Since Inter Partes Reviews (IPR) first became available in September 2012, patent challengers have filed over 2,553 petitions (as of February 28 2015). Yet, only 193 (7.5%) involve biotech- or pharma-related patents assigned to Technology Center 1600 (Life Sciences IPRs). The majority of the Petitioners in these IPRs appear to be second or subsequent ANDA filers or companies considering bringing biosimilars to the market. In those 193 cases, there have, thus far, been 110 Institution of Trial Decisions (74 granting institution (67%); 36 denying institution) and 25 Final Written Decisions. In those Final Written Decisions, the Patent Trial and Appeal Board (PTAB) has invalidated 51% of the claims on which the IPR was instituted (or the Patent Owner canceled those claims.)
Some lessons can be learned from the strategies that Patent Owners have employed in these Life Sciences IPRs: be specific, get into the details, and support your arguments with evidence-based, non-conclusory fact and expert declarations.
Successful Patent Owner Strategies
Institution of Trial Denials
In many cases where the PTAB has denied Institution of Trial, its reasoning has been procedural (for example, time barred, redundancy, etc.) However, when the PTAB's denial was substantive, successful Preliminary Responses (which cannot be supported by IPR-based declarations of expert or fact witnesses) have typically challenged a dispositive, discrete failure in the art and Petitioner's characterization of it or its purported combination.
Some examples of these substantive institution denials are (uspto.gov/PTAB (see PRPS):
- In IPR2013-00023, the Patent Owner showed that the Petitioner's reliance on inherency was unfounded and unsupported.
- In IPR2014-00331, the Patent Owner demonstrated that one claim element -- the automated seed sampler system -- was missing from the prior art.
- In IPR2014-00651, the Patent Owner demonstrated that the Petition attempted to "gloss over" the distinction between the claimed compound (hydroxypropyl methylcellulose) and the prior art compound (hydroxyethyl cellulose).
- In IPR2014-00842, the Patent Owner showed that "[i]dentifying patients that do not respond (or respond poorly) to a particular type of therapy does not suggest whether or how to treat these patients."
- In IPR2014-00885, the Patent Owner showed that the motivation to combine the obviousness references was missing.
- In IPR2014-01126, the Patent Owner showed that the disclosure of a large genus failed to anticipate a single species within the genus.
Final Written Decisions
The Patent Owner has successfully defended all of the challenged claims in six of the 25 Life Sciences IPRs that have resulted in Final Written Decisions. In all six, the key seems to have been a specific and fact-based attack on a critical flaw in the prior art and the PTAB's characterization of it. By contrast, conclusory statements about the prior art and the equities have been unpersuasive.
In the related IPR2013-00276 and IPR2013-00277, Patent Owner argued the art failed to disclose elements of the challenged claims. Perhaps, because the PTAB had already analyzed the prior art and the claims in its Institution Decision, these arguments fell on deaf ears. What carried the day was Patent Owner's expert-supported specific and fact-based evidence that an ordinary skilled worker would not -- and in fact, could not -- have combined the prior art.
Similarly, in the related IPR2013-00368, IPR2013-00371 and IPR2013-00372, the Patent Owner argued that "modified sustained release" was different from "delayed release." This illustrated a critical misunderstanding in the Institution Decision.
Unsuccessful Patent Owner Strategies
The two most glaring unsuccessful Patent Owner strategies have been (1) amending claims and (2) arguing objective indicia of nonobviousness.
Patent Owners may file a Motion to Amend after conferring with the PTAB. Any proposed claim amendment must: (1) respond to a ground of unpatentability involved in the trial, (2) not enlarge the scope of the claims or introduce new subject matter, and (3) be supported by the patent's written description. The Patent Owner must also "show patentability [of the amended claims] over the prior art in general, and not just over the references applied by the petitioner against the original patent claims."
To date, claim amendment successfully saved the claims in one Life Sciences IPR. And, there, the Petitioner did not challenge the substitute claims. In the remaining eight Life Sciences IPRs, where the PTAB has ruled on Motions to Amend, it has either denied the motion or granted the motion to cancel claims but denied the motion to substitute new claims. The denials have had varying bases, including enlarged claim scope, unresponsiveness to a ground of unpatentability at issue, unpatentability of the amended claims and lack of written description support.
Objective Indicia of Nonobviousness
Patent Owner's arguments regarding objective indicia of nonobviousness have also typically failed in Life Sciences IPRs. At the Institution stage, the PTAB rarely addresses objective indicia. The few times it has done so, it has found the evidence of record -- which cannot include IPR-initiated declarations -- insufficient to prevent Petitioner from meeting its burden that there was a reasonable likelihood that Petitioner would prevail (by a preponderance of the evidence) as to at least one challenged claim.
In Final Written Decisions, the PTAB has not yet found any objective indicia arguments persuasive. For example, in IPR2013-00117, where much of Patent Owner's response was devoted to such objective indicia, the PTAB found that there was no nexus between the objective indicia and the claimed invention. In other IPRs, the PTAB has rejected the evidence of objective indicia as not credible or unpersuasive. Indeed, even in the six decisions validating all claims on which the PTAB had instituted trial, the objective indicia analysis was said to be moot in light of the substantive analysis.
Although the sample size for Life Sciences IPRs is small, especially in comparison to IPRs in other technologies, the PTAB's Life Sciences decisions have shown important trends. Conclusory, equity-based or invalidity contentions litigation-style responses have been ineffective. So too has reliance on claim amendments or objective indicia of nonobviousness. By contrast, Patent Owners, who have prevailed before the PTAB, have made focused and evidence-and expert-supported detailed arguments demonstrating specific flaws in the prior art and its purported combination.