Two-Step Eligibility for Genomic Analysis Systems

Attorney: Daniel J. Pereira, Ph.D.
February 4, 2021

For practitioners at the USPTO, the reversal of a 101 rejection in Ex parte Patil (PTAB January 7, 2021), APJs Grimes, Scneider and Valek, in Appeal 2020-002775 should be interesting if not provide some light on the dance floor for doing the two-step with the USPTO.

The invention focused on assessing genetic variability with a system including databases and processors and as recited in Claim 27 U.S. 15/169,498:<... Read more

USPTO: Proposed Changes to Terminal Disclaimer Practice in Joint Research Agreement Situations

Attorney: Marina I. Miller, Ph.D.
February 1, 2021

The USPTO proposes to modify the rules of practice when certain types of patent applicants and patentees may obtain or enforce a second patent for an invention that is similar (i.e., patentably indistinct) to a first patent. Generally, an application for a second patent covering a similar invention would be rejected. The proposed rule change is limited to the situation where owners of the first and second patents or patent applications are different but have an agreement to conduct research together (i.e., a joint research agreement or JRA). The proposed rule change would increase the ability to file a terminal disclaimer (TD) that ties the rights of a second patent to the first patent. The proposed rule change intends to expand when a TD can be filed in the JRA situation by eliminating the requirement that the second patent or patent application be filed later than the first patent or patent application. The USPTO also proposes to amend the rules to explicitly state existing practices in the rules regarding when certain affidavits and declarations, as well as TDs, may be filed.<... Read more

Small Entity Government Use License Exception: Amendment of the Rules of Practice in Patent Cases

Attorney: Marina I. Miller, Ph.D.
January 4, 2021

The USPTO is amending the rules of practice in patent cases to clarify and expand exceptions to the rule pertaining to government use licenses and their effect on small entity status for purposes of paying reduced patent fees. The USPTO explained that the rule change is designed to support independent inventors, small business concerns, and nonprofit organizations in filing patent applications and to encourage collaboration with the Federal Government by expanding the opportunities to qualify for the small entity patent fees discount for inventions made during the course of federally funded or federally supported research.<... Read more

Must a "Human Antibody" Be Entirely Human? Or May It Also Be "Partially Human?"

Attorney: Marina I. Miller, Ph.D.
October 16, 2020

This is a consolidated appeal from two Patent Trial and Appeal Board (“Board”) decisions in inter partes reviews (“IPRs”) of U.S. Patent 8,679,487 (“the ’487 patent”), owned by Immunex Corp. (“Immunex”). Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuti-cals, Inc. (“Sanofi”) challenged the ’487 patent. The Board invalidated all challenged claims in IPR 2017-01884. Immunex appealed, contesting the construction of the claim term “human antibodies.” The Court of Appeals for the Federal Circuit (“the Court”) agreed with the Board’s claim construction and affirmed the invalidity decision.<... Read more

The USPTO Strikes Again: More First Action Final Rejections = More Money + Diminished Quality

Attorney: Vincent K. Shier, Ph.D.
September 17, 2020

While looking at a first action final rejection after an RCE that I received this week from an Examiner that I respect, I was asking myself why I had received what appeared to be such a shockingly improper action. The answer was provided to me during part of the on-going IPO annual meeting.... Read more

USPTO Launches National Council for Expanding American Innovation

Attorney: Daniel J. Pereira, Ph.D.
September 16, 2020

On Monday, September 14, 2020, the USPTO issued a press release announcing the launch of "a major initiative aimed at expanding invention, innovation, and entrepreneurship in the United States." As the USPTO describes, the initiative stems from recommendations to facilitate women and minority participation in innovation and invention because the USPTO's own 2018 "Success Act" study found that both women and minorities were underrepresented in patents as inventors.... Read more

RCE/National Stage Kerfuffle: PTO Creates a Nightmare Scenario

Attorney: Vincent K. Shier, Ph.D.
August 6, 2020

Much has been written lately about the USPTO's recent enforcement of its controversial interpretation of filing Requests for Continued Examination (RCE) in National Stage applications (i.e., applications under 35 U.S.C. ยง371) where the oath/declaration was not filed prior to filing the RCE. This post will not address the legal merits of the USPTO's position.... Read more

An Automated Notification System for Providing Advance Notification of the Pickup or Delivery of Goods was Found Patent Ineligible

Attorney: Marina I. Miller, Ph.D.
July 20, 2020

Electronic Communication Technologies, LLC (“ECT”) sued ShoppersChoice.com, LLC (“ShoppersChoice”), alleging that ShoppersChoice infringed claim 11 of U.S. Patent 9,373,261 (“the ’261 patent”). The district court granted ShoppersChoice’s motion for judgment on the pleadings that claim 11 was invalid under 35 U.S.C. § 101. ECT appealed. The Federal Circuit (“the Court”) affirmed the judgment of the district court.<... Read more

Can One Have Too Many Patents?

Attorney: Richard D. Kelly
July 7, 2020

As is common with a blockbuster drug, AbbVie's Humira faced an antitrust challenge from third-party payers. The third-party payers filed an antitrust action claiming AbbVie's patent strategy stifled competition by forcing prospective competitors to settle on terms allowing Humira to enjoy a monopoly long after patent protection should have ended. The complaint alleges that AbbVie cornered the market for Humira and its biosimilars by obtaining a thicket of patents which allowed it to gain the market power it needed to prevent competitors from entering the U.S. market (violation of Sherman Act section 2). It used this market power to enter into settlement agreements with potential competitors to keep their products out of the U.S. market in return for early launch dates in Europe, also an important market which they termed a pay-for delay and market division (violation of Sherman Act section 1). Judge Shah, of the Northern District of Illinois, dismissed the complaint without prejudice on June 8, 2020. The opinion begins with a discussion of three reasons Humira might hold its commanding position foreshadowing his decision. First, the more than one hundred Humira-related patents made it difficult if not impossible to seek a non-infringing competing product.... Read more

Final Rules on PTA Calculations in View of Supernus

Attorney: Vincent K. Shier, Ph.D.
June 24, 2020

Although long overdue, the U.S. Patent and Trademark Office (USPTO) released its Final Rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu (85 Fed. Reg. 36335-36342, June 16, 2020). Unfortunately, the Final Rule does not fully address Supernus.<... Read more