Category Archives: PTAB Decisions

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Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field. The survey captured IPR filings by fourteen (14) of the most active generic petitioners among the world’s top-20 generic drug companies.  This study … Continue reading this entry

2017 Mid-Year Statistics Point to Continued Rise in IPR Petitions

March 31st marked the mid-point of the PTAB’s fiscal year and the release of mid-year statistics on AIA proceedings.  The full report of the mid-year statistics is found here.  One interesting trend is a continued increase in overall number of IPR petitions (mid-year there are 996 IPR petitions compared to a total of 1565 for all … Continue reading this entry

Reduced Scope of Post-IPR Estoppel Imperils Litigation Stays

In Depomed, Inc. v. Purdue Pharma LP et al., 3-13-cv-00571 (NJD November 4, 2016, Mem. Op. Dkt. 238) (Bongiovanni, MJ), the Court analyzed and applied recent Federal Circuit decisions limiting the scope of post-IPR estoppel under 35 U.S.C. § 315(e) to only those claims and grounds subject to a final written decision from the PTAB.  … Continue reading this entry

Seeking Balance: A Review of the First 4 Years of the PTAB

Looking back on the major developments that have shaped AIA proceedings over the first four years, three sources have contributed to changes: (1) rulemaking, (2) informative decisions by the PTAB, and (3) key appellate decisions of the US Supreme Court and the Court of Appeals for the Federal Circuit.  While a number of improvements have been … Continue reading this entry

Sovereign Immunity of State Universities: Can It Shield Them from AIA Patent Challenges?

In what appears to be a case of first impression, the PTAB is poised to rule on the question of whether state sovereign immunity prevents an IPR challenge from being maintained against a University of Florida (“UF”) patent (IPR2016-01274).  Under the 11th Amendment to the Constitution, “[t]he Judicial power of the United States shall not be … Continue reading this entry

Estoppel Prevents Second IPR Petition Even When New References Were Missed By First Search

In a case that appears to be a case of first impression, the PTAB found in its decision denying institution in IPR2016-00781 that a final written decision in an earlier IPR created estoppel under 35 U.S.C. § 315(e)(1), preventing a second IPR petition from being instituted that used additional references which reasonably could have been raised before, even though … Continue reading this entry

PTAB Holds Technical Difficulties Will Not Save Late-Filed IPR Petitions

The PTAB recently stood firm in denying a petitioner’s motion to change the filing dates of two IPR petitions that missed a statutory deadline by less than ten minutes. Case IPR2016-00281 and IPR2016-00282 (Patents 8,603,514 B2 and 8,017,150 B2). The petitioner, Teva Pharmaceuticals USA, Inc., was facing a 1-year statutory IPR filing deadline of December … Continue reading this entry

Survey of Pharmaceutical IPRs Filed By Generic Drug Company Petitioners

We have reviewed a sub-group of 111 IPRs filed by generic drug companies against pharmaceutical patents to assess outcomes and trends.  While our survey was not  intended to capture every IPR filed by a generic drug company,  it does cover the most active generic company filers to date (see Fig. 2 below).  Examining this particular group … Continue reading this entry

Reading The Cuozzo Tea Leaves: Best Practices Pending The Supreme Court's Decision

The Supreme Court of the United States heard oral argument today on claim construction in inter parte review (IPR) proceedings and the reviewability of institution decisions (a copy of the petition for certiorari is reported at “Supreme Court Accepts 1st IPR Appeal: Cuozzo Could Mark Turning Point for Patent Owners”). On the claim construction issue, … Continue reading this entry

Guarding Against Conclusory Statements & Why It Matters Even More Under The New PTAB Rules

A common deficiency highlighted in recent PTAB decisions denying institution of an IPR petition is that an expert declaration offers only “conclusory” statements in relation to one or more key aspects of the alleged ground of unpatentability. For example, in a decision denying institution in IPR2016-00011, the PTAB commented that “Dr. Harrigan’s opinion in this … Continue reading this entry

Patent Due Diligence: All That Glitters May Not Be PTAB Gold

An obvious but sometimes overlooked item when conducting patent due diligence is to check for PTAB proceedings (CBM, IPR, or PGR). Although the Patent Application Information Retrieval System (PAIR) does show whether patents have been subjected to reexamination (by clicking on the “continuation” tab of a file displayed in PAIR), whether or not a patent … Continue reading this entry

PTAB Institutes Kyle Bass IPR Against Pharmaceutical Patent Based On SEC Document

Kyle Bass has filed numerous prior IPR petitions against pharmaceutical patents, some of which have been denied due to use of prior art references that were not sufficiently proven to be “publicly accessible” (see “Clinical Trials as Prior Art: PTAB Denies Bass IPR With Only A “Hope” Of Efficacy”). However, in IPR2015-01850, the PTAB instituted … Continue reading this entry

The Latest Twist In The Apple v. VirnetX IPRs: Appeals Court Issues Temporary Stay

On March 7, 2016, the Federal Circuit issued a temporary stay to permit briefing by the parties on the question of whether the PTAB properly ruled that Apple could use the joinder process in Mangrove Capital’s IPR against VirnetX to avoid the one-year bar that prevents a litigation defendant like Apple from filing its own … Continue reading this entry

