Fitch Even News Feedhttp://full.fitcheven.com/?t=39&format=xml&stylesheet=rss&directive=0&records=20en-us27 Feb 2024 00:00:00 -0800firmwisehttp://blogs.law.harvard.edu/tech/rssIP Alert: USPTO Proposes Expanding Opportunities to Appear Before the PTABhttp://full.fitcheven.com/?t=40&an=138341&format=xml<p>In a recent announcement, the United States Patent and Trademark Office (USPTO) is proposing <a href="https://federalregister.gov/d/2024-03523">new rulemaking</a> to expand access to practice before the PTAB. Specifically, the USPTO is proposing four changes. First, the USPTO is proposing to amend the rules regarding admission to practice before the Patent Trial and Appeal Board (PTAB) in proceedings under the Leahy-Smith America Invents Act (AIA proceedings) to give parties the option to designate non-registered practitioners who are recognized <i>pro hac vice</i> (i.e., granted recognition in a specific PTAB proceeding) as lead counsel. The second change would establish a streamlined alternative procedure for recognizing counsel <i>pro hac vice</i> that is available when counsel has previously been recognized <i>pro hac vice</i> in a different PTAB proceeding. The third proposes excusing parties from the requirement to designate back-up counsel upon a showing of good cause, such as a lack of resources to hire two counsel. Finally, the fourth proposed change attempts to clarify that those recognized <i>pro hac vice</i> have a duty to inform the Board of subsequent events that render inaccurate or incomplete representations they made to obtain <i>pro hac vice</i> recognition.</p> <p>In October 2022, the USPTO published a Request for Comments regarding ways to expand opportunities for nonregistered practitioners to appear before the PTAB. Based in part on the received comments, the USPTO is proposing to retain the requirement that parties be represented by a registered practitioner, but &ldquo;would permit parties to designate a non-registered practitioner as lead counsel and the registered practitioner as back-up counsel.&rdquo; The USPTO believes such changes &ldquo;may better support individuals, smaller entities and others who may be under resourced.&rdquo; Additionally, in attempts to &ldquo;increase efficiency and reduce unnecessary expenses,&rdquo; the USPTO is further proposing the second change in attempts to streamline procedures once counsel has previously been recognized <i>pro hac vice</i> in a PTAB proceeding.</p> <p>Comments can be submitted to the USPTO regarding these rule changes. Any such comments must be received by May 21, 2024 (within 90 days after the date of publication in the Federal Register) through the Federal eRulemaking Portal at <a href="http://www.regulations.gov/">www.regulations.gov</a>.</p> <p>For more information on this announcement, please contact Fitch Even partner <a href="https://www.fitcheven.com/?t=3&amp;A=2582&amp;format=xml&amp;p=5482">Steve M. Freeland</a>, author of this alert.<br /> <b><br /> <br /> Fitch Even IP Alert</b><sup><b>&reg;</b></sup></p>IP Alerts22 Feb 2024 00:00:00 -0800http://full.fitcheven.com/?t=40&an=138341&format=xmlFitch Even Partner Karl Fink to Copresent AIPLA Webinar on IP Damageshttp://full.fitcheven.com/?t=40&an=138297&format=xml<p>Fitch Even partner <a href="https://www.fitcheven.com/?t=3&amp;A=2581&amp;format=xml&amp;p=5482">Karl R. Fink</a> will copresent the AIPLA CLE webinar &ldquo;<a href="https://www.aipla.org/detail/event/2024/03/12/default-calendar/aipla-cle-webinar-damages-2023-year-in-review">Damages 2023 Year-in-Review: Lessons and Litigation Strategies</a>&rdquo; on March 12 from 1:00 p.m. to 2:30 p.m. CST.</p> <p>This year&rsquo;s panel of experts will leverage decades of deep litigation experience in patent- and other IP-related matters to provide webinar attendees with additional insight on recent cases from the perspectives of private practice litigators and testifying experts. In a conversational format, the panel will address issues of high importance from 2023&rsquo;s most interesting IP damages cases.&nbsp;Among other topics, the panel will discuss recent developments in admissibility, apportionment, reliance on technical expert opinions, post-trial royalties, trade secret damages, and copyright statutory damages.