By Kevin E. Noonan --
The lawsuit filed by plaintiffs and represented by lawyers from the American Civil Liberties Union and the Public Patent Foundation (PUBPAT) is easy to decry in the biotechnology patent community. Patent Docs will provide a detailed explication of the complaint, including a discussion of its many falsehoods, misstatements and half-truths in a coming post. However, before the complaint can be properly assessed, it is illustrative to consider the patents-in-suit and the claims expressly recited in the complaint as being unpatentable and unenforceable for violating 35 U.S.C. § 101, and Article I, section 8, clause 8, and the 1st and 14th Amendments to the Constitution.
The complaint identifies the following U.S. Patents: Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; and 6,033,857. They are assigned to Myriad Genetics, the University of Utah Research Foundation, and the National Institutes of Health (the '282, '001 and '441 patents); Myriad Genetics, Centre de Recherche du Chul, and the Japanese Cancer Institute (the '473 and 999 patents); and Myriad Genetics, Endo Recherche, HCS R&D Ltd. Partnership, and the University of Pennsylvania (the '492 and '857 patents). All but the '492 and '857 patents claim priority to an application filed August 12, 1994; all but the '473 patent (December 2014) and the '857 patent (March 2017) will expire (upon timely payment of maintenance fees) in 2015.
The claims targeted in the complaint illustrate, on the one hand, the plaintiffs' purpose: to have a court rule on the patentability of genes per se. This is shown by a consideration of the claims of the '282 patent expressly called out in the complaint:
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
7. An isolated DNA selected from the group consisting of:
(a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056;
(b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385;
(c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.
20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
However, the inclusion of claim 20 is curious, for several reasons. First, this is a method of screening claim, which would encompass use of cells expressing a recombinant expression construct encoding an altered BRCA1 gene. Such claims are recited in the '282 patent as compositions of matter (claims 8-13) but they are not named. Moreover, this claim does not impact basic genetic research, overcoming restrictions of which are purportedly plaintiffs' purpose in filing the complaint.
The claims recited in the complaint for the remaining patents in suit are more consistent with this purported purpose: for the '492 patent:
6. An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer.
7. The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1.
(recombinant vector and transformed recombinant cell claims are not named); the '473 patent:
(nucleic acid probe claims are not recited in the complaint); the '999 patent:
the '001 patent:
(other method of diagnostic screening claims, including ones using antibodies to detect altered BRCA1 proteins, are not recited in the complaint); the '441 patent:
(other method of diagnostic screening claims, including ones using antibodies to detect altered BRCA1 proteins, are not recited in the complaint); and the '857 patent:
2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.
The pattern of gene claims asserted (and not asserted) indicates that plaintiffs do not intend, for now, to pursue abrogation of the Supreme Court's Diamond v. Chakrabarty decision, insofar as that case held recombinant cells expressing heterologous proteins were patentable subject matter. Accordingly, classical biotechnology -- providing cells for producing useful amounts of proteins such as erythropoietin, tissue plasminogen activator, insulin, and growth hormone, among many others -- are not likely to be at risk (unless plaintiffs amend their complaint to include such claims or the Supreme Court decides to revisit Chakrabarty). However, gene patenting claims, including methods for using gene sequences for genetic diagnosis, are clearly in plaintiffs' sights. The motivations for the lawsuit, and a more detailed analysis of the complaint, will be presented in future posts.