommendations approved on February 5th. It is to be hoped that HHS Secretary Kathleen Sebelius will take them with a grain of salt.
† Attorneys with Elman Technology Law, P.C. Opinions expressed herein should not be attributed to anyone else. However, the authors wish to thank Geoffrey Karny for his thoughtful discussions on the subject of this article. This article is published at Biotechnology Law Report. February 2010, 29(1): 23-27.
 Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., 1:2009cv04515, S.D.N.Y., May 12, 2009. The plaintiffs are: Association For Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, College of American Pathologists, Breast Cancer Action, Boston Women’s Health Book Collective and certain gene researchers and individuals potentially affected by breast cancer. The named defendants are: United States Patent and Trademark Office (“USPTO”), Myriad Genetics, and the directors of the University of Utah Research Foundation.