For U.S. patent law, if one sought a life science patent, there was a quid pro quo arraignment. Essentially, in exchange for disclosing the “secret sauce,” the inventor of the life science breakthrough received a limited monopoly on that breakthrough, allowing them to exclusively profit from that invention. Recently though, federal case law has made that quid pro quo arraignment much more complicated.
The blurring line of disclosure
The issue is how to describe the invention to get that limited monopoly. In other words, there is a requirement that a written description be given in the patent application, which specifies the skill in the art of the inventors that makes the invention distinct. This was explained in Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Though, what is required in that disclosure has gotten complicated for life sciences.
Life science ranges
In General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018), the courts explained that simply disclosing a broad range of values is not enough because a skilled artisan must be able to discern the specific details of the claimed value.
Claiming antibodies has also become more complicated. In most antibody patent applications, a genus of antibodies is cited. This includes their functional characteristics, like blocking abilities and binding affinities and locations. Though, the disclosure must still disclose enough to qualify as a representative number of species or structural features, according to Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1299 (Fed. Cir. 2014). This, again, is not always straight forward.
For those Minneapolis, Minnesota, residents looking into a life science patent, the case law is about as clear as mud, which is why it is so important to contact an attorney. An attorney can help one ensure that a patent application includes the needed information and specificity to ensure the highest likelihood of a granted patent.