Category Archives: Practice Insights

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Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on June 14th, the Senate Judiciary Committee voted 16-5 to bring it to the Senate floor for a vote.  Presently, generic ANDA … Continue reading this entry

PTAB Releases Frequently Asked Questions about the implications of SAS on AIA trial proceedings

The PTAB has released a Frequently Asked Questions and Answers document.  The Questions and Answers are grouped into the following categories: Effect of SAS on AIA proceedings generally Effect of SAS on on-going partially-instituted proceedings Effect of SAS on instituted challenges previously denied for statutory reasons Effect of SAS on future challenges that could be denied for … Continue reading this entry

New informative order providing guidance on motions to amend

In view of the Federal Circuit Decision in Aqua Products, the PTAB has de-designated as precedential MasterImage 3D, Inc. v. RealD Inc., Case IPR2015-00040 (PTAB July 15, 2015) (Paper 42) and has de-designated as informative Idle Free Sys., Inc. v. Bergstrom, Inc., Case IPR2012-00027 (June 11, 2013) (Paper 26).  As a replacement, Western Digital Corp. … Continue reading this entry

SAS Institute: One Month In

We are now a little over a month since the Supreme Court issued its decision in SAS Institute v. Iancu, where the Court held that “[w]hen the Patent Office institutes an inter partes review, it must decide the patentability of all of the claims the petitioner has challenged.”  As previously reported, the PTAB issued  Guidance … Continue reading this entry

Recent PTAB Studies: Expanded Panels and Orange Book-Listed Patents

In connection with a recent “Chat with the Chief” webinar, the Patent Trials and Appeal Board (“PTAB”) released two studies – a study of expanded panels and a study of proceedings challenging orange book-listed patents.[1]  Practitioners may find value in reviewing these studies and the conclusions drawn by the PTAB. … Continue reading this entry

Successful Appeals of PTAB Decisions: In re Hodges

Obtaining a remand on an appeal from the Patent Trial & Appeal Board (PTAB) is of course a win for the Patent Owner, but may result in an ultimate loss when the case is revisited at the PTAB. The Feb. 12, 2018 Federal Circuit opinion, In Re Hodges, No. 2017-1434, (Fed. Cir. Feb. 12, 2018), highlights … Continue reading this entry

PTAB -A Year In Review of 2017

2017 was a year for the record books at the Patent Trials and Appeal Board (PTAB), which has included newly created standard operating procedures from the PTAB, a landmark en banc ruling from the Court of Appeals for the Federal Circuit impacting amendment practice, and a series of informative decisions from PTAB impacting multiple proceedings … Continue reading this entry

Expanded PTAB Panel Finds Sovereign Immunity Waived By Patent Enforcement

In a case of first impression, an expanded PTAB panel (including Chief APJ Ruschke) found that a parallel enforcement action by a patent owner waives its sovereign immunity defense against under the 11th Amendment an AIA petition in Ericsson v. Regents of the University of Minnesota.  The expanded panel first affirmed its earlier decisions finding … Continue reading this entry

PTAB Grants Rare Request for Additional Discovery In IPR

In Mylan v. Allergan (IPR2016-00127, Paper No. 73), the PTAB granted a rare request for discovery filed be Petitioner in response to summaries of data presented in a Patent Owner Response used to rebut obviousness.  In particular, the PTAB found that the Garmin factors for analyzing discovery requests weighed in favor of granting Petitioner’s motion.  However, the … Continue reading this entry

CAFC Eases Amendment Process In IPR Proceedings

Today in Aqua Products, Inc. v. Matal, a fractured Court of Appeals for the Federal Circuit (CAFC) sitting en banc decided to flip the burden of persuasion onto petitioners in IPR proceedings to show that an amendment is not patentable, removing from patent owners the burden previously placed upon them by the PTAB.  In its conclusion, the … Continue reading this entry

Pharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review

As we have previously reported, sovereign immunity of state universities (who are instruments of state government) has been used to avoid IPRs under the immunity clause of the US Constitution (“Sovereign Immunity of State Universities:  Can It Shield Them From AIA Patent Challenges?” and “Are State-Owned Patents Immune From IPRs Under The 11th Amendment?“).  Now, a pharmaceutical company … Continue reading this entry

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

Federal Circuit Again Reverses PTAB Obviousness Determination

In what is becoming a familiar basis for reversal of PTAB decisions, the Federal Circuit yet again reversed the PTAB for its failure to adequately explain the basis for combining multiple prior art references in support of its conclusion of obviousness in Personal Web Technologies, LLC v. Apple, Inc.  Specifically, the Federal Circuit (Taranto, Chen, Stoll) … Continue reading this entry

CAFC Upholds Preliminary Injunction Despite Unpatentability Ruling of PTAB

This week in Tinnus Enterprises LLC v. Telebrands Corp. (Moore, Wallach and Stoll), the Federal Circuit upheld the grant of a preliminary injunction by the Eastern District of Texas, despite a PTAB Final Written Decision finding the claims at issue to be indefinite.  While the petitioner’s failure to directly raise the PTAB’s grounds as a basis to … 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

PTAB Post-Grant Fees Slated To Increase

The USPTO recently announced a proposed new fee schedule in a Notice of Proposed Rulemaking (NPRM) in search of revenue to recover its projected $3 billion aggregated operating costs for the 2017 fiscal year. If enacted, it would be the Office’s most significant fee adjustment since March 2013. The Office is proposing to increase 205 … 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

Magnum Offers New Path for Challenging AIA Decisions: Burden of Production

Yesterday, the Court of Appeals for the Federal Circuit (CAFC) held in In re Magnum Oil Tools International (Newman, O’Malley & Chen) that the burden of production to show unobviousness does not shift to a patent owner based upon the Board’s institution decision.  In particular, the CAFC found that Cuozzo’s prohibition of appealing institution decisions does not prevent patent owners from … Continue reading this entry

Straight From The Judges’ Mouths: Lessons For Persuading the Board

The USPTO’s Patent Trial & Appeal Board (PTAB) hosted its June Boardside Chat, which addressed best practices for presenting patentability/unpatentability arguments before the board. The Chat, which was hosted by Administrative Patent Judges (APJs) Jay Moore, Christopher Crumbley, and Kal Deshpande, provided valuable guidance for best-practices in the context of IPR proceedings.… 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