By Tiffany Palmer, Junior Editor
Over the last decade, the biotechnology world has struggled to come to an agreement about whether scientists should be patenting genes. It is unclear whether the practice is even constitutional. The most recent discussion of the matter centers on the 2010 New York district court case in which the ACLU filed a claim to have Myriad laboratory’s gene BRCA-1 and BRCA-2 patents invalidated. All humans carry Myriad’s BRCA-1 and BRCA2- genes. They vary in sequence from one person to the next. Roughly 5–10% of women who develop breast cancer are likely predisposed due to a mutation in their BRCA genes. Myriad also holds a patent on a test that allows women to determine whether they possess one of the mutations. This is very beneficial to women looking to catch cancer at its inception. Yet, opponents of Myriad’s test argues that some women who desire testing will be denied it due to her socioeconomic status. Myriad currently charges a little over $3000 per test, and does not accept all insurance carriers. The district court found that the genes were not patentable. On appeal, the circuit court found that the genes were patentable, reversing the district court’s decision. In December 2012, the Supreme Court granted certiorari in the case. The industry is hopeful that the Court will resolve this debate once and for all. Below, there is a discussion of factors and potential solutions the Court should consider.
The Horrid Hysterectomy
Notwithstanding the benefits, there are a number of additional burdens associated with this testing. On the one hand, as a consequence of the alleged monopoly Myriad holds over BRCA genes, women who test positive for the mutation are unable to seek a second interpretation of her results or confirm that Myriad’s finding are accurate. Ascertaining a second opinion is commonplace in healthcare and the unavailability of options is unnerving. Although a woman could always choose to test again with Myriad, an increased peace of mind may be found in having a completely different lab conduct the testing. For example, when doctors provide diagnoses, one often seeks a second opinion from a different doctor. A similar framework is unavailable in this instance as Myriad is the only lab permitted to administer this type of test. The monopoly makes a decision to undergo prophylactic surgery exceedingly more complex, as a woman could be dispensing with her ability to have children in response to a potential false-positive on the test.
A BRCA mutation diagnosis also creates stigma issues, similar in effect to the stigma created by an HIV diagnosis. A number of women will be less desirable to men who wish to have families or who simply do not want the burden of entering into a relationship with a woman likely to develop a disease as life-threatening as cancer. Thus, it is essential that women undergo quality diagnostic testing to ensure that they are not faced with these challenges in vain. Absent other tests on the market to compare to Myriad’s test, is it impossible to determine its precision.
Everyone Take a Seat at the Table: A Limitation and a Safe Harbor
Perhaps companies such as Myriad have been afforded too many rights at the expense of science and public health. Scientists need to continue to discover mutations and tailor tests to other racial and ethnic groups. Women need more meaningful options for testing. Prophylactic surgeries are burdensome and arguably, a woman can never offer true informed consent to them if she feels she needs more information about her BRCA gene status. These seem to be the two most compelling reasons to modify Myriad’s rights. Accordingly, the optimal solution should be two-fold. On the one hand it should limit restrictions on researching the BRCA genes for other mutations. On the other hand, it should carve out an exception for those women desiring a second opinion from a lab other than Myriad.
Myriad should not be permitted to claim property rights over the entire gene; and Myriad’s constituents would agree. In 2001, the European Patent Office granted Myriad one patent for both of its BRCA genes. In an action brought by a number of French research and human genetics centers, Myriad’s patent was revoked. The company subsequently filed an appeal, requesting to maintain the patent with amended, limited claims. According to the EPO, “the patent now relates to diagnostic methods for the detection of a predisposition for breast and ovarian cancer caused by a specific group of mutations of the gene, so-called shift mutations. It does not contain claims directed to the BRCA1 gene itself or to mutated forms thereof.” This solution cures any restrictions in research efforts, while leaving Myriad some patent protection.
However, if Myriad is still the only company who may administer the diagnostic test, women desiring second opinions would be left without remedy. In the midst of recent reform efforts by Congress, Lamar Smith of the House introduced a “second-opinion safe harbor option.” It would create for women the option to seek testing from other companies for second-opinion purposes only. It was adopted from the safe-harbor legislation in place under Section 287(d) of the Patent Act, for medical practitioner related activities. The ACLU responded in opposition to the amendment, arguing that the safe harbor “would fail to block all patent holder objections to [second opinion] testing, [and] fails to address the many other limitations on scientific research arising out of the issuance of [gene patents]…” This is true if this is the only modification to the rules. If Congress would embrace a combination of limiting gene patent claims to diagnostic methods with the safe harbor option, all of the issues would have been addressed, all while leaving Myriad’s fiduciary incentives intact.
The fact that Congress is merely proposing amendments, it may be implicitly affirming support of gene patents. If that is a fair assessment, then a hybrid solution as this one may be the best relief they provide. Perhaps this is the solution the ACLU should begin fighting for.
Dispensing with the 20-year Patent Term for Gene Patents
Congress should consider implementing an alternative patent term for the field of genetics. Under current U.S. law, the term of patent is 20 years from the earliest claimed filing date. For applications filed before June 8, 1995, the term is either 17 years from the issue date or 20 years from the earliest claimed domestic priority date, whichever is longer.
