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Patent Prosecution Strategies for Life Sciences Companies Under the AIA

Wednesday, February 15, 2012

 Contributed by Eldora L. Ellison, Ph.D. and Judith U. Kim, Sterne, Kessler, Goldstein & Fox

The America Invents Act (“AIA”), signed into law on September 16, 2011, presents new challenges and strategy considerations for inventors, and biotechnology and pharmaceutical companies that seek to obtain ― or preclude others from obtaining ― patents in the United States. Notably, beginning with patent applications having an effective filing date (“EFD”) on or after March 16, 2013, the U.S. Patent and Trademark Office (“USPTO”) will award patents to the “first inventor to file” (“FTF”) rather than to the “first inventor to invent” (“FTI”).1 We explore here various strategy considerations for operating under a FTF system as compared with a FTI system.

OVERVIEW OF THE FIRST INVENTOR TO FILE SYSTEM

Under the AIA’s FTF system, a patent applicant will no longer be able to rely upon his or her date of invention to establish prior entitlement to an invention. Rather, the applicant will be vulnerable to prior art that were previously unavailable to be used against him or her.2 For example, public uses or sales that occur anywhere in the world ― not just in the United States ― before the effective filing date will be available as prior art. Additionally, a published U.S. patent application that claims priority under 35 U.S.C. §119 to the filing date of a foreign application may become effective as a prior art reference as of the foreign priority date.

Even before the FTF provisions take effect on March 16, 2013, prospective patent applicants should be careful not to inadvertently create prior art against themselves. For example, a sale of an invention outside of the United States prior to March 16, 2013 may constitute a novelty-destroying disclosure of an invention claimed in an application filed after March 16, 2013.

With a few exceptions, the effective filing date of a U.S. patent application will be the relevant date for determining whether other information qualifies as prior art. Thus, an applicant will no longer be able to “swear behind” the date of another party’s printed publication or patent application.

This expansion of the scope of available prior art, along with the inability to antedate such art, creates an incentive for an applicant to file his or her patent application as soon as is practicable. Additionally, an applicant who continues to refine her invention and/or gather additional information that may be deemed necessary for written description or enablement ― and thus necessary to have an “effective filing date” ― is incentivized to file multiple provisional patent applications that include updated information.

WAITING FOR DATA?

Of course, as a practical matter, not every applicant can file multiple provisional patent applications that include updated information. Should an applicant in the life sciences wait to file her application until she can include relevant experimental data?

In recent years, a few decisions of the Federal Circuit have raised concerns regarding the amount of experimental data that must be set forth in a patent application or patent directed to a therapeutic method. In both Rasmusson v. SmithKline Beecham Corp.3 and Janssen Pharm. v. Teva,4 the patent specification lacked a credible utility for the claimed invention given the absence of relevant experimental data provided in the specification. These cases are noteworthy in that, in each, the asserted utility was later proved to be correct. These cases arguably suggest that an applicant who seeks to patent a therapeutic method should delay filing her application until after having obtained at least some in vitro experimental data.

The concept of delaying filing in order to obtain such data is significantly at odds with the concept of being the first to file. A more recent 2011 decision may put applicants somewhat more at ease, even though it is a non-precedential decision. In Lilly v. Actavis, the Federal Circuit distinguished Rasmusson on the ground that it was an “interference” case: “[w]hen priority is not at issue, generally the applicant may provide data obtained either before or after the patent application was filed.”5 If Lilly signals a shift in the thoughts of the Federal Circuit, and in view of the changes in law provided under the AIA, applicants in the life sciences have incentive to file their patent applications early on and provide any data later if necessary. As discussed below, however, such a filing strategy may not be feasible for applicants who also wish to obtain patent protection outside of the United States.

THE SAVING GRACE OF BEING FIRST-TO-DISCLOSE

Of course, not every applicant is positioned to file early and file often.6 Fortunately for such inventors, the AIA provides another option for staking out one’s territory. In addition to providing incentives to file patent applications early on, the AIA provides incentive for researchers to publicly disclose their inventions early on. As an important component of a statutory scheme that encourages early disclosure, the AIA provides a limited grace period to allow an applicant time to file her patent application after having disclosed the invention. Accordingly, a disclosure by the inventor (or by someone who obtained the disclosed subject matter from the inventor) does not qualify as prior art in the United States if the disclosure is made one year or less before the effective filing date of an application claiming the invention. 

For applicants in the life sciences, public disclosure is often an essential predicate to obtaining adequate research and development funding. For such applicants, the one-year grace period may provide welcome relief. Thus, an applicant may seek rapid publication or other disclosure of an invention while retaining the possibility of obtaining U.S. patent rights.

