The Federal Circuit decides appeals addressing patent law, government contracts, trade disputes, tax appeals, suits against the federal government, veterans’ benefits, and federal employment cases. Federal Circuitry takes a data-driven look at the Federal Circuit. Our <a href="/statistics" target="_self">Federal Circuit Statistics</a> empirically analyze appeal timing, outcomes, and other quantifiable aspects of the Court.  Our <a href="/trackers/en-banc-tracker" target="_self">En Banc Tracker</a> shows pending and past petitions where the Court has called for a response. Our <a href="/trackers/substantive-orders-tracker" target="_self">Substantive Order Tracker</a> allows you to search for less-discussed and hard-to-find orders that affect practice before the Court. Check back weekly for <a href="/topics/last-week-in-the-federal-circuit" target="_self">Last Week in the Federal Circuit</a> and monthly for our <a href="/topics/oral-argument-recap" target="_self">Oral Argument Recap</a>.<h2>About Morrison Foerster's Appellate + Supreme Court Practice</h2>Morrison Foerster’s market-leading <a href="https://www.mofo.com/capabilities/appellate-supreme-court.html">Appellate and Supreme Court practice</a> wins appeals with deep strategic thinking, clear writing, and forceful oral advocacy. Our work spans the Supreme Court of the United States, every federal court of appeals, and state appellate courts in California, New York, and elsewhere. And we handle appeals in every area of law—from intellectual property to class actions, arbitration to antitrust, environmental law to ERISA. We are consistently ranked as one of the top appellate and Supreme Court practices in the country by Chambers USA and Legal 500 USA, and our practice has been named to the National Law Journal’s Appellate Hot List multiple times.<h2>About Morrison Foerster's Patent Litigation Practice</h2>We are a global <a href="https://www.mofo.com/capabilities/patent-litigation.html">IP litigation</a> powerhouse, dedicated to fiercely protecting innovation in high-stakes and complex patent litigation matters. While we are skilled at resolving disputes short of trial, some cases do see the inside of a courtroom. When they do, our trial lawyers stand out for their superb knowledge of patent law, experience with judges in high-volume patent venues, facility with explaining cutting-edge technologies to juries, and history defending against patent assertion entities and other habitual plaintiffs. From cross-border matters and multiparty disputes to global litigation management and NPE litigations, we develop novel solutions to protecting and enforcing some of the most prized patents in the world.<h2>About Morrison Foerster</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

