Source: https://www.straffordpub.com/products/patent-term-adjustments-and-extensions-leveraging-recent-decisions-and-uspto-rule-changes-2018-10-11
Timestamp: 2019-04-18 21:37:02+00:00

Document:
This CLE webinar will guide IP counsel in calculating patent term adjustments, interplay with patent term extensions, examine recent court treatment, and offer approaches for preserving rights and maximizing patent term adjustments and patent term extensions.
Since then, the Federal Circuit decided Gilead Sciences Inc. v. Lee (2015), Mohsenzadeh v. Lee (2015), Daiichi Sankyo Co. Ltd. v. Lee (2015), Pfizer v. Lee, (Fed. Cir. 2016), and Actelion Pharm Ltd. v. Matal (Fed. Cir. 2018). In Gilead, the Federal Circuit upheld the USPTO’s PTA calculation that subtracted days between Gilead filing a response to a restriction requirement and a supplemental IDS. In Mohsenzadeh, Pfizer and Actelion, the Federal Circuit addressed A-delay, holding that a patent is only entitled to PTA for a delay in the prosecution of the application from which the patent directly issued, not the application from which it derived priority. In Daiichi, the Federal Circuit again decided in favor of the USPTO with regards to the “Interim Procedure” instituted post-Wyeth.
We now have district court decisions, such as Supernus Pharms. Inc. and United Therapeutics v. Lee, (E.D. Va. 2016), appeal pending, challenging the USPTO’s application of its rules and Gilead in its PTA calculations. The impact of prosecution actions on eventual PTA remains an essential aspect of practitioners’ considerations as the case law continues to evolve.
Patent term extensions under 35 U.S.C. 156 were designed to create new incentives for research and development of specific products subject to pre-market government approval by a regulatory agency. The statute enables the owners of patents on certain human drugs, food or color additives, medical devices, animal drugs, and veterinary biological products to restore to the terms of those patents some of the time lost while awaiting pre-market government approval from a regulatory agency.
These extensions can be significant for some products, primarily pharmaceutical products. There is little room for error in these applications, as a denied application can mean the loss of millions to billions of dollars. Familiarity with the statute, governing rules, and legal precedent is thus crucial.
Listen as our authoritative panel of patent attorneys, in combination having well over 100 years of practical U.S. patent law experience, examines the recent developments for PTAs and their potential impact, methods for calculating PTA, and what can be done to preserve rights, and offers best practices for maximizing PTA. Also included in the discussion will be patent term extension considerations.
What are the lessons from the recent Federal Circuit decisions regarding the patent term calculation?
How will the recent changes for the USPTO alter the landscape for PTA and PTE practice?
What best practices should patent applicants take to preserve rights and maximize PTA and PTE?
Mr. Van Horn has a strong working knowledge of the specialized areas of patent reexamination, patent term extension, and procedures under the Patent Cooperation Treaty. After a 31-year career at the USPTO, he joined the firm and has served in a variety of leadership positions relating to patent policy and practice. While deputy solicitor, he argued cases in the federal courts. As deputy assistant commissioner, he established the policy and practice for examining patent applications.
The webinar gave us a timely, up-to-date review of PTAs and PTEs, incorporating review of new PTO rules and recent court cases.
The presentations of the timelines by each speaker were especially valuable! This was an excellent introduction to Strafford's offerings!
The slides were very clear and informative. The lecturers provided a lucid explanation of the materials. Indeed, they were very knowledgeable of the subject matter and advised of the latest developments in the area, including the latest relevant court decisions and the latest rules and proposed rules from the USPTO.
The webinar provided insightful analysis of the complicated issues that related to the material.

References: v. 
 v. 
 v. 
 v. 
 v. 
 v.