An Old Trap in the New “First-to-File” EraJanuary 2, 2013 – Articles New Jersey Law Journal
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. This will also cause a shift in the new norm for inventors to file early and often. This new norm brings 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).
At stake in Centocorwas about $13 billion involving two blockbuster drugs. After a trial in the district court, the jury found Abbott liable for willful infringement. Yet, on appeal, the Federal Circuit reversed and ruled that the claims were invalid since they did not meet the "written description" requirement.
In the lawsuit, the Federal Circuit agreed with Abbott that the asserted claims were invalid for failure to meet the written description requirement. In particular, despite the testimony that general library technologies could be used to make antibodies, including human antibodies, the Federal Circuit stated that, "[T]he fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody." The court further stated: "The specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations. But a 'mere wish or plan' for obtaining the claimed invention is not sufficient."
The Centocor case is not the first time that the Federal Circuit used the written description requirement to invalidate biotech/pharmaceutical patents. In fact, there seems to be a trend that the Federal Circuit is increasingly willing to use this requirement for that purpose. Another three prominent biotech/pharmaceutical cases are Regents of the Univ. of California v. Eli Lilly, 119 F.3d 1559 (Fed. Cir. 1997), Univ. of Rochester v. G.D. Searle, 358 F.3d 916 (Fed. Cir. 2004), and Ariad Pharm. v. Eli Lilly, 598 F.3d 1336 (Fed. Cir. 2010) (en banc)).
The mantra in these cases is that a patent claim can be invalidated for failing the written description requirement even though it complies with the enablement requirement. The aftermath of these cases shows that the written description requirement is distinct from the enablement requirement and can be harder to meet.
Given the stricter written description requirement, the timing of filing patent applications will become even more critical in the AIA "first-to-file" era. On one hand, not filing until after all products or uses are ascertained and possessed would incur a substantial amount of resources and, more seriously, lose the race to the USPTO against competitors. On the other hand, filing too early in the research discovery process risks an outcome like that in the Regents of the Univ. of California, Univ. of Rochester, Ariad, Centocor andHelicoscases. Striking the right balance in the new era requires even higher commitment and collaboration than before by researchers, technology transfer officers, investors, corporate partners and their patent counsels so as to make sure that possession of a claimed invention is demonstrated in the four corners of the specification.
Reprinted with permission from the January 2 issue of The New Jersey Law Journal. © 2013 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved.