Patents4Life | Biotechnology Patent Law Blog

Let’s Get Physical! Australian Patent Office Wrestles With Method Claims

Posted on November 17, 2010 by Warren Woessner

The Australian Patent Office appears to grappling with the requirement that a physical effect take place in order for a business method to be patentable. This note sent by Bill Bennett of Pizzeys Patent and Trademark Attorneys raises interesting issues about the need for a “physical effect” as “the touchstone of patentability.”

The APO has issued a decision which has created uncertainty regarding the patentability of business methods.

Until recently, our advice to clients was that business methods were patentable in AU, provided that the claims were limited to execution of the business method in a computer environment.

The APO has now issued the Iowa Lottery decision in which the Deputy Commissioner of Patents concludes (at para 17) that:

I do not believe there is any authority in Australian law for the proposition that the mere identification of a physical effect is sufficient for patentability. (underlining added)

The decision can be viewed here:
https://www8.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/APO/2010/25.html

The above reference to “physical effect” is a reference to the precedential decision of the Full Federal Court in the Grant case. In 2006, the Full Federal Court concluded in the Grant case (at para 32) that:-

A physical effect in the sense of a concrete effect or phenomenon or manifestation or transformation is required. In NRDC, an artificial effect was physically created on the land. In Catuity and CCOM as in State Street and AT&T, there was a component that was physically affected or a change in state or information in a part of a machine. These can all be regarded as physical effects. (underlining added)

Thus, the Full Federal Court in Grant found that “physical effect” is the touchstone of patentability. It is especially noteworthy that the Full Federal Court expressly referred with approval to cases where a business method was implemented in a computer environment such that performance of the method resulted in a “change of state or information” in a part of the computer.

We find it very difficult to reconcile the Deputy Commissioner’s statement in Iowa Lottery with the precedential statements of the Full Federal Court in Grant. The apparent discord between the Deputy Commissioner’s view and legal precedent may ultimately only be clarified by further appeals to the Federal Court by patent applicants denied claims to business methods.

Until such time that the law is further clarified, our practical advice to applicants is to draft and claim inventions in the context of being a method of operating a computer (as opposed to being a business method which happens to be implemented in a computer). Such description and claims should focus heavily on the changes in state or information which occur within the computer and should make these features central to the invention. For cases which have already been filed in AU, we suggest re-drafting, within the limits of allowable amendments, to focus heavily on the changes in state or information that occur within the computer.

Posted in Non-U.S. Practice | Tagged Australia, Bill Bennett, business methods, intellectual property, ip, IP law tools, Patent Law, patent strategy, patents, Warren Woessner | 1 Comment

PTO Proposes Simplified Appeal Process – Compared to What?

Posted on November 16, 2010 by Warren Woessner

On November 15^th, Director Kappos published 21 pages of proposed rulemaking entitled “Rules of Practice Before the [BPAI] in Ex parte Appeals.” 75 Fed. Reg. 69828 (Nov. 15, 2010). (A copy is available at the end of this post.) There is an entire column of “Background” which summarizes the fate of the rule changes first proposed on July 30, 2007, widely criticized, never implemented, currently stayed and now proposed to be rescinded in favor of these new proposed rules. The new rules have two main thrusts: to simply the briefing process and to get the appeal before the Board more quickly (and to keep it there).

To provide some context, I filed an Appeal Brief under the rules then in effect on Oct. 12, 2007, the Examiner filed an answer in January 2009 and I filed a Reply in February 2009. The application was not forwarded to the Board and docketed until January 2010 (!) Most of the delay was apparently caused by the Examiner’s failure to list one piece of art in the “evidence relied upon” section of his Answer. The new rules intend to prevent this sort of delay by transmitting the appeal to the Board after the Reply is received (and the Examiner would not be able to respond to the Reply Brief). The Board has the sole authority to determine non-compliance but would not be able to remand an application to the Examiner without the Director’s approval. There are many other changes, too numerous to “reprint” here, but some stuck in my head after reading most of the notice.

Preparation of the Brief is simplified somewhat by not requiring a statement of the detailed history of the claims on appeal, not requiring that support be given for every claim limitation in the independent claims – only those in dispute — and by omitting the requirement for the “claims appendix” and the “evidence appendix.” The Board is to presume that the appeal is taken from all claims under rejection, even if appellant fails to list them all. The options if the Examiner enters a new ground of rejection are clarified (I think), as well as the required statement of related appeals, interferences and judicial proceedings (I think), and examples of new grounds of rejection are given. The proposed rules make it perfectly clear, however, that substantive prosecution stops after filing the appeal brief (not upon filing the notice of appeal). However, applicants can still send in case law that advances their position. Importantly, the new rules eliminate the “presumption of Examiner correctness” from the rules. For background on this presumption, see 75 Fed. Reg. at 69835.

With the Board currently affirming rejections 65-70% of the time, the new rules, even if they are finalized, may only smooth your prosecution highway to the edge of a cliff, but at least the Director seems well aware that “justice delayed is justice denied.” Now let’s work on the “justice” part a little harder.

