Patent Trial & Appeal Board

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Secondary Indicia of Greater Value in Bio/Pharma

The submission of objective evidence of non-obviousness is rarely effective in the predictable arts (i.e., mechanical/electrical).  This is because such evidence must have a “nexus” to the claimed invention.  And, as the most common secondary indicia is “commercial success,” rarely do broadly drafted patent claim elements so cleanly coincide with sales results.  Long-felt but unsolved need is a further secondary consideration that is less prevalent in the predictable arts as it is in more traditional, laboratory driven industries.  Nexus is a significant hurdle in the predictable arts.

On the other hand, patent claims in the unpredictable arts, such as new drug formulations can have an especially compelling nexus to market appeal and unfilled need.  Where a drug is an improvement over existing formulations, or an altogether new treatment, commercial success and long, unmet need are easily tied to the specific formulations of the claims.  For this reason, secondary indicia of non-obviousness is a far more compelling rebuttal to a patentability challenge of the USPTO’s Patent Trial & Appeal Board (PTAB).

Given the modest, but growing rate of PTAB challenges in the unpredictable arts, petitioners should be wary of challenging especially popular drug formulations.
Continue Reading Secondary Considerations More Effective in Unpredictable Arts

New De Facto Precedent on Question of Issue Joinder

In Target Corp. v. Destination Maternity Corp (IPR2014-00508), the Board departed from previous PTAB practice on issue joinder for the first time. That is, up until Target, a same petitioner was able to join a first-filed petition with a later filed, second petition (i.e., “issue joinder). The first Target decision determined that issue joinder was outside of the statutory authority granted by 35 U.S.C. § 315(c). cf. Microsoft Corp. v. Proxyconn, Inc., (IPR2013-00109, Feb. 25, 2013). Thereafter, an expanded, but divided, panel, reversed, that finding on rehearing. Since that time, as the ultimate decision in Target  was not precedential, the question of whether or not issue joinder is permitted by statute has become panel dependent.

Now, based upon a recent decision of the Board (which tracks a recent brief filed by the USPTO with the CAFC), it appears the Board is moving toward a more consistent policy of accepting issue joinder.
Continue Reading PTAB Moves Toward Consistency on Question of Issue Joinder

PTAB Finds IPR Filing of Hedge Fund Has Merit

Today, in IPR2015-00988, the Patent Trial & Appeal Board (PTAB) instituted review of Cosmo Technologies patent 7,773,720. The patent is directed to controlled release oral pharmaceutical compositions containing 5-amino salicylic acid, also known as mesalazine or 5-ASA, as an active ingredient. Mesalazine is used to treat Crohn’s…

Strafford Legal Webinar This Thursday

This Thursday October 8th, I, along with former USPTO Commissioner for Patents Peggy Focarino, will host the Strafford Legal webinar Proactive Patent Procurement and Prosecution Strategies: Minimizing the Threat of Post-Grant Challenges. The program will assess the changing assertion and procurement landscapes with a particular focus on strategies that…

USPTO AIA Implementation Report Explains Progress, Recommends Changes

Two weeks back, the USPTO provided a report to Congress on the implementation of the America Invents Act (AIA) (as required by the legislation). The 65 page report (here) explains the administrative effort to implement the mechanisms of the AIA, as well as four years of statistics. Of particular interest to me are the recommendations to Congress on adjusting IPR/PGR mechanisms, as well as some of the statistics on such procedures as third party submissions and (the all but forgotten) supplemental examination. …
Continue Reading USPTO Recommends PTAB Changes to Congress in AIA Report

315(b) Bar is Not an Ultimate Issue of PTAB Authority to Invalidate

Back in July, the Court of Appeal for the Federal Circuit (CAFC) determined that a question of CBM eligibility was excepted from the appellate review bar for PTAB institution determinations. The exception for CBM eligibility was found because this question pertains to the PTAB’s “ultimate authority to invalidate.” Versata Dev. Grp., Inc. v. SAP America, Inc. 793 F.3d 1306 (Fed. Cir. 2015). Since the Versata decision, subsequent appeals from the PTAB have probed the boundaries of the exception for other “standing” type issues.

In Achates Reference Publishing Inc. v. Apple Inc., decided yesterday (here), the question presented to the Court was whether or not the petitioner time bar to IPR (35 U.S.C. § 315 (b), i.e.,12 month widow) was an issue of the PTAB’s “ultimate authority to invalidate.”…
Continue Reading CAFC Finds 315(b) Bar to IPR Not Reviewable on Merits Appeal

Senate Proposal Seeks Separate Reexamination Track

Last year, I pointed out that the Central Reexamination Unit (CRU) had extra capacity since inter partes patent reexamination filings were abolished with the passage of the America Invents ACT (AIA) . And, given the adjudicatory mission of the Patent Trial & Appeal Board (PTAB), and the examination depth of the CRU, I recommended that perhaps there could be some joint cooperation between the entities to more effectively review amendments submitted in AIA trial proceedings. Specifically, I envisioned a “Motion to Reissue” that would extend the PTAB 12 month trial schedule another 6 months to allow for a truncated reissue proceeding. This reissue phase would be performed by the CRU with results returned to the PTAB within the 18 month trial schedule. In that same post, I recommended some other changes to the motion to amend process such as allowing claims be submitted in an appendix (since adopted by the Board) and a change to Rule 42.73(d)(3).

A Senate proposal floated last week proposed to change Rule 42. 73(d)(3) and, rather than reissue, add a reexamination component to substitute for the existing motion to amend process at the PTAB.

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Continue Reading Senate Proposes to Add Examiners to PTAB Amendment Process

Board Finds Profit Motive Acceptable for IPR

While all hedge fund filings considered by the PTAB to date have failed on the merits (Kyle Bass is 0-3 & Ferrum Ferro Capital 0-1), today, the Board declined to outlaw such filings as a matter of policy.  In IPR2015-01092, 1096, 1002, and 1103, Patentee Celgene filed Motion for Sanctions against the Coalition for Affordable Drugs. Celgene sought termination of the IPRs on the basis that the use of the IPR mechanism for pure financial gain (short selling and other investment strategy) was repugnant to the Congressional intent for this alternative to patent litigation. Decisions on the merits of the Celgene petitions remain outstanding.
Continue Reading PTAB Denies Sanctions in Hedge Fund Filings