Social

Search

Editors

federal-circuitry-blog-promo-tile.jpg

Federal Circuitry

Brian Matsui co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Brian is a go-to appellate advocate for sophisticated clients in complex appeals nationwide. Brian has a nationwide appellate practice. He has argued many cases in federal and state appellate courts throughout the country, winning appeals involving federal preemption, securities litigation and enforcement, consumer class actions, and intellectual property. He has led appeals in the D.C., Second, Fourth, Fifth, Ninth, Eleventh, and Federal Circuits. His arguments include significant victories in class action appeals and in appeals for leading financial services companies, with multiple victories in the Ninth Circuit, where he clerked. Brian recently has gone five for five when representing appellants, including a precedential victory in the Ninth Circuit in a licensing dispute concerning alleged patent misuse. He also argued and won a D.C. Circuit appeal against the Securities and Exchange Commission (SEC) about the retroactivity of part of the Dodd-Frank Act. As a result of Brian’s win, the SEC had to change its enforcement practices against certain securities industry professionals.Clients frequently turn to Brian for his substantial experience with appeals in the Federal Circuit, praising him as “an invaluable advocate in patent matters” (Chambers USA). Brian has won 13 of his last 14 appeals in that Court. His arguments before the Federal Circuit include winning appeals from district courts, the Patent Trial and Appeal Board, and the International Trade Commission. He has handled appeals in a myriad of industries, including mobile devices, pharmaceuticals, medical devices, semiconductors, and software.Brian also plays a key role on trial teams, advising clients on both critical legal issues and appellate preservation. He recently argued and prevailed against a summary judgment invalidity motion in a case involving Chugai Pharmaceutical Co. Ltd.’s revolutionary antibody recycling technology, which ultimately led to a $775 million settlement on the eve of trial for Chugai.A former law clerk for the United States Supreme Court, Brian has authored many briefs in that Court, including on important constitutional and statutory interpretation issues. He often represents clients’ interests in amicus briefs in significant Supreme Court cases affecting the business community.Leading publications have recognized Brian for his appellate skills. The Legal 500 US recommends him for appellate litigation, and the National Law Journal named Brian a “Minority 40 Under 40.”Brian is an editor of Morrison Foerster’s <a href="https://federalcircuitry.mofo.com/" target="_blank">Federal Circuitry</a> blog, which takes a data-driven approach to analyzing the Federal Circuit and its decisions.Brian also dedicates significant time to pro bono matters. He argued and won two significant appeals—in the Second and Ninth Circuits—obtaining reversals of judgments that had denied private rights of action under the Child Welfare Act in precedential decisions. Brian also led the Morrison Foerster team who co-counseled a successful Eighth Amendment challenge to Florida’s imposition of a “life without the possibility of parole” sentence to a juvenile offender convicted of a non-homicide crime.For years, Brian chaired the ABA’s seven-person Standing Committee for Amicus Curiae Briefs. He served on the American Intellectual Property Law Association’s amicus committee and co-chaired the National Asian Pacific American Bar Association’s amicus committee. Brian served as an appellate lawyer representative for the Ninth Circuit. Brian also serves on the board of directors for the Lawyers’ Committee for Civil Rights Under Law.Before entering private practice, Brian clerked on the United States Supreme Court for Justice Anthony M. Kennedy. He also clerked for Judge Pamela Ann Rymer in the Ninth Circuit and Judge David F. Levi in the Eastern District of California.While in law school, Brian served as managing editor of Volume 51 of the Stanford Law Review and was elected to the Order of the Coif.<h4>Representative Oral Arguments</h4><ul><li><a href="https://oralarguments.cafc.uscourts.gov/default.aspx?fl=22-1260_02102023.mp3" target="_blank">SNIPR Technologies Ltd. v. Rockefeller University </a>(Fed. Cir.) Prevailed in a precedential decision reversing the Patent Office’s interpretation of the America Invents Act (AIA) that subjected patents post-dating the Act to pre-AIA interference proceedings. The decision revived five of SNIPR’s patents related to CRISPR technology.</li><li><a href="/resources/video-audio/220114-broadcom-corporation-v-renesas-matsui" target="_blank">Renesas Electronics Corporation v. Broadcom Corporation</a> (12:40) (Fed. Cir.) Successfully argued and briefed multiple appeals from an International Trade Commission (ITC) decision and several Patent Trial and Appeal Board decisions related to an ITC investigation initiated by Broadcom involving systems-on-chip powering automobile infotainment systems.</li><li><a href="/resources/video-audio/210706-cr-bard-v-medline-industries" target="_self">C.R. Bard Inc. v. Medline Industries, Inc.</a> (0:45) (Fed. Cir.) Won vacatur of three Patent Trial and Appeal Board decisions on obviousness.</li><li><a href="https://oralarguments.cafc.uscourts.gov/default.aspx?fl=21-1745_03102022.mp3" target="_blank">Advanced Voice Recognition Systems, Inc. v. Apple Inc.</a> (14:30) (Fed. Cir.) Secured a complete victory in appeal from Patent Trial and Appeal Board that all challenged patent claims were unpatentable.</li><li><a href="/resources/video-audio/200515-william-paulus-v-ocera-therapeutics-inc.html" target="_self">William Paulus v. Ocera Therapeutics, Inc.</a> (13:25) (9th Cir.) Successfully argued and briefed appeal in a putative shareholder class action involving a tender offer.</li><li><a href="/resources/video-audio/200410-kurtz-v-costco.html" target="_blank">Kurtz v. Costco Wholesale Corporation </a>(9:23) (2d Cir.) Successfully petitioned for review of a class certification decision, then argued and obtained a remand for the district court to reconsider its certification decision and an eventual reversal on an injunctive class certification decision.</li><li><a href="/resources/video-audio/161117-gregory-bartko-v-sec.html" target="_self">Gregory Bartko v. SEC</a> (0:53) (D.C. Cir.) Successfully argued and obtained precedential ruling that the Securities and Exchange Commission could not retroactively apply Dodd-Frank’s industry-wide sanctions on securities professionals for certain securities violations.</li></ul>