</p> <p>In addition to Karl, the other featured panelist will be Kyle Friesen, Senior Counsel at Shook, Hardy &amp; Bacon LLP and David Duski, Principal at Charles Rivers Associates, with David J. Harkavy, Managing Director of Ankura Consulting Group as moderator.</p> <p>CLE credit will be available for multiple states. For more information and to register, please visit the <a href="https://www.aipla.org/detail/event/2024/03/12/default-calendar/aipla-cle-webinar-damages-2023-year-in-review">AIPLA website</a>.</p>Professional Activities20 Feb 2024 00:00:00 -0800http://full.fitcheven.com/?t=40&an=138297&format=xmlIP Alert: Government’s Royalty-Free Licensing Rights Affirmed Over USF Patenthttp://full.fitcheven.com/?t=40&an=138268&format=xml<p>On February 9, in <em><a href="https://cafc.uscourts.gov/opinions-orders/22-2248.OPINION.2-9-2024_2267724.pdf">University of South Florida Board of Trustees v. United States</a></em>, the Federal Circuit upheld royalty-free license rights of the U.S. government over a University of South Florida (USF) patent directed to Alzheimer&rsquo;s disease research under the Bayh-Dole Act. The Federal Circuit&rsquo;s decision confirms that 35 U.S.C. &sect;202(c)(4) confers to the U.S. government a broad scope of licensing rights under the Bayh-Dole Act, including &nbsp;in some instances inventions that predate the funding agreement with the government.</p> <p>In 2015, USF sued the U.S. government for infringement of its U.S. Patent No. 5,898,094 (the &rsquo;094 patent), directed to transgenic mice expressing mutated genes linked to Alzheimer&rsquo;s disease, asserting a government contractor, The Jackson Laboratory, used the patented mice without authorization. Notably, the transgenic mice covered by the &rsquo;094 patent were developed at USF and Mayo Clinic (Mayo) with partial funding from a National Institutes of Health (NIH) grant.</p> <p>The Bayh-Dole Act, under 35 U.S.C. &sect;202(c)(4), gives federal funding agencies &ldquo;a nonexclusive, nontransferrable, irrevocable, paid-up license.&rdquo; As a defense, the government argued the work that resulted in the invention covered by the &rsquo;094 patent occurred &ldquo;under&rdquo; a grant funding agreement between the government and Mayo. After summary judgment proceedings and a trial, the Court of Federal Claims agreed with the government and entered a final judgment of noninfringement. USF appealed this decision to the Federal Circuit.</p> <p>The Federal Circuit pointed out that USF&rsquo;s argument for reversal rested on two necessary premises: (1) 35 U.S.C. &sect;202(c)(4) applies only if the funding agreement predates the inventive work that resulted in the granted patent; and (2) there was no legally adequate implied agreement at the time the inventive work that resulted in the granted patent was performed. In particular, USF&rsquo;s argument was that the subcontract between Mayo and USF was not executed until months after the experiments that resulted in the invention covered by the &rsquo;094 patent. However, the Federal Circuit determined that the language of 35 U.S.C. &sect;202(c)(4) is broad enough to support inclusion within the provision of a subcontract that provides for, among other things, payment for work already performed before the subcontract is executed or before the subcontract&rsquo;s effective date.</p> <p>The Federal Circuit held that work already performed may be covered by a later-signed agreement if the scope of the funding grant specifies payment for the earlier-performed work. As a result, the Federal Circuit ruled that 35 U.S.C. &sect;202(c)(4) does not impose strict timing requirements for federal funding agreements to establish the government&rsquo;s license rights, and that 35 U.S.C. &sect;202(c)(4) applies to give the government a license to use the patented transgenic mice because USF accepted federal grant funds for the inventive experiments under its subcontract with Mayo. More specifically, the Federal Circuit stated that &ldquo;[w]e reject this [USF]-suggested temporal limitation on the scope of the relevant Bayh-Dole Act language.