On March 16, the U.S. patent system will change from a “first-to-invent” to a “first-to-file” system under the Leahy-Smith America Invents Act (AIA). This will trigger a race to the U.S. Patent and Trademark Office (USPTO) with every new idea and invention. Beginning on that date, or even now, the new norm for inventors will be to file early and file often. With the new norm, there are many traps, new and old, for the unwary. One of the most discussed new traps is the effective filing date. Yet another elephant in the room is the old written description requirement, which should not be ignored when the race is on.
To obtain a patent, an applicant must meet a number of requirements, including the “written description” and “enablement” requirements under 35 U.S.C. §112. The two requirements serve two different policy purposes of patent law. The enablement requirement allows for weeding out inventions that cannot be made or used by a hypothetical person in a relevant art, known as a person skilled in the art. In contrast, the written description requirement, by requiring “possession,” serves to eliminate protection for inventions not made by the inventors themselves and give others incentive to continue to invent. For inventors, especially those in the biotech/pharmaceutical field, these two requirements are tricky and sometimes confusing. Indeed, some used to call the written description requirement a “super enablement” in the chemical and biotechnology art and believed that an enabling disclosure should satisfy both requirements. Yet, this belief creates a “written description” trap, which can be very costly, as evidenced by Centocor Ortho Biotech v. Abbott Laboratories, 636 F.3d 1341 (Fed. Cir. 2011), its predecessors and, most recently, Helicos Biosciences v. Illumina, case number 10-CV-00735, (D. Del. 2012).
