When the Supreme Court hands down a decision bearing on a hotly contested area of law, it means the work has just begun for any agency tasked with administering its consequences. Last term, the Court rendered such a decision in Association for Molecular Pathology v. Myriad Genetics, adding a new wrinkle to the already confounding question of patentable subject matter under §101 of the Patent Act.
In the wake of this important decision, the United States Patent and Trademark Office (USPTO) was left to struggle with perhaps the only question more difficult than the one before the Court: how to translate the decision into routine examination guidance affecting hundreds of thousands of pending patent applications. In March, the USPTO released a memorandum titled Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products in an effort to address that question.
As companies consider current cases related to patents before the Supreme Court, they would be wise to learn from the challenges the USPTO faced in implementing the Myriad decision. And for the reasons set forth below, we believe that the USPTO and the entire business community are well served by engaging in rigorous public debate about the guidelines that should be established to implement the decision from the Supreme Court.
Myriad held that “a naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated.” Understandably, the patent system does not want to endow private parties with overbroad exclusive rights. The Supreme Court found that the contested patent claims focused not on the chemical composition of the isolated DNA, which may be patentable, but rather on the genetic information encoded within it. As such, the Supreme Court held the patentee’s accomplishment to be one of “finding” a product of nature, and thus ineligible for patent protection.
The language of the Myriad decision did not on its face mandate drastic, innovation-dampening action. The Supreme Court chose to narrowly decide the Myriad case, stating that a DNA segment merely “found” from nature without further human innovative intervention is not patentable subject matter. The Court went on to carefully note what was unaffected by its decision, for example altered DNA, DNA isolation, or application of the knowledge gained from such isolation.
Indeed, the stakes are high – the decision and the USPTO’s interpretation may impact a number of industries that depend on patent protection to provide products, goods and services to the market and jobs to Americans, not to mention the future of life-saving medical discoveries. Of the over 300 drugs on the World Health Organization’s Essential Medicines List, fewer than a dozen were brought to market without having received patent protection. From the ibuprofen ubiquitous in the world’s medicine cabinets to breakthrough treatments for epidemics like the HIV-inhibitor AZT, the patent system has long played a pivotal role in global health.
The Court’s narrow decision reflects its effort to articulate as clear a rule as possible, which is key to promote certainty in a field as complex and often ambiguous as biotechnology. The Court recognizes the heavily contested debate in the public regarding competitive access to naturally occurring wild type genetic sequences, intricately balanced against a need to continue promoting innovation covering the application of such naturally occurring sequences or modified forms thereof.
Many intellectual property experts believe the USPTO’s guidelines are broader than required by the Myriad decision, taking an overly expansive interpretation of what no longer constitutes patentable subject matter. Concerns have been raised in the biotechnology industry that innovation could be chilled, with companies less certain they can effectively protect their innovative products using patents and less certain of their freedom to operate in the technology space, thus less willing to invest or conduct research.
Nobody wants to see innovation chilled in such an important field, and without commenting on the exact appropriate lines to be drawn in the USPTO’s guidelines, it is fair to say great care must be exercised to steer the right course. Fortunately, the process provides the opportunity to course-correct on the Myriad guidelines. The USPTO will now hear from patent holders, legal experts and thought leaders. This public debate is of the utmost importance – theoretical discussion over subject matter eligibility must not proceed in a vacuum, decoupled from the incentivizing purpose of the patent system. Moving forward, facilitating and encouraging this exchange of information can yield guidelines that provide necessary clarity as well as fidelity to the Supreme Court’s decision.
As policymakers wrestle with re-calibrating America’s innovation engine—our patent system—a continued search for balance will be crucial to success. Short-term exigencies such as affordable access to known medical treatments must be properly weighed against the responsibility to ensure future generations can enjoy more great innovations. Innovation is the fundamental driver of the American economy, and it requires incentives that protect true inventions from copycats. Our Patent Office and its examining corps are charged with the hard work and judgment calls that translate policy into positive economic outcomes. Empowering our country’s patent examiners to make the right decisions is critical to the functioning of our patent system and thus to America’s continued success.