matsui_brian_blog_150x150.png

matsui_brian_common_640x280.jpg

matsui_brian_heroretina_2700x1160.jpg

matsui_brian_mobileretina_750x1040.jpg

matsui_brian_social_600x600.jpg

Partner

Brian Matsui is a partner in Morrison Foerster’s Appellate and Supreme Court practice. For nearly 20 years, Brian has been a go-to appellate advocate for sophisticated clients in complex appeals nationwide. Clients turn to Brian for his substantial experience in patent appeals in the Federal Circuit. He has argued more than 10 times in that Court, winning appeals from both district courts and the Patent Trial and Appeal Board. Brian excels at applying significant legal principles to complex technologies in a way that distills them for the Court. He has done so for companies in a myriad of industries, including mobile device manufacturers, pharmaceutical companies, medical device companies, memory manufacturers, movie studios, and software companies.

Brian Matsui

Seth Lloyd, a member of Morrison Foerster’s Appellate and Supreme Court practice, has been counsel in more than a hundred appeals in federal and state courts nationwide. Seth has presented oral arguments in the U.S. Courts of Appeals for the D.C. Circuit, the Seventh Circuit, the Ninth Circuit, and the Federal Circuit, as well as in the New Jersey Appellate Division.Seth has particular experience in patent appeals before the Federal Circuit. He has authored successful briefs for both patentees and defendants on a wide range of technologies, from medical devices to pharmaceuticals to computer hardware and software. His practice includes appeals from district courts, the Patent Trial and Appeal Board, and the International Trade Commission. Seth also has argued five times in the Federal Circuit. His winning arguments include a successful reversal of three PTAB decisions in a consolidated appeal for a computer memory designer. Seth is co-chair of the Federal Circuit Bar Association’s Administrative Law & Regulatory Committee. And he is an Editor of Morrison Foerster’s <a href="https://federalcircuitry.mofo.com/" target="_blank">Federal Circuitry</a> blog, which takes a data-driven approach to analyzing the Federal Circuit and its decisions.Seth regularly practices in the United States Supreme Court. He has drafted petitions and amicus briefs at the certiorari stage, as well as party and amicus briefs at the merits stage. Seth also moots members of the bar for Supreme Court arguments through the Georgetown Supreme Court Institute and is a member of the Edward Coke Appellate Inn of Court.Seth’s clients and peers recognize his expertise. Legal 500 named Seth a Key Lawyer; Super Lawyers called him a Rising Star; and Best Lawyers in America added him to its Ones to Watch list, all for appellate practice. Before joining Morrison Foerster, Seth served as a law clerk for Judge Richard G. Taranto of the Federal Circuit. He earned his J.D. from Stanford Law School, where he worked on two successful certiorari petitions and one successful merits case through Stanford’s Supreme Court Litigation Clinic.Seth also holds a Ph.D. and M.S. in electrical engineering from Stanford University. During his graduate studies, he received the National Defense Science and Engineering Graduate Fellowship, published 10 peer-reviewed articles, and co-invented the subject matter of five U.S. patents.<h4>Appellate Arguments</h4><ul><li><a href="/resources/video-audio/220114-renesas-electronics-v-broadcom-corporation" target="_self">Renesas Electronics Corp. v. Broadcom Corp.</a> (00:10) (Fed. Cir.) Argued and won affirmance for inter partes review petitioner in challenge to electronic device claims</li><li><a href="/resources/video-audio/170609-netlist-inc-v-diablo-technologies" target="_self">Netlist, Inc. v. Diablo Technologies, Inc.</a> (02:56) (Fed. Cir.) Argued and won reversal for owner of computer memory patents in appeals from three consolidated inter partes reviews</li><li><a href="/resources/video-audio/200610-google-llc-v-netlist-inc" target="_self">Google LLC v. Netlist, Inc.