Geneva Pharmaceuticals v. Glaxosmithkline Plc

• Decision Date: 25 February 2002
• Docket Number: Nos. CIV.A. 2:01CV391, CIV.A. 2:01CV677, CIV.A. 2:01CV925.,s. CIV.A. 2:01CV391, CIV.A. 2:01CV677, CIV.A. 2:01CV925.
• Citation: 189 F.Supp.2d 377
• Court: U.S. District Court — Eastern District of Virginia
• Parties: GENEVA PHARMACEUTICALS, INC., et. al., Plaintiff, v. GLAXOSMITHKLINE PLC and Smithkline Beecham Corporation, d/b/a Glaxosmithkline Inc., Defendants.

189 F.Supp.2d 377

GENEVA PHARMACEUTICALS, INC., et. al., Plaintiff, v. GLAXOSMITHKLINE PLC and Smithkline Beecham Corporation, d/b/a Glaxosmithkline Inc., Defendants.

Nos. CIV.A. 2:01CV391, CIV.A. 2:01CV677, CIV.A. 2:01CV925.

United States District Court, E.D. Virginia, Norfolk Division.

February 25, 2002.

Conrad Moss Shumadine, Wilcox & Savage, Norfolk, VA, Leslie Morioka, DimitriosTheodore Drivas, Louis Sebastian Silvestri, White & Case LLP, New York, NY, for Geneva Pharmaceuticals, Inc.

Alan Dale Albert, Troutman Sanders Mays & Valentine LLP, Norfolk, VA, William Michael Merone, William K. Wells, Jr., Thomas J. Meloro, Steven Jeffrey Lee, Jeremiah Francis Manning, Larissa Ann Soccoli, Kenyon & Kenyon, New York, NY, for Teva Pharmaceuticals USA, Inc.

Beth Hirsch Berman, Hofheimer Nusbaum, P.C., Norfolk, VA, Christy Lynn Green, Joseph Francis Jennings, Knobbe Martens Olson & Bear LLP, Newport Beach, VA, for Ranbaxy Pharmaceuticals, Inc.

Liam O'Grady, Finnegan, Henderson, Farabow, Garrett & Dunner, Washington, DC, Kelly Ann Casey, Richard Lawrence Rainey, Walter Wayne Brown, Russell Leon Sandidge, Finnegan Henderson Farabow Garrett & Dunner LLP, Atlanta, GA, Stephen Edward Noona, Kristan Boyd Burch, Kaufman & Canoles, PC, Norfolk, VA, for Glaxosmithkline PLC.

OPINION AND ORDER

MORGAN, District Judge.

This matter comes before the Court on Plaintiff Teva Pharmaceuticals' (Teva) motion for summary judgment, alleging that both U.S. Patent Nos. 4,560,552 (the '552 patent) and 6,218,380 B1 (the '380 patent) are invalid on the grounds of obviousness-type double patenting. Both are owned by Defendant Glaxosmithkline, et. al., (Defendants and all predecessors in interest are collectively referred to as GSK). GSK filed a cross-motion for partial summary judgment, arguing that these same patents are not invalid for double patenting as a matter of law. Both motions are pursuant to Federal Rule of Civil Procedure 56. After a hearing on December 14, 2001, the Court GRANTED GSK's motion with regard to the '552 patent, because Title 35 U.S.C. § 121 precludes it from legal attack in this Court. The Court further GRANTED Teva's motion with regard to the '380 patent, FINDING that patent invalid because of obviousness-type double patenting. This opinion further sets forth the reasoning for the Court's decision.

FACTUAL¹ AND PROCEDURAL BACKGROUND

While it is not necessary to repeat the factual background contained in the Court's August 27, 2001 order declining to dismiss or transfer venue in the related matter, Geneva Pharmaceuticals v. GSK,² a brief factual recitation is appropriate.

AUGMENTIN® is an oral antibacterial combination consisting of the antibiotic amoxicillin and the β-lactamase inhibitor, potassium clavulanate, which is the potassium salt form of clavulanic acid. GSK has been marketing AUGMENTIN® in the United States since the FDA first approved the antibiotic in 1984. AUGMENTIN® and its component parts are the subject of a number of patents. The subject of Plaintiffs' motion is that its proposed generic version of AUGMENTIN® will not infringe upon the '552 patent and '380 patent held by Defendant GSK, which expire in 2002 and 2017, respectively, because they are invalid due to double patenting. The original patents for AUGMENTIN® begin expiring in the summer of 2002. The Plaintiff has applied to the Food and Drug Administration to begin producing generic AUGMENTIN® upon the expiration of the original patents. In this action, Plaintiff seeks a declaratory judgment, pursuant to 28 U.S.C. §§ 2201-2 and Rule 57 of the Federal Rules of Civil Procedure, that the '552 patent and the latest patents issued covering AUGMENTIN® are invalid.

