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Articles by Emer Simic
Federal Circuit Weighs in Again on Obviousness-Type Double Patenting to Limit In re Cellect and Preserve PTA for First-Filed, First-Issued Patents | JD Supra
Obviousness-type double patenting (ODP), a judicially-created ground of patent invalidity, has become the subject of intense interest after the Federal Circuit issued two decisions refining the application of the doctrine in a little over a year. This update discusses these recent developments, which impact the amount of U.S. patent terms that may be enjoyed by patent owners.
What Vidal’s Sua Sponte Director Review of Unprecedented PTAB Sanctions Order Could Mean for PTAB Practice
“Whatever action Vidal takes in Longhorn, the PTAB’s recent sanctions orders serve as a warning that the Board is ready and willing to sanction litigants severely for misconduct.” If a sanctions order is the stuff of a Patent Trial and Appeal Board (PTAB) practitioner’s bad dreams, then the issuance of sanctions outright cancelling a client’s patent(s) qualifies as their worst nightmare.
USPTO Guidance Reduces PTAB Discretionary Denials, Signaling Potential Uptick of IPRs in 2023
“In the short term, we have seen a dramatic drop off in discretionary denials and we should expect that trend to continue, which could result in an increase in the number of PTAB trials in 2023.” The appointment of USPTO Director Kathi Vidal in April 2022 and her introduction of interim guidance in June 2022 has spurred changes at the Patent Trial and Appeal Board (PTAB) that may result in an increase in instituted inter partes reviews (IPRs) due to a dramatic decline in discretionary denials.
Strategic Considerations for Generics and Brands in Light of GSK v. Teva
Event Session October 26, 2022 @ 3:00 PM EST 3:00 PM ET Strategic Considerations for Generics and Brands in Light of GSK v. Teva View Session Speakers Under the Hatch-Waxman Act, so-called “Section VIII carveout” also known as a skinny label, are intended to give generic drug companies protection from patent infringement liability as long as the uses the ANDA applicant lists are not covered by the innovator’s patents. GSK v.
01.07.22 -- Method-Of-Treatment Patents: Increasing Value & Risk
Article | By Kate Hammeke, ISR Reports Are CDMOs evaluated on the same metrics for simple and complex oral dose manufacturing projects? Data from ISR’s new report provides insight on these questions and more. Article | By Mike Rust, T-FIT R-values are the received wisdom for evaluating thermal insulation efficiency; however, there are several inherent flaws in the arguments for R-values as a dominant measurement of insulation efficiency.
Method-of-Treatment Patents: Increasing Value & Risk
By Michael Harlin, Emer Simic, and Tom Campbell Patents on methods-of-treatment using pharmaceuticals are being asserted in broad ways against a variety of parties, with potential liabilities of hundreds of millions of dollars. Method patents can be obtained not only for new indications but also for other discoveries made after the initial approval, like dosing regimens. These post-marketing discoveries ultimately may end up in the drug’s label.
Method-of-Treatment Patents: Increasing Value & Risk
By Michael Harlin, Emer Simic, and Tom Campbell Patents on methods-of-treatment using pharmaceuticals are being asserted in broad ways against a variety of parties, with potential liabilities of hundreds of millions of dollars. Method patents can be obtained not only for new indications but also for other discoveries made after the initial approval, like dosing regimens. These post-marketing discoveries ultimately may end up in the drug’s label.
On Tiffany Cunningham’s Appointment to the CAFC: An Impeccable Candidate and a Rallying Call for More Diversity in IP
By Emer Simic July 11, 2021 “Unlike the majority of the current Federal Circuit bench, Cunningham has almost 20 years of IP litigation experience representing industry giants including Intel, Microsoft, Amazon and Panasonic in federal courts…. [This should] inject a practical perspective and enhance the Court’s understanding of the client interests at stake in these cases.” On March 30, 2021, President Biden tapped Tiffany Cunningham to be the first African American to sit on the Federal Circuit.
Artificial Intelligence in the Life Sciences Industry - Strategies for IP Protection
“As AI uptake and application in the life sciences continues to increase, companies, investors and patent professionals alike will face complex questions and uncertainty surrounding protection and ownership of AI-related IP.
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