To get a patent, a patent application must be filed with the United States Patent and Trademark Office to satisfy the written description requirement. However, writing a patent application to satisfy the written description requirement is harder than you think. If the patent application does not sufficiently describe the invention, then the patent may be deemed invalid as in Novozymes v. Dupont (Fed. Cir. 2013). To determine whether one has satisfied the written description requirement when writing the patent application, the patent application must sufficiently describe the invention to show that the inventor possessed the claimed invention. The Novozymes case will illustrate what this means.
Novozymes invented and obtained a patent on a thermo-stable enzyme. In describing this thermo-stable enzyme in the patent application, Novozymes describe one or two different species but also loosely stated that other variants are possible. One of the variants involved modification to any one of 33 mutation sites.
After Novozymes obtained its initial patent application, Dupont researched, identified and obtained a patent for the preferred one of the 33 mutation sites (i.e., mutation site 293). Novozymes filed a continuation patent application claiming priority to the parent application and obtained a patent with claims to an enzyme directed to mutation site 293.
For the Novozymes patent to be valid, the mutation site 293 must find written description support in the original parent application. Otherwise, the Dupont patent would be prior art against the Novozymes patent and invalidate the Novozymes patent. Interestingly, the jury found sufficient written description support in the original Novozymes patent application but the court reversed as a matter of law. They held that no reasonable jury could come to the conclusion that sufficient written description support could have been found in the initial patent application of Novozymes for mutation site 293.
In the unpredictable art of bioscience and life science, the courts want more than just a roadmap in the patent application that leads to the claimed invention. They want the inventors to have test data and a clear indication of the specific species being claimed. In this case, the court recognized that all of the limitations including the mutation site 293 limitation were disclosed in the original patent application.
Nonetheless, the court did not find written description support for the claimed invention. The court stated that “while the [original patent ] application provides formal textual support for each individual limitation recited in the claims of the ‘723 patent, it nowhere describes the actual functioning, theremo-stable alpha-amylase variants that those limitations together define.”
The court went on to state that “one searches for the [original patent] application in vain for the disclosure of even a single species that falls within the claims or for any ‘blaze marks’ that would lead an ordinarily skilled investigator toward such a species among a slew of competing possibilities.”
The courts also used the lack of test data to show that the inventors did not possess the claimed invention. “In this case, to actually possess the variant enzymes claimed in the ‘723 patent would have required Novozymes to confirm its predictions by actually making and testing individual variants or at least identifying subclasses of variants that could be expected to possess the claimed properties, which it did not do before filing the [original patent] application.”
Based on this case, in unpredictable arts such as biosciences, the courts are looking for test data to confirm that the inventors possessed the invention when it filed the patent application. For the more predictable arts (i.e., mechanical, electrical and electro-mechanical), the patent application can still loosely mention other variants to claim at a later date. It is important to speak with your patent attorney to determine how much information should be included in the patent application so that your claimed invention finds written description support in the original patent application. In my opinion, writing the patent application yourself will lower your short term costs, but may prove to be costly when the validity of your patent matters during litigation. Hire a patent attorney. Don’t try to write the patent application yourself.
I invite you to contact me with your patent questions at (949) 433-0900 or [email protected]. Please feel free to forward this article to your friends. As an Irvine Patent Attorney, I serve Orange County, Irvine, Los Angeles, San Diego and surrounding cities.