In Medtronic CoreValve, LLC v. Edwards Lifesciences Corp., the Federal Circuit affirmed the district court’s finding that the patent at issue was invalid because of a defective priority claim. While practitioners may cringe at the apparent clerical error underlying the decision, the USPTO’s new requirement that priority claims be included in an Application Data Sheet may safeguard future patents from this pitfall.

The Patent At Issue

The patent at issue was Medtronic CoreValve’s U.S. Patent 7,892,281, directed to prosthetic valves. Relevant to this case is its extensive priority claim:

The present application claims priority under 35 U.S.C. § 120 as a continuation of U.S. application Ser. No. 12/029,031, filed Feb. 11, 2008, which is a continuation of U.S. application Ser. No. 11/352,614 filed Feb. 13, 2006, now U.S. Pat. No. 7,329,278, which is a continuation of U.S. application Ser. No. 10/412,634 filed Apr. 10, 2003, now U.S. Pat. No. 7,018,406, which is a continuation-in-part of U.S. application Ser. No. 10/130,355, now U.S. Pat. No. 6,830,584, which has a 371(c) date of Nov. 26, 2002 and is the U.S. national phase under § 371 of International Application No. PCT/FR00/03176, filed on Nov. 15, 2000, which was published in a language other than English and which claims priority from French Application No. 99/14462 filed on Nov. 17, 1999, now French Patent No. 2,800,984; application Ser. No. 10/412,634 is also a continuation-in-part of International Application No. PCT/FR01/03258 filed on Oct. 19, 2001, which was published in a language other than English and which claims priority from French Application No. 00/14028 filed on Oct. 31, 2000, now French Patent No. 2,815,844. The present application also claims priority under 35 U.S.C. § 120 as a continuation of U.S. application Ser. No. 11/434,506 filed May 15, 2006,which is a continuation-in-part of U.S. application Ser. No. 10/772,101 filed Feb. 4, 2004, which is a continuation-in-part of U.S. application Ser. No. 10/412,634 filed Apr. 10, 2003, now U.S. Pat. No. 7,018,406, which is a continuation-in-part of U.S. application Ser. No. 10/130,355, now U.S. Pat. No. 6,830,584, which has a 371(c) date of Nov. 26, 2002 and is the U.S. national phase under § 371 of International Application No. PCT/FR00/03176, filed on Nov. 15, 2000, which was published in a language other than English and which claims priority from French Application No. 99/14462 filed on Nov. 17, 1999, now French Patent No. 2,800,984; application Ser. No. 10/412,634 is also a continuation-in-part of International Application No. PCT/FR01/03258 filed on Oct. 19, 2001, which was published in a language other than English and which claims priority from French Application No. 00/14028 filed Oct. 31, 2000, now French Patent No. 2,815,844.

The Federal Circuit identified the following chain of priority as essential to the validity of the patent:

French Application 1b (FR 00/14028) filed October 31, 2000
International Application 2b (PCT/FR 01/03258) filed October 19, 2001
U.S. Application 4 (10/412,634) filed Apr. 10, 2003
U.S. Application 6 (11/352,614) filed February 13, 2006
U.S. Application 8 (12/029,031) filed Feb. 11, 2008
U.S. Application 10 (12/348,892 — the ’281 patent) filed January 5, 2009

The Defective Priority Claim

As summarized by the Federal Circuit, the district determined that “the ’281 patent was not entitled to a priority date earlier than April 10, 2003 because it was neither in compliance with 35 U.S.C. § 119 to claim the benefit of the October 31, 2000 filing date of French Application 1b, nor in compliance with 35 U.S.C. § 120 to claim the benefit of the October 19, 2001 filing date of International Application 2b.”

The § 119 defect identified by the district court was that “not every intervening application in the priority chain … claimed priority to French Application 1b.” The § 120 defect identified by the district court was that “U.S. Application 6 broke the priority chain by leaving out U.S. Application 4 in making its claim for priority to International Application 2b; likewise, U.S. Application 8 failed to link U.S. Applications 4 and 6 in its priority claim to International Application 2b.”

The priority claim in Application 6 reads in its entirety as follows:

The present application is a continuation of U.S. Ser. No. 10/412,634 filed Apr. 10, 2003, now U.S. Pat. No. ______, which is a continuation-in-part of U.S. Ser. No. 10/130,355 filed on May 17, 2002, now U.S. Pat. No. 6,830,584, which is the U.S. national phase under § 371 of International Application No. PCT/FR00/03176, filed on Nov. 15, 2000, which was published in a language other than English and which claimed priority from French Application No. 99/14462 filed on Nov. 17, 1999, now French Patent No. 2,800,984; this application is also a continuation-in-part of International Application No. PCT/FR01/03258 filed on Oct. 19, 2001, which was published in a language other than English.

(emphasis added).

The Federal Circuit Decision 

The Federal Circuit decision was authored by Judge Prost and joined by Judge Plager and Judge Taranto.

The Federal Circuit noted that the patent needed both its domestic (§120) and foreign (§119) priority claims in order to be valid, and decided to address only the validity of the domestic priority claim under §120. As the court noted, the relevant portion of  §120 provides:

[A] later filed patent application [may] claim the benefit of an earlier filing date in the United States if, among other requirements, “it contains or is amended to contain a specific reference to the earlier filed application . . . submitted at such time during the  pendency of the application as required by the Director.” 35 U.S.C. § 120.

The court also referenced its 2010 decision in Encyclopaedia Britannica, Inc. v. Alpine Electronics of America, Inc., 609 F.3d 1345 (Fed. Cir. 2010), where it held that “each [intermediate] application in the chain of priority [must] refer to the prior applications.”

Turning to the priority claims at issue, the relevant and problematic language resides in the “this application …” clause highlighted above. That language apparently originated in Application 4, but was not updated for Application 6 or Application 8.  The Federal Circuit agreed with the district court that this clause incorrectly described the subject application (Application 6 or Application 6) as being a CIP of International Application 2b, and so problematically omitted the required link to that application through Application 4.

The court rejected Medtronic’s arguments that the clause should be read in context, by a “reasonable person” or a “person of ordinary skill in the art,” who would understand that “this application” refers to Application 4. In particular, the court found that the statute’s requirement for a “specific reference” plainly placed the burden on the applicant, while Medtronic’s position “improperly places the burden of deciphering a priority claim upon the reader or the public.”

Having found that the priority claim under § 120 was defective, the Federal Circuit affirmed the determination that the patent was invalid as anticipated by the French priority applications and International Application 2b.

Application Data Sheet Practice

Since November 2000, the USPTO has permitted applicants to file their applications with “Application Data Sheets” setting forth formal details such as inventor names and addresses, assignee information, and priority application information. Originally, the use of ADSs was encouraged to facilitate more accurate capture of this information, but for applications filed on or after September 16, 2012, priority information must be included in an ADS to be given effect.See 37 CFR §§ 1.55, 1.78. Relevant to the issues in this case, 37 CFR § 1.76(b)(5) holds that providing domestic priority information in an ADS ”constitutes the specific reference required by 35 USC §119(e) or 120,” and 37 CFR § 1.76(b)(6) holds that providing foreign priority information in an ADS ”constitutes the claim for priority as required by 35 USC §119(b).” Thus, while any priority information set forth in a specification should be updated when a continuing application is filed, the failure to do so should not result in a fatal priority claim defect if the priority applications are correctly listed in a timely filed ADS.