• January 10, 2018
      Wi-Fi One, LLC v. Broadcom Corp. (Fed. Cir. 2018) By David Emery In an en banc decision, the Federal Circuit reigned in the scope of 35 U.S.C. § 314(d) by deciding that time-bar determinations under  § 315(b) are appealable.  While § 314(d) states that a determination whether to institute is nonappealable, the Court limited this prohibition...
    • November 30, 2017
      On November 27, 2017, the Supreme Court Justices posed many interesting questions to attorneys representing the parties involved in two underlying Inter Partes Reviews (IPRs) and the federal respondents in these two cases, which will impact the future of IPRs significantly.  Of the two cases, Oil States Energy Services v. Greene’s Energy Group (16-612) has...
    • October 25, 2017
      General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha. (IPR2016-01357 through IPR2016-01361; “Decision”) In an expanded panel where General Plastics sought reversal of multiple decisions that denied instituting follow-on petitions, the PTAB confirmed these decisions were proper based on the factors established in NVIDIA.  This decision has been added to the PTAB’s list of precedential...
    • October 10, 2017
      In Aqua Products, Inc., v. Matal, 2015-1177, Oct. 4, 2017, the en banc Federal Circuit cut against the grain of current PTAB proceeding and held that the petitioner in an inter partes review proceeding has the burden to prove unpatentability for amended claims. The patent owner in a patent office trial may file one motion...
    Patent Office Trials Blog
    • 1/17/2018
      Sughrue Mion, PLLC is pleased to announce that our firm has been ranked among the top 2 patent firms in the annual rankings done by Ocean Tomo and IAM (International Asset Management) Magazine. This ranking was based on the quality of the patents obtained by Sughrue among other high volume patent firms. Rather than focusing only on USPTO statistics as a measure of quality, this year's IAM ranking considered how well patents would withstand being challenged in a more adversarial setting, such as U.S. district court litigation and post-grant proceedings such as inter partes review.
    • 1/15/2018
      Sughrue partner, Jennifer Hayes, will be part of a webinar on Friday, January 26th from 12 pm - 1:30 pm EST.  The webinar will cover the topic of "Patent Protection for Pharma and Biotechnology in 2018". 
    • 12/13/2017
      On December 12, 2017, the Federal Circuit ruled in favor of Sughrue’s client Accord Healthcare, affirming the PTAB’s inter partes judgment that two Orange Book listed patents for an anti-clotting drug prasugrel (Effient®) were invalid. Accord was sued in the Southern District of Illinois by Eli Lilly and Daiichi-Sankyo for patent infringement based on their filing of an ANDA seeking approval for prasugrel. Sughrue attorneys Michael Dzwonczyk, Chid Iyer and Azy Kokabi, along with several codefendants, successfully obtained a stay of the litigation based upon the PTAB’s institution of two inter partes review petitions, without extending the automatic 30-month stay of FDA approval for ANDAs covering the generic versions. At the U.S. Patent Office, Accord and petitioners successfully argued that every claim of the two patents claiming a combination of prasugrel and aspirin were unpatentable based on prior art that showed it would have been obvious to coadminister the two compounds. Less than one week after the oral argument before the Federal Circuit, the Court summarily affirmed the Board’s decision that the patents were invalid as obvious.
    • 11/30/2017
      On November 27, 2017, the Supreme Court Justices posed many interesting questions to attorneys representing the parties involved in two underlying Inter Partes Reviews (IPRs) and the federal respondents in these two cases, which will impact the future of IPRs significantly.  Of the two cases, Oil States Energy Services v. Greene's Energy Group (16-612) has received the most commentary by far.  This is not surprising since Oil States will answer the question of whether IPRs violate the Seventh Amendment right to jury by allowing the Patent Trial and Appeal Board (PTAB), a non-Article III tribunal, to extinguish patent claims.  In other words, must questions of unpatentability be reserved for an Article III court? The second case, SAS Institute v. Matal (16-969) focuses on a narrower issue of whether the PTAB must issue final written decisions for every claim challenged by Petitioner, or whether the PTAB may properly issue final written decisions only for claims instituted for an IPR proceeding, a question of the proper interpretation of IPR statute 35 U.S.C. 318(a).
    More News
    • 12/19/2017
    • 9/30/2017
      In Garmin Int’l, Inc. v. Cuozzo Speed Tech. LLC, the Patent Trial and Appeal Board (Board) set forth fi ve factors—commonly referred to as the Garmin factors—for determining whether “additional discovery” will be granted to a party during a proceeding before the Board, such as an inter partes review, covered business method review, or post-grant review. In their article, Nelson D. Runkle and Tyler Del Rosario, of Sughrue Mion, PLLC, discuss the five factors and when to ask for additional discovery.
    • 07/27/2017

      Regeneron creates an interesting, and highly controversial, intersection between prosecution inequitable conduct and litigation misconduct in U.S. patent law.  In particular, Regeneron raises questions regarding the proper implementation of Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011).

