Tafas v. Dudas
| Citation | 511 F.Supp.2d 652 |
| Decision Date | 31 October 2007 |
| Docket Number | No. 1:07cv1008 (JCC).,No. 1:07cv846 (JCC).,1:07cv846 (JCC).,1:07cv1008 (JCC). |
| Court | United States District Courts. 4th Circuit. United States District Court (Eastern District of Virginia) |
| Parties | Triantafyllos TAFAS, Plaintiff, v. Jon W. DUDAS, et al., Defendants. Smithkline Beecham Corporation, et al., Plaintiffs v. Jon W. Dudas, et al., Defendants. |
Joseph Dale Wilson, III, Kelley Drye & Warren LLP, Daniel Sean Trainor, Elizabeth Marie Locke, Kirkland & Ellis LLP, Washington, DC, Craig Crandall Reilly, Richard McGettigan Reilly & West PC, Alexandria, VA, for Plaintiffs.
Lauren A. Wetzler, United States Attorney's Office, Alexandria, VA, for Defendants.
This matter is before the Court on: (1) Plaintiffs Smithkline Beecham Corporation and Glaxo Group Limited's ("GSK") Motion for a Temporary Restraining Order ("TRO") and Preliminary Injunction; (2) Defendants Jon W. Dudas and United States Patent and Trademark Office's ("PTO") Motion to Strike Exhibit E of the Memorandum in Support of GSK's Motion; (3) the Motion of Amicus Curiae American Intellectual Property Law Association ("AIPLA") for Leave to File its Brief in Support of GSK's Motion; (4) HEXAS, LLC ("Hexas"), The Roskamp Institute, and Tikvah Therapeutics, Inc.'s ("Tikvah") Joint Motion in Support of Motion for Leave to File Amici Curiae Brief in Support of GSK's Motion; and (5) the Motion of Amicus Curiae Elan Pharmaceutical Corp. for Leave to File its Brief in Support of GSK's Motion. For the reasons stated below, the Court will grant GSK's motion, deny the PTO's motion, and grant the motions for leave to file as amici.
GSK is the second largest pharmaceutical company in the world and is responsible for developing and marketing drugs that treat numerous ailments, including cancer, cardiovascular disease, respiratory diseases, HIV, and depression. The patent system encourages companies like GSK to engage in the research and development of new drugs by providing them with the legal protection that enables them to recover the significant costs that accompany development and regulatory approval of new drugs. This case deals with potential changes to this system brought on by the PTO's modification of several long-established rules.
Under both the old and new rules, to obtain patent protection an inventor first files a patent application with the PTO. The first application filed for a given invention is a "parent" or "initial" application. A parent application contains two primary parts: a "specification," which describes the invention and how to make and use it, and one or more "claims," which identify the scope of the legal protection that the invention should receive, and come in either "independent" or "dependent" forms. Once the application is filed, a patent examiner determines whether the claimed invention meets the statutory requirements found in Title 35 of the United State Code. If it is rejected, the examiner will issue an "Office Action" that contains the grounds for rejection. An applicant may then amend the claims, argue against the rejection, or present evidence to show why the invention is patentable. The patent examiner must respond by either allowing or rejecting the claim.
Upon receiving a final rejection, an applicant has four choices: (1) appeal to the Board of Patent Appeals and Interferences and from there to the Federal Circuit; (2) file a "request for continued examination" ("RCE") of the application; (3) file a "continuation" or "continuation-in-part" application; or (4) file an after final "amendment." A continuation application uses the same specification as the pending parent application and enjoys the benefit of the filing date of the parent application (the "priority date").
In situations where an applicant claims more than one independent invention in the initial application, the examiner may impose a "restriction requirement" that forces an applicant to separate their multiple independent inventions into "divisional" applications that claim a single invention. The applicant must then choose one of the inventions to prosecute in their initial application, and can prosecute the remaining inventions in their divisional applications, which claim the priority date of the parent application.