</a> (13:15) (Fed. Cir.) Argued and won affirmance for owner of computer memory patents in consolidated appeals from decade-long reexamination</li><li><a href="/resources/video-audio/220309-apple-inc-v-mph-technologies" target="_self">Apple Inc. v. MPH Technologies Oy</a> (00:16) (Fed. Cir.) Argued for inter partes review petitioner in challenge to computer security claims</li><li><a href="/resources/video-audio/180808-netlist-inc-v-sandisk-llc" target="_self">Netlist, Inc. v. SanDisk LLC</a> (01:53) (Fed. Cir.) Argued for patent owner in consolidated appeals raising APA challenges to inter partes review decisions</li><li><a href="/resources/video-audio/201026-nicole-k-v-stigdon" target="_self">Nicole K. v. Stigdon</a> (00:16) (7th Cir.) Argued for children in Indiana foster care raising constitutional due process claims</li><li><a href="/resources/video-audio/200306-strike-3-holdings" target="_self">Strike 3 Holdings, LLC v. Doe</a> (21:40) (D.C. Cir.) Argued as court-appointed amicus defending an order refusing a subpoena to unmask an internet subscriber’s identity</li><li><a href="/resources/video-audio/161118-harris-v-mangum" target="_self">Harris v. Mangum</a> (00:02) (9th Cir.) Argued as court-appointed amicus defending indigent prisoner’s right to a guardian ad litem</li></ul><h4>Additional Representative Matters</h4><ul><li>SNIPR Technologies Ltd. v. Rockefeller University (Fed. Cir.) Revived five SNIPR patents related to CRISPR technology after prevailing in a precedential decision that reversed the Patent Office’s interpretation of the America Invents Act (AIA), under which post-AIA patents could be subjected to pre-AIA interference proceedings</li><li>Broadcom Corp. v. International Trade Commission (Fed. Cir.) Successfully defended ITC’s determination of no Section 337 violation in case involving multiple patents directed to system-on-chip technology for automobile infotainment systems</li><li>Chugai Pharmaceutical Co. v. Alexion Pharmaceuticals (D. Del.) Successfully beat back defendant’s push for summary judgment of invalidity for lack of written description on pharmaceutical genus claims, ultimately helping to secure a $775 million settlement for the patent owner</li><li>C.R. Bard Inc. v. AngioDynamics, Inc. (Fed. Cir.) Secured reversal of district court judgment of non-infringement, no willfulness, and invalidity, reviving Bard’s infringement case on three patents</li><li>Washington University v. Wisconsin Alumni Research Foundation (3d Cir.) Successfully defended trial victory for breach of patent licensing agreement and further won judgment entitling Washington University to prejudgment interest</li><li>Nevro Corp. v. Boston Scientific Corp. (Fed. Cir.) Secured reversal for Nevro of district court judgment of invalidity for indefiniteness</li><li>Federal National Mortgage Association v. Zabriskie (9th Cir.) Won reversal for Fannie Mae of a Fair Credit Reporting Act judgment</li><li>Henson v. Santander Consumer USA Inc. (S. Ct.) Represented U.S. Chamber of Commerce and others as amici supporting respondent in unanimous affirmance of Fair Debt Collection Act decision</li><li>BASF Corp. v. Johnson Matthey Inc. (Fed. Cir.) Won reversal of an invalidity ruling against patentee BASF, reviving its patent claims</li><li>C.R. Bard Inc. v. Medline Industries, Inc. (Fed. Cir.) Won vacatur for petitioner of three Patent Trial and Appeal Board decisions on obviousness for patents to medical device technology</li><li>Altayyar v. Etsy, Inc. (2d Cir.) Secured dismissal of securities fraud case for failure to adequately plead falsity</li><li>Bridge & Post, Inc. v. Verizon Communications, Inc. (Fed. Cir.) Secured dismissal because asserted patents claimed unpatentable subject matter</li><li>Sam Francis Foundation v. Christie’s, Inc. (S. Ct.) Successfully preserved Sotheby’s en banc win at the Ninth Circuit based on the dormant Commerce Clause</li><li>Phigenix, Inc. v. Genentech, Inc. (Fed. Cir.) Secured total victory of noninfringement for Genentech</li><li>Deason v. Fujifilm Holdings Corp. (New York Appellate Division, First Department) Secured reversal in major shareholder challenge to corporate acquisition</li><li>V.L. v. E.L. (S. Ct.) As counsel for children’s guardian ad litem, secured reversal of Alabama Supreme Court’s refusal to grant full faith and credit to Georgia judgment recognizing lesbian mother as legal parent</li></ul>