&rdquo;</p> <p>In this case, several of the government&rsquo;s witnesses testified, without contradiction, that it was common for there to be a delay in subcontracting after an award of a government grant to a research institution. The Federal Circuit pointed out that its conclusion is &ldquo;strongly bolstered by the record in this case, which suggests that what occurred here is not an uncommon fact pattern in government funding of research conducted in part by non-grantee members of a consortium called for in a government grant.&rdquo; More specifically, the Federal Circuit stated that &ldquo;the record makes clear that subcontracts are commonly not executed until sometime after the grant is awarded, yet the grant-covered work proceeds without waiting for the inking of a subcontract.&rdquo;</p> <p>The Federal Circuit&rsquo;s decision in <em>University of South Florida Board of Trustees v. United States</em> supports the broad rights of the U.S. government under the Bayh-Dole Act to license a patented invention of an entity that accepted research funding from the federal government, even in some instances where the contract with respect to the federal funding for the work is executed between the parties after the work that results in the invention occurred.</p> <p>For more information on this ruling, please contact Fitch Even partner&nbsp;<a href="https://www.fitcheven.com/?t=3&amp;A=4141&amp;format=xml&amp;p=5482">David M. Kogan</a>, author of this alert.</p> <p>&nbsp;</p> <p><b>Fitch Even IP Alert<sup>&reg;</sup></b></p> IP Alerts13 Feb 2024 00:00:00 -0800http://full.fitcheven.com/?t=40&an=138268&format=xmlIP Alert: Federal Circuit Holds Operating Manuals Disclosed with Confidentiality Restrictions to be Prior Arthttp://full.fitcheven.com/?t=40&an=138260&format=xml<p>On February 8, in <i><a href="https://cafc.uscourts.gov/opinions-orders/22-1751.OPINION.2-8-2024_2267070.pdf">Weber, Inc. v. Provisur Technologies, Inc.</a></i>, the Federal Circuit reversed the Patent Trial and Appeal Board (PTAB) and held that Weber&rsquo;s operating manuals are prior art printed publications despite their limited distribution and distribution subject to confidentiality restrictions based on the operating manuals being sufficiently accessible to the public interested in the art.</p> <p>In this case, the PTAB instituted <i>inter partes</i> review (IPR) proceedings based on obviousness theories involving Weber&rsquo;s operating manuals in combination with other patent references. In the PTAB&rsquo;s final written decisions, the Board found that Weber&rsquo;s operating manuals did not qualify as printed publications.</p> <p>In support of this finding, the PTAB found that the operating manuals were only distributed to ten unique customers and subject to confidentiality restrictions in the copyright notice, which stated that the operating manuals should not &ldquo;be reproduced or transferred in any way.&rdquo; The PTAB also found another confidentiality restriction based on the intellectual property rights clause from Weber&rsquo;s terms and conditions covering sales stating that &ldquo;[c]ost estimates, drafts, drawings and other documents remain the property of [Weber].&rdquo;</p> <p>The Federal Circuit reversed the PTAB&rsquo;s finding that the Weber operating manuals did not qualify as prior art printed publications under 35 U.S.C. &sect; 102. The Federal Circuit explained that the statutory phrase &ldquo;printed publication&rdquo; in the patent statute is defined as a reference that was sufficiently accessible to the public interested in the art. The standard for public accessibility is whether interested members of the relevant public could locate the reference by reasonable diligence.</p> <p>The Federal Circuit criticized the PTAB&rsquo;s analysis, stating that the PTAB misapplied public-accessibility precedent and misinterpreted the record evidence. In concluding the Weber operating manuals were not publicly accessible, the PTAB relied on a prior Federal Circuit case, <i>Cordis Corp. v. Boston Scientific Corp.</i>, where two academic monographs were found not to be publicly accessible where they were distributed under academic norms that gave rise to an expectation of confidentiality. In <i>Weber</i>, the Federal Circuit found <i>Cordis</i> distinguishable because Weber&rsquo;s operating manuals were created for dissemination to provide instructions about how to use Weber&rsquo;s product and were not distributed under circumstances where there was an expectation of confidentiality.