Rasmusson v. Smithkline Beecham Corp.
| Decision Date | 27 June 2005 |
| Docket Number | No. 04-1192.,No. 04-1191.,04-1191.,04-1192. |
| Citation | 413 F.3d 1318 |
| Parties | Gary H. RASMUSSON and Glenn F. Reynolds, Appellants, v. SMITHKLINE BEECHAM CORPORATION, Cross-Appellant. |
| Court | U.S. Court of Appeals — Federal Circuit |
Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, New York, argued for appellants. With him on the brief were Daniel S. Glueck and Stephen E. Belisle, of Washington, DC.
Herbert H. Mintz, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for cross appellant. With him on the brief was Lara C. Kelley.
Before BRYSON, Circuit Judge, PLAGER, Senior Circuit Judge, and PROST, Circuit Judge.
This is an appeal from an interference proceeding before the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office ("PTO"). At issue in the interference proceeding were a set of claims from U.S. Patent Application Serial No. 08/460,296 ("the '296 application"), and another set of claims from U.S. Patent Nos. 5,637,310 ("the '310 patent") and 5,496,556 ("the '556 patent") and their corresponding reissue applications, U.S. Patent Application Serial Nos. 09/964,383 ("the '310 reissue patent application") and 09/984,083 ("the '556 reissue patent application"). Gary H. Rasmusson and Glenn F. Reynolds (collectively, "Rasmusson") are the inventors named on the '296 application. SmithKline Beecham Corporation is the assignee of the '310 and '556 patents and the corresponding reissue patent applications. The Board of Patent Appeals and Interferences held that Rasmusson was not entitled to the benefit of a priority date based on certain previous applications and that Rasmusson could not defeat the priority date accorded to SmithKline's patents and reissue applications. Because that decision is supported by substantial evidence and is not contrary to law, we affirm. The Board also held that SmithKline's patents and reissue patent applications were not anticipated by a European patent application, EP No. 285383 ("EP '383"). The Board based that ruling on its conclusion that EP '383 was not enabled. We reverse that aspect of the Board's decision and find that EP '383 was enabled for purposes of anticipation. We therefore remand this case to the Board for a determination of the effect of that application on the claims of SmithKline's patents and reissue patent applications and Rasmusson's '296 application.
This case relates to a method of treating a type of prostate cancer by administering a chemical compound called finasteride. Finasteride inhibits the production of an enzyme known as 5-α-reductase ("5αR"), which is responsible for converting the hormone testosterone to dihydrotestosterone ("DHT"). Both testosterone and DHT are in the class of hormones known as androgens, which bind to receptors on certain target cells and initiate a chain of biological events that are important in the expression of male sex characteristics. DHT is known to be a more potent androgen than testosterone, and high levels of DHT are associated with prostate cancer. As a result, numerous attempts have been made to decrease DHT levels by seeking out inhibitors of the 5αR enzyme.
There are two main categories of 5αR inhibitors: "selective" (or "pure") and "multi-active." Multi-active inhibitors not only inhibit the 5AR enzyme, but also reduce the effects of testosterone by competing with testosterone for the same target receptor sites. Selective 5α inhibitors decrease the level of DHT solely by inhibiting the production of the 5AR enzyme, thereby eliminating any side effects associated with blocking testosterone. The parties agree that finasteride acts as a selective 5αR inhibitor.
Rasmusson's '296 application was filed on June 2, 1995. It is the ninth in a series of applications stemming from U.S. Patent Application No. 07/034,808, which was filed on April 3, 1987. The '296 application is directed to "Methods of treating Prostatic Carcinoma with 17-Beta-N-mon osubstituted-carbamoyl-4-aza-5α-androst-1-en-3-ones." SmithKline's '310 and '556 patents and the corresponding reissue applications were previously accorded the benefit of a filing date of another issued patent, U.S. Patent No. 5,300,294 ("the '294 patent"). That filing date is June 27, 1990. Those patents and their corresponding reissue applications cover a "Method of Treating Prostatic Adenocarcinoma by employing a steroid 5-α-reductase inhibiting compound or a combination of steroid 5-A-reductase inhibiting compounds."