On October 31, 2001, this cause of action was joined with an action previously filed in this Court by Geneva Pharmaceuticals, Inc., against these same defendants. Subsequently, all parties have agreed to join another cause of action to this litigation, i.e. Ranbaxy Pharmaceuticals Inc. v. Glaxosmithkline, et al.,³ which was filed on January 16, 2002.

STANDARD OF REVIEW

District courts may enter summary judgment only when there is no genuine issue of material fact and the movant is entitled to judgment as a matter of law. Fed. R.Civ. P. 56(c); Eli Lilly and Co. v. Barr Laboratories, et al., 251, F.3d 955, 962 (Fed.Cir.2001); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The burden falls on the moving party to show that there is no genuine issue of material fact. Fed. R.Civ. P. 56(c); Charbonnages de France v. Smith, 597 F.2d 406, 414 (4th Cir.1979). The non-moving party who bears the burden of proof on a particular claim, however, must present evidence to support each element of his claim. See Celotex v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). This evidence must be more than a mere scintilla, and summary judgment may be granted "[i]f the evidence is merely colorable, or is not significantly probative." Anderson, 477 U.S. at 249-50, 106 S.Ct. 2505. Nonetheless, all inferences drawn from the facts must be viewed in the light most favorable to the non-moving party, with "his version of all that is in dispute accepted, [and] all internal conflicts in it resolved favorably to him." Charbonnages de France, 597 F.2d at 414. When evaluating a motion for summary judgment in a patent case, the court views the record evidence through the prism of the evidentiary standard of proof that would pertain at a trial on the merits. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252-53, 106 S.Ct. 2505, 91 L.Ed.2d 202, (1986).

Statutorily, a patent enjoys a presumption of validity,⁴ which can only be overcome through clear and convincing evidence. United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1563 (Fed. Cir.1997). Therefore, a moving party seeking to invalidate a patent "must submit clear and convincing evidence of invalidity so that no reasonable jury could find otherwise." Eli Lilly, 251 F.3d at 962. "Alternatively, a moving party seeking to have a patent held not invalid at summary judgment must show that the non-moving party, who bears the burden of proof at trial, failed to produce clear and convincing evidence on an essential element of a defense upon which a reasonable jury could invalidate the patent." Id.

TITLE 35 U.S.C. § 121

Before the Court can reach the substantive issues before it on these matters, 35 U.S.C. § 121 ("Section 121" or "§ 121") must be examined. Section 121 provides in pertinent part:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them.

In simplified terms, this section of the code shields a patent-holder from a charge of double patenting when the holder was forced by the Patent and Trademark Office ("PTO") to sever the disputed patents from a single application into multiple applications. See Applied Materials, Inc. v. Advanced Semiconductor Materials, 98 F.3d 1563, 1568 (Fed.Cir.1996). In her concurring opinion in Studiengesellschaft Kohle mbH v. Northern Petrochemical Co., Judge Pauline Newman set out the purpose of § 121 rather succinctly by stating, "Section 121 effects a form of estoppel that shields the applicant from having to prove the correctness of the restriction requirement in order to preserve the validity of the second patent." 784 F.2d 351, 361 (Fed.Cir.1986).

THE '552 PATENT

On April 17, 1975, SmithKline Beecham Corporation, a predecessor in interest of GSK, filed a patent application⁵ with the PTO seeking patent protection for the combination of compounds that would eventually become the drug AUGMENTIN®. That application contained 35 claims related to the varying aspects of clavulanic acid and its properties and uses. In April, 1976, Examiner Richard J. Gallagher imposed a four-way restriction requirement ordering that the 35 claims in the application be submitted in multiple applications.

After Gallagher issued this restriction requirement, the claims were separated and pursued in separate applications. The claim that eventually issued as the '552 patent was included as part of the divisional application designated as Serial Number 726,480 (the '480 application). That application, too, was subject to a requirement of restriction. The claim that eventually became the '552 patent was included in a number of applications subject to restriction requirements, as the PTO ordered the claims from the '480 application further broken down over the ensuing years.

On March 5, 1979, Examiner Jerome D. Goldberg imposed the final restriction requirement leading to the '552 patent. Goldberg ordered that claims 36-105 of the claims in application Serial Number 964,035 be separated due to his requirement of restriction. Unmistakably marked on the form issued that day, Goldberg stated that these claims were "subject to a restriction or election requirement." "Applicants are ... required to elect an invention of a single disclosed composition containing clavulanic acid and one penicillin or celpahosporin antibiotic for examination on the merits." GSK Cross-Mot. at Exhibit 52. From this requirement of restriction, GSK filed applications for, and was issued, the '552 patent and U.S. Patent Number 4,525,352 (the '352 patent).

Plaintiffs now come to the Court and ask it to decide the question of whether the '552 patent was obvious over the '352 patent, and therefore improperly issued. The Court, however, cannot reach that issue. As stated earlier, § 121 says, "[A]n application filed as a result of ... a [restriction] requirement, shall not be used as a reference ... in the courts against a divisional application or against the original application or...