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The federal statutes governing U.S. patent law set forth several requirements that must be fulfilled in order to obtain a patent from the U.S. Patent and Trademark Office. Of these, the enablement requirement under 35 U.S.C. 112 and the utility requirement under 35 U.S.C. 101 have been at the forefront of decisions of the U.S. Court of Appeals for the Federal Circuit on patent disputes over biotechnology inventions. It appears that the current holdings on enablement and utility collide in the recent Federal Circuit case of Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005), where the ruling has the puzzling effect of a nonenabled prior patent application serving as an enabling prior art reference. A closer look at the Federal Circuit’s earlier decisions on enablement and utility and their apparent impact on the court’s reasoning in this case raises strategic issues for consideration by patent practitioners seeking protection of inventions, particularly in the field of biotechnology. Section 112 requires that an inventor adequately set forth and describe the invention (written-description requirement), the manner and process of making and using the invention (the enablement requirement) and the best mode contemplated by the inventor for carrying out his or her invention. To fulfill the enablement requirement, an applicant need not describe actual embodiments or examples. Nevertheless, the presence or absence of examples in a patent application is a factor in determining the extent to which claims, particularly broad claims involving an unpredictable technology, are enabled. What is important is that a person of ordinary skill in the art is able to practice the invention without undue experimentation. Johns Hopkins University v. Cellpro Inc., 152 F.3d 1342, 1354 (Fed. Cir. 1998). Patent claims to inventions concerning biotechnology have frequently raised enablement issues. A recurring problem is whether a specification that sets forth a single or a limited number of examples can be enabling for broad claims when the subject matter concerns biological materials or reactions, which are generally considered to be unpredictable. A lack of enablement rejection under � 112 is appropriate when the written description fails to teach those skilled in the art how to make and use the invention as broadly as it is claimed without undue experimentation. The courts have also deemed it appropriate to make an enablement rejection when the claims are rejected under 35 U.S.C. 101 for lacking utility. As the Federal Circuit has reasoned, “[o]bviously, if a claimed invention does not have utility, the specification cannot enable one to use it.” In re Brana, 51 F.3d 1560, 1564 (Fed. Cir. 1995). For novel pharmaceutical compounds, the Federal Circuit has required specific therapeutic uses in humans, and support for those uses with at least animal test data. When a use is asserted but no data are presented to support the use, the Federal Circuit has found that the application did not satisfy the requirements for a specific and substantial utility under �101 and the enablement requirement under � 112. In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005). In accordance with �101, an invention must be of some benefit. Historically, any utility, however small, is enough to meet the requirement. The court has recognized that whether an application discloses a utility for a claimed invention is a question of fact. In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir. 1993). The Supreme Court announced a more rigorous test for utility in Brenner v. Manson, 383 U.S. 519 (1966), requiring a specific benefit. As the court noted, what constitutes “useful” for purposes of the requirement can be difficult to determine. Id. at 529 (simple everyday word like “useful” can be “pregnant with ambiguity when applied to the facts of life.”). When a specific and substantial utility is described in an application, the burden is on the Patent Office to challenge a presumptively correct assertion of utility in the disclosure. It is only after the examiner provides evidence that a skilled artisan would doubt the asserted utility that the burden shifts to the applicant to provide rebuttal evidence. In re Brana, 51 F.3d 1560 (Fed. Cir. 1995). TIMING OF ENABLEMENT A specification must be enabling as of the filing date of the patent application. However, data that are collected based on the teachings of the specification can be submitted during prosecution for consideration by the examiner. In re Armbruster, 512 F.2d 676 (C.C.P.A. 1975). Affidavit evidence can be employed, but only to demonstrate that the teaching in the specification is truly enabling. In re Marzocchi, 439 F.2d 220, 223 (C.C.P.A. 1971). As with enablement, data or evidence can be submitted after filing of the application to support utility. In re Jolles, 628 F.2d 1322 (C.C.P.A. 1980). In Jolles, affidavit evidence was submitted during prosecution detailing results using the claimed compositions. Based on the evidence that was submitted