On September 15, 2009, Director David Kappos spoke at the National IPO Meeting in Chicago. (A link to the text is found below). I got calls almost immediately about various aspects of his comments. Like the blind folks trying to characterize an elephant, there are many “hints” in the remarks of changes to come. One caller said that the Director commented that an appeal process that is so complex that nearly half of the appeal briefs filed are rejected for formal defects is a failure by definition (my gloss). But note that he called for cutting the pendency of appeals to 3 months. The Director also seems to be willing to develop a “satellite examiner” program along the lines of the satellite attorney program that has worked well for our firm from the beginning (SLW now has six satellite shareholders). His comments about how he will not tolerate discrimination among technologies might relate to attacks on business method patents but could just as easily relate to the difficulties we practitioners encounter in getting biotech claims of reasonable scope. I will leave it to you to root other acorns of hope from the Director’s remarks. Perhaps this is the beginning of another chapter of change we can believe in!
Archive for September, 2009
On September 16, 2009, the Federal Circuit reversed the holding of the district court that a process for monitoring and adjusting a method of medical treatment was unpatentable as attempting to claim non-statutory subject matter (Prometheus Labs., Inc. v. Mayo Collaborative Services, Appeal No. 2008-1403 (Fed. Cir. Sept. 16, 2009)). (A copy of the decision is available at the end of this post.) The patent’s claims at issue recited (a) administering a drug such as AZA that provides 6-TG metabolites to a subject and (b) determining the levels of the metabolites. The measured metabolite levels are then compared to pre-determined metabolite levels and may “indicate a need” (e.g., provide a warning to the doctor) to increase or decrease the amount of drug that is administered so as to maximize efficacy of treatment. Claim 1 of U.S. Pat. No. 6,355,623 begins: “A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising (a)….”
Applying the transformation test set forth in Bilski, Judge Lourie, writing for the panel, considered almost every aspect of the “natural phenomena” debate surrounding the patent-eligibility of methods of medical treatment and diagnosis. The court found that both the administering steps and the determining steps are “transformative.” Judge Lourie wrote:
“The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition….The transformation here…is the result of the physical administration of a drug to a subject to transform–i.e., treat–the subject, which is itself not a natural process.”
The court also found that the determining step is also transformative and central to the claimed methods, since “[d]etermining the levels of [the metabolites] in a subject necessarily involves a transformation … it is necessary to extract the metabolites from a bodily sample and determine their concentration…this transformation [of clinical samples] is central to the purpose of the claims…Measuring the levels of [the metabolites] is what enables possible adjustments [in the administered drug].”
The court went on the hold that the administering and determining steps are not merely “insignificant extra-solution activity” but “[i]stead the administering and determining steps are part of a treatment protocol, and they are transformative….the claims are therefore not drawn merely to correlations between metabolite levels and toxicity or efficacy.”
The court went further to clarify that the presence of mental steps, e.g., recognition that a dose modification may be needed, does not detract from patentability. While the court agreed that the “wherein” clauses are mental steps and not patent-eligible per se, it stated that “the final step of providing a warning based on the results of the prior steps does not detract from the patentability of the … claimed methods as a whole…The addition of the mental steps to the claimed methods thus does not remove the prior two [administering and determining steps] from the [the realm of patentable subject matter].” (citing with approval In re Abele, 684 F.2d 902 (CCPA 1982.)) At least the court did not agree that the correlating steps are themselves natural phenomena, which was part of the district court’s opinion.
Furthermore (and importantly), the court held that the claims do not wholly preempt use of correlations between metabolite levels and efficacy or toxicity of the administered immunosuppressive drug: “As discussed above, the claims are to transformative methods of treatment, not correlations…Moreover the claims do not preempt natural processes; they utilize them in a series of specific steps…because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.” (This is an interesting “rule” that perhaps was developed to show the utility of the Bilski M or T test. It also can easily be extended to rebut Justice Breyer’s dissent in Lab. Corp., 548 U.S. 124 (2006) in which the dissenters argued that a diagnostic method that recited an analyte-determining step and a correlating step simply was an attempt to claim a natural phenomenon.) Earlier in the opinion, Judge Lourie reiterated the rule that “the patent eligibility of a claim as a whole should not be based on whether selected limitations constitute patent-eligible subject matter (citing Diehr and Parker v. Flook).
Finally, and this is my opinion, the next action of the Federal Circuit should be to reconsider and withdraw its summary affirmance in Classen v. Biogen IDEC, supposedly compelled by Bilski, of a district court ruling that a claim to a method of evaluating a treatment method that involves a vaccination protocol was not-patent eligible. As discussed in my March 2009 post in this blog on Classen (2008 WL 5273107 Fed. Cir. 2008). There is no question that a vaccination method that is, in effect, a method of treatment of an immune-mediated disorder, is transformative of the vaccinated subject.
Federal Circuit Reverses District Court's Finding that Generic Eloxatins do not Infringe Sanofi's PatentFriday, September 11th, 2009
In my June 22, 2009 post, I discussed the district court decision that found a claim to optically-pure oxaliplatin (U.S. Pat. No 5,338,874) not infringed by defendants who made it by processes other than the HPLC process disclosed in the specification. I noted that this was an extreme case of “patent profanity” being used against a patentee to effectively convert a compound claim into a product-by-process claim, despite qualifying language used in the specification that HPLC purification is an “illustrative method” and a “representative process” by which the claimed compound may be prepared. I suggested that such language should always be employed and that applicants should focus on the distinguishing properties of the claimed compound when arguing patentability, not on the need to use a specific process to prepare it.