lloyd_seth_blog_150x150.png

lloyd_seth_common_640x280.jpg

lloyd_seth_heroretina_2700x1160.jpg

lloyd_seth_mobileretina_750x1040.jpg

lloyd_seth_social_600x600.jpg

Of Counsel

Seth Lloyd is an associate in Morrison Foerster’s Appellate and Supreme Court Practice with broad experience briefing and arguing appeals. Seth has particular experience in patent appeals before the Federal Circuit. He has been a primary author of successful briefs on a wide range of technologies, from medical devices to chemistry to computer hardware and software. He also has successfully argued multiple times in that Court, including obtaining reversal of three Patent Trial and Appeal Board decisions in a consolidated appeal for a computer memory designer. Before joining Morrison Foerster, Seth served as a law clerk for Judge Richard G. Taranto of the Federal Circuit. He earned his J.D. from Stanford Law School and also holds a Ph.D. in electrical engineering from Stanford University.

Seth Lloyd is an associate in Morrison Foerster’s Appellate and Supreme Court Practice with broad experience briefing and arguing appeals. Seth has particular experience in patent appeals before the Federal Circuit. He has been a primary author of successful briefs on a wide range of technologies, from medical devices to chemistry to computer hardware and software. He also has successfully argued multiple times in that Court, including obtaining reversal of three Patent Trial and Appeal Board decisions in a consolidated appeal for a computer memory designer. Before joining Morrison & Foerster, Seth served as a law clerk for Judge Richard G. Taranto of the Federal Circuit. He earned his J.D. from Stanford Law School and also holds a Ph.D. in electrical engineering from Stanford University.

Seth Lloyd

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

Federal Circuitry is a data-driven Federal Circuit blog. Our <a href="https://federalcircuitry.mofo.com/statistics">Federal Circuit Statistics</a> empirically analyze quantifiable aspects of the Court. Our <a href="https://federalcircuitry.mofo.com/trackers/en-banc-tracker">En Banc Tracker</a> highlights pending and past petitions. Our <a href="https://federalcircuitry.mofo.com/trackers/substantive-orders-tracker">Substantive Order Tracker</a> allows you to search less-discussed orders. Check back weekly for <a href="https://federalcircuitry.mofo.com/topics/last-week-in-the-federal-circuit" target="_self">Last Week in the Federal Circuit</a> and monthly for our <a href="https://federalcircuitry.mofo.com/topics/oral-argument-recap" target="_self">Oral Argument Recap</a>. Follow us on Twitter <a href="https://twitter.com/Fed_Circuitry" target="_blank">@Fed_Circuitry</a>.

fed-circuitry-welcome.jpg

fed-circuitry-welcome

Announcements

Welcome to Federal Circuitry

Blog - Terms of Use

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

Timely legal and business insights and in-depth analyses on trends at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

MoFo Life Sciences

Brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry.