</p> <p>In finding the Weber operating manuals to be publicly accessible, the Federal Circuit relied on record evidence establishing that the Weber operating manuals could be obtained upon purchase of the Weber product or upon request to a Weber employee. The Federal Circuit noted that the number of actual occasions of access is not dispositive to the inquiry of public accessibility, and that the copyright notice itself permitted the original owners to copy the operating manuals for their own internal use and Weber expressly instructed customers reselling their Weber products to transfer the operating manual to the purchasers.</p> <p>The <i>Weber</i> decision provides guidance in determining what disclosures qualify as prior art to patent filings. The circumstances surrounding the disclosure, such as the purpose of the document and industry expectations of confidentiality, must be considered. To ensure disclosures do not qualify as prior art, such disclosures should be made with clear and express expectations of confidentiality, for example, under a non-disclosure agreement.</p> <p>For more information on this ruling, please contact Fitch Even attorney <a href="https://www.fitcheven.com/?t=3&amp;A=19279&amp;format=xml&amp;p=5482">Zachary Van Engen</a>, author of this alert.<br /> <b><br /> <br /> Fitch Even IP Alert<sup>&reg;</sup></b></p>IP Alerts12 Feb 2024 00:00:00 -0800http://full.fitcheven.com/?t=40&an=138260&format=xmlFitch Even Partners Named Illinois Leading Lawyers for 2024http://full.fitcheven.com/?t=40&an=138242&format=xml<p>We are pleased to announce that fourteen Fitch Even partners have been named Leading Lawyers in Illinois for 2024.</p> <p><i>Leading Lawyers: </i></p> <p><a href="https://www.fitcheven.com/?t=3&amp;A=2580&amp;format=xml&amp;p=5482">Stephen S. Favakeh</a>&mdash;Intellectual Property Law, International Business &amp; Trade Law, Patent Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2581&amp;format=xml&amp;p=5482">Karl R. Fink</a>&mdash;Intellectual Property Law, Patent Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2588&amp;format=xml&amp;p=5482">Mark W. Hetzler</a>&mdash;Intellectual Property Law, Trade Secrets/Unfair Competition Law, Copyright &amp; Trademark Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2589&amp;format=xml&amp;p=5482">Allen E. Hoover</a>&mdash;Intellectual Property Law, Patent Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2600&amp;format=xml&amp;p=5482">John E. Lyhus</a>&mdash;Advertising &amp; Media Law, Copyright &amp; Trademark Law, Intellectual Property Law, International Business &amp; Trade Law, Trade Secrets/Unfair Competition Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2601&amp;format=xml&amp;p=5482">Timothy P. Maloney</a>&mdash; Intellectual Property Law, Patent Law, Trade Secrets/Unfair Competition Law, Copyright &amp; Trademark Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2607&amp;format=xml&amp;p=5482">Calista J. Mitchell</a>&mdash;Intellectual Property Law, Patent Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2609&amp;format=xml&amp;p=5482">Joseph T. Nabor</a>&mdash;Advertising &amp; Media Law, Copyright &amp; Trademark Law, Intellectual Property Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2599&amp;format=xml&amp;p=5482">Amanda Lowerre O&rsquo;Donnell</a>&mdash;Intellectual Property Law, Patent Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2610&amp;format=xml&amp;p=5482">Steven G. Parmelee</a>&mdash;Intellectual Property Law, Patent Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2611&amp;format=xml&amp;p=5482">Nicholas T. Peters</a>&mdash;Intellectual Property Law, Patent Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2616&amp;format=xml&amp;p=5482">Joseph E. Shipley</a>&mdash;Intellectual Property Law, Patent Law, Trade Secrets/Unfair Competition Law, Copyright &amp; Trademark Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=2617&amp;format=xml&amp;p=5482">Alisa C. Simmons</a>&mdash;Intellectual Property Law, Copyright &amp; Trademark Law<br /> <a href="https://www.fitcheven.com/?t=3&amp;A=18527&amp;format=xml&amp;p=5482">Maureen R. Smith</a>&mdash;Intellectual Property Law, Copyright &amp; Trademark Law</p> <p>Those who are designated Leading Lawyers were recommended by their peers to be among the top lawyers in Illinois. Less than five percent of all lawyers licensed in to practice in Illinois have received the distinction of being named a Leading Lawyer.