75 FedReg at 69835

Posted in USPTO Practice and Policy | Tagged biotechnology law, biotechnology news, David Kappos, Federal Circuit, intellectual property, ip, IP law tools, USPTO, Warren Woessner | Leave a comment

Federal Circuit Clarifies Prosecution Laches

Posted on November 10, 2010 by Warren Woessner

The facts of Cancer Research Tech. v. Barr Labs., Inc., App. No. 2010-1204 (Fed. Cir. November 9, 2010) (PDF at end of post) are almost more interesting than the holding, which is : “We…now hold that to establish [the prejudice necessary for a finding of prosecution laches] an accused infringer must show evidence of intervening rights. Since the accused infringer, Barr, was seeking approval of an ANDA on a drug patented by Cancer Research Tech., and brought to market by Schering (not surprisingly) well before Barr filed its ANDA, Barr was not going to be able to meet this burden.

However, the back-story is of some interest to patent prosecutors in the life sciences/pharma area, if only for the light it sheds on PTO prosecution policy. The original application for the patent-in-suit, that covers the anti-cancer drug Temodar, was filed in 1982. In November 1983, in the first substantive office action, the Examiner rejected the claims to a method for treating leukemia as facially lacking utility because leukemia was clearly untreatable, and went on to say that utility could be established by FDA approved tests. The Examiner cited Ex parte Timris, which, ironically was one of the first Board decisions to hold that methods of medical treatment are patentable subject matter. Of course, we take this for granted, as the Fed. Cir. did recently in Prometheus v. Mayo, but Timris was a 1959 decision, not an 1859 decision(!). Still, Examiners threw up every imaginable legal and policy roadblock to support lack of utility and nonenablement rejections of claims to compounds and their uses disclosed to be useful to treat cancer, and then AIDS, at least well into the 90’s. (Just a few years ago, an Examiner asserted that the PTO was the “gatekeeper for the FDA” but that’s another story.)

In vitro inhibition of cancer cells was routinely disregarded. Ex parte Balzarini,(1991), the Board agreed with the Examiner that in vitro efficacy of anti-HIV drugs did not correlate to an expectation of success of human treatment, providing unwarranted difficulties to applicants seeking to slow the epidemic. It was not until In re Brana in 1995 that the Fed. Cir. held that animal models of human disease could suffice to establish utility/enablement in the case of an anti-cancer drug. This holding did not help those of us prosecuting claims to potential anti-HIV drugs, since there was no readily available animal model for the disease but, to its credit, the PTO informally ignored Balzarini almost before it was decided, at least in the HIV area. Interestingly, the Cancer Research Tech. decision mentions that Cancer Research eventually cited In re Buting, a 1969 CCPA decision that held, as did Brana, 27 years later, that positive test results in accepted animal models could establish utility of a compound in humans.

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Posted in Post-Grant Issues | Tagged barr, biotechnology, biotechnology news, cancer research tech, Federal Circuit, intellectual property, ip, IP law tools, temodar, Warren Woessner | Leave a comment

Supreme Court To Address Scope Of Bayh-Dole Act

Posted on November 3, 2010 by Warren Woessner

On Monday, November 1st, the Supreme Court granted certiorari in Stanford v. Roche, 583 F.3d 832 (Fed. Cir. 2009), in which the Fed. Cir. decided that a professor could void his University-employer’s rights under the Bayh-Dole act to elect title to an invention he made with government grant support, by assigning his rights in the invention to a third-party, prior to the University’s electing title. The Solicitor General, at the Invitation of the Court, has filed an persuasive and informative amicus brief, which contains a very clear summary of the history and features of the Bayh-Dole Act, that should be perused by any patent attorney who has a substantial university-institutional practice. A copy of that amicus brief can be found at the end of this post.

Prior to enactment of the Act in 1980 – note that Chakrabarty was decided in 1980 and the Cohen-Boyer patent issued in 1980 – few university inventions made with Government grant support ever made it from “bench to bedside,” due to a patchwork of regulations on ownership and patent rights that differed from agency to agency. The Act founded the “industry” of modern university “tech transfer.” After passage of the Bayh-Dole Act, a university could elect to take title to an invention made with, say, NIH grant support, usually by filing a patent application on it, reporting it and making its election to the appropriate agency. The inventor(s) had no personal rights to inventions made with such grant support, but they were not left out in the cold. The Act required sharing of any royalties earned by licensing the patent with the inventor(s), and the university was required to use some of the funds to support research; often a portion of the royalties were returned to the inventor’s department. If a professor wished to patent, he/she was required to work with the university tech transfer office, who would in turn work with outside counsel to file patent applications and hopefully, license them to industry or to a v.c.-funded start –up. Over the last 30 years, this system has yielded hundreds of millions of dollars to universities and other non-profit organizations, and led to the commercialization of inventions as diverse as anti-HIV drugs (Ziagen), therapeutic enzymes (Myozyme), medical software, organic herbicides and a shrub willow bioenergy source. See http://www.betterworldproject.net/. A few universities even show up in annual lists of top patent-obtaining organizations.

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