413 F.3d 1318 (Fed. Cir. 2005), 04-1191, Rasmusson v. SmithKline Beecham Corp.

Docket Nº:04-1191, 04-1192.
Citation:413 F.3d 1318
Party Name:75 U.S.P.Q.2d 1297 Gary H. RASMUSSON and Glenn F. Reynolds, Appellants, v. SMITHKLINE BEECHAM CORPORATION, Cross-Appellant.
Case Date:June 27, 2005
Court:United States Courts of Appeals, Court of Appeals for the Federal Circuit
 
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Page 1318

413 F.3d 1318 (Fed. Cir. 2005)

75 U.S.P.Q.2d 1297

Gary H. RASMUSSON and Glenn F. Reynolds, Appellants,

v.

SMITHKLINE BEECHAM CORPORATION, Cross-Appellant.

Nos. 04-1191, 04-1192.

United States Court of Appeals, Federal Circuit

June 27, 2005

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[Copyrighted Material Omitted]

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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.

BRYSON, 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.

I

A

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--reductase ("5R"), 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 5R enzyme.

There are two main categories of 5R inhibitors: "selective" (or "pure") and "multi-active." Multi-active inhibitors not only inhibit the 5vR enzyme, but also reduce

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the effects of testosterone by competing with testosterone for the same target receptor sites. Selective 5 inhibitors decrease the level of DHT solely by inhibiting the production of the 5vR enzyme, thereby eliminating any side effects associated with blocking testosterone. The parties agree that finasteride acts as a selective 5R inhibitor.

B

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-5-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--reductase inhibiting compound or a combination of steroid 5-v-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

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17J-(N-tertbutylcarbamoyl)-4-aza-5-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...

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