</p> <p>The entity Leading Lawyers is a division of Law Bulletin Media, a diversified print and electronic information company that has been serving the Chicago legal and business communities since 1854. For more information, please visit&nbsp;<a href="http://www.leadinglawyers.com/">www.leadinglawyers.com</a>.&nbsp; &nbsp;</p>Firm News09 Feb 2024 00:00:00 -0800http://full.fitcheven.com/?t=40&an=138242&format=xmlFitch Even Attorneys Named to Illinois Super Lawyers and Illinois Rising Stars Lists for 2024http://full.fitcheven.com/?t=40&an=137838&format=xml<p>Six Fitch Even partners have been selected for inclusion in the 2024 list of Illinois Super Lawyers and two associates have been selected for inclusion in the 2024 list of Illinois Rising Stars.</p> <p><a href="https://www.fitcheven.com/?t=3&amp;A=2581&amp;format=xml&amp;p=5482">Karl R. Fink</a> and <a href="https://www.fitcheven.com/?t=3&amp;A=2601&amp;format=xml&amp;p=5482">Timothy P. Maloney</a> were once again recognized as top attorneys in Intellectual Property Litigation in Illinois. In addition, <a href="https://www.fitcheven.com/?t=3&amp;A=2580&amp;format=xml&amp;p=5482">Stephen S. Favakeh</a>, <a href="https://www.fitcheven.com/?t=3&amp;A=2588&amp;format=xml&amp;p=5482">Mark W. Hetzler</a>, <a href="https://www.fitcheven.com/?t=3&amp;A=2589&amp;format=xml&amp;p=5482">Allen E. Hoover</a>, and <a href="https://www.fitcheven.com/?t=3&amp;A=2609&amp;format=xml&amp;p=5482">Joseph T. Nabor</a> were once again recognized as top attorneys in Intellectual Property Law in Illinois. No more than 5 percent of all lawyers in the state are selected by the research team at Super Lawyers to receive this honor each year.</p> <p><a href="https://www.fitcheven.com/?t=3&amp;A=28222&amp;format=xml&amp;p=5482">Mary F. Fetsco</a> was once again named to this year&rsquo;s Illinois Rising Stars list as a top-rated attorney in Intellectual Property Litigation. <a href="https://www.fitcheven.com/?t=3&amp;A=16851&amp;format=xml&amp;p=5482">Kerianne A. Strachan</a> was once again named to this year&rsquo;s Illinois Rising Stars list as a top-rated attorney in Intellectual Property Law. They were included among the top up-and-coming attorneys in the state who are 40 years old or younger or who have been practicing for 10 years or less. No more than 2.5 percent of Illinois lawyers receive this honor each year.</p> <p>Super Lawyers<sup>&reg;</sup>, a Thomson Reuters business, is a rating service of outstanding lawyers from more than 70 practice areas who have attained a high degree of peer recognition and professional achievement. Attorneys are selected using a multiphase process that includes independent research, peer nominations, and peer evaluations. For more information, please visit <a href="http://www.superlawyers.com/">www.superlawyers.com</a>.</p>Firm News30 Jan 2024 00:00:00 -0800http://full.fitcheven.com/?t=40&an=137838&format=xmlFitch Even Attorneys Ken Colton and Alvaro Cure Dominguez Published in <i>IP Litigator</i>http://full.fitcheven.com/?t=40&an=137452&format=xml<p>An article written by Fitch Even partner <a href="https://www.fitcheven.com/?t=3&amp;A=2568&amp;format=xml&amp;p=5482">Kendrew H. Colton</a> and associate <a href="https://www.fitcheven.com/?t=3&amp;A=29533&amp;format=xml&amp;p=5482">Alvaro Cure Dominguez</a> is featured in the September/October 2023 issue of <i><a href="https://law-store.wolterskluwer.com/s/product/ip-litigator3mo-subvitallaw-3r/01t0f00000NY7aWAAT">IP Litigator</a></i>, a Wolters Kluwer publication.</p> <p>In the article, &ldquo;<a href="http://full.fitcheven.com/2E8FB4/assets/files/documents/IPPL_091023_Colton-Dominguez.pdf">Federal Circuit Warns Against Patent Owner Sandbagging in IPR Claim Construction</a>,&rdquo; Ken and Alvaro discuss the case of <i>Axonics, Inc. v. Medtronic, Inc.</i>, and the Federal Circuit&rsquo;s ruling that the Patent Trial and Appeal Board must consider an <i>inter partes</i> review petitioner&rsquo;s arguments raised in their reply brief regarding a claim construction proposed by the patent owner&rsquo;s response brief. The article was originally published as a <a href="https://www.fitcheven.com/?t=40&amp;an=134846&amp;anc=180&amp;format=xml&amp;p=5486">Fitch Even IP Alert<sup>&reg;</sup></a>.