United States District Court, District of Columbia
[Copyrighted Material Omitted]
Christopher Michael Loveland, Sheppard, Mullin, Richter & Hampton LLP, Washington, DC, William A. Scofield, Jr., Lathrop & Gage LLP, Boston, MA, for Plaintiffs.
Fred Elmore Haynes, U.S. Attorney's Office, Washington, DC, for Defendant.
ELLEN SEGAL HUVELLE, District Judge.
Plaintiffs University of Massachusetts and Medarex, Inc. have sued David J. Kappos, the Under Secretary of Commerce for Intellectual Property and the Director of the U.S. Patent and Trademark Office (" PTO" ). Plaintiffs bring this suit under 35 U.S.C. § 154 and the Administrative Procedure Act (" APA" ), 5 U.S.C. §§ 701 et seq., claiming that defendant improperly determined the patent term adjustment (" PTA" ) to which they are entitled for patent '559. Before the Court are plaintiffs' Motion for Summary Judgment and defendant's Cross-Motion for Summary Judgment. For the reasons set forth below, plaintiffs' motion will be denied and defendant's motion will be granted.
I. LEGAL FRAMEWORK
Prior to 1994, U.S. patents were granted for a term of seventeen years from the date the patent issued. In 1994, Congress adjusted the term of a U.S. patent to twenty years from the date the application was filed to bring the U.S. in line with other countries' patent terms. However, because the examination of a patent application often takes more than three years from filing to the issuance of a patent, this meant that many patentees received effective patent terms of less than the historical seventeen-year period. Thus, in 1999, Congress amended the Patent Act bye creating patent term adjustments (" PTA" ) to extend patent terms in response to unreasonable delays in the examination of a patent application. See 35 U.S.C. § 154(b).
The Patent Act created several types of PTA. First, a patentee can accrue PTA if the PTO fails to take certain specified actions within fixed windows of time. Specifically, § 154(b)(1)(A) provides, in relevant part, that:
[I]f the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to ... provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after ... the date on which an application was filed under section 111(a) ...
the term of the patent shall be extended 1 day for each day after the end of the period specified ... until the action [notification or notice of allowance] is taken.
For example, if the PTO does not issue an Office action responding to a patent application within 14 months after the application was filed, the patentee will be awarded one day of PTA for every day from the end of the 14-month period until the first Office action is issued. Id. This type of PTA is known as " A delay." The PTO notifies the patentee of the amount of A delay that has been awarded when it issues the Notice of Allowance.
The PTO has promulgated a set of final rules interpreting the proper calculation of A delay under § 154(b)(1)(A), through notice-and-comment rulemaking. First, 37 C.F.R. § 1.702(a) restates the text of the statute, providing that the patent term shall be adjusted if the issuance of the patent was delayed due to the failure of the PTO to " [m]ail at least one of a notification under 35 U.S.C. § 132 or a notice of allowance under 35 U.S.C. § 151 not later than fourteen months after the date on which the application was filed[.]" Second, 37 C.F.R. § 1.703(a) provides that the period of adjustment shall include " [t]he number of days, if any, in the period beginning on the day after the date that is fourteen months after the date on which the application was filed under 35 U.S.C. § 111(a) or fulfilled the requirements of 35 U.S.C. § 371 and ending on the date of mailing of either an action under 35 U.S.C. § 132, or a notice of allowance under 35 U.S.C. § 151, whichever occurs first[.]" Third, 37 C.F.R. § 1.704(a), (b), which restates the text of 35 U.S.C. § 154(b)(2)(c)(i), (ii), provides that the term adjustment " shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application," which is defined to include " any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request[.]" This is known as " applicant delay."
A second type of PTA— known as " B delay" — accrues if the PTO fails to issue a patent within three years of the filing of the application. See 35 U.S.C. § 154(b)(1)(B). After determining the proper amount of A and B delay, the PTO must determine the extent of any overlap between the two types of delay. While plaintiffs initially challenged the PTO's calculations regarding B delay and the overlap between A delay and B delay, the PTO resolved both issues to plaintiffs' satisfaction on remand, leaving the calculations of A delay as the only remaining matter in dispute.
The subject of this case is U.S. Patent No. 7,625,559 (" '559" ), entitled " Antibodies Against Clostridium Difficile Toxins and Uses Thereof." (Plaintiffs' Motion for Summary Judgment (" Pl. Mot" ) at 4.) " The patent is for monoclonal antibodies, and antigen binding portions thereof, that specifically bind to toxins of Clostridium difficile (" C. difficile " ), and methods of making and using the same." ( Id. ) The patent application was filed with the PTO on February 4, 2005. ( Id. ) The original patent application addressed " three main embodiments of the invention— monoclonal
antibodies that bind to C. difficile toxin A, or toxin B, or both toxin A toxin B." ( Id. ) The application included other " embodiments" as well, such as methods for making the antibodies and methods of treatment using the antibodies. ( Id. at 5.) In total, the application included 80 claims. ( Id. )
On July 13, 2007, the PTO issued a first Office action establishing a " restriction requirement" pursuant to 35 U.S.C. § 121. ( Id. ) " Restriction is the practice of requiring an applicant to elect a single claimed invention (e.g., a combination or subcombination invention, a product or process invention, a species within a genus) for examination when two or more independent inventions and/or two or more distinct inventions are claimed in an application." Manual of Patenting Exam Procedure (" MPEP" ) § 802.02. The procedure is authorized by 35 U.S.C. § 121 (" If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions." ) See also 37 C.F.R. § 1.142. In the first restriction requirement issued in this matter, the Examiner divided the claims into ten different groups, each of which was purportedly related to a different and distinct invention. (Pl. Mot. at 5.) " The Examiner lumped the majority of the antibody claims together in a single Group I" and failed to divide the claims based on " whether the antibody, or antigen binding portion thereof, could specifically bind to either C. difficile toxin A or toxin B." ( Id. at 6-7.) This ran counter to the classification scheme devised by plaintiffs.
On October 9, 2007, plaintiffs filed a Preliminary Amendment and Response to the Restriction Requirement. ( Id. at 8.) They " elected" Group VIII— defined as a " ‘ composition’ comprising both an antibody that specifically binds to C. difficile toxin A and an antibody that specifically binds to C. difficile toxin B" — for continued examination, canceled original claims 1-80, and added new claims 81-95, " which fell within the elected Group VIII." ( Id. at 7, 8.) Plaintiffs did not challenge the groupings designated by the ...