I’ve been working my way through the massive 156 page opinion in Association for Molecular Pathology v. USPTO, where – in case you’ve been living under a rock – Judge Sweet of the Southern District of New York ruled that gene patents are invalid under Section 101.
The writing was on the wall in this opinion by page 63, whereupon Judge Sweet spent 11 pages discussion the policy implications of gene patents – a discussion heavily weighted in favor of why gene patents are bad.
I’ll admit up front that I don’t generally deal with biotech patents, so I’m not familiar with some of the cases cited by Judge Sweet other than, of course, Chakrabarty. What bothers me is that this decision does not in any way convince me that he is right and the Patent Office is wrong for issuing gene patents; his decision seems based more on policy and less on the law. Judge Sweet appears to state his own interpretation of the cases, while ignoring the interpretation that the USPTO has discussed in its examination guidelines. I dug up the January 5, 2001 utility patent examination guidelines, which discuss gene patents. Judge Sweet dismisses these guidelines in one fell swoop (pp. 103-104), and does not even attempt to explain the disparity between his position and that of the USPTO. Does he have to? No, I guess not. But certainly some mention of the diparity or support for his interpretation would have been nice. While the word of the Patent Office is not law, and technically Judge Sweet doesn’t need to give it any deference, the logic and conclusion of this opinion do not seem to indicate that he even realized the enormity and impact of what he was saying.
For example, at pages 114-116, Judge Sweet dismisses the Parke-Davis case (slamming Judge Hand in footnote 46), stating essentially that it wasn’t relevant because it dealt with novelty. Here’s what the Patent Office said about the case in the 2001 examination guidelines:
The Patent Office goes on to discuss the Bergstrom case (also rejected by Judge Sweet because it dealt with novelty) in a similar manner:Patenting compositions or compounds isolated from nature follows well-established principles, and is not a new practice. For example, Louis Pasteur received U.S. Patent 141,072 in 1873, claiming `[y]east, free from organic germs of disease, as an article of manufacture.' Another example is an early patent for adrenaline. In a decision finding the patent valid, the court explained that compounds isolated from nature are patentable: `even if it were merely an extracted product without change, there is no rule that such products are not patentable. Takamine was the first to make it [adrenaline] available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.' Parke-Davis & Co. v. H. K. Mulford Co., 189 F. 95, 103 (S.D.N.Y. 1911) (J. Learned Hand).
In a more recent case dealing with the prostaglandins PGE2 and PGE3, extracted from human or animal prostate glands, a patent examiner had rejected the claims, reasoning that `inasmuch as the `claimed compounds are naturally occurring' * * * they therefore `are not 1new' within the connotation of the patent statute.'' In re Bergstrom, 427 F.2d 1394, 1397, 166 USPQ 256, 259 (CCPA 1970). The Court reversed the Patent Office and explained the error: `what appellants claimMpure PGE2 and PGE3Mis not `naturally occurring.' Those compounds, as far as the record establishes, do not exist in nature in pure form, and appellants have neither merely discovered, nor claimed sufficiently broadly to encompass, what has previously existed in fact in nature's storehouse, albeit unknown, or what has previously been known to exist.' Id. at 1401, 166 USPQ at 261-62. Like other chemical compounds, DNA molecules are eligible for patents when isolated from their natural state and purified or when synthesized in a laboratory from chemical starting materials.
Judge Sweet also gives short shrift to any responsibility by Congress to legislate such a massive change in the current process at page 105. The Patent Office had this to say in the 2001 examination guidelines:
Congress adopted the current statute defining patentable subject matter (35 U.S.C. 101) in 1952. The legislative history indicates that Congress intended `anything under the sun that is made by man' to be eligible for patenting. S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H.R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952). The Supreme Court interprets the statute to cover a `nonnaturally occurring manufacture or composition of matter-a product of human ingenuity.' Diamond v. Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193, 197 (1980). Thus, the intent of Congress with regard to patent eligibility for chemical compounds has already been determined: DNA compounds having naturally occurring sequences are eligible for patenting when isolated from their natural state and purified, and when the application meets the statutory criteria for patentability.
Note that at page 110, fn. 43 Judge Sweet refers to the “anything under the sun that is made by man” quote as “misleading.”
Something else is odd. Here is one of the claims at issue: “an isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.”
Here is an example claim from the MPEP, Section 803.4: “an isolated and purified DNA fragment comprising DNA having at least 95% identity to a DNA sequence selected from SEQ ID Nos. 1-1,000.”
Pretty similar format, no?
More comments to come…