The biotech industry has recently become the latest battleground for the patentable subject matter debate. At issue is the patentability of claims directed to “isolated” DNA molecules. In the past, the patentability of isolated DNA sequences primarily turned on the written description requirement set forth in 35 U.S.C. § 112. For example, in Regents of the University of California v. Eli Lilly and Co., 119 F.3 1559 (Fed. Cir. 1997), the court held that “[a]n adequate written description of a DNA…‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” Four years later, the United States Patent and Trademark Office addressed the utility requirement set forth in 35 U.S.C. §§ 101 and 112, by releasing its Final Guidelines For Determining Utility Of Gene-Related Inventions.

 Until recently, however, the issue of the patentable subject matter requirement set forth in U.S.C. § 101 went largely unnoticed. That changed on March 29, 2010, when Judge Sweet of the Southern District of New York issued his opinion in Assoc. For Molecular Pathology v. U.S.P.T.O., 702 F. Supp. 2d 181 (S.D. N.Y. 2010) (commonly referred to as the ACLU v. Myriad case), which in no uncertain terms held that isolated DNA was not patentable subject matter and was instead merely a “product of nature.”

According to the court in ACLU v. Myriad, the PTO grants patents on “isolated DNA” under the standard patentable subject matter jurisprudence related to isolated chemical compounds. Noting that “scientists in the fields of molecular biology and genomics have considered this practice a ‘lawyer’s trick,’” the court explains that it is premised on the PTO’s view that DNA should be treated no differently from other chemical compounds and that purification from its natural state in the body is the “transformation” giving rise to patentability. Id. at 185.

Expressly rejecting the PTO’s view, and noting that it owes no deference to the PTO, the court stated that “patentable subject matter must be ‘markedly differen[t]’ from a product of nature” and held that the “claimed isolated DNA is not ‘markedly different’ from native DNA.” Id. at 221-229. Undaunted by the impact that such an opinion may have on the thousands of issued DNA-related patents, the court notes that the Federal Circuit had issued its opinion in In re Bilski, which “set out a test for the patentability of method claims that potentially will invalidate thousands of patents on business method[s].” Id. at 221.

At the end of the day, ACLU v. Myriad was a district court opinion and therefore did not instantly invalidate thousands of issued patents. The Federal Circuit, however, is beginning to make its opinion known on the issue, and it appears there may be a split of opinion on the court related to the patentability of isolated DNA.

On August 4, 2010, a three-judge panel consisting of Circuit Judges Bryson, Dyk, and Prost issued its opinion in Intervet Inc. v. Merial Ltd., No. 2009-1568 (Fed. Cir. Aug. 4, 2010), which related to patent claims directed to “an isolated DNA molecule.” While the majority opinion vacated the district court’s entry of summary judgment of noninfringement without considering the question of patentable subject matter, Circuit Judge Dyk picked up the issue in a separate opinion. In particular, Dyk explained that the claim directed to isolated DNA “raises substantial issues of patentable subject matter” because “allowing the patenting of naturally occurring substances preempts the use by others of substances that should be freely available to the public.” Judge Dyk continued, “[I]t appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with ‘markedly different characteristics from any found in nature’” and “it is far from clear that an ‘isolated’ DNA sequence is qualitatively different from the product occurring in nature.”

This question is sure to wind its way up through the courts and may be the next hot Federal Circuit issue. To be sure, it will be interesting to see how the Federal Circuit confronts the issue when it is squarely before it and whether the Supreme Court and even Congress will decide to make their opinions on the matter known.