5 Key Takeaways | Best Practices in Patent Drafting: Addressing 112 and Enablement after Amgen
In the biotechnology and chemical spaces, genus claims are often sought by patent applicants to protect not only a specific product of interest, but also as a means to protect against others making related products that...more
Recently, a Director Review was granted where Director Vidal vacated the Patent Trial and Appeals Board’s (“PTAB”) Final Written Decision and remanded back to the PTAB for further consideration of enablement. Duration Media...more
The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...more
The USPTO has issued “Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.” The Guidelines set forth the U.S. Patent and Trademark...more
In the wake of the U.S. Supreme Court’s decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) (Amgen), in which the Court addressed whether Amgen’s functional antibody genus claims satisfy the enablement requirement, the U.S....more
Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023) Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme...more
In a post-grant review appeal, the US Court of Appeals for the Federal Circuit explained that patent claims reciting a range must enable the full scope of that range and, under the Administrative Procedure Act (APA), the...more
The Supreme Court heard oral argument in Amgen v. Sanofi last week in an extended session with argument from the parties and the U.S. government. Petitioner was represented by Jeffrey Lamken, Respondents by Paul Clement, and...more
The Supreme Court's (re)consideration of the enablement requirement expected in its decision later this year in Amgen v. Sanofi may be the most closely watched patent case since AMP v. Myriad Genetics. But in a decision...more
Sanofi and Regeneron filed their brief at the Supreme Court in Amgen v. Sanofi, in which Amgen seeks to have the Court overturn the District Court's grant of JMOL in the issue of whether Amgen's claims were invalid for...more
Facing what is likely to be something of an uphill battle in seeking to have the Federal Circuit's decision against it in Amgen v Sanofi overturned before a not always patent-friendly Supreme Court, Amgen in late December...more
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more
ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more
Long before the AIA, declarations were a tool that was available during patent prosecution to put evidence, e.g., post-filing data and expert opinions, in front of an Examiner to rebut obviousness or lack of enablement...more
The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
Ericsson Inc. v. Intellectual Ventures I LLC (No. 2017-1521, 8/27/18) (Reyna, Taranto, Chen) Reyna, J. - Vacating and remanding the PTAB’s IPR decision because the PTAB erred in not considering portions of the petitioner’s...more
Federal Circuit Summary - Before Dyk, Reyna, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: A two-dimensional drawing of a three-dimensional object may meet the enablement and definiteness...more
On July 2, 2018, the Federal Circuit Court of Appeals affirmed the decision of the Patent Trial and Appeal Board holding that some of the claims relating to artificial glands and various methods of creating them were not...more
The US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) decision, rendered in the context of a patent interference contest, resolving priority of invention to a hepatitis C treatment on...more
In a final written decision, the Patent Trial and Appeal Board (PTAB) found claims 12-16 of U.S. Patent No. 8,876,991 (the “’991 patent”) unpatentable under §§ 112 and 102. US Endodontics, LLC (“Petitioner”) filed a...more
In its 2013 decision in In re Morsa, the Federal Circuit vacated an anticipation rejection where “both the Board and the examiner failed to engage in a proper enablement analysis” to establish the enabling quality of the...more