</p>Professional Activities20 Nov 2023 00:00:00 -0800http://full.fitcheven.com/?t=40&an=137452&format=xml180 Days of UPC: How It Started… How It's Going…http://full.fitcheven.com/https://register.gotowebinar.com/register/4355871879323734874&format=xml<p>Please join Fitch Even for a free webinar, &ldquo;<a href="https://register.gotowebinar.com/register/4355871879323734874">180 Days of UPC: How It Started&hellip; How It&rsquo;s Going&hellip;</a>,&rdquo; on Wednesday, November 29, at 9:00 a.m. PST / 10:00 a.m. MST / 11:00 a.m. CST / 12 Noon EST.</p> <p>The Unified Patent Court (UPC) went live on June 1, 2023. While it&rsquo;s still early, we now have almost six months of data on the unitary patent and the UPC to help guide decisions as to whether to request unitary effect for European patents, and whether to bring enforcement actions in the UPC.</p> <p>During this webinar, our presenters will address these topics and more:</p> <ul> <li>Latest Developments</li> <li>Predicted Trends</li> <li>Considerations for U.S. Attorneys Contemplating the UP/UPC Pathway</li> <li>Highlights from the U.S. Bar - EPO Liaison Council&#39;s Discussions with EPO Managing Officials last month</li> </ul> <p>Our speakers will be Fitch Even attorneys <a href="https://www.fitcheven.com/?t=3&amp;A=2616&amp;format=xml&amp;p=5482">Joe Shipley</a> and <a href="https://www.fitcheven.com/?t=3&amp;A=28222&amp;format=xml&amp;p=5482">Mary Fetsco</a> and Appleyard Lees partner <a href="https://www.appleyardlees.com/people/simon-bradbury/">Simon Bradbury</a>.</p> <p>Joe has assisted clients with international patent portfolio management, litigation, and other IP matters for over 40 years. He is a delegate to the U.S. Bar &ndash; EPO Liaison Council and has been elected to serve as secretary to the Council next year.</p> <p>Mary is an experienced IP litigator, with an extensive background in both patent litigation and trademark anti-counterfeiting litigation and enforcement.</p> <p>Simon is a partner at Appleyard Lees in the UK.&nbsp;Simon&rsquo;s practice encompasses a wide range of technologies within life sciences and biotechnology, and he is particularly involved in formulating IP strategies for start-ups, spin-outs and SMEs. &nbsp;&nbsp;<br /> <br /> A recording of this webinar is available through November 28, 2024.</p> Past Webinars16 Nov 2023 00:00:00 -0800http://full.fitcheven.com/https://register.gotowebinar.com/register/4355871879323734874&format=xmlFitch Even Partner Dani Muñoz to Speak at UIC's 67th Annual Intellectual Property, Information & Privacy Law Conferencehttp://full.fitcheven.com/?t=40&an=137344&format=xml<p>Fitch Even partner <a href="https://www.fitcheven.com/?t=3&amp;A=29546&amp;format=xml&amp;p=5482">Danielle K. Mu&ntilde;oz</a> will be a panelist at UIC Law Center&rsquo;s 67<sup>th</sup> Annual Intellectual Property, Information &amp; Privacy Law Conference at the Union League Club Chicago on November 10 at 7:00 a.m. CST.</p> <p>Dani will be a co-panelist during the Trademarks session. The panelists will discuss &quot;Trademarks at the Supreme Court&rdquo;, covering <i>Jack Daniels v. VIP Products </i>and <i>Vidal v. Ester</i>. This session is scheduled for 1:30 p.m. CST.</p> <p>CLE credit will be available for Illinois attorneys. For more information and to register, please visit <a href="https://www.eventbrite.com/e/67th-annual-intellectual-property-information-privacy-law-conference-registration-733605623167?aff=oddtdtcreator">here</a>.</p>Professional Activities03 Nov 2023 00:00:00 -0800http://full.fitcheven.com/?t=40&an=137344&format=xmlIP Alert: Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date?http://full.fitcheven.com/?t=40&an=135317&format=xml<p>The Federal Circuit appeal in <i>Merck Sharp &amp; Dohme B.V., Merck Sharp &amp; Dohme, LLC v. Aurobindo Pharma USA, Inc. et al.</i>, concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug approval, should be calculated from the date the original patent issued or the date the reissue patent issued. The appeal is from the decision of the U.S. District Court for the District of New Jersey in <a href="http://full.fitcheven.com/2E8FB4/assets/files/documents/IN%20RE%20SUGAMMADEX.pdf"><i>In</i><i> re Sugammadex</i></a>. The patent at issue, assigned to Merck, is reissue patent RE 44,733 listed in the Orange Book for the Bridion<sup>&reg;</sup> intravenous product containing sugammadex as the active ingredient. Bridion<sup>&reg;</sup> is used to reverse a neuromuscular blockade induced by rocuronium and vecuronium in general anesthesia.