VirnetX Faces Follow-on IPR Petition from a Different Petitioner After Settling Previously Instituted IPR

In IPR2014-00614, Microsoft filed a petition for IPR against US Patent No. 7,418,504 (“the ‘504 patent) owned by VirnetX, which was instituted based upon anticipation grounds over Kiuchi (see institution decision).  This IPR later settled, and the PTAB granted termination before a final written decision.  Yesterday, a new entity (Black Swamp IP, LLC) filed a petition … Continue reading this entry

PTAB Institutes Trial On Previously Challenged Cabilly Patent

The Cabilly ’415 patent is well known in the bio/pharma space as relating to the artificial synthesis of antibody molecules. The Cabilly ‘415 patent’s notoriety was aided by a previous interference, a merged ex parte reexamination proceeding, and several Federal District Court Litigations. Nevertheless, Petitioners Sanofi-Aventis and Regeneron Pharmaceuticals petitioned for inter partes review (IPR2015-01624), … Continue reading this entry

High Stakes Race Between Apple and VirnetX: Will PTAB Trump The Texas Jury's Award of $625M?

A Texas jury today raised the stakes even higher in a race involving parallel proceedings between the PTAB and Texas district court when it found that Apple infringed the VirnetX patents and awarded to VirnetX $625M in damages. While the Texas jury found the patents to be valid and infringed in today’s verdict, the PTAB … Continue reading this entry

Split Federal Circuit Upholds Constitutionality of Single PTAB Panels Rendering Both Institution & Final Written Decisions

On January 13, 2016, the Federal Circuit affirmed the decision of the PTAB in Ethicon Endo-Surgery, Inc. v. Covidien LP, IPR2013-00209, that all of the claims of U.S. Patent 8,317,070 are obvious. While the obviousness analysis in both the PTAB decision and the subsequent appeal were unremarkable, the Federal Circuit’s decision was nevertheless precedential for … Continue reading this entry

Denying Prior Art Status In PTAB Proceedings: Petitioner's Failure to Show Section 112 Support in Priority Applications May Be Fatal

Several of our recent posts have discussed petitioners’ use of priority denial to attack patents with intervening prior art, but the issue of adequate support in an earlier filed application may also work in reverse against the petitioner when the prior art relied upon is a published patent application or granted patent with multiple filing … Continue reading this entry

Federal Circuit Backs PTAB Decision Curtailing A Party's Use Of "Supplemental" Information

In Redline Detection v. Star Envirotech, the Federal Circuit confirmed that the PTAB can decline to consider timely filed “supplemental” information from a petitioner (after filing its petition) pursuant to 37 C.F.R. § 42.123(a). While some PTAB decisions have permitted very limited use of Rule 123(a) by petitioners to supplement their petition after an institution … Continue reading this entry

Use of Priority Denial to Subject Apparent "Pre-AIA" Patents to PGR: Inguran v. Premium Genetics

A recent decision by the PTAB, Inguran v. Premium Genetics, demonstrates that a Petitioner may subject an apparent “pre-AIA” patent, having at least one priority date before and at least one priority date after March 16, 2012, to the post-grant review (PGR) process. By arguing that at least one claim is not entitled to the … Continue reading this entry

Federal Circuit Affirms PTAB's IPR Decision Invalidating A Pharmaceutical Patent

Today in Merck v. Gnosis, the Federal Circuit affirmed the PTAB’s IPR Decision finding a pharmaceutical patent invalid for obviousness. Justice Newman vigorously dissented from the majority’s view (Justices Hughes and Plager) that a “substantial evidence” standard should apply to review of PTAB IPR decisions, which may encourage the patent owner to pursue a request … Continue reading this entry

PTAB Refuses To Sanction Kyle Bass

Many pharmaceutical companies have complained about the IPR petitions filed by Kyle Bass and the Coalition for Affordable Drugs against Orange Book-listed patents covering approved pharmaceutical products, but Celgene Corp. took more serious action, and filed motions for sanctions in the IPRs launched against its patents relating to Thalomid® (thalidomide) and Revlamid® (lenalidomide). However, the USPTO Patent … Continue reading this entry

Estoppel Versus Discretion: How is the PTAB Deciding Multiple Petitions Against the Same Patent?

The PTAB has denied petitions filed by the same petitioner against the same claims, even where the subsequent petition relied upon completely different prior art (IPR2014-00506), reasoning that a petitioner should not hold back its best references for a subsequent attempt.  But what happens when the same petitioner files a new petition (after a first petition is denied) against … Continue reading this entry

Clinical Trials as Prior Art: PTAB Denies Bass IPR Petition With Only a "Hope" of Efficacy

By Shaun R. Snader[1] & Stephen B. Maebius In the most recent loss for Kyle Bass’ hedge fund in IPR proceedings, the Board denied institution of an IPR based on a petition filed by Coalition for Affordable Drugs V LLC (CFAD) against Biogen MA Inc. IPR2015-01136, Paper 23 (Sept. 2, 2015).  The Board (per Judge McKelvey) … Continue reading this entry