Monday, April 04, 2005

More on Noelle v. Lederman; antibodies

Noelle v. Lederman, 355 F.3d 1343 (CAFC 2004) is an interference case between Noelle (junior party) and Lederman. The CAFC affirmed the finding of the BPAI of no interference-in-fact between the '480 application of Noelle and the '771 patent of Lederman. Certain claims of the '480 were found invalid under 102(b). Noelle was not a patentee and no claims were found invalid under 112.

The claims of Noelle's '480 application were directed to the genus, murine ("mouse"), chimeric ("hybrid"), humanized, and human forms of the CD40CR monoclonal antibody.

The count reads as follows:

The monoclonal antibody of claim 1 of 5,474,771 or the monoclonal antibody of claim 42 or claim 51 of 08/742,480.

For sake of the simplicity, Claim 1 of Lederman's '771 patent and
Claim 52 of Noelle's '480 application will be referred to as claims to the "human" form of CD40CR antibody. Claims 42 and 51 of Noelle's '480 application will be referred to as claims to the "mouse" and "genus" forms of CD40CR antibody,

An issue was whether the '480 was entitled to receive the benefit of the filing date of a prior application, and that is how the written description requirement entered the case.

The Noelle court noted: Therefore, based on our past precedent, as long as an applicant has disclosed a "fully characterized antigen," either by its structure, formula, chemical name, or physical properties, or by depositing the protein in a public
depository, the applicant can then claim an antibody by its binding affinity to that described antigen.

Noelle lost because Noelle did not sufficiently describe the human CD40CR antigen at the time of the filing of the '799 patent application. In fact, Noelle only described the mouse antigen when he claimed the mouse, human, and genus forms of CD40CR antibodies.

The intervening art to Noelle was, in part, Lederman, who had succeeded in describing the antigens, thereby showing that such description was not an impossible task.

Discussion of Noelle v. Lederman in Burke and Lemley, 54 Case W. Res. 691 (2004) [earlier version, appeared as chapter 16 in PERSPECTIVES ON PROPERTIES OF THE HUMAN GENOME PROJECT: ADVANCES IN GENETICS 50 (F. Scott Kieff ed., 2003)]:

Any thought that Enzo v. Gen-Probe had limited the restrictive rules
of Fiers and Eli Lilly to DNA sequences was dispelled by the decision in Noelle v. Lederman. In that case, the patentee claimed a genus of mammalian antibodies. The court acknowledged that antibodies could be claimed on the basis of their functional characteristics--that is, their binding affinities--"as long
as an applicant has disclosed a 'fully characterized antigen.'" n42
But the court refused to permit the patentee to claim a genus of mammalian antibodies to a particular type of antigen because it had described only the mouse antigen. In order to justify claims to a genus of mammalian antibodies, the patentee was required to describe the antigens specific to each species, as well as the
binding affinity of each of the antibodies in the genus. The effect of Noelle is precisely analogous to Eli Lilly--in order to claim a genus in biotechnology on the basis of functional characteristics, the patentee must meet the impossible burden of describing all or at least most of the species in the genus.

Separately, from Passino et al., 86 J. Pat. & Trademark Off. Soc'y 317 (April 2004):

Noelle v. Lederman held that a specification that discloses a "fully characterized antigen" will support a claim to an antibody defined by its binding affinity to an antigen.

Noelle's application described a mouse CD40CR antigen and claimed not only mouse CD40CR antibodies but also human
CD40CR antibodies and a genus of CD40CR antibodies.

the Noelle Court followed the written description guidance of Enzo Biochem v. Gen-Probe, Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) ("Enzo Biochem II")
Indeed, according to Noelle, Enzo Biochem II stated that "the
written description requirement would be met for all of the claims [of the patent at issue] if the functional characteristic of [the claimed invention was] coupled with a disclosed correlation between that function and a structure that is sufficiently known or disclosed." For example, the USPTO would find that a claim
directed to "any antibody which is capable of binding to antigen X"
would have sufficient support in a written description that disclosed fully characterized antigens.

Furthermore, Noelle has implications wider than § 112, first
paragraph rejections. The doctrine may be used against the USPTO, infringers alleging invalidity, and parties of a contested case. Under 35 U.S.C. § 102, a patent or printed publication will not anticipate a claim unless it "describes" the
claimed invention. If the courts take the position that a patent or
printed publication fails to describe an embodiment for the purposes of § 112, first paragraph, then it is difficult to believe that the same patent or printed publication describes the same embodiment for the purposes of § 102.


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