Dr. Robert Schwartzman

		Recent decisions by the US Supreme Court addressing the question of subject matter eligibility, i.e., what is and is not eligible to be patented, are changing fundamental aspects of the patent system. Unfortunately, these changes have not been friendly to the life sciences industry, shaking up the patent portfolios of many companies and pushing inventors and companies toward keeping new discoveries as trade secrets rather than pursuing patenting.

		This is the antithesis of the patent system, which is designed to promote progress by disclosing breakthroughs and allowing others to continually make improvements.

		Two decisions in particular—Assoc. for Molecular Pathology v. Myriad Genetics (“Myriad”) and Mayo Collaborative Services v. Prometheus Laboratories Inc. (“Mayo”)&mdash;call into question the validity of thousands of previously issued patents that may no longer be considered to be directed to patent-eligible subject matter, substantially impacting life sciences patents both going forward and retroactively.

		The question addressed in Myriad was whether human genes are patentable. The answer, according to the Court, is that DNA is a natural product and therefore not patent-eligible subject matter, even if the DNA has been isolated from its natural location in the genome. In contrast, according to the Court, complementary DNA does not exist in nature and therefore is patent-eligible. If this decision is interpreted and applied narrowly by the courts and the US Patent and Trademark Office (USPTO), it may not have a major impact because there are many ways to claim a gene of interest without it encompassing a natural product. The concern is that the decision will be applied broadly so that it renders patent-ineligible short fragments of DNA such as primers and probes as well as other isolated natural products such as proteins, peptides, antibodies, vaccines, cells, and even small molecules isolated from natural organisms. A memorandum issued by the USPTO shortly after the decision came down has already expanded the holding to fragments of nucleic acids and even suggested that the eligibility of methods involving the use of naturally occurring nucleic acids may also come under question, something that the Court explicitly said was not affected by the decision.

		Also addressing subject matter eligibility, in Mayo the Court held that a correlation that occurs in nature, such as the relationship between the concentration of a blood metabolite and the response to a therapeutic drug, is a “law of nature.” A claim that is directed to such a law of nature without more, or that only adds well understood routine, conventional steps, specified at a high level of generality, is not patent-eligible. This decision has significantly impacted patent applications in the area of diagnostics and personalized medicine. The USPTO now routinely rejects claims in these areas as patent-ineligible unless the claims include narrow limitations to specific reagents and/or steps that are not previously known in the art. Unfortunately, such narrow claims do little to protect the patentee as they are easy to design around.

		Following these two decisions, patent owners need to assess the overall strength of their patent portfolios in light of potential damage caused by the decisions. For granted patents affected by these cases, it is important to evaluate the issued claims and perhaps use the USPTO reissue process to amend potentially invalid claims to be directed to patent-eligible subject matter.

		Going forward, patent drafters will need to consider these two cases and any follow-up decisions as they prepare new applications. Pursuant to Myriad, patent applications and claims will need to be carefully drafted with the expectation that all natural products may be affected by this decision. Numerous fall-back positions and alternative claim formats should be incorporated in case patent-eligible subject matter continues to be narrowed. Myriad Genetics itself exemplifies the importance of maintaining a broad patent portfolio with many different types of claims. While a handful of claims in their patents were invalidated, a BRCA1/BRCA2 gene portfolio of more than 20 patents and over 500 claims allows Myriad Genetics to continue to assert this portfolio against competitors that jumped into the BRCA testing arena after the Myriad decision was announced.

		Patent applications will also need to be carefully drafted in light of the Mayo decision. Including support for alternative claim language and formats that might be used to overcome the rejections now being made by the USPTO will be essential. For both decisions, it will be important to keep a close eye on trends at the USPTO and the courts in order to stay up-to-date as this area of law rapidly evolves.

		Dr. Alice Bonnen and Dr. Robert Schwartzman are shareholders at Myers Bigel Sibley & Sajovec P.A., an intellectual-property law firm (Raleigh, NC; www.myersbigel.com). Dr. Bonnen has a PhD in plant pathology from Michigan State Univ., and a JD from Wake Forest Univ. Dr. Schwartzman has a PhD in pharmacology from Univ. of North Carolina-Chapel Hill, a JD from Georgetown Univ. Law Center, and has worked

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