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Administrative Agency Intellectual Property Science, Computers & Technology

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Due Diligence: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more

FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

by Goodwin on

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer,...more

Ex Parte Hafner Provides Clarity in Assessing Patent Subject Matter Eligibility for Software Patents

In Ex Parte Hafner, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (the “Board”) reversed the Examiner’s rejection that claims directed to an energy transaction plan were subject-matter ineligible. Ex...more

Why Design Patents Are Surviving Post-Grant Challenges

As of January 2017, the institution rate for Patent Trial and Appeal Board trials involving design patents was 37 percent. That is significantly lower than every other technology area and makes design patents the only...more

What Rights Will I Lose if I Pitch My Invention to Investors Before I File a Patent Application?

by Ward and Smith, P.A. on

Did you know that the individual often credited with popularizing karaoke did not reap the financial rewards of his invention to the extent possible? It's true—Japanese musician Daisuke Inoue invented karaoke in Kobe, Japan...more

EDTX Interprets Federal Circuit Precedent Narrowly, Recommends Applying §315 Estoppel Broadly

by Jones Day on

In Biscotti Inc. v. Microsoft Corp., Magistrate Judge Payne recommended that estoppel under §315(e) apply broadly against Microsoft in an upcoming patent infringement trial scheduled for early June 2017. No....more

PTAB Invalidates Patent for Blockbuster Drug HUMIRA®

The PTAB issued a Final Written Decision in Coherus BioSciences Inc. v. AbbVie Biotechnology Ltd., IPR2016-00172 (P.T.A.B. May 16, 2017) finding claims 1-5 of U.S. Patent No. 8,889,135 (“the ‘135 patent”) unpatentable....more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

Magistrate Judge Recommends IPR Estoppel Bar of Prior Art References

A magistrate judge in the Eastern District of Texas recommended in Biscotti, Inc. v. Microsoft Corp., No. 2:13-CV-01015, DI 191 (E.D. Tex. May 11, 2017) that Microsoft should be estopped from asserting invalidity grounds that...more

Secondary Considerations Carry The Day

by Jones Day on

We have previously reported (on February 1, on March 1, and on March 30) how patent owners have seen a mixed bag of results in trying to convince PTAB panels that secondary considerations of non-obviousness were sufficient to...more

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

Amgen Sues Coherus Under BPCIA After Completing Patent Dance

On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S....more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

Our report includes discussions of six of the precedential cases decided in the past week and will include the other three cases in next week’s report. In Aylus v. Apple, the panel finds prosecution disclaimer in a...more

Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

by Foley & Lardner LLP on

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...more

Federal Circuit Maintains Pre-AIA Interpretation of the On-Sale Bar for Public Sales

by Brinks Gilson & Lione on

In Helsinn Healthcare S.A., v. Teva Pharm. USA, Inc., the Federal Circuit recently held that, despite changes to the statutory language of § 102 under the Leahy-Smith America Invents Act (“AIA”), the Court’s pre-AIA...more

Is The Real IPR Institution Rate Higher When Petitioner Errors & Pre-Institution Settlements Are Considered?

by Foley & Lardner LLP on

We have previously noted that the increasing rate of pre-institution settlement may in part be responsible for the declining institution rate in IPR proceedings because stronger petitions may drive earlier settlements,...more

PTAB Holds All Claims Unpatentable in Reversal on Remand

The PTAB recently issued a final written decision on remand from the Federal Circuit, holding all claims to be unpatentable in Athena Automation Ltd., v. Husky Injection Molding Sys. Ltd., IPR2013-00290, Paper 61 (P.T.A.B....more

Semicolons Strongly Indicate Each Step is Separate and Distinct; Confuse Most Non-Patent Lawyers

In In re Affinity Labs of Texas, LLC, [2016-1173] (May 5, 2017), the Federal Circuit affirmed the Board’s decision that §317(b) did not bar the reexamination and that the reexamined claims were invalid....more

Federal Circuit Holds Objective Indicia Must Be Linked to Novel Features

by Jones Day on

In Novartis AG v. Torrent Pharms. Ltd. (2016-1352), the Federal Circuit affirmed the PTAB’s decision in consolidated IPR proceedings (IPR2014-00784, IPR2015-00518) invalidating all claims of U.S. Patent 8,324,283. In doing...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Nichia the Circuit affirms the denial of a permanent injunction because Nichia failed to prove irreparable injury. In RecogniCorp the panel throws out as not being directed to patentable subject matter claims directed to...more

How to Obtain Multiple Patent Term Extensions for a Single Product

by Pepper Hamilton LLP on

This is the second article in our five-part series on PTE. Everywhere you look, patent term extension (PTE) is described using the “Rule of Ones:” one patent, one product, one PTE. However, the Rule of Ones does not...more

Product-by-Process Claims Invalid when the Process Does Not Impart Structural or Functional Differences

by Jones Day on

The PTAB issued a final written decision in IPR2016-00006, holding claims 1–22 of U.S. Patent No. 8,497,393 (“the ’393 patent”) unpatentable under 35 U.S.C. § 102(b) and 35 U.S.C. § 103(a). All of the claims are...more

Will Courts Consider Evidence of Patent Eligibility?

Patent enforcement by Texas-based DataTreasury Corp. (“DataTreasury”) was a key motivation for the creation of Covered Business Method Review (“CBM”) proceedings. Senator Charles Schumer of New York, referring to...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

Novartis’ Gilenya Patent Invalidated as Obvious

On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were...more

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