On January 22, 2001, the PTO declared an interference between the claims of Rasmusson's '296 application and SmithKline's '310, '556, and '294 patents, although the Board later dismissed the '294 patent from the interference. Before the Board, Rasmusson moved to have SmithKline's claims rejected, and SmithKline moved to deny Rasmusson the benefit of its eight earlier applications and to add claims to the interference from the reissue patent applications corresponding to the '310 and '556 patents.
After considering preliminary motions from both sides, the Board granted SmithKline's motion to deny Rasmusson the benefit of its eight earlier applications and to add the '310 and '556 reissue patent applications to the interference. The Board also granted Rasmusson's motion to hold the relevant claims from SmithKline's '310 and '556 patents invalid, but denied Rasmusson's motion to hold the claims of the '310 and '556 reissue patent applications invalid based on anticipation by the European counterpart to Rasmusson's first application.
As a result of its rulings on invalidity, the Board issued an Order Redeclaring Interference, which substituted a new count for the count previously declared in the interference.1 The replacement count reads as follows:
The method of claim 4 of the Rasmusson 08/460,296 application wherein the animal is human[;] or [t]he method of claim 3 of the [SmithKline] 09/964,383 application[;] or [t]he method of claim 2 of the [SmithKline] 09/984,083 application.
Claim 4 of Rasmusson's '296 application depends on claim 3, which, in turn, depends on claim 1. Taking the language of all three claims into account, the Board summarized claim 4 as follows:
A method of treating prostatic carcinoma in animals including humans which comprises administering a therapeutically effective amount of the compound 17β-(N-tertbutylcarbamoyl)-4-aza-5α-androst-1-en-3-one.
The chemical compound recited in claim 4 is a formula for finasteride.
Claim 3 of SmithKline's '383 application reads as follows:
A method of treating human prostatic adenocarcinoma which comprises administering to a subject in need thereof an oral dosage unit containing about 1 mg. to about 500 mg. of a steroid 5-α-reductase inhibiting compound from 1-6 times during a twenty four hour period.
Claim 2 of SmithKline's '083 application reads as follows:
A method of treating human prostatic adenocarcinoma which comprises administering in a human subject in need thereof, a dosage unit containing about 0.1 mg/kg to about 100 mg/kg of 17β-(Ntertbutylcar boxamide)-5-α-androst-1-ene-4-aza-3-one from one to six times daily.
The chemical formula recited in claim 2 is a representation of finasteride.
After the Board issued its decision on the parties' preliminary motions and its Order Redeclaring Interference, Rasmusson requested reconsideration of the Board's motion decision. The Board reaffirmed its earlier decision. Rasmusson appeals from aspects of the Board's ruling; SmithKline has filed a conditional cross-appeal.
The June 27, 1990, filing date accorded to SmithKline's patents and reissue applications falls between the filing dates of Rasmusson's third and fourth applications. In order to overcome the June 27, 1990, filing date, Rasmusson therefore sought priority on the basis of his first, second, and third applications, which were filed on April 3, 1987; May 19, 1988; and June 21, 1989, respectively. The Board found that Rasmusson was not entitled to priority based on any of those filing dates because the corresponding applications failed to satisfy the written description and enablement requirements of 35 U.S.C. § 112.
With respect to enablement, the Board found that none of the applications filed before the ninth application "would have enabled a person of ordinary skill in the art as of each of the respective filing date[s] to treat human prostate cancer by administering a therapeutically effective amount of finasteride to a human in need thereof without undue experimentation." The Board based that finding on its determination that a person of ordinary skill in the art would have had no basis as of the filing date of the eighth application for believing that finasteride could be used to treat prostate cancer in light of the state of the art and in light of Rasmusson's failure to provide any data to demonstrate the effects of finasteride in treating prostate cancer.
On appeal, Rasmusson asserts that the specifications of the respective applications are enabling because a person of ordinary skill in the art could perform the steps of the disclosed method without the need for any experimentation. Rasmusson argues that the Board's finding regarding efficacy does not support its finding of lack of enablement. According to Rasmusson, efficacy is not relevant to enablement, but pertains only to the issue of utility under 35 U.S.C. § 101. Because the Board did not make a determination based on section 101, Rasmusson asserts that the Board erred.
We disagree. In order to satisfy the enablement requirement of section 112, an applicant must describe the manner of making and using the invention "in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same . . . ." 35 U.S.C. § 112, para. 1. As this court has explained "the how to use prong of section 112 incorporates as a matter of law the requirement...
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