      Under Therasense, inequitable conduct is an equitable defense to patent infringement that, if proved, bars enforcement of a patent.  Therasense established two requirements: 1) the inequitable conduct must be but-for material; and 2) the accused infringer must prove that the patentee acted with the specific intent to deceive the USPTO.  A prior art reference is but-for material if the USPTO would not have allowed a claim had it been aware of the undisclosed prior art.  The standard of proof for both the but-for materiality and the intent to deceive is clear and convincing evidence.

      Plaintiff Regeneron appealed from the Southern District of New York judgement that U.S. Patent No. 8,502,018 is unenforceable because of Regeneron’s prosecution inequitable conduct.  In detail, Regeneron's prosecutors withheld four references from the USPTO during prosecution, which were cited in a third-party submission in a related case and in European opposition briefs.  The District Court held that under Therasense: 1) the withheld references were but-for material; and 2) Regeneron was sanctioned for litigation discovery misconduct by drawing an adverse inference of specific intent to deceive the USPTO.  There was no trial for the intent to deceive.

      The technology of the ‘018 Patent is directed to mouse DNA coding for antibodies that are modified using human DNA in different ways.  As shown in the figure reproduced and annotated below, the mouse DNA coding includes a "variable" region toward the top of the "Y," and a "constant" region toward the bottom.

      Independent claim 1 of the ‘018 Patent recites:

      A genetically modified mouse, comprising in its germline human unrearranged variable region gene segments inserted at an endogenous mouse immunoglobulin locus.

      As shown in the figure reproduced above, Regeneron argued that the broadest reasonable interpretation (BRI) of claim 1 includes only the “reverse chimeric” embodiment in which the human DNA is inserted in only the variable region.  On the other hand, defendant Merus argued that the BRI of claim 1 additionally includes the “humanized” and “fully human” embodiments in which the human DNA is inserted in the variable and constant regions, mainly because of the claimed term “comprising.”

      The Federal Circuit agreed with the District Court and held that the withheld references were but-for material.  In particular, the Federal Circuit determined that the District Court correctly adopted Merus' BRI of claim 1, and that the withheld references taught modifying mouse regions with human regions and thus taught the humanized and fully human embodiments.  The Federal Circuit further agreed that the withheld references were not cumulative over the cited prior art.

      Moreover, the Federal Circuit agreed with sanctioning Regeneron for litigation discovery misconduct by drawing an adverse inference of specific intent to deceive the USPTO.  The litigation discovery misconduct included the following examples:

      improperly withholding and citing on privilege logs documents clearly not privileged (such as experimental data);

      withholding as privileged information where the privilege had been waived; and

      withholding evidence of prosecution counsels' reasoning and state of mind relevant to whether counsel had an intent to deceive.

      Drawing an adverse inference to sanction litigation misconduct was based on the law of the Second Circuit, namely, Residential Funding Corp. v. DE George Fin. Corp., 306 F.3d 99, 107 (2d Cir. 2002).  Notably, the Residential case is unrelated to U.S. patent law.

      In her long and vigorous dissent, Judge Newman argued that the District Court inferred the intent to device without clear and convincing evidence, contrary to the standard provided in Therasense.  For example, she argued, "there was no evidentiary record developed on intent to deceive, with no testimony and no opportunity for examination and cross-examination of witnesses."

      Regeneron raises many questions regarding whether Therasense is hopelessly eroded.  With respect to the but-for materiality, the Federal Circuit and the District Court both chose to adopt Merus’ BRI.  However, one is left to wonder whether a district court should be bound by evidence of an Examiner's BRI instead of adopting its own BRI as in this case.  With respect to the intent to device, Regeneron opens up the issues of whether prosecutors will be sanctioned for litigators' misconduct, whether U.S. patent law including Therasense controls over regional circuit law, and whether property rights would be taken without due process in similar cases.

    • 7/9/2017
      Inter partes review (“IPR”) has been popularly adopted and used as a strategy for invalidating patent claims due to its compact and expedited process. The Board is required to render an institution decision within 3 months of preliminary briefings on issues of claim patentability and a final decision within 12 months of any instituted proceeding. Such a time frame allows both a petitioner and a patent owner to reach a conclusion on the patentability dispute. Further, the expedited schedule allows each party to understand its relative strength of argument, leading to a settlement within a relatively short period of time as compared to a proceeding before a federal district courts, thereby saving time and expense in the patent dispute.
    More Publications
    More Events