MoFo Tech

In-depth analysis of developments and trends impacting government contracting.

Government Contracts Insight

Government Contract Insights

Stay on top of emerging issues and stay informed of developments related to the law and business of social media.

Socially Aware

Provides insights and reports on the most current class actions lawsuits and product liability issues that affect consumer-facing companies.

Class Dismissed Blog

Class Dismissed

Equips our clients with the most up-to-date and relevant information on employment and labor law issues.

Employment Law Commentary

Federal Circuitry is a data-driven Federal Circuit blog, covering federal circuit statistics, pending & past petitions, order tracking, and more.

Federal Circuitry

Federal Circuit Blog - News & Statistics | Federal Circuitry

  Linkedin

MoFo LinkedIN

Federal Circuitry Blog - RSS

Stay Connected

Never miss a post from Federal Circuitry. Enter your email below to stay up-to-date.

Subscribe

Processing All Things Federal Circuit

Morrison Foerster - Footer

We’re now in the waning days of summer, and the Court’s activity last week somewhat reflected that: two decisions and a few orders. 

Blogs -  Home Button

Home

Federal Circuitry- Statistics

Statistics

Blog - Trackers

Many petitions for rehearing are filed; only the smallest handful are granted. Rather than track every filed petition, we track those that have a chance. Our database tracks petitions for rehearing once the Federal Circuit has called for a response (CFR). A CFR is the first real indication that the Court might have interest in the petition, as it indicates that at least one judge on the Court may be taking a second look. Our En Banc Tracker allows you to see the amount of time it takes for various cases to get a CFR, and you can sift through the data to see what types of cases have captured the potential attention of the Court. Our data goes back to January 2020.<div data-reactroot=""><iframe allowfullscreen="" frameBorder="0" height="2350" width="100%" src="https://public.tableau.com/views/RehearingCFRsandSubstantiveOrders/RehearingCFRs?:language=en&amp;:display_count=y&amp;:origin=viz_share_link&amp;:showVizHome=no&amp;:embed=yes&amp;:showShareOptions=false"></iframe><style media="(min-width:48.0625em)">#embed-wrapper-839223549{padding: 0 0 2350px;}</style></div>

En Banc Tracker

Many orders from the Federal Circuit are not reported but can affect practice and procedure before the Court. We track and reproduce those orders here, highlighting ones that may be of significant interest to those who have cases before the Federal Circuit.<div data-reactroot=""><iframe src="https://public.tableau.com/views/RehearingCFRsandSubstantiveOrders/SubstantiveOrders?:language=en&amp;:display_count=y&amp;:origin=viz_share_link&amp;:showVizHome=no&amp;:embed=yes&amp;:showShareOptions=false" width="100%" height="3030" allowfullscreen="" frameBorder="0"></iframe></div>

Substantive Orders Tracker

Trackers

Blog - Editors

Blog - About

About

Blog - Subscribe

Last Week In The Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt To Read ANDA Application In Isolation | Federal Circuitry

Last Week In The Federal Circuit (August 15 – August 19): The Court Rebuffs Patent Owner’s Attempt To Read ANDA Application In Isolation | Federal Circuit Blog - News & Statistics | Federal Circuitry

