In the following case, the patentee (“Centocor”) filed a patent application to an antibody having various characteristics.  For simplification, the characteristics relate to a constant region and a variable region of an antibody.  Centocor utilized a variable region of a mouse and a constant region of a human to produce the antibody.  A competitior (“Abbott”) produced an antibody having the same purpose as Centocor’s antibody except that both the variable and constant regions of Abbott’s antibody was “fully human” which is more desireable than Centocor’s antibody.  Centocor filed claims in one of their pending patent application directed to a “fully human” antibody which ultimately issued as a patent and is at issue in the current litigation.

During litigation, Centocor had to show that the Centocor patent application had a “written description” of the “fully human” antibody.  Centocor contended that Centocor’s patent applications disclosed (1) terms such as human variable region and human constant region, (2) the desirability of a “fully human” antibody, and (3) an article that suggested the possibility of developing such invention.  However, the Court characterized these instances as a “mere wish or plan” for obtaining the claimed invention.  The steps to develop a “fully human” antibody was not routine or convention and was not within a well developed and mature technology.  The Court held that none of these instances in the patent application referring to “fully human” antibodies showed that the inventor had possession of the claimed invention.  Accordingly, the Court held the claims at issue invalid for lack of written description.  Centocor v. Abbott, 2010-1144 (Fed. Cir. Feb. 23,2011).

The Court also provided guidance as to how much a patent application needs to disclose in order to satisfy the “written description” requirement.  The bottom line is that “routine”, “conventional” and “well developed and mature” technology requires less explanation.  If one is unsure whether a certain concept is conventional, routine or well developed and mature, then one should lean toward a fuller and more detailed disclosure in order to avoid downstream legal expenses relating to proving up “written description”.

I invite you to contact me with your patent questions at (949) 433-0900 or James@OCPatentLawyer.com. Please feel free to forward this article to your friends. As an Orange County Patent Attorney, I serve Orange County, Irvine, Los Angeles, San Diego and surrounding cities.

In New Railhead Manufacturing, LLC v. Vermeer Mfg. Co., 298 F.3d 1290 (Fed. Cir. 2002), the invention was related to a drill bit for drilling rock formations and a method for drilling rock formations. The drill bit was actually used underground, out of plain sight of others. Nonetheless, the Court explained that the phrase “public use” under U.S. patent laws does not mean open and visible in the ordinary sense. The meaning of “public use” does not hinge on whether the device was seen by others. “Public use” includes “any use of the claimed invention by a person other than the inventor who is under no limitation, restriction, or obligation of secrecy to the inventor”. Hence, the use of the drill bit was “public use”.

Testing and experimentation of the invention could negate the use of the device as a “public use” for the purposes of determining when the “one year” time period begins. However, such testing and experimentation must cease at the time the inventor realizes that the invention works for its intended purpose. Otherwise, continued use may constitute “public use” which would bar the inventor from seeking patent protection after the “one year” time period. In New Railhead, the inventor made a second prototype which contained some improvements to the first prototype. Unfortunately, the record did not indicate that there was an issue as to the efficacy of the drill bit. Hence, the use of the first drill bit prototype was not considered to be an experimental use.

U.S. Patent Law provides a limited time period (i.e., one year) in which inventors can market and sell their invention for various reasons without filing a patent application. However, it is typically beneficial to file as early as possible. Also, if interested in seeking patent protection in foreign countries, a patent application should be filed prior to any type of public disclosure, offer for sale or distribution of any printed material to the public in order to preserve the maximum rights.

You may also be interested in reading Preventing Loss of Patent Rights.

Should you have any further questions, please feel free to contact me.