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How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

PTAB Puts Method Of Treatment Patents Under The 101 Knife

While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more

District Court Dismisses USPTO December 2015 Holidays Case

On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December...more

PTAB Holds Oral Hearings In Tecfidera Patent IPR and Interference

On November 30, 2016, the USPTO Patent Trial and Appeal Board (PTAB) held oral hearings in two different inter partes proceedings involving the Biogen Tecfidera® patent with the latest expiation date. First, it heard...more

Swearing Behind A Reference With Reasonably Continuous Diligence

In Perfect Surgical Techniques, Inc. v. Olympus America, Inc., the Federal Circuit vacated and remanded a USPTO Patent Trial and Appeal Board decision in an Inter Partes Review proceeding, finding that the PTAB imposed too...more

USPTO Examination Time Goals -- How Much Time Should Examiners Have To Examine A Patent Application?

As part of its ongoing efforts to improve patent quality, the USPTO is reevaluating its examination time goals and seeking public feedback on how much time examiners should have to examine a patent application. Examination...more

USPTO Again Proposes To Revise Duty Of Disclosure In View Of Therasense

More than five years after the Federal Circuit’s en banc decision in Therasense and its first proposed rulemaking under that decision, the USPTO has issued a new proposed rulemaking to adapt its duty of disclosure rule (37...more

District Court Denies Extra Patent Term Adjustment When National Stage Entry Date Falls On A Holiday

Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a...more

Biogen TYSABRI Patents Spared Inter Partes Review

The USPTO Patent Trial and Appeals Board (PTAB) declined to institute Inter Partes Review (IPR) proceedings against three Biogen Idec TYSABRI patents. The IPR petitions were filed by Swiss Pharma International, and asserted...more

Higher US Patent Fees On The Horizon

The USPTO has published a proposed fee schedule for patent fees likely to take effect October 1, 2017–the start of the USPTO’s next fiscal year. The proposed fee schedule makes “slight” changes to many fees, and more...more

Help The USPTO Leverage Prior Art From Related Patent Applications

The USPTO is seeking input on how it can leverage prior art information available on-line in related patent applications in order to “improve patent examination quality and efficiency” and reduce “applicant’s burden to...more

USPTO Sued Over December 2015 Holidays

Elm 3DS Innovations, LLC has sued the USPTO in the U.S. District Court for the Eastern District of Virginia to challenge its authority to declare that December 22-24, 2015 were “holidays” because the USPTO had experienced a...more

USPTO Launches Patents 4 Patients

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

The Promise And Pitfalls Of 3D Printing

3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more

USPTO Patent Eligibility Guidance In View Of CellzDirect And Sequenom

On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more

New USPTO P3 Program Offers Applicant Participation In After Final Conference

The USPTO has launched a new after final program available starting July 11, 2016. The Post-Prosecution Pilot Program (P3) combines features of the After Final Consideration Pilot 2.0 (AFCP 2.0) and Pre-Appeal Brief...more

CAFC Finds Cryopreservation Method Patent Eligible

The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S....more

Supreme Court Deals Blow To Diagnostic Method Patents, Denies Cert In Sequenom

“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom, the silence is deafening–and could have a chilling impact...more

Supreme Court Declines to Review Sequenom Ruling

The U.S. Supreme Court has denied certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc. (No. 15-1182), declining to review the Federal Circuit’s June 12, 2015, decision that certain methods of detecting paternally...more

CAFC Upholds Same Day Continuation Applications

The Federal Circuit decided not to disturb the “longstanding administrative construction” of 35 USC § 120 that permits the filing of a continuation application on the same day its parent application grants as a patent. The...more

Federal Circuit Emphasizes Reason In Application Of Broadest Reasonable Interpretation

As we wait for the Supreme Court decision in Cuozzo Speed Technologies, LLC v. Lee, where the Court has been asked to decide whether the USPTO Patent Trial and Appeal Board (PTAB) should apply the “broadest reasonable...more

USPTO 101 Guidance: Microneedles Versus Prosthetic Devices

When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a...more

New USPTO Guidance On Patent Eligibility Of Natural Products

The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although...more

New USPTO Guidance On Patent Eligibility Of Diagnostic Methods

The patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic...more

USPTO Issues New Patent Eligibility Examples

The USPTO has issued new patent eligibility examples, including several examples relating to diagnostic methods and “nature-based” products. Surprisingly, most of the claims are said to satisfy 35 USC § 101. The USPTO also...more

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