The patent term on genes need not last for 20 years. First, the current term of patents in the US is largely arbitrary and outdated. The original patent term under the first Patent Act was decided individually for each patent, but “not exceeding fourteen years”. It was adapted from the English Statute of Monopolies of 1623.
The duration of patents has been determined by historical precedent and political compromise. The 14-year term of the English patents after 1624 was based on the idea that 2 sets of apprentices should, in 7 years each, be trained in the new techniques, though a prolongation by another 7 years was to be allowed in exceptional cases.
The Patent Act of 1836 provided (in addition to the fourteen year term) an extension “for the term of seven years from and after the expiration of the first term” in certain circumstances. In 1861, the seven year extension was eliminated and the term changed to seventeen years. The signing of the 1994 Uruguay Round Agreements Act then changed the patent term from seventeen years from the date of issue to the current twenty years from the earliest filing date. There is no evidence that these terms support the needs of modern society. At least with respect to gene patents, they do not.
Drug development is pursued primarily with private funding. So, not only do scientists in this field front most of the money, but they are also expected to pay interest on funds they have borrowed from investors. Gene discovery is funded in large part with public funding in the form of NIH grants. In 2000, not-for-profit organizations and our federal government spent $1.8 billion of taxpayer dollars on gene research. Myriad used 5 million dollars in NIH grants to discover the BRCA-1 gene.
Also, unlike the pharmaceutical industry, newly discovered gene sequences do not require clinical trials or approval from the Food and Drug Administration. This process can take a. Gene patent holders can take their products to market as soon as their patents are granted. So, the biologists conducting gene research do not need as many years to collect royalties and recoup their investments.
Not All Patent Rights Created Equal: The Preservation of Life Exception
In contract law, frustration of purpose is a theory often used to declare a contract unenforceable. It occurs when “an unforeseen event undermines a party’s principal purpose for entering into a contract, and both parties knew of this principal purpose at the time the contract was made.” While its application to this gene patent dispute is not perfect, it provides some basis for considering new contract terms between the government and the inventor. It may be safe to argue that technology where patents of human micro-organisms would be so useful or even in existence as major discoveries were not being made in cells, DNA, and genes until the 1900s, two centuries after the drafting of current patent law.
One way courts could address the social implications of gene patents is by creating additional contract terms for biotechnology patents that concern public health and the preservation of human life. In contracting, parties are free to bargain for a unique set of obligations. Since its inception, the Patent Clause has anticipated a simple bargain where inventors would apply for patents for financial gain and the government awarded these rights for a term of years to gain an ultimate public benefit. This transaction is illustrated below. However, biotechnology patents present an added layer of complexity that may warrant a modification of the original rule. Patented technologies in the biotechnology field, such as gene patents, are not only products of human ingenuity, but also are “the actual tools for research, the pathways of biological processes, and components of life.” Put another way, biotechnology patents, as those in the Myriad case, may confer rights not only to man-made innovations but also to the raw materials from which the innovations are created. Accordingly, unlike in other life preservation fields, such as pharmaceuticals or medical devices, biotechnology patents could completely preclude access to remedies that aid in saving human lives. To ensure that the government realizes the benefits of its bargain in these instances, perhaps some additional terms are appropriate. For example, patent holders could be required to license their technologies more readily to ensure quality and accuracy of testing or make a limited number of tests available to those unable to afford it otherwise. As an illustration, Myriad offered a license to U. Penn. to carryout diagnostic testing on Ashenazi Jewish persons and provided a limited number of tests each year to those ordinarily unable to afford it. Reforms as these keep patent protection in tact while ensuring that the government and ultimately the people receive the full benefit of its bargain.
 See Georgia L. Wiesner, Clinical Implications of BRCA1 Genetic Testing for Ashkenazi Jewish Women, 7 Health Matrix 3, 15 (1997).
 Association for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 203 (S.D.N.Y. March 29, 2010) (overturned on different grounds).
 Association for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 204 (S.D.N.Y. March 29, 2010) (overturned on different grounds).
 See Association for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181, 207 (2010) (overturned on different grounds).
 Myriad Wins BRCA1 Patent Appeal in Europe; Scope Limited, GenomeWeb Daily News (Nov. 21, 2008), http://www.genomeweb.com/myriad-wins-brca1-patent-appeal-europe-scope-limited.
 Dan Vorhaus, Update: Proposed Second Opinion Safe Harbor, Gemome Law Report (June 16, 2011), http://www.genomicslawreport.com/index.php/2011/06/16/update-proposed-second-opinion-safe-harbor-for-genetic-diagnostic-testing-withdrawn/.
 Fritz Machlup, An Economic Review of the Patent System (1958), available at http://library.mises.org/books/Fritz%20Machlup/An%20Economic%20Review%20of%20the%20Patent%20System_Vol_3.pdf.
 Lori B. Andrews & Jordan Paradise, Gene Patents: The Need for Bioethics Scrutiny and Legal Change, 5 Yale J. Health Pol’y L. & Ethics 403, 406 (2005).