These are just the arguments that Sanofi used on appeal (Please see disposition attached at the bottom of this post), and the Federal Circuit found them convincing.:
“[H]ere the patent specification and prosecution history focus on the property of the composition (optical purity) and not the process used to obtain that property. The specification defines the invention as oxaliplatin of optically high purity, not oxaliplatin prepared by the disclosed HPLC process. … The specification never asserts that HPLC is required to obtain optically pure oxaliplatin … the prosecution history also illustrates that it is the optical purity of oxaliplatin that distinguished it from the prior art, not the process used to obtain that purity.”
Nonetheless, as noted in my prior post, the district court did locate enough references of the need to use a “specific” process to obtain the optically-pure material, to justify reading the HPLC process limitation into the claim. While the Federal Circuit barely references the defendants’ arguments, the court distinguished the primary decision relied upon by the district court, Andersen Corp. v Fiber Composites, LLC, 474 F.3d 1361 (Fed. Cir. 2007). In that case, a processing limitation was added to a structural claim, “where that patentee relied on that process both to define the invention and to distinguish the prior art.” The Federal Circuit “determined that the specification attributed the claimed physical properties to the process and that the specification indicated that the pelletizing step was a requirement, not a preference, of the invention …[and] that the patentee had clearly disavowed other processes during prosecution.”
I don’t think that this decision provides the “last word” on what constitutes clear disavowal of “other processes”, but it is clear that drafters should always use lots of qualifying language, even if only one method is disclosed to yield the claimed product. Also, the novel and unobvious properties of the resultant product should be the only focus of patentability arguments, and not how clever applicants were to figure out the process that finally yielded it, let alone that the process is essential to the novel and unobvious properties, e.g., that it imparts them in some way. Also, other processes that could conceivably yield the claimed product should not be disparaged, even if they are in the prior art. Can you reliably protect your compound claims (much less your process claims) from this sort of attack? Probably not, but don’t expect generic oxaliplatin on the market any time soon.
Commissioner for Patents John Doll to Retire; Robert L. Stoll Nominated as Successor, Margaret Focarino Named Deputy Commissioner
The USPTO today announced significant changes among the senior management team of its Patent organization. After 35 years at the USPTO, Commissioner for Patents John Doll has announced his intention to retire from the agency on October 2. Under Secretary of Commerce for Intellectual Property and Director of the USPTO David Kappos has, in turn, nominated longtime USPTO executive Robert (“Bob”) Stoll to the position of Commissioner for Patents, and has named Margaret (“Peggy”) Focarino Deputy Commissioner for Patents.
“Bob brings to this position a rare expertise in patent policy and practice, as well as a strong command of the inner-workings of the USPTO and the federal government,” Kappos said. “Working hand-in-hand with Peggy, who has shown incredible skill in Patents management and operations, I know they will meet the formidable challenges facing the Patent organization, including the need to drastically reduce pendency, improve quality and boost efficiency, all while managing costs in a tough budgetary environment.”
U.S. Commerce Secretary Gary Locke, who will appoint Doll’s replacement, expressed support for Stoll’s nomination.
“I have directed the USTPO to pursue an aggressive agenda to significantly reduce the time it takes to process patent applications,” Locke said. “The length of time it takes causes uncertainty for inventors and entrepreneurs, stifles innovation and impedes our economic recovery. Bob’s deep knowledge of the Patent Office will make him an important addition to the senior management team as they reform the system and help us regain America’s competitiveness.”
Locke will appoint Stoll after Doll’s retirement becomes official.
“John is to be commended on his accomplished, 35-year career at the USPTO,” Kappos said. “We are grateful for his service to the agency, and, specifically, for leading the Patent organization through a period of unprecedented growth—in terms of filings, new examiner hires and adoption of electronic processing. He has earned respect both inside and outside the agency for his leadership, his knowledge and his passion for the USPTO and the U.S. intellectual property system. We wish him all the best.”
“We thank John for his public service and congratulate him on his retirement,” Locke said. “He had a remarkable career at the USPTO and we wish him well.”
Bob Stoll has held a series of leadership positions during his 27-year career with the USPTO. He began his USPTO career as a patent examiner, then later held critical management roles including Supervisory Patent Examiner; Executive Assistant to the Assistant Secretary of Commerce and Commissioner of Patents and Trademarks; Administrator of the Office of Legislative and International Affairs where he led a staff of attorneys representing the USPTO before Congress and in diplomatic and policy arenas worldwide; and Director of Enforcement, where he led the USPTO’s efforts to fight the counterfeiting and piracy of American intellectual property. Most recently, Stoll served as Dean of Training and Education for the USPTO where he directed efforts to train foreign officials and the public on all aspects of IP. He holds a bachelor of science in chemical engineering from the University of Maryland, a J.D. from Catholic University and is a member of the Maryland state bar.
The appointment of Peggy Focarino to the position of Deputy Commissioner for Patents creates a streamlined management structure for the Patent organization. Focarino has been with the agency for more than 32 years, and has significant experience as a patent examiner, supervisory patent examiner and technology center director. During her tenure as Deputy Commissioner for Patent Operations, where she had oversight of the agency’s patent examining corps, Focarino implemented a new approach to training examiners, and supported telework programs for patent examiners and technical support staff.
The Commissioner for Patents is nominated by the Under Secretary of Commerce for Intellectual Property and is appointed by the Secretary of Commerce for a term of five years.