DC Court Rejects PTO’s Novel Theory of Double Patenting

Takeda v. Dudas (D.D.C. 2007)

Takeda’s priority date stretches back to 1974 when the company filed a Japanese patent application disclosing a set of anti-microbial agents known as cephem compounds. The first US patent did not issue until 1988 (‘606 patent). In 1996, Takeda’s ‘216 patent issued – also reaching back to the 1974 priority date. The ‘216 patent claims a process of compounds claimed in the earlier ‘606 patent — those process claims were not, however, added until 15 years after the priority date.

During a reexamination, the PTO Board of Patent Appeals rejected the ‘216 patent after applying the non-statutory double-patenting doctrine. Under the Board’s decision, the Takeda was guilty of attempted double patenting despite the fact that the two sets of claims were not obvioius variations. Instead, the Board found that the second patent was invalid becaues it “unjustly extends the patent rights of the first patent.”

In particular, the Board held that a process patent with an extended patent term will be invalid for double-patenting “where (1) the claimed method for making the [compound] is described in the [original] patent and (2) there is no credible alternative method for making the [compound] which does not involve an infringement of the method patent?” The Board also faulted Takeda for its 15 year delay in presenting the new claims.

Takeda appealed the BPAI rejection to the DC District court. That court granted summary judgment — ordering the PTO to issue a reexamination certificate.

Only way to make a previously patented product: Takeda submitted an unrebutted declaration that convinced the court that there were multiple ways to create the cephem compounds. Thus, the PTO’s conclusions regarding the lack of alternative methods were factually incorrect.  In its decision, the court rejected the PTO’s argument that the alternative methods must have existed as of 1974. Rather, the court held that those methods may be shown in subsequent technological advances.

Double Patenting Based on Delay: The court went on to find that a patentees delay in pursuing claims could never, on its on, be grounds for a double patenting rejection. Rather, the grounds for double patenting always primarily rest on the lack of patentable differences between the two inventions.

Rejection Reversed

Notes:

• Hal Wegner along with Ed Polk, Leon Radomsky & Steve Maebious handled the appeal for Takeda
• BPAI Decision