Boston Scientific Corp. v. Johnson & Johnson, Inc.

June 17, 2011 – Blog Post

On June 7, 2011, the Federal Circuit issued its decision in Boston Scientific Corp. v. Johnson & Johnson, Inc. The Federal Circuit affirmed the district court’s grant of summary judgment to Boston Scientific Corp, finding the patents-in-suit invalid for lack of adequate written description.

The case involved the use of drug-eluting coronary stents to prevent the collapse of an artery following balloon angioplasty. Johnson & Johnson, Inc. (J&J), its subsidiary Cordis Corp. (Cordis), and Wyeth (collectively, Appellants) owned the four patents-in-suit, which generally claimed drug-eluting stents using the drug sirolimus and its analogs. During prosecution, Appellants amended the claims of all four patents-in-suit, which originally claimed only sirolimus, to include analogs of sirolimus. Three of the patents (1997 patents) shared a common specification and included amended claims to the same subgenus of sirolimus, “lactone analog[s].” The fourth patent (‘662 patent) came from a later-filed application and included amended claims to a different subgenus of sirolimus, “triene analogs.” The specifications for all four patents-in-suit only contained functional language and one sole mention of the claimed subgenus. The specifications did not provide a description of any species within the subgenus. The ‘662 patent specification differed slightly from the 1997 patent specification because it contained additional information regarding the mechanism of action of sirolimus and broadly defined sirolimus to include the genus of all “analogs.” Boston Scientific Corp. (BSC), a competitor of Appellants, sold a drug-eluting coronary stent system using everolimus, a lactone and triene analog of sirolimus. After commencing a declaratory judgment action in the District of Delaware, BSC filed a motion for summary judgment asserting that the claims of the patents-in-suit were invalid under 35 U.S.C § 112.

The district court granted BSC’s motion for summary judgment, finding the asserted claims of the ‘662 patent invalid for lack of written description, and the asserted claims of the 1997 patents invalid for lack of written description and lack of enablement. Appellants appealed to the Federal Circuit.

Judge Moore, writing for the majority, addressed the 1997 patents first and found the claims invalid for lack of sufficient written description. This holding rendered it unnecessary for the majority to address invalidity of the claims based on the enablement requirement. Appellants, ostensibly conceding that specification alone does not satisfy the written description requirement, argued that the specification’s description, when combined with the knowledge of one skilled in the art, satisfied the written description requirement.

Specifically, Appellants agreed that the claimed subgenus was sufficiently well-known in the art such that a more detailed disclosure was not required to meet the written description requirement. The majority rejected this assertion by finding the small number of species known in the art insufficient to claim the broad subgenus. In support of this finding, the majority noted that the claimed subgenus covered tens of thousands of possible analogs, but the specification contained no guidance on how to properly identify or select the claimed analogs, and the art was both unpredictable and nascent in nature. Appellants also argued that the functional claim language was sufficient to meet the written description requirement because the correlation between structure and function in sirolimus was well-known in the art at the time of filing. The majority also rejected this argument by pointing to the language of the specification which explicitly stated that “the precise mechanism of [sirolimus] is still under investigation.” The majority emphasized that “when the four corners of the specification directly contradict information that the patentee alleges is ‘well-known’ to a person of skill at the effective filing date, no reasonable jury could conclude that the patentee possessed the invention.”

The majority next examined the ‘662 patent and similarly held the claims invalid for lack of sufficient written description. Specifically, the majority noted that the ‘662 patent disclosed the broad genus of “analogs,” but only claimed a subgenus. That disclosure did not satisfy the written description requirement because the it failed to provide any “blaze marks” indicating that the claimed subgenus was of special interest. The majority also rejected the Appellants’ argument that the functional disclosure satisfied the written description requirement for the claimed subgenus relying upon the same contradictory language from the specification used in the Court’s earlier analysis of the 1997 patents.

In a separate opinion, Judge Gajarsa, concurring-in-part, fully joined the majority’s opinion regarding the ‘662 patent, but only agreed with the majority’s judgment regarding the 1997 patents. Judge Gajarsa disagreed with the majority’s use of the written description requirement to invalidate the 1997 patents; he would have found the 1997 patents invalid for lack of enablement. In his concurring opinion in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), Judge Gajarsa argued that a separate written description requirement was unnecessary. He reiterated his opinion here by asserting that “the enablement requirement of 35 U.S.C. § 112 ¶ 1 [was] the appropriate tool for invalidating claims that are broader than their disclosure.”

The outcome of this case should come as no surprise given the Federal Circuit’s recent en banc decision in Ariad which strongly affirmed the Eli Lilly line of cases that invalidated broad claims for lack of written description outside of the priority context. This case resuscitates the importance of the written description requirement before submitting a patent application, during prosecution, and in litigation, particularly in cases involving chemical and biological inventions because they generally require a more complete disclosure due to the unpredictable nature of the art. Prior to submitting a patent application, it is imperative that the parties ensure the specification contains sufficient detail in anticipation of the need/desire to broaden or narrow the claim’s scope during prosecution. Furthermore, parties should exercise caution when amending claims during prosecution and make certain that the scope of the amended claims is sufficiently described by the specification.