Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                                                      March  2011   

In This Issue

·    Federal Circuit Distinguishes PTO’s Written Description Guidelines re: antibodies.

·    Biotech Notes

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Centocor Patent Invalid for Lack of Written Description (Distinguishing PTO’s Written Description Guidelines)  

In Centocor Ortho Biotech, Inc. v. Abbott Laboratories (Fed. Cir. 2011), the Federal Circuit invalidated Centocor’s U.S. Patent No. 7,070,775 based on lack of written description as required by 35 U.S.C. §112, vacating a $1.67 billion jury verdict against Abbott Laboratories’ Humira® product, which is an antibody used to treat arthritis.

Centocor developed a TNF-α antibody by identifying a mouse antibody to human TNF-α, then changing certain portions to make it more human.  Abbott, on the other hand, developed a fully human antibody, which led to Humira®.  After Abbott launched its product, Centocor filed claims to cover fully human antibodies, which issued as the ‘775 patent.  Cenocor sued Abbott, who argued that Centocor’s fully human antibody claims lacked adequate written description. 

Centocor argued that its patent satisfied § 112 because it disclosed the antigen (TNF-α protein) and the PTO’s March 24, 2008 Written Description Guidelines indicate that disclosing an antigen can provide § 112 support for any antibody that binds to that antigen.  Centocor also pointed to a 2004 Federal Circuit case that stated "as long as an applicant has disclosed a ‘fully characterized antigen’ . . . the applicant can then claim an antibody by its binding affinity to that described antigen."  Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004).

The Federal Circuit disagreed with Centocor and distinguished Noelle and the PTO guidelines by stating that disclosing an antigen may provide §112 support for an antibody, but only where creating the antibody is routine.  In this case, creating the antibody was far from routine and the claimed antibody had specific properties.  Centocor did not establish that generating a fully-human antibody as claimed would be within the knowledge of one skilled in the art. 


Fujifilm Holdings Corp. announced in February that it would buy Merck BioManufacturing Network in a deal reportedly worth $490 million

Lycera Corp., a biotech spinoff from the University of Michigan, entered into an agreement with Merck that could pay Lycera more than $300 million to develop and commercialize small molecule drugs that target T-helper cells, which play an important role in autoimmune-related diseases.


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