after filing of the application, the Federal Circuit reversed the Patent and Trademark Office Board of Appeals and found that there was not sufficient evidence for lack of utility. One can look to this historical backdrop for insight into the recent Rasmusson v. SmithKline decision, wherein the Federal Circuit considered the enabling aspects of a single disclosure for establishing priority and for anticipating a subsequently filed application. The claims at issue in Rasmusson were drawn to a method of treating a type of prostate cancer by administering a chemical compound called finasteride, which inhibits the production of an enzyme known as 5-alpha-reductase. This compound is responsible for converting the hormone testosterone to dihydrotestosterone (DHT). High levels of DHT are associated with prostate cancer. The Rasmusson patent application at issue, U.S. Patent Application No. 08/460,296 (the ’296 application), was filed on June 2, 1995, claiming priority back to a number of applications beginning with the priority document filed on April 3, 1987. The SmithKline patents claiming the same invention, U.S. Patent No. 5,637,310 (the ’310 patent) and U.S. Patent No. 5,496,556 (the ’556 patent), were accorded the benefit of a filing date of U.S. Patent No. 5,300,294 (the ’294 patent), filed on June 27, 1990. An interference was declared between the claims of the Rasmusson ’296 application and the SmithKline ’310 and ’556 patents. The parties agreed that a person of ordinary skill in the art at the time of Gary H. Rasmusson’s earlier applications would have recognized that finasteride was a selective 5-alpha-reductase inhibitor as set forth in the Rasmusson claims. However, the parties disagreed as to whether a person of ordinary skill in the art would have believed, before June 27, 1990, that finasteride would be effective in treating prostate cancer. Rasmusson would be entitled to an earlier priority date if any of his earlier-filed applications were enabled and had utility. The Board of Patent Appeals and Interferences found that a person of ordinary skill in the art would not have believed, as of the earlier Rasmusson application filing dates, that finasteride was effective in treating prostate cancer. Based on scientific articles and expert testimony, the board concluded that a person of ordinary skill as of Aug. 10, 1993, the date of Rasmusson’s eighth application, would not have concluded that a selective 5-alpha-reductase inhibitor would have any anti-tumor effects, because the anti-tumor effects shown by published experiments could be attributable to contaminating activities having no relation to 5-alpha-reductase inhibition. Rasmusson’s June 2, 1995, application was found to meet the utility requirement in view of a 1994 presentation that reported successful results from treating prostate cancer with finasteride. Therefore Rasmusson could not claim the benefit of any of his earlier-filed applications. The Federal Circuit noted that the evidence cited by Rasmusson on appeal did not contravene the board’s finding, because that evidence was either dated too late with respect to the filing dates of the earlier applications or pertained only to the use of multiactive inhibitors to treat prostate cancer. The Federal Circuit reasoned that in order to obtain a priority date earlier than June 27, 1990, Rasmusson needed to provide experimental proof that his invention could be effective in treating cancer. Because Rasmusson failed to do so, the Federal Circuit agreed that all applications prior to his last application were not enabled and that Rasmusson was not entitled to a priority date earlier than the priority date of SmithKline’s ’310 and ’553 patents. Interestingly, post-filing publications by others are often used during prosecution to support enablement. Such publications are submitted by applicants as evidence that the invention works, particularly when the publication data were generated using protocols as set forth in the application. Instead of allowing the 1994 presentation to support Rasmusson’s earlier applications, it was only considered as evidence to support the later-filed application. However, the 1994 presentation would also anticipate the later-filed Rasmusson claims. This outcome leaves applicants in a no-win situation regarding post-filing publications. THE EUROPEAN APPLICATION The second part of the Federal Circuit’s ruling is just as perplexing as the first. The court noted that Rasmusson’s European application was published on Oct. 5, 1988, more than one year before the priority date assigned to SmithKline’s patents and reissue patent applications. In contrast to the board, the Federal Circuit found the European application to be enabling as an anticipatory reference. The Federal Circuit stopped here and remanded to the board to determine whether the European publication anticipated the SmithKline applications. The Federal Circuit noted that the standard for what constitutes proper enablement of a prior art reference for purposes of anticipation under 35 U.S.C. 102 differs from the enablement