Vanderbilt University v. Icos Corp.

• Decision Date: 27 January 2009
• Docket Number: No. 05-506-SLR.,05-506-SLR.
• Citation: 594 F.Supp.2d 482
• Parties: VANDERBILT UNIVERSITY, Plaintiff, v. ICOS CORPORATION, Defendant.
• Court: U.S. District Court — District of Delaware

Page 482

594 F.Supp.2d 482

VANDERBILT UNIVERSITY, Plaintiff, v. ICOS CORPORATION, Defendant.

Civ. No. 05-506-SLR.

United States District Court, D. Delaware.

January 27, 2009.

Vincent A. Bifferato, Jr., Esquire, Ian Connor Bifferato, Esquire, and Raj Srovatsan, Esquire of Bifferato Gentilotti LLC, Wilmington, DE, Of Counsel: Kurt C. Rommel, Esquire of Miles & Stockbridge P.C., McLean, VA; Robert S. Brennen, Esquire and Donald E. English, Jr., Esquire of Miles & Stockbridge P.C., Baltimore, MD, for Plaintiff.

Richard K. Hermann, Esquire and Mary B. Matterer, Esquire of Morris James LLP, Wilmington, DE, Of Counsel: Kevin M. Flowers, Esquire, Thomas I. Ross, Esquire, and Matthew C. Nielsen, Esquire of Marshall, Gerstein & Borun LLP, Chicago, IL, for Defendant.

OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

Plaintiff Vanderbilt University ("plaintiff" or "Vanderbilt") brought the present action pursuant to 35 U.S.C. § 256 against defendant ICOS Corporation ("defendant" or "ICOS") on July 20, 2005, requesting that the court direct the United States Patent and Trademark Office ("PTO") to correct U.S. Patent Nos. 5,859,006 ("the '006 patent") and 6,140,329 ("the '329 patent") by adding three Vanderbilt professors as inventors. (D.I. 1) A bench trial was held between January 7, 2008 and January 15, 2008 on the issues of inventorship of the '006 and '329 patents. Posttrial briefing has been completed. (D.I. 153, 150, 154) The court has jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338. Having considered the documentary evidence and testimony, the court makes the following findings of fact and conclusions of law pursuant to Fed.R.Civ.P. 52(a).

II. FINDINGS OF FACT AND COCLUSIONS OF LAW¹

A. The Parties

1. Vanderbilt is a Tennessee not-forprofit corporation with its principal place of business in Nashville, Tennessee. (D.I. 130, ex. 1 at ¶ 1) Vanderbilt brought this action pursuant to 35 U.S.C. § 256, requesting that the court add Jackie D. Corbin, Ph.D., Sharron H. Francis, Ph.D., and Sekhar R. Konjeti, Ph.D. as inventors on the '006 and '329 patents. (D.I. 1) All three scientists are employed as professors at Vanderbilt and, consistent with their terms of employment, have assigned all rights that they may have in the '006 or '329 patents to Vanderbilt. (PTX-6; PTX-7; PTX-8) 2. ICOS is a Delaware corporation with its principal place of business in Bothell, Washington.² (Id. at ¶ 2) ICOS is the owner by assignment of the '006 and '329 patents (together, the "patents at issue").

3. Glaxo Wellcome Inc. is a North Carolina corporation (hereinafter, "Glaxo").³ Glaxo Group Limited is Glaxo's English subsidiary (hereinafter, "Glaxo U.K."). In 1991, Glaxo⁴ and Glaxo U.K. entered into a collaboration with ICOS, assigning to ICOS the rights, title, and interest in the compounds covered by the patents at issue. (PTX-406) At all times relevant to the present litigation, Glaxo maintained a research facility in Les Ulis, France (hereinafter, "Glaxo France").

B. The Technology at Issue

4. Cyclic guanosine monophosphate ("cGMP") is a chemical messenger in the body that activates cGMP kinase,⁵ resulting in the relaxation of smooth muscle tissue. The relaxation of vascular smooth muscles lead to vasodilation⁶ and increased blood flow. (103:5-23) Phosphodiesterase-5 ("PDE5") is an enzyme that breaks down cGMP. (Tr. 103:4-5) PDE5 has two different binding sites: one for binding cGMP to regulate it, and another for binding cGMP to break it down. (D.I. 140 at 115:20-116:24) Phosphodiesterase (or "PDE") inhibitors prevent the degradation of cGMP, thereby enhancing and/or prolonging smooth muscle relaxation.

