Genes and Information: The Problem of Disease-specific Databases

by McDonnell Boehnen Hulbert & Berghoff LLP
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GeneOne of the many untruthful positions taken by the ACLU in the AMP v. Myriad Genetics case was that DNA is merely information, like a computer program, and as such Myriad's patent claims were invalid as reciting patent-ineligible subject matter.  The ACLU also alleged (in counts of their declaratory judgment complaint legally avoided by the District Court, the Federal Circuit, and the Supreme Court) that claims reciting methods for determining the sequence of a woman's BRCA genes were a violation of the First and Fourteenth Amendments as interfering with a woman's right to her genetic information.  And the strategy was effective:  for example, the District Court distinguished DNA as subject matter from all other biologically derived materials (such as antibiotics or antibodies) because DNA is the "physical embodiment of genetic information," and Justice Thomas stated in the Court's opinion that "[i]t is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes" and "[w]e merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material."

DNA is not information, of course; it is "but a chemical compound, albeit a complex one."  While the informational content of the molecule determines its chemical structure, the sequence information is not encompassed by the patent claims, and the information can be used without infringement of the isolated DNA claims (either those invalidated or those upheld by the Court's opinion).  However, the diagnostic method claims determine the genetic information of a patient's BRCA genes, and one of the enduring conundrums of the Myriad patent situation is the fate of the genetic information discerned by Myriad in the exclusive practice of their patented methods (putting aside the issue of whether these claims are patent-eligible, either specifically or as a genus).  Patient privacy prevents Myriad from releasing that information to anyone other than the patient's physician, genetic counselor, or the patient herself, and laws such as Health Insurance Portability and Accountability Act (HIPAA) and Genetic Information Non-disclosure Act (GINA) exist to prevent unauthorized disclosure.  But collectively, the genetic information from the plurality of women tested by Myriad (and anyone else doing such testing) produces a higher order, population genetic picture of the mutations responsible for increased risk of cancer that has its own value and in which the public has an interest.

Recently, Myriad's decision (since 2004) to maintain this collective genetic information in a proprietary database has become another battleground in the debate on how best to promote progress in the genetic diagnostic method arts.  Groups are calling for a grass roots effort by individual women to submit their genetic information to a common (albeit privately held) database in an effort to reconstitute Myriad's database (see "Consortium Launches Public Database of BRCA Data" and "Myriad Genetic Database Under Siege").  This information, while a product of the patented methods is not limited to them and is not subject to the disclosure requirements imposed as part of the quid pro quo of patent protection.  This leads to the anomaly that Myriad's patents will expire, permitting competition by others using Myriad's primers, probes, and methods, while Myriad will continue to enjoy a competitive advantage due to its proprietary database.  The consequences are readily envisioned -- a doctor will be faced with two possibilities:  one that a patient has a published BRCA gene mutation so that a test by either Myriad or a lower-cost competitor will provide the same diagnostic information, or that the patient has a mutation whose significance is known only by consideration of the information in Myriad's database.  Faced with this choice, the doctor will either have her patient (or the insurance company or governmental payor) incur a first cost (from the competitor) and a second cost (from Myriad) or one cost (from Myriad).  Depending on the frequency of informative mutations in Myriad's database but not otherwise known, the cost-benefit analysis may (and likely will) tip in favor of using Myriad's test, either preferentially or exclusively.  And this will lead to a de facto extension of the competitive advantage Myriad has enjoyed via its patents for the past twenty years.

This is an important policy issue but limiting patents for genetic diagnostic testing will, paradoxically, exacerbate rather than solve this problem.  The absence of patent protection will provide strong incentives for all genetic diagnostic information to be undisclosed, kept as a trade secret and otherwise not shared with patients, their doctors, or genetic researchers.  With patent protection, the policy-based obligation to disclose the diagnostically relevant mutations arises from the patent grant itself and the quid pro quo of disclosure in exchange for such exclusivity.  Abolishing the exclusivity would abolish the obligation, and would provide incentives for companies to disclose as little information as possible.  Instead of identifying the mutations, for example, future (unpatented) genetic diagnostic methods could come merely with the information that a patient has a genetic mutation associated with an increased risk of a particular disease, with statistics on survival and treatment options and their success rates but no information on which mutation(s) were involved.  While this outcome would be even more inconsistent with the way genetic diagnostics is and has been developing than Myriad's behavior bemoaned by many, what patients and their doctors want most are reliable diagnostic results, and a company offering such advanced diagnostics would be in a position to adopt a "take it or leave it" attitude regarding disclosure.  This possibility is even more likely for the majority of diseases that, unlike breast cancer and BRCA are multivariate and less readily reverse engineered.  Solving this conundrum is important, in ways proponents of the ACLU's lawsuit have not provided and which the recent "victory" over Myriad's "gene patents" does not achieve.

The key to a solution may be to strengthen, not weaken, patent protection for genetic diagnostic methods.  This is because the exclusivity of patent protection provides a single actor motivated to take advantage of the limited exclusivity period and provides the return on investment making development of the testing possible.  Because the government provides this exclusivity and the profits stemming from it, the public nature of the patent grant may justify the government imposing conditions for the practice of these patented methods.  One of the reasons the DOJ took the somewhat ridiculous position it did in the Myriad case, and that the Obama Administration has been antagonistic to patenting generally, is that the Federal government is the largest payor for drugs and (now or in future) genetic diagnostic testing, which should (ultimately) be beneficial to ameliorating increased medical care costs due to the potential for early treatment or other interventions that are less costly than a patient developing breast cancer or other disease with a genetic component.  And perhaps the leverage that stems from government payment for genetic diagnostic testing is the one that could be used to prevent the anomaly of a company having a valid patent that produces genetic information but that can extend at least a portion of its exclusivity past the expiration date of the patent by accumulating patent-ineligible information in a proprietary database.  The government could, presumably, require that the genetic information for every patient produced by the practice of a patented genetic diagnostic method be deposited (in a HIPAA- and GINA-compliant way) with the NIH or other (public) agency, and that database would be freely available after the patent has expired, been found invalid or unenforceable or licensed.  A precedent exists for patented cells, antibodies and other biological material:  the ATCC has a patent depository that requires patentees to agree to maintain their deposit of patented material for a term (30 years) even longer than the patent term, and will give requestors samples (subject to notification of the patentee) once the patent has granted.  (As a non-government agency the ATCC is in no position to monitor whether a requestor is entitled to the sample, but notice to the patentee permits the patent owner to pursue legal remedies against any requestor who obtains the deposit sample improperly.)

Such a scheme is more consistent with achieving a balance between the benefits of disclosure provided by the patent system and the needs of the public for effective disclosure of disease-related genetic information than all the litigations, gene patent-banning bills, Congressionally mandated (and still to be released) "second opinion" studies, and speculative conclusions of blue-ribbon commissions that have led us to where we now are -- a situation where less, not more, genetic information disclosure is likely to be in our future.

Hat tip to Jennifer Gottwald and Victoria Sutton for discussions on this topic.

 

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