On January 3, 2006, the PTO proposed changes to its rules that would limit the number of continuing applications, RCEs, and claims that an applicant could make. The PTO justified the proposed changes on the ground that the growing number of continuing applications and increasing number and complexity of claims in applications had crippled the PTO's ability to examine newly-filed applications. After a four month public comment period where the PTO received more than 500 written comments, many of which expressed disapproval with the proposed rules, on August 21, 2007, the PTO published the Final Rules, titled "Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications." 72 Fed.Reg. 46716-46843 (Aug. 21, 2007)(to be codified at 37 C.F.R. pt. 1). The Final Rules are set to take effect on November 1, 2007.
Under the old system, an applicant could file an unlimited number of continuing applications, RCEs, and claims. The Final Rules modify that system in the several ways. First, Final Rules 78 and 114 allow an applicant to file two continuation or continuation-in-part applications, plus a single RCE, after an initial application as a matter of right. If the applicant wants to engage in further prosecution, a third continuation or continuation-in-part application or a second RCE can be filed with a "petition and showing" that explains why the amendment, argument, or evidence could not have been presented in one of the previously-filed applications. These Final Rules apply to all initial and continuing applications filed on or after November 1, 2007. In addition, under Final Rule 142, if the applicant submits an application with multiple independent inventions, with the examiner's permission a divisional application may be filed for each invention, and each divisional application will be treated as an initial application.
Second, Final Rule 75 permits an applicant to present a total of five independent claims and twenty-five total claims without providing any further information about those claims. An applicant who wants to exceed either of these limitations must provide an "examination support document" ("ESD") containing information about the claims that may assist the examiner in determining the patentability of the claimed invention. The requirements of an ESD are set out in Final Rule 265. These Final Rules apply to all applications filed on or after November 1, 2007, and all pending applications for which a first Office Action on the merits was not mailed before November 1, 2007.
Under the old system, GSK would traditionally prosecute patents in the following manner. When GSK discovered a potential class of new drug products (a "genus"), it would typically file an initial application containing a broad disclosure that includes numerous structurally-related compounds (a "species"). This broad disclosure would include a number of different inventions and disclose more than it claims. Because GSK does not know until after extensive research is performed which member of the genus will be brought to market, it would file an initial application with the understanding that it will prosecute narrower or additional patent claims in subsequent continuing applications.1 These continuing applications can claim the priority date of the parent application; consequently, publications and public information generated between the priority date and the date of the later-filed applications cannot be used against patentability.
GSK currently has roughly one hundred or more pending applications in which two or more continuing applications have been filed, and approximately thirty or more pending applications in which two or more continuing applications and a RCE have been filed. GSK also has several pending applications that have not yet received an Office Action on the merits and contain enough claims to trigger an ESD.
On October 9, 2007, GSK filed a Complaint against the PTO seeking a preliminary injunction staying the implementation of the Final Rules until the resolution of the lawsuit, a permanent injunction against the implementation of the Final Rules, a declaratory judgment that the Final Rules are contrary to law, and a request that the Final Rules be vacated. Two days later, GSK filed an Amended Complaint against the PTO seeking the same relief. On October 15, 2007, GSK moved for a TRO and preliminary injunction enjoining the implementation of the Final Rules. On October 19, the PTO moved to strike the declaration of Harry F. Manbeck, Jr., Exhibit E of the Memorandum in Support of GSK's Motion. In addition, numerous entities have filed motions for leave to file amicus curiae briefs, including: (1) AIPLA on October 25; (2) HEXAS, The Roskamp Institute, and Tikvah, jointly, on October 26; and (3) Elan Pharmaceuticals on October 29. These motions are currently before the Court.
The Federal Circuit has generally treated the grant or denial of a preliminary injunction as a procedural matter and thus has applied the procedural law of the regional circuit in which the case was brought. See Texas Instruments, Inc. v. Tessera, Inc., 231 F.3d 1325, 1328 (Fed Cir.2000); Mikohn v. Gaming Corp. v. Acres Gaming, Inc., 165 F.3d 891, 894 (Fed.Cir.1998). However, where "the issue pertains to or is unique to patent law," the Federal Circuit has applied its own law to both substantive and procedural issues "intimately involved in the substance of enforcement of the patent right." Amana Refrigeration, Inc., v. Quadlux, Inc., 172...
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