Amgen v. Sanofi and Patent Enablement One Year Later: Guidance for Drafting, Defending, Challenging Patent Claims

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Patent
- event Date
Tuesday, September 24, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE webinar will guide patent counsel on the Supreme Court decision in Amgen Inc. v. Sanofi and the implications one year after the decision. The panel will discuss the decision's impact on the patent enablement requirement. The panel will offer best practices for satisfying the patent enablement requirement or challenging that the requirement is met.
Faculty

John Augustyn successfully represents clients in high stakes intellectual property litigation, agreements, client counseling, and prosecution.  Leveraging his prior experience in management and as an engineer at Fortune 100 companies, John understands that IP and business issues require creative and cost effective legal solutions. He has authored several articles and chapters for books, has appeared on multiple television and radio programs, has taught law school classes, and has provided over 30 CLE programs to thousands of corporate and outside counsel.  His legal success has been recognized by selection to Best Lawyers, Super Lawyers, IAM Patent 1000, Top 100 High Stakes Litigators, Fellow to Litigation Counsel of America, and other honors. Please click on his photo above for more information.
Litigation
John has been lead counsel in patent and trade secret litigations throughout the country at the trial and appellate levels. He also has been lead counsel in Post Grant proceedings at the USPTO and coordinated post grant proceedings in other countries.  In addition, he has litigated cases at the International Trade Commission. His litigation experience has involved several areas, including electronics, magnetics, sensors, control systems, medical devices, automotive, and consumer products.
Opinions
John counsels and renders opinions on patent infringement and invalidity including major product launches in competitive patent landscapes. These opinions often involve large patent families with multiple US patents and with existing litigations and patent office proceedings throughout the world.
Patent Prosecution
He has extensive experience in formulating patent strategies and managing patent portfolios. John manages the US and non-US patent prosecution for several international corporations. He has prepared or supervised the preparation of over 1000 US original patent applications and oversaw the prosecution of over 3000 non-US patent applications.
Due Diligence
John performs due diligence for mergers and acquisitions. The due diligence involves an analysis of the patents, trademarks, trade secrets, licenses, agreements, products, services, manufacturing processes, software, marketing, and standards by standard setting organizations.
IP Agreements
He successfully negotiates and prepares agreements relating to well-known products and brands for both the seller/ licensor and the buyer/ licensee, including patent licenses, technology licenses, trade secret agreements, joint venture agreements, trademark agreements, and research and development agreements.
Trade Secrets
John advises clients on trade secret matters including: litigating trade secret cases, negotiating trade secret agreements, advising clients on the best techniques for protecting their trade secrets, and helping clients decide whether to use trade secret versus patent protection.

Prof. Sarnoff has received numerous awards for his scholarship. He is an internationally recognized expert on the intersections of intellectual property law, environmental law, health law, and constitutional, administrative, and international law.  In June 2019, he testified before the Intellectual Property Subcommittee of the Senate Judiciary Committee on pending legislation to revise subject matter eligibility doctrine under Section 101 of the Patent Act.  From January 2014 to July 2015, he served as the Thomas A. Edison Distinguished Scholar at the U.S. Patent and Trademark Office. Prof. Sarnoff directed the DePaul Center for Intellectual Property and Information Technology (CIPLIT®) and organized and moderated the 2018 Jaharis Health Law Symposium on Emergency and Technological Responses to Pandemic Diseases and the 2011, 2015, and 2019 Intellectual Property Scholars Conferences (IPSC). He also hosts the annual Edward D. Manzo Scholars in Patent Law series.

Mr. Hamp assists clients in all aspects of intellectual property law, with a particular focus on the litigation and enforcement of patent, trademark, copyright and trade secret rights. He represents clients from a variety of industries in the preparation and prosecution of utility and design patent applications before the USPTO, including applications related to the chemical, healthcare, mechanical, computer software, sporting goods, and household products fields. Mr. Hamp has successfully prepared and/or prosecuted applications in many technology areas, including for pharmaceuticals, food and beverage compositions, chemical catalysts, malware detection methods, and semiconductor devices. He also provides counseling and opinion work for utility patent, design patent, trademark and copyright matters, including freedom to practice and validity assessments, domestic and foreign infringement investigations, drafting of license and transfer agreements, and other strategy counseling.
Description
The Supreme Court in Amgen Inc. v. Sanofi (2023) held that Amgen's patent claims were invalid under the patent enablement requirement. The Court had not decided a case on patent enablement in almost 100 years. The Court held Amgen's broad claims covering a functional result--however achieved--failed to satisfy the enablement requirement when Amgen had comparatively few examples teaching how to achieve that claimed result out of the potential millions of unpredictable options available. In so doing, however, the decision gave mixed signals on how the enablement doctrine should be applied in other scenarios and how practitioners should best proceed when drafting, defending, or challenging patent claims.
Despite holding against Amgen, the Court agreed with Amgen on key issues. The Court stated that the statutory standard--in place for hundreds of years with little change--applies in all cases and that the amount of "cumulative" effort to make all the claimed embodiments does not control the enablement analysis. Yet Amgen's claims still fell short.
In striking this balance, the decision provides lifelines to all sides on how enablement should be applied. For example, the decision arguably raises the bar for genus claims, stating "the more one claims, the more one must enable," and specifying that "if a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent's specification must enable a person skilled in the art to make and use the entire class." But at the same time, the decision stated that a patentee can do so through "an example" and without "specify[ing]" every facet of the claimed genus in their patent, and further stressed that "some" testing and "reasonable" experimentation--which will vary in every case--can be still required to enact an enabled invention. What's more, the decision did not mention, much less overturn, existing Federal Circuit case law with similar flexible considerations, such as the seminal case of In re Wands that patentees have relied on for decades. Given this, Courts have still relied on the Wands factors to assess enablement under the Amgen framework.
Listen as our authoritative panel of patent attorneys reviews the Supreme Court's decision and its impact on the enablement requirement after one year, including through discussion of illustrative cases applying Amgen and the U.S. Patent Office’s new enablement guidance. The panel will offer best practices for satisfying the enablement requirement.
Outline
- The enablement requirement
- Amgen v. Sanofi
- Implications for enablement in courts and before the U.S. Patent Office
- Best practices
Benefits
The panel will review these and other critical issues:
- What lessons can patent counsel draw from the Supreme Court's decision when making arguments of enablement?
- What steps should counsel take to meet the enablement requirement when drafting patent applications?
- How can patentees and patent challengers leverage the decision in invalidity/unpatentability challenges based on enablement?
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