Filing a patent application is a key step in protecting the intellectual property of a company. As patent reform under the Leahy-Smith America Invents Act becomes effective, the timing of patent application filing becomes even more important because the U.S. is changing from a first-to-invent system to a first-to-file system. Under a first-to-file system, a dispute over who gets a patent when more than one party files a patent application directed to the same invention is generally resolved by comparing filing dates. Thus, having an early filing date is paramount.
Nonetheless, the decision about when to file a patent application is not simply a matter of how quickly the invention can be written on paper and sent to the Patent Office. The patent application must still contain sufficient information to satisfy the requirements for patentability and, in the case of continuing applications, for claiming an earlier effective filing date.
For example, the specification must enable one of ordinary skill in the art to make and use the full scope of the invention that is claimed or eventually claimed. The disclosure necessary to meet the enablement requirement varies greatly depending upon the technology and the scope of the claims but, generally, the more detail and examples one can provide, the more likely one is to meet the enablement requirement.
Thus, there are competing considerations for when to file a patent application–file too soon in the invention process and your claims may be rejected as lacking enablement, or file too late and an earlier competitor may win the race to the mailbox.
Many biotech and chemical cases demonstrate the downside of filing prematurely: See for example, Janssen Pharmaceutica N.V. v. Teva Pharmaceuticals USA, Inc. (claimed method for treating Alzheimer’s disease with galantamine not enabled by specification of just over one page in length with no testing results or dosage information); Par Pharmaceuticals v. Roxane Labs (claims directed to a megastrol acetate suspended in any surfactant in any concentration not enabled by three working examples using one surfactant); Amgen v. Chugai Pharm. Co. (claims directed to purified DNA sequences encoding analogs of erythropoietin were not enabled by disclosure of only a few EPO analog genes).
Enablement is not solely an issue for chemical and biotech inventions as shown, for example, in Liebel-Flarsheim v. Medrad (claim scope that covered both jacketed and jacket-free needle holders was not enabled by description of only jacketed needle holders); Automotive Technologies International v. BMW (claims scope that covered both mechanical and electronic side impact crash sensors were not enabled by description of only mechanical crash sensor); and Sitrick v. Dreamworks LLC (claim scope that covered both movies and video games was not enabled by description of only video games).
The timing of a publication of the invention also is a factor. The new patent laws still allow a grace period under which an earlier publication by the inventor does not count as prior art. If the invention is published, a patent application must be filed within one year or that publication may be the basis for a prior art rejection or grounds for patent invalidity. But that earlier publication could also doom your ex-U.S. patent applications, including European patent applications, as many foreign jurisdictions do not provide a grace period.
A strategy that may be useful for developing technologies is the serial filing of multiple provisional patent applications. Provisional applications have a relatively inexpensive filing fee ($250 vs. $1250 for a regular utility application filing, search and examination fees), will provide an effective filing date for the disclosed subject matter and will act as a placeholder for one year.
During that year, one or more updated provisional patent applications with additional information and examples can be filed as the invention is further developed. That way, the earliest possible filing date is preserved for each stage of data and results for a given invention. A utility application filed by the end of the one year can then claim priority to the earlier provisional applications.
Alternatively, if at the end of the one year window, the invention has not lived up to its technological and commercial expectations, it can be abandoned without having incurred further prosecution expense.
The effective date of the new law is March 13, 2013. Companies who want to maximize their rights under the first-to-invent system should file patent applications before March 13, 2013. Patent applications having an effective filing date after that date will be governed by the first-to-file system.