standard under �112. The Federal Circuit relied on Bristol-Myers Squibb Co. v. Ben Venue Laboratories Inc., 246 F.3d 1368 (Fed. Cir. 2001), for the holding that proof of efficacy was not required in order for a reference to be enabled for purposes of anticipation. In Bristol-Myers Squibb, the Federal Circuit upheld the district court’s determination that Bristol-Myers’ claims to methods for treating patients for regression of a taxol-sensitive tumor with taxol were invalid in view of a prior art reference that administered taxol to patients but reported no anti-tumor response. Id. at 1377. Even when the claims required a premedication step and the prior art reference suggested premedication but did not premedicate, the court concluded that “anticipation does not require actual performance of suggestions in a disclosure. Rather, anticipation only requires that those suggestions be enabling to one of skill in the art.” Id. at 1379. In Rasmusson, the court noted that the board found that at the time of the European publication, there was no reasonable scientific basis for a person of ordinary skill in the art to conclude that the claimed method would be effective in treating prostate cancer. The board also found that given the lack of proof provided in the publication, a person of ordinary skill in the art as of the publication date would not have believed that the method would be effective. The Federal Circuit however, noted that these findings were insufficient to support the board’s conclusion that the reference was not an enabling reference for purposes of anticipation. A DOUBLE STANDARD? It appears incongruous to consider that a patent application held to be deficient in enabling a claimed invention is yet enabled for anticipation purposes. Having evaluated the reference one way to determine patentability, it would seem logical to evaluate the reference in the same manner to evaluate anticipation. In the Bristol-Myers case, the court did indicate that whether a reference teaches away from the invention is inapplicable to an anticipation analysis, citing Celeritas Techs. Ltd. v. Rockwell Int’l. Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998). Bristol-Myers, 246 F.3d at 1378. However, unlike the Bristol-Myers case, Rasmusson had never actually performed any steps of the claimed method. The Federal Circuit noted that it has always held that a prior art reference does not need utility in order to serve as an anticipating reference under �102. This commonly arises with nucleic acid sequence claims. For example, a published DNA sequence, even one in which no function has been associated with it, would suffice to anticipate a claim to the same sequence. Perhaps the confusion lies in the court’s rationale that “necessarily, compliance with � 112 requires a description of how to use [currently] useful inventions, otherwise an applicant would anomalously be required to teach how to use a useless invention.” In re Brana, 51 F.3d 1560, 1564 (Fed. Cir. 1995). The holding under 35 U.S.C. 101 that the invention lacks utility because one of skill in the art would not believe that the invention would work is sufficient to prevent patentability without the need for an additional rejection under 35 U.S.C. 112 for lack of enablement. This would prevent the Rasmusson outcome of a nonenabled application being an enabled publication. The holding in Rasmussonhighlights the risks in filing an application too early if no data are available to support the claims. In such cases, care should be taken in drafting the application. Prophetic examples of experiments to prove that the invention works should be included. If no experimentation is planned, the Rasmusson ruling would discourage early filing. While not resolved, the facts of this case urge caution in citing post-filing publications to support patentability, even though previous case law is clear that utility and enablement can be established post-filing. When confronted with a reference such as the Rasmusson priority document, adding a claim limitation requiring a desired therapeutic outcome could serve to eliminate the publication as anticipatory. When no drug is administered, as with Rasmusson, one could argue there is no inherent benefit from the teachings. If the reference lacks any of the claim limitations, it is not anticipatory, and only an obviousness rejection can be made. It is clear that to render a claim obvious, a reference must suggest the claimed invention with a reasonable expectation of success. The Rasmusson case highlights the different standards of enablement under �102 and �112. The outcome suggests caution in dealing with these issues before the Patent Office. W. Murray Spruill is a partner in the Raleigh, N.C., office of Atlanta’s Alston & Bird and is chairman of the firm’s biotechnology and pharmaceutical patent group. He can be reached at [email protected]. Leslie T. Henry is a patent agent in that office and a member of the firm’s biotechnology patent practice. She can be reached at [email protected].

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