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Abelman, Frayne, &Schwab

ARE ISOLATED HUMAN GENES PATENTABLE?
By Harry K. Ahn, Partner, and Theodore J. Pierson, Associate, both of Abelman, Frayne, & Schwab

In a highly anticipated decision, federal district court Judge Robert W. Sweet on March 29, 2010 surprisingly held that human genes that have been isolated from its natural form do not qualify as patentable subject matter despite the fact that the U.S. Patent Office has already issued patents covering approximately 2,000 isolated human genes. Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al., No. 09-Civ-4515 (S.D.N.Y.) ("AMP case").

As a background, most patent practitioners generally believed that these isolated human genes are patentable subject matter under 35 U.S.C. §101 for two reasons. First, the U.S. Patent Office issued specific guidelines for the eligibility of gene-related patents. See Utility Examination Guidelines 66 Fed. Reg. 1092, 1092-99 (Jan. 5, 2001). In fact, as stated above, the U.S. Patent Office has already granted patents covering approximately 2,000 isolated human genes. Second, although no courts have directly addressed the issue of patentable subject matter (under §101) for isolated human genes, there are cases where anticipation (under § 102) and obviousness (under § 103) challenges were made on patents directed to isolated human genes. In those cases, the fact that there were no invalidity challenges on patentable subject matter grounds suggests that the patent bar had not seen fit to assert a lack of patentable subject matter.

Thus, it came as a big surprise to many in the patent community that the court in the AMP case ruled that two isolated human genes linked to breast cancer and the comparison of their sequences are not patentable subject matter for failing to satisfy the requirements of §101.

This case was brought on behalf of several physicians and individuals diagnosed with breast cancer, who were represented by the ACLU and the Public Patent Foundation. The plaintiffs argued that fifteen claims of seven patents, which were directed to two isolated human genes, known as BRCA1 and BRCA2, should be declared invalid for not qualifying as patentable subject matter under §101.

Although not specifically recited in §101, courts have consistently held that "products of nature" are not patentable. See Diamond v. Chakrabarty, 447 U.S. 303 (1980) (stating that the relevant distinction for §101 patentability is "between products of nature, whether living or not, and human-made inventions"). The plaintiffs argued that these two isolated human genes should not be patented and privately owned because, even in their isolated form, they are still merely "products of nature".

Judge Sweet agreed with the plaintiffs despite the U.S. Patent Office's specific guidelines mentioned above, pointing out that "the Federal Circuit has previously held that it owes no deference to USPTO legal determinations." Judge Sweet concluded that "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes. Therefore, the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C. § 101."

This case will most likely be appealed to the Court of Appeals for the Federal Circuit and ultimately may wind up at the Supreme Court. We will be closely monitoring the appellate process of this case and will be publishing updates on our website as appropriate.

We continue to recommend to our clients that when preparing a patent application directed to any "unsettled" subject matter, several types of claims of varying scope should be included, to tie the claimed invention to a more "traditional" type of patentable subject matter, such as a machine or device. It is important to note that the "kit claims" and most of the "probe claims" of the patents at issue in the AMP case were not challenged by the plaintiffs.