5. The '006 patent claims at issue (claims 1-8, 10, 12 and 13) are directed to chemical compounds and methods for making those compounds. The compounds are tetracyclic derivatives of the following general structure:

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

The '006 patent provides that such compounds are "potent and selective inhibitors of cyclic guanosine 3',5'-monophosphate specific phosphodiesterase (cGMP specific PDE)." ('006 patent, col. 1, II. 8-12)

6. The '006 patent teaches that PDE5 inhibition caused by the claimed compounds results in elevated cGMP levels, resulting in, amongst other benefits, improved vasodilation. ('006 patent, col. 5, II. 15-35) Such compounds are of interest "for the treatment of a variety of conditions where inhibition of [PDE5] is thought to be beneficial," for example, the treatment of cardiovascular disorders. ('006 patent, col. 1, II. 12-15; col. 5, II. 9-14)

7. The '329 patent claims at issue (1, 2, 3, 5-12, and 15-21) are directed to compositions and methods of treating impotence, also called erectile dysfunction ("ED"), in a male animal involving the administration of at least one of the compounds claimed in the '006 patent. One such compound is "tadalafil,"⁷ the active ingredient in the prescription ED drug Cialis®. Tadalafil has the following structural formula:

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

C. Nature of the Dispute

8. Plaintiff asserts that Corbin, Francis and Konjeti conceived of a compound, 8(4-hydroxy phenylthio)-IMBX (also referred to as 8-(4-OH-PT)-IMBX), which was communicated to Glaxo in 1992 pursuant to a research agreement. According to plaintiff, the disclosure of 8-(4-OPT)-IMBX led to Glaxo's development of two molecules incorporating the same molecular scaffold and, ultimately, the general chemical structure of formula 1 of the '006 and '329 patents.

9. Glaxo scientist Dr. Alain Daugan, who began work on Glaxo's PDE inhibitor project in June 1992, is the sole named inventor on the '006 and '329 patents. Defendant asserts that Daugan independently conceived the claimed compounds by conducting a comprehensive medicinal chemistry study between June 1992 and January 1994.

D. Legal Framework

10. 35 U.S.C. § 116 provides that "[w]hen an invention is made by two or more persons jointly, they shall apply for a patent jointly and each make the required oath, except as otherwise provided in this title. Inventors may apply for a patent jointly even though (1) they did not physically work together or at the same time, (2) each did not make the same type or amount of contribution, or (3) each did not make a contribution to the subject matter of every claim of the patent."

All that is required of a joint inventor is that he or she (1) contribute in some significant manner to the conception or reduction to practice of the invention, (2) make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention, and (3) do more than merely explain to the real inventors well-known concepts and/or the current state of the art.

Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed.Cir.1998). Section 116 "sets no explicit lower limit on the quantum or quality of inventive contribution required for a person to qualify as a joint inventor. Rather, a joint invention is simply the product of a collaboration between two or more persons working together to solve the problem addressed." Fina Oil and Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed.Cir.1997) (citing Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1227 (Fed.Cir.1994)).

11. "A patent is invalid if, more or fewer than the true inventors are named." Gemstar-TV Guide Intern., Inc. v. Int'l Trade Com'n, 383 F.3d 1352, 1381 (Fed.Cir.2004) (citing Jamesbury Corp. v. United States, 207 Ct.Cl. 516, 518 F.2d 1384, 1395 (1975)); 35 U.S.C. § 102(f) ("A person shall be entitled to a patent unless ... he did not himself invent the subject matter sought to be patented[.]") Because patents are presumed valid, 35 U.S.C. § 282, there is a presumption that the named inventors on a patent are the true inventors. Gemstar, 383 F.3d at 1381 (citation omitted). This presumption may be overcome by demonstrating, by clear and convincing evidence, that the alleged omitted inventor "contribute[d] in some significant mariner to the conception of the invention" claimed. Id. (quoting Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed.Cir.1997)).

12. 35 U.S.C. § 256 provides that an error in naming persons who are not inventors or in omitting inventors will not invalidate a patent where a correction is requested (and approved by) the PTO Director, or where "[t]he court before which such matter is called in question [orders] correction of the patent on notice or hearing of all parties concerned[.]" Plaintiff at bar does not seek to invalidate the '006 and '329 patents, but seeks an order directing the Director of the PTO to correct the named inventorship. (D.I. 153 at 50) Regardless of the relief requested, Corbin, Francis, and Konjeti must establish their co-inventorship by facts supported by clear and convincing evidence.⁸ See Gemstar, 383 F.3d at 1382.

E. Inventorship Evidence

The court turns now to the findings of fact upon which its ultimate conclusion on inventorship will be based.

1. Pre-collaboration

13. Corbin and Francis have been professors of molecular physiology at Vanderbilt University School of Medicine since the 1970s. Their research focuses on the molecular aspects of smooth muscle relaxation. Francis specifically focuses on cGMP. Corbin and Francis identified PDE5 in the late-1970s. (D.I. 140 at 115:20-116:24)

14. Prior to their collaboration with Glaxo, Corbin and Francis tested several dozen cGMP analogs. (PTX-35 at VM601; D.I. 140 at 133:9-10) They discovered that there were two forms of cGMP kinase, type lα and lβ (D.I. 140 at 133:17-19)

2. Plaintiff's cGMP analog work & the communication of 8-(4-OH-PT)-IMBX to Glaxo

15. On December 16, 1988, Corbin completed an application for a "Glaxo Cardiovascular Discovery Grant." (PTX-32) Along with this application, Corbin and Francis submitted an abstract of their research proposal and the research proposal itself (hereina...