Centocor and New York University v. Abbott (CAFC 2010-1144) precedential

Patents are presumed to be valid and overcoming this presumption requires clear and convincing evidence. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1354 (Fed. Cir. 2010) (en banc). Compliance with the written description requirement of 35 U.S.C. § 112, ¶ 1 is a question of fact, and "'we review a jury's determinations of facts relating to compliance with the written description requirement for substantial evidence.'" Id. at 1355 (quoting PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1243 (Fed. Cir. 2002)). A patent also can be held invalid for failure to meet the written description requirement based solely on the face of the patent specification. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927 (Fed. Cir. 2004); PIN/NIP, 304 F.3d at 1247-48 (reversing the district court's denial of JMOL because no reasonable juror could have concluded that the asserted claim was supported by adequate written description).

The written description requirement of 35 U.S.C. § 112, ¶ 1 provides, in pertinent part, that:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

To satisfy the written description requirement, "the applicant must 'convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,' and demonstrate that by disclosure in the specification of the patent." Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)). Assessing such "possession as shown in the disclosure" requires "an objective inquiry into the four corners of the specification." Ariad, 598 F.3d at 1351. Ultimately, "the specification must describe an invention understandable to [a person of ordinary skill in the art] and show that the inventor actually invented the invention claimed." Id. A "mere wish or plan" for obtaining the claimed invention is not adequate written description. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997).

Centocor tried to beat Abbott by claiming an earlier priority date than its disclosed technology entitled.

Centocor first sought claims to human variable regions and fully-human antibodies in 2002. At that time, Abbott had already discovered and patented a fully-human antibody to TNF-a that had high affinity and neutralizing activity. To ensnare Abbott with later-filed claims, Centocor must use a priority date from an earlier application. Because Abbott's application was filed in 1996, Centocor relies on a priority claim to the 1994 CIP applications. Thus, in order for Centocor to prevail, the asserted claims must be supported by adequate written description in the 1994 CIP applications.

The asserted claims cover fully-human antibodies that possess the same therapeutic properties as Centocor's chimeric antibody, i.e., high affinity, neutralizing activity, and binding at a specific place on human TNF-a. Accordingly, the 1994 CIP applications must provide written description for an antibody to human TNF-a with (1) a human constant region, (2) a human variable region, (3) high affinity for human TNF-a, (4) neutralizing activity, and (5) the ability to bind to TNF-a in the same place as Centocor's A2 mouse antibody ("A2 specificity").

Those claimed five requirements were too tall an order to find spec support in the 1994 application.

At trial, Abbott's expert, Dr. James Marks, testified about the disclosure in the 1994 CIP applications and explained why a person of ordinary skill in the art would not have understood that Centocor had possession of a high affinity, neutralizing, A2 specific, fully-human antibody. J.A. 18472-75. On appeal, Abbott emphasizes that Dr. Marks provided the only expert testimony that the jury heard about written description... Abbott contends that Centocor is attempting to claim as its own the fruit of Abbott's innovative work.

In response, Centocor points to specific disclosures in the 1994 CIP applications identified by inventor Dr. John Ghrayeb as evidence that the asserted claims are adequately described and enabled. Centocor presented no expert testimony on written description at trial and instead chose to rest on the '775 patent specification and the testimony of its inventors. Without directly relying on the PTO written description guidelines or what it refers to as "dicta" in Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), Centocor contends on appeal that the '775 patent "does much more than what the Guidelines and Noelle suggest," in that it not only describes the antibodies by their binding affinity for TNF-a, but further describes the antibodies by specifying that they competitively inhibit binding of the A2 mouse antibody to TNF-a. Centocor also argues that the written description requirement demands neither actual reduction to practice nor working examples to claim an invention.

We turn to the four corners of the 1994 CIP applications to assess whether their disclosure provides adequate written description for the asserted claims. Because the pertinent disclosure from the 1994 applications appears in the '775 patent as issued, we refer only to the '775 patent for clarity.

The findings for written description support were thin.

Contrary to Centocor's assertions, very little in the '775 patent supports that Centocor possessed a high affinity, neutralizing, A2 specific antibody that also contained a human variable region.

Centocor's lawyers concocted an amazing argument, which simply had no basis in law. Many litigators enjoy rich fantasy lives, for which they bill their clients $500 or more an hour to participate in.

Besides pointing to these limited references to fully human antibodies, none of which relate to the specific critical limitations in the asserted claims, Centocor suggests that written description for the asserted claims comes from the limitations described in the claim language itself. However, this specific claim language was not added until 2002 and is not part of the 1994 CIP applications as filed.

This was nowhere near a close call.

At bottom, the asserted claims constitute a wish list of properties that a fully-human, therapeutic TNF-a antibody should have: high affinity, neutralizing activity, and the ability to bind in the same place as the mouse A2 antibody. The specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations. But a "mere wish or plan" for obtaining the claimed invention is not sufficient. See id. at 1566. At the time the 1994 CIP applications were filed, it was entirely possible that that no fully human antibody existed that satisfied the claims. Because Centocor had not invented a fully-human, high affinity, neutralizing, A2 specific antibody in 1994, a reasonable jury could not conclude that it possessed one.

Claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-a with A2 specificity, can result in a claim that does not meet written description even if the human TNF-a protein is disclosed because antibodies with those properties have not been adequately described.

As discussed above, obtaining a high affinity, neutralizing, A2 specific antibody with a human variable region was not possible in 1994 using "conventional," "routine," "well developed and mature" technology. PTO guidelines at 46. Centocor highlights Dr. Jochen Salfeld's testimony analogizing the antibody-antigen relationship to "a key in a lock." J.A. 18436, 154:4-5. What Centocor ignores is the remainder of Dr. Salfeld's testimony, which pointed to the challenges of finding an appropriate antibody on "a ring with a million keys on it." Id., 154:2-3. Centocor simply failed to support its contention that generating fully-human antibodies with the claimed properties would be straightforward for a person of ordinary skill in the art given the state of human antibody technology in 1994. Unlike the antibody example cited in the PTO guidelines, therefore, simple possession of the known TNF-a protein did not place Centocor in possession of the claimed antibodies.

We have repeatedly indicated that the written description requirement does not demand either examples or an actual reduction to practice. Ariad, 598 F.3d at 1352. What it does demand is that one of skill in the art can "visualize or recognize" the claimed antibodies based on the specification's disclosure. Eli Lilly, 119 F.3d at 1568. In other words, the specification must demonstrate constructive possession, and the '775 patent's specification fails to do so. Ariad, 598 F.3d at 1352. Centocor's asserted claims to fully-human antibodies "merely recite a description of the problem to be solved while claiming all solutions to it." Ariad, 598 F.3d at 1353. The actual inventive work of producing a human variable region was left for subsequent inventors to complete.

The scope of Centocor's right to exclude cannot "overreach the scope of [its] contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). Its fullyhuman antibody claims are beyond the scope of its disclosure. As in Ariad, we conclude that the jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description. The [Eastern District of Texas] district court [Judge T. John Ward] erred when it declined to grant Abbott a JMOL that the asserted claims fail to satisfy the written description requirement of 35 U.S.C. § 112.

Reversed.