The Way Forward The significance of the Supreme Court’s Prometheus decision for medical devic

The Way Forward
The significance of the Supreme Court’s Prometheus decision for medical device and life-sciences companies depends on how broadly the lower courts interpret the Supreme Court’s mandate. Any patent claims reciting “laws of nature” could be impacted. All types of method claims could be affected, including methods of treatment, computer implementing methods, diagnostic methods and dosing methods. Even if granted claims look uncomfortably similar to Prometheus’ claims, all may not be lost and it may be possible to strengthen or uphold the validity of the patent.

In light of the landmark Prometheus decision, companies should take a number of steps to assess and strengthen their patent portfolios. Those steps include:

1. Conducting a patent audit. Companies should review their patent portfolios to assess any potential vulnerabilities given the new Prometheus playing field. Issued patents and pending patent applications need critical review to determine options for strengthening the portfolio.
2. Reviewing issued patents. Patent claims that cover novel applications of laws of nature, including delivery processes for personalized medicine, may be unaffected by Prometheus. However, patents that fall under the Prometheus umbrella may be strengthened through reissue or reexamination proceedings in the USPTO.
3. Positioning pending patent applications. Companies should review pending patents applications to see if the claims can be strengthened by adding additional transformative steps to the claims. Amending patent claims to recite novel “determining” steps may help overcome Prometheus. For example, claims can include steps of administering novel substances, steps that involve novel relationships between what is detected and a particular disease, or novel steps for administering or detecting a biological molecule.
4. A chilling effect on new patent application filings. While companies may think twice before filing a new patent application on diagnostic methods, more prudent approaches include claiming specific useful applications of natural laws and drafting claims that have a transformative step in the inventive limitation of the claims. The Supreme Court in Prometheus expressed concern that broad claims to laws of nature tie up the use of laws of nature and stifle innovation, even when the recited laws of nature are narrow and have only limited applications. Accordingly, to obtain patentable claims after Prometheus, the claims reciting a law of nature also should include unconventional, specific steps that transform the claimed method from one that preempts all use of the laws of nature into an inventive application of the natural law.
5. Following USPTO guidance. One day after the Prometheus decision, on March 21, the USPTO sent its Patent Examiners a memo offering “preliminary guidance” on how to apply the Prometheus ruling that requires rejection of patent applications directed to natural phenomena unless they include elements causing the claimed invention to amount to “significantly more” than a law of nature. The USPTO told patent examiners that the Prometheus ruling makes clear that: (1) because laws of nature, like the natural correlation between drug doses and toxin levels at issue in the Prometheus patents, are not patent-eligible, methods related to such phenomena also are ineligible unless they include features that ensure the patent is a genuine application of those laws; (2) adding “conventional” steps with a high level of generality to natural phenomena cannot make those phenomena patent-eligible, and in order to be patent-eligible, a claimed invention must involve an application of such a law; and (3) “A claim that recites a law of nature or natural correlation, with additional steps that involve well-understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation.” The USPTO plans to issue additional guidance on patent subject matter eligibility soon, and companies should strive to follow these USPTO guidelines.

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The unanimous Prometheus Supreme Court decision casts a dark cloud over diagnostics and personalized medicine patents. The full repercussions will not be known for many years. To build and maintain a strong patent portfolio in this uncertain environment, medtech companies need to pursue creative patent strategies that account for this major decision.