A further advantage provided by the U.S. grace period is that it allows a public disclosure to be used as defensive weapon in the race to the USPTO. Under the AIA, if an inventor publicly discloses her invention prior to a third party’s disclosure of the invention, the third party’s disclosure does not qualify as prior art against the invention, provided the inventor files a patent application within one year of her disclosure. (See Figure 1) To rely upon this safeguard, the inventor’s prior public disclosure must have been made one year or less before the inventor’s effective filing date for a patent application claiming the invention. In this regard, the AIA creates incentive to disclose one’s invention early on.

The AIA also provides a similar safeguard for an applicant who publicly discloses an invention before a third party files a patent application directed to the same invention. Thus, third party patents and applications filed before an inventor’s effective filing date but after the inventor has publicly disclosed the invention do not qualify as prior art under the AIA, provided the inventor timely files a patent application. (See Figure 2)

Consequently, early publication may be a useful “insurance policy” for would-be patent applicants who are unable to seek early patent protection. To this end, some parties may rely upon early publication solely as a mechanism to create prior art that precludes others from obtaining patent rights to the disclosed invention. As discussed further below, however, public disclosure prior to filing a patent application comes at a cost, viz., it forecloses the possibility of obtaining foreign patent protection.

CONSIDERATION OF FOREIGN PATENT RIGHTS

The potential benefits of publicly disclosing one’s invention prior to filing a patent application may come at a cost. While the AIA provides a one year grace period for an inventor’s own public disclosure of his or her invention prior to filing of a patent application, for those inventors and companies interested in obtaining patents outside the United States, the grace period does not provide practical utility. Each country has its own laws on what constitutes a public disclosure, who made the public disclosure of whose invention, and when the public disclosure was made in relation to the effective filing date of the subject patent application. For example, in Europe, a public disclosure of an invention any day prior to filing of a patent application bars an inventor from obtaining a patent, except when the invention becomes known to the public against the applicant’s will, there is a six month grace period. In Japan, there is a six month grace period for disclosures made through an experiment, publication, presentation at a study meeting or an exhibition (a trade fair or the World’s Fair) or for abusive disclosure.

Currently in the United States, an applicant may rely on an earlier date of invention to antedate a prior art reference that may arise between the date of invention and the effective date of filing of a patent application. However, with the FTF system under the AIA, an applicant cannot rely on an earlier date of invention in the United States. Two scenarios under the current system are compared below with the new FTF system

In a first scenario under the current system, Inventor invents on a date of invention and subsequently a Third Party files a U.S. patent application before Inventor files her U.S. patent application. In this scenario, because Inventor invented before the Third Party filed its U.S. patent application, Inventor may be able to antedate the Third Party’s filing by showing evidence of conception and diligence towards filing of a patent application (constructive reduction to practice) or actual reduction to practice, prior to the third party’s filing. Moreover, in an interference proceeding, Inventor may also show he invented first and defeat the Third Party’s ability to obtain a U.S. patent. However, in this scenario, because there is no antedating process available outside the United States, the Third Party may be able to obtain a patent outside the United States because the Third Party filed first and Inventor may not be able to obtain a patent outside the United States.

Under the FTF system, the same scenario would play out differently in the United States. While Inventor invented before the Third Party filed its U.S. patent application, Inventor can no longer antedate the Third Party’s filing and thus will not be able to obtain a patent in the United States. Outside the United States, the FTF system does not alter the outcome of the Third Party being able to obtain a patent because the Third Party filed first.

In a second scenario under the current system, Inventor invents on a date of invention, then publicly discloses her invention less than one year before Inventor files her U.S. patent application, and subsequently a Third Party files a U.S. patent application before Inventor files her U.S. patent application. Similar to the first scenario under the current system, because Inventor invented before the Third Party filed its U.S. patent application, Inventor may be able to antedate the Third Party’s filing by showing evidence of conception and diligence or reduction to practice, prior to the Third Party’s filing. Moreover, in an interference proceeding, Inventor may also show she invented first and defeat the Third Party’s ability to obtain a U.S. patent. Because Inventor publicly disclosed her invention one year or less prior to filing of her U.S. patent application, Inventor’s public disclosure cannot be considered as prior art against her own patent application in the United States. However, under this scenario, because there is no antedating process available outside the United States, neither Inventor or Third Party may be able to obtain a patent outside the United States because while the Third Party filed first, Inventor’s public disclosure is prior art to the Third Party’s filing and may be prior art to Inventor’s filing, depending on the timing of the public disclosure and the effective filing date of Inventor’s application, and whether any grace period is available in that country.