</p> <p>Aurobindo contends the district erred in upholding five years of PTE for the &rsquo;733 reissue patent, which was calculated from the issue date of surrendered original patent rather than the issue date of the &rsquo;733 reissue patent.</p> <p>As background, the original patent was issued in December 2003. In early 2004, Merck filed an application for an Investigational New Drug. Merck then filed a New Drug Application (NDA) in 2007. Merck&rsquo;s predecessor-in-interest filed an application for a reissue patent on March 28, 2012. The &rsquo;733 reissue patent issued on January 28, 2014. The &rsquo;733 reissue patent includes claims 1-9 from the original patent and twelve new narrower dependent claims (10&ndash;21) added in the reissue. Merck surrendered the original patent. The FDA approved Merck&rsquo;s NDA on December 15, 2015.</p> <p>Within months of receiving the FDA approval on its NDA, Merck applied for the maximum allowable five years of PTE. Merck&rsquo;s application for PTE identified original claims (including claim 4) and new claims (<i>e.g.</i>, claims 12 and 21) as covering sugammadex.</p> <p>On appeal, Aurobindo maintains the PTE calculation for Merck&rsquo;s reissue patent should have been based on the January 28, 2014, issue date for the reissue patent. Aurobindo points to 35 U.S.C. &sect; 156(c) referring to &ldquo;regulatory review period for the approved product&rdquo; that &ldquo;occurs after the date the patent is issued.&rdquo;</p> <p>Depending on whether the delay period is calculated from the issue date of Merck&rsquo;s original patent or the &rsquo;733 reissue patent has a significant effect on the PTE because the regulatory review period is longer if calculated from the date of the original patent as compared to the &rsquo;733 reissue patent. According to Aurobindo, the delay period should be calculated from the issue date of the reissue patent, which equates to 686 days&nbsp;of PTE. The USPTO&nbsp;accorded Merck five years of PTE, which was based on the issue date of the surrendered original patent. According to Aurobindo&rsquo;s calculation, the &rsquo;733 reissue patent would have expired on December 14, 2022. By the USPTO&rsquo;s PTE calculation, the patent expires on January 27, 2026. The difference is significant because the longer the patent is alive, the longer Merck can capitalize on its patent coverage of the Bridion<sup>&reg;</sup> intravenous product with sugammadex as the active ingredient.</p> <p>As an aside, while the MPEP is not law binding a federal court, MPEP &sect;2766 states that &ldquo;[w]ith respect to calculating the amount of extension to which the reissued patent is entitled to receive, so long as the original patent claimed the approved product and the reissued patent claims the approved product, the original patent grant date would be used to calculate the extension to which the reissued patent would be entitled.&rdquo;</p> <p>The district court did not invalidate the &rsquo;733 reissue patent under 35 U.S.C. 282(c) by overturning the five years of PTE. The district court concluded &ldquo;understanding &sect; 156(c) within its place in the statutory scheme and alongside other relevant provisions of the Patent Act&mdash;as this Court must&mdash;it is clear that, for reissue patents seeking patent term extensions, &lsquo;the date the patent is issued&rsquo; refers to the date the original patent issued.&rdquo;<i> In re Sugammadex</i>.</p> <p>The Federal Circuit&rsquo;s decision in this case will be important for calculating PTE for reissue patents. Fitch Even&nbsp;attorneys are closely monitoring this appeal and will provide updates as the appeal progresses.</p> <p>For more information on this case, please contact Fitch Even partner <a href="https://www.fitcheven.com/?t=3&amp;A=2568&amp;format=xml&amp;p=5482">Kendrew H. Colton</a>, author of this alert.<br /> &nbsp;</p> <p><b>Fitch Even IP Alert<sup>&reg;</sup></b></p>IP Alerts31 Oct 2023 00:00:00 -0800http://full.fitcheven.com/?t=40&an=135317&format=xml