One of the statistics gleaned from Director Michelle Lee's recent blog on the post-issuance review provisions of the America Invents Act is that only 42% of inter partes review petitions have been granted over the past three years. There is no statistic in the Director's link to a more detailed description of the data regarding the correlation between petitions being denied and the patentee exercising its right to challenge the petition by filing a Preliminary Response (see "Patent Trial and Appeal Board Statistics," July 31, 2015). But logic suggests that the Board might be less likely to grant a petition if the patentee gave them reasons not to do so.
This is what happened in two petitions for inter partes review filed by the Coalition for Affordable Drugs (ADROCA) against two patents owned by Acorda Therapeutics. The Patent Trial and Appeal Board (PTAB) issued a pair of decisions on August 24, 2015 denying these petitions, using almost identical language and based on parallel reasoning.
The patents were directed to a multiple sclerosis drug (4-aminopyridine) and methods for treating MS by administering this drug. In one petition, ADROCA challenged claims 1-8 of U.S. Patent No. 8,663,685; claim 1 is representative:
1. A method of improving walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein the sustained release composition further comprises one or more pharmaceutically acceptable excipients.
In the other, claims 1-3, 5-8 and 10-41 of U.S. Patent No. 8,007,826 were the subject of the ADROCA petition; claim 1 and 6 are representative:
1. A method for maintaining a therapeutically effective concentration of 4-aminopyridine in order to improve walking in a human with multiple sclerosis in need thereof, said method comprising: orally administering to the human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a day; and thereafter, maintaining administration of 4-aminopyridine by orally administering to said human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, whereby an in vivo 4-aminopyridine CmaxSS:CminSS ratio of 1.0 to 3.5 and a CavSS of 15 ng/ml to 35 ng/ml are obtained in the human.
6. A dosing regimen method for providing a 4-aminopyridine at a therapeutically effective concentration in order to improve walking in a human with multiple sclerosis in need thereof, said method comprising: initiating administration of 4-aminopyridine by orally administering to said human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a day without a prior period of 4-aminopyridine titration, and then, maintaining administration of 4-aminopyridine by orally administering to said human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily; without a subsequent period of 4-aminopyridine titration, whereby an in vivo 4-aminopyridine CmaxSS:CminSS ratio of 1.0 to 3.5 and a CavSS of 15 ng/ml to 35 ng/ml are maintained in the human.
In the petition regarding the claims of the '685 patent, petitioner asserted three grounds of invalidity, all sounding in obviousness. The asserted references were a poster by Goodman, entitled "Placebo-Controlled Double-Blinded Dose Ranging Study of Fampridine-SR in Multiple Sclerosis" which was used alone or in combination with a poster by Hayes entitled "Open-Label, Multiple-Dose Study to Determine the Pharmacokinetics and Safety of Fampridine-SR (Sustained-Release 4- Aminopyridine) in Patients with Chronic Spinal Cord Injury." These same references were asserted against the claims of the '826 patent, in support of two grounds of asserted obviousness in view of either the Goodman or the Hayes posters.
The Board denied the petitions to initiate based on their determination that petitioner had not established that either poster was prior art. As an initial matter, the Board stated that the presence of both poster references on Information Disclosure Statements (IDSs) filed by the inventors was not an admission that the references were prior art, citing citing 37 C.F.R. § 1.97(h) and Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1274, 1279 (Fed. Cir. 2003). The Board then set out the relevant considerations for whether a poster was a "printed publication" under 35 U.S.C. §102(b), citing In re Klopfenstein, 380 F.3d 1345, 1349 n.4 (Fed. Cir. 2004). The evidence established that the poster was "a temporarily displayed reference that was neither distributed nor indexed" and under these circumstances the standard under Klopfenstein for showing a reference to be §102(b) prior art required consideration of the following:
[1] the length of time the display was exhibited, [2] the expertise of the target audience, [3] the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and [4] the simplicity or ease with which the material displayed could have been copied.
Here, the Board found that there was insufficient evidence regarding the first prong or second prongs of the test. The Board also commented that the posters comprised "relatively dense material in a small space," and that the "more complex a display, the more difficult it will be for members of the public to effectively capture its information," citing Klopfenstein. On this basis the Board found that the petitioner presented insufficient evidence that there could be "any reasonable expectation that one could have copied the poster material, or evidence regarding the ease with which the poster material could have been copied."
These determinations applied to both the Goodman and the Hayes posters and in the petitions for inter partes review of both the '685 and '826 patents, and accordingly the Board denied the petitions to institute inter partes review against either patent.
Petitions like the ones filed against the Acorda patent have raised concerns regarding potential abuses to the inter partes review process. However, outcomes like these, and the statistics contained in the Director's blog, suggest that any such problems may be less compelling than has been feared, particularly as more savvy observers realize that there can be a great difference between filing an inter partes review petition and having a trial instituted by the Board.