Brian R. Matsui

We’re now in the waning days of summer, and the Court’s activity last week somewhat reflected that: two decisions and a few orders. One of those orders was for something you don’t see often: an appeal being dismissed for an appellant missing the deadline to file its opening brief by 11 days. So fair warning: an appellant that doesn’t file an opening brief may have its appeal dismissed. But rather than write about that one-line order, we’re going to discuss instead a case about numbers. Below we provide our usual weekly statistics and a detailed discussion of our case of the week—our highly subjective selection based on whatever case piqued our interest.Precedential opinions: 2Non-precedential opinions: 0Rule 36: 0Longest pending case from argument: <a href="https://cafc.uscourts.gov/opinions-orders/22-1016.OPINION.8-17-2022_1992553.pdf">Click-to-Call Technologies, LP v. Ingenio, Inc</a>., No. 22-1016 (69 days)Shortest (non-Rule 36) pending case from argument: <a href="https://cafc.uscourts.gov/opinions-orders/21-2342.OPINION.8-18-2022_1993064.pdf">Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc</a>., No. 21-2342 (42 days)Case of the week: <a href="https://cafc.uscourts.gov/opinions-orders/21-2342.OPINION.8-18-2022_1993064.pdf">Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc</a>., No. 21-2342Panel: Chief Judge Moore and Judges Prost and Hughes, with Chief Judge Moore writing the opinionYou should read this case if: you have an ANDA case involving “actual, real-world evidence” that might conflict with what the ANDA saysFor our case of the week, we turn to the ANDA world. As readers know and in the simplest of terms, an ANDA is an Abbreviated New Drug Application, which a generic drug manufacturer (which we’ll off-and-on refer to as the ANDA applicant) files with the FDA to seek approval to sell a generic version of a brand name drug. Before the generic goes on the market, the brand manufacturer can file an action to enjoin the generic from reaching the market. Ordinarily, it does so under Section 271(e)(2), which makes it an (artificial) act of infringement for an ANDA applicant to file an ANDA that infringes the brand manufacturer’s patent claims. Section 271(e)(2) requires comparing the patent claims to the ANDA’s specification—as the proposed generic product must meet the ANDA’s specifications.Here the dispute concerned only one claim requirement—the product’s pH range. If the product specified in the ANDA practiced the claimed pH range, then it infringed. So did it? Nope. The claims specified a pH between 3.7-3.9 (or 3.65-3.94 before rounding). The ANDA specified a pH range of 3.4-3.6 (or 3.35-3.65 before rounding). So close, but of course close only counts in horseshoes and hand grenades—not literal infringement.On appeal, the patent owner argued that the real-world evidence showed that the pH of the generic manufacturer’s product would drift upward during the product’s shelf life. And it noted that the generic sought approval to release a product at 3.64 pH, just 0.01 below the patent owner’s claims—the implication being the product released at 3.64 pH would inevitably drift to 3.65 pH or higher and thereby infringe the claims. While a not completely unappealing argument (double negative intentional), the Court noted a key problem. The patent owner was looking at the ANDA’s pH range in isolation. In addition to a pH specification, the ANDA also had a stability specification. Taken together, both “restrict the pH of the proposed product to a pH range between 3.4-3.6 at release and throughout the product’s shelf life—outside the infringing range.” And to remove any doubt, the Court cited the oral argument where the ANDA applicant’s counsel acknowledged that the ANDA product must “have a pH between 3.4-3.6 throughout its shelf life, not just at release.” Thus, to the extent there was real world evidence of pH drift, that evidence didn’t matter under the Section 271(e)(2) analysis here.In addition to alleging infringement under Section 271(e)(2), the patent owner also sought a declaratory judgment that the generic would infringe in the future, because of the pH drift. But essentially the same findings that thwarted the patent owner’s case under Section 271(e)(2) thwarted its attempt to get declaratory relief. The Court said there could be no real threat that the generic was going to infringe the patents (with upward pH drift) when the ANDA stated that the proposed product must meet both the pH and stability requirements. In addition, the Court noted that the real‑world evidence didn’t support the upward drift anyway. It noted that the district court made no clear error in several findings that there was no upward drift along the lines the patent owner was talking about.