In the second scenario under the FTF system, while Inventor may no longer be able to rely on her date of invention to antedate the Third Party’s filing, Inventor may rely on the AIA provision that a public disclosure by Inventor made one year or less before the effective filing date does not count as prior art. Moreover, the Third Party that filed its application prior to Inventor cannot obtain a U.S. patent. However, similar to the second scenario under the current system, neither Inventor or Third Party may be able to obtain a patent outside the United States.

While the AIA takes away Inventor’s opportunity to obtain a U.S. patent under the first scenario, and maintains the same the end result for obtaining a U.S. patent in the second scenario, the second scenario has generally not been an option for those who want to also obtain patents outside the United States. The net result of the AIA is that an applicant generally should file her patent application as soon as possible after a date of invention, especially since a U.S. applicant would no longer have home court advantage for obtaining a U.S. patent against unforeseeable third party filers and publications.

The practice of filing as soon as possible is especially hard on biotech and pharmaceutical inventions where at least in vitro data is often needed to obtain a patent. For pharmaceutical products, there is an additional type of public disclosure that must be dealt with. In 2004, the International Committee of Medical Journal Editors (“ICMJE”) member journals published a statement requiring, as a condition for consideration for publication in one of its member journals, registration in a public trials registry at or before the onset of patient enrollment. The policy applied to any clinical trial starting enrollment after July 1, 2005.7 While an applicant may decide to not publish her clinical trial study and thus may not need to register her clinical trial, many applicants do register for full disclosure. Thus, a typical patent filing strategy is to file a provisional patent application, then register at a public clinical trial registry, such as clinicaltrials.gov, and then generate data prior to filing of the nonprovisional application and foreign filing within one year from the filing of the provisional application. The goal is to add claims covering the invention in the provisional application so that at the time of filing the U.S. nonprovisional and foreign applications, the applications will contain clinical data to support the claims in the provisional application, as well as additional inventions arising out of the data generated from the clinical trial.

Under the AIA, the desire to follow this typical patent strategy will not change but may incentivize an applicant to file sooner. However, the consequence of filing sooner than later means earlier spending of big dollars. Moreover, while the United States and European patent offices will consider post filing data in granting patents, Asian countries, notably China, Japan, and South Korea, generally will not consider post filing data and grant patents based on the disclosure and data provided in the patent application. Thus, with limited funding and resources, maintaining a strong worldwide patent strategy will continue to be a challenge.

HURRY UP AND FILE?

As we ring in the New Year of 2012, it becomes clear that the March 16, 2013 date is just around the corner. Should applicants in the life sciences hurry up and file before the first-to-file provisions take effect? The advantages of doing so generally outweigh the negatives. As mentioned herein, inventions based on discoveries in the life sciences appear to be more susceptible to near-simultaneous development by more than one research group than do inventions in other technical areas. Thus, an applicant who may want to rely upon a date of invention, rather than the filing date of a patent application, would generally fare better under the current FTI system. Such applicants include those who, under the current system, might become involved in an interference or those who might want to antedate a reference. Additionally, as discussed herein, the definition of prior art will be expanded for applications having an effective filing date on or after March 16, 2013. Thus, for this additional reason, an applicant generally would fare better under the current system.

Furthermore, applications filed under the FTF system will be vulnerable to challenges in post-grant review (“PGR”) proceedings, which (with few exceptions) will not be available for patents having an earlier effective filing date.8 In a PGR proceeding, a third party may petition the USPTO to find the claims of a patent to be unpatentable on any ground for invalidity, including lack of enablement or lack of written description. In contrast, under the current system, a third party cannot directly attack a patent for lack of enablement or lack of written description in a post-issuance proceeding at the USPTO (other than in an interference). Patent challenges based on lack of enablement or lack of written description are particularly attractive to participants in the life sciences, where these requirements of the patent statute can be difficult to meet. The AIA does not clearly provide incentive to file a patent application after March 16, 2013, if filing the application before such date is a viable option.9

In sum, under optimal circumstances under the AIA, an applicant in the life sciences generally will file a comprehensive patent application that contains substantiating data, and the applicant will file this application early on and prior to public disclosure of the invention by the inventor or third parties. Such a strategy will maximize opportunities for the applicant to obtain meaningful patent protection worldwide. However, as discussed herein, there may be circumstances that bode for making strategic use of public disclosures of the invention.

Eldora L. Ellison, Ph.D., is a Director in the firm’s Biotechnology/Chemical Group where she has extensive experience in representing clients in patent reexaminations and concurrent patent litigation in the federal courts, and has overseen more than a dozen patent interferences before the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office.  

Judith U. Kim is a Director in the firm’s Biotechnology/Chemical Group where she counsels clients on patent portfolio strategy and long-term corporate development. Her practice involves preparation of patent applications and their prosecution and appeal worldwide, reexaminations, interferences before the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences, and management of oppositions worldwide.  

 

Disclaimer  

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