Archive for October, 2011

DNA Patenting “Urban Legend” Debunked At AIPLA

Friday, October 21st, 2011

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.

EU High Court Bans Patents on Cells Requiring Processing Human Embryos

Tuesday, October 18th, 2011

Defining “human embryos” broadly, The Court of Justice of the European Union has ruled that pluripotent stem cells derived from human embryos and totipotent stem cells derived from blastocysts are not patentable if they are obtained by destroying human embryos or using them “as base material”, at any point in the  production of the stem cells. The definition of “human embryo” was also extended to cover enucleated oocytes that may incorporate nuclear material from other cells or be induced to divide by parthenogenesis. The later essentially bans “adult cell cloning” for research on the early stage cells, e.g., if it involves destruction of resultant “embryo.” Individual pluripotent stem cells were not included in that concept, e.g., neuronal stem cells, since they cannot develop into a human being. But since they are obtained by disassembling a blastocyst, this is a distinction without a difference. For a refresher on the science, see W. Woessner, JPTOS, 83, 830 (November 2001).

The EU decision was based on Article 72(2) of TRIPS which stipulates that Members may exclude from patentability inventions, the prevention of the commercial exploitation of which is necessary to protect ordre public or morality. Thus, Greenpeace and its friends have accomplished what organizations with similar political (if not religious) leanings have failed to accomplish in their attempts to ban Government funding for embryonic stem cell research in the U.S.  Of course, such court battles will be refocused by the AIA. Sec. 33 bans patents with claims “directed to or encompassing a human organism.” This provision is retroactive to all pending applications, but not to issued patents. How broadly the term “human organism” will be defined is still an open question but, groups supporting a very broad definition will be encouraged by this decision.

The only exception “to the non-patentability of uses of human embryos for industrial and commercial purposes concerns only invention  for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it.” This exception would seem to permit some types of gene therapy or other medical treatments aimed at correcting genetic defects in the developing embryo. As noted above, this decision, which involved the isolation of pluripotent stem cells, does not purport to ban human cloning, so long as birth results – the embryo would not be harmed by such a procedure. This type of research, termed “therapeutic cloning” has not been banned in Europe. The charter of Fundamental Rights of the European Union prohibits reproductive cloning. In the U.S., the “Dickey-Wicker Amendment” to the annual HHS appropriations bill bars Federal funding for the creation of a human embryo for research purposes or for research in which human embryos are destroyed.  In 2010, HR 4808 was introduced by Diana DeGette (D-CO) to expressly permit funding for embryonic stem cell research, but it has not been passed.

Judgement of the Court – October 18th, 2011

Infringement by Unobvious Changes – A Look (Way) Back

Sunday, October 16th, 2011

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:

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“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].

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Obviousness = Equivalence? Saint-Gobain v. Siemens

Friday, October 14th, 2011

Saint-Gobain Ceramics (“S-G”) has asked the Supreme Court to review the Fed. Cir. panel below, 647 F.3d 1373 (Fed. Cir. 2011) in which the panel decision refused to reverse a district court decision that instructed the jury that it could find infringement  by S-G under the doctrine of equivalents (DOE) of a Siemens Medical Solutions USA patent on “LSO crystals” using a preponderance of the evidence standard, rather than the higher “clear and convincing” evidence standard, even though S-G held its own patent on a variation of the infringing crystals – “10% Y LYSO crystals.”

The jury found S-G guilty of infringement under the DOE and assessed damages. The Fed. Cir. affirmed that the jury had been instructed to apply the  appropriate legal standard and a divided court denied the petition for rehearing en banc. 647 F.3d 1373 (2011). The denial crystallizes the central point that will be appealed, and it is all you need to read to get at the heart of the case. The majority opinions affirming the district court and the order denying rehearing were both authored by Judge Lourie, but there were three concurring opinions denying rehearing and a dissenting opinion by Judge Dyk, joined by Gajarsa and Prost- and all in twenty pages. This one is teed up for Supreme Court review.

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