It is with sadness that I note that Genie Hansen died suddenly at her home on Monday. She had been at Richard, Medlock and Andrews and Sidley and Austin and started Hemingway & Hansen in 2005 in Dallas. She had served on the Board of AIPLA and chaired the Women in IP Law and Public Relations Committees. I met her when Rochelle Seide and Kathleen Terry revived the Chem/Biotech Patent Practice Seminars for AIPLA, which were offered in three cities, every two years from 1994 into the 2000’s. In 1994 she presented the ethics part of the seminar with David Hitchcock. In 1996, she and David spoke on interferences, In 1998, she spoke on optimizing international filings and in 2000, she spoke on writing process claims. This was a tough schedule, but Genie’s ability to work hard and smile easily made these IP “Roadshows” effective and almost fun. She will be missed!
Posts Tagged ‘AIPLA’
On Saturday, October 27th, I will one of the speakers in the Closing Plenary Session of the Annual AIPLA Meeting in Washington, DC. Since I was assigned to do part of the “Ethics” track, I will be speaking on post-Therasense Fed. Cir. opinions. Is the defense of inequitable conduct a limping zombie that can be easily avoided if you don’t just run into a corner and scream, or does it still have fangs? Also speaking on “Ethics – Privacy” will be Prof. Paul Ohm from the University of Colorado School of Law. David H. Harper will sum up the year in copyrights and trade secrets, Steven J. Wadya will handle trademark law developments, and Mark Lemley of Stanford will do the patent law wrap-up. Moderator Mary Kocialski of Oracle will try to keep us on schedule (Good Luck!).
From a biotech perspective, probably the most interesting session will be the Educational Session sponsored by the Biotechnology/IP Practice in Europe and (I think) the Chemical Practice Committees from 330-530 on Thursday that will – thoroughly, I am sure – discuss the “antibody exception” to the written description requirement. Apparently, reports of its demise in the wake of Ariad were untimely. I particularly anticipate learning the USPTO perspective. Now, how about a session on patenting diagnostic assays post-Prometheus and Myriad?
The most interesting presentation at the Annual AIPLA Meeting – which is not yet over – was Professor Christopher M. Holman’s talk – “Deconstructing the myth that 20% of the human genome is patented” which was based on his paper in IP Theory, Vol.2, 1 (2011). The “20%” number originated from a single paper, K Jensen and F. Murray, Science 310, 239 (2005)(“The Study”), and has been cited in a number of the briefs by AMP and others attempting to invalidate the Myriad BRCA1/2 patents. However, the authors only searched for patents having claims that recited human DNA SEQ ID NOS or DNA encoding a human protein having SEQ ID NO: X. You might expect this to produce a lot of false positives, and it did.
Holman analyzed the claims of 533 of the 4270 “gene patents” that the Study included in its “20%” estimate, and grouped them into three categories. Category I were patents with claims deemed irrelevant to genetic testing. These included claims to GMOs, chimeric genes and fusion proteins and recombinant vaccines, for example. About 144 patents fell into this category. Category II included patents with claims to isolated human DNA of SEQ ID NO: X. These patents included those claiming cDNA as well as genomic DNA. Holman felt that most of these patents would not impede genetic testing since it would normally not be necessary to isolate the target gene sequence. Of course whole genome sequencing would not require the isolation and purification of individual genes. Most of these patents related to the use of cDNA for protein production. Three hundred sixty-six patents were assigned to this category, although there was some overlap with Category III.
Category III patents did contain claims to methods of testing that might be infringed by Myriad-type claims to identifying mutations of interest in personalized medicine. However, only 48 patents fell into this category (!) and only 12 claim the detection of genetic variation by “any means.” (21 of the patents also had Category II claims.) Holman explains, how, even if valid, such claims could be avoided, e.g., by getting your genome sequenced abroad, “importing” the data, and having it read by your U.S. physician. Also, other “gene patents” had lapsed, are about to expire or recite outmoded detection or sequencing methodologies. So the next time someone tries to sell the idea that personalized medicine is hopelessly mired by patent thickets, refer them to this post – or keep a copy of Holman’s timely article close at hand.
As a much younger attorney, I gave a presentation at the 1990 AIPLA Annual Meeting: “A Review of Recent Federal Circuit Decisions Relating to Infringement” (AIPLA Selected Legal Papers, 9, 3 (July 1991)), in which I wrestled with the question of whether or not a novel and unobvious chemical composition would infringe under the doctrine of equivalents. Since this is the central issue that the Supreme Court will be asked to resolve in Saint-Gobain Ceramics v. Siemens Med. Sol’ns, Supreme Ct. No. 11-301, I thought these excerpts might be of interest:
* * *
“Although no recent case (or any case) was found where the unobviousness of a substituted ingredient led to a holding of non-infringement of an accused composition that otherwise met the tripartite test, such a holding would be appropriate. At the very least, Atlas Powder Co. v. DuPont DeNemours & Co., 750 F.2d 1569 (Fed. Cir. 1985), suggests that an unexpected result achieved by the accused composition would support a finding of non-interchangeability [and thus, noninfringement].