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NY Federal District Court Increases Limits on Patentable Subject Matter
Douglas A. Miro & Joel J. Felber - 4/16/2010

In a ruling that is considered by many in the legal community to be in conflict with established patent law, the U.S. District Court for the Southern District of New York recently ruled in Association for Molecular Pathology v. U.S. Patent and Trademark Office, S.D.N.Y., No. 09-Civ. 4515 (2010), that claims directed to “isolated” DNA do not recite patentable subject matter.  The complaint contested the validity of claims in seven issued patents covering genes that are “isolated” from their natural state and are “purified.”  The genes in question have been associated with breast cancer and ovarian cancer, and may be useful to detect a person’s likelihood of contracting the diseases.

In the ruling, Judge Robert Sweet held that the claims in question did not satisfy the requirements for subject matter eligibility for patent protection under 35 U.S.C. §101.  Relying on Supreme Court precedent from 1980 in Diamond v. Chakrabarty, the judge ruled that “a purified product” (i.e., the isolated DNA) must not lack “markedly different characteristics” from non-isolated DNA to be eligible for patent protection.  The decision held that the “isolated DNA is not markedly different from native DNA as it exists in nature” and invalidated the patent claims.

Judge Sweet distinguished DNA molecules from chemical compounds, which have long been held to be eligible for patent protection, on the grounds that “information encoded by DNA reflects its primary biological function: directing the synthesis of other molecules in the body.”  Thus, the judge decided that legal standards for patent protection of various other chemical compounds do not apply to isolated DNA.  Further, the judge noted that the encoded information is retained by both isolated DNA and native (non-isolated) DNA, which reveals a lack of markedly different characteristics.

The decision also cited to the recent Federal Circuit decision, In re Bilski, in connection with process or method claims for diagnosing and screening in the patents.  Construing that DNA encodes information like a computer, Judge Sweet held that the “claims would fail the ‘machine or transformation’ test under 101 for subject matter eligibility” ( See, U.S. Supreme Court Hears Oral Argument in Bilski v. Kappos).

The decision has been lauded by critics of the patent system in general, and by critics of gene-related patents in particular.  Most patent practioners would agree, however, that Judge Sweet’s new application of judicial precedent, particularly the test for determining whether subject matter has “markedly different characteristics” from known subject matter, will likely be challenged and appealed.

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