Update: Orange Book Listing of Drug Delivery Device Patents After In re Lantus, February 2020

April 21, 2020

Update: Orange Book Listing of Drug Delivery Device Patents After In re Lantus, February 20201 Introduction The U.S. Court of Appeals for the First Circuit recently ruled that Sanofi could potentially be held liable for an antitrust violation for improperly listing an insulin delivery device-related patent in the U.S. Food and Drug Administration’s (“FDA”) Orange… Read more »

“General Knowledge” is Alive and Well When Analyzing Obviousness

February 18, 2020

In Koninklijke Philips N.V. v. Google LLC et al.,1 the Federal Circuit reaffirmed that the “general knowledge” of a person of ordinary skill in the art can be used to supply a missing claim limitation in an obviousness analysis during inter partes review under 35 USC § 311(b). Google LLC (“Google”) filed a petition with the Patent Trial and Appeal… Read more »

Subject Matter Eligibility – Reform Coming Soon?

April 29, 2019

In several previous blog posts, we discussed the USPTO’s revised guidance for determining subject matter eligibility under 35 U.S.C. § 101, including a review of potential inconsistencies between the USPTO guidance and Mayo and a recent Federal Circuit decision, which did not defer to the USPTO guidance. We ended on a hopeful note that some combination of the courts,… Read more »

The Federal Circuit Flexes Its Muscle in Cleveland Clinic (But Not the One it Should Have)

April 08, 2019

In our January Blog Post related to the January 2019 USPTO Subject Matter Eligibility Guidance (“the Guidance”), and our subsequent Blog Post in February , we noted that it was unclear how the courts will view issued personalized medicine claims examined under the Guidance, as it appeared that the USPTO may want to push the courts to reexamine the… Read more »

USPTO Subject Matter Eligibility Guidance, the Federal Circuit and Diagnostic Method Claims: Clear as Mud?

February 11, 2019

In our January 22, 2019 Blog Post related to the January 2019 USPTO Subject Matter Eligibility Guidance (“the Guidance”), we noted that in Prong Two of Step 2A of the Guidance, an Examiner is tasked with evaluating “whether the claim as a whole integrates the recited judicial exception into a practical application of the exception.”1 More importantly, we… Read more »

Does USPTO Subject Matter Eligibility Guidance Muddy the Personalized Medicine Waters?

January 22, 2019

The USPTO’s recently revised guidance for determining subject matter eligibility under 35 U.S.C. § 101 (“the Guidance”),1 provides some clarity to Examiners and Applicants as to what constitutes an “abstract idea.” While the Guidance identifies several abstract ideas that fall within the scope of a “Judicial Exception” during Prong One of the Alice/Mayo test (Step 2A of the… Read more »

USPTO Revised Guidance for Subject Matter Eligibility, Effective January 7, 2019

January 08, 2019

On January 4, 2019, the USPTO announced revised guidance taking effect on January 7, 2019, for determining subject matter eligibility under 35 U.S.C. § 101 (“2019 Revised Patent Subject Matter Eligibility Guidance”). The revised guidance supersedes all versions of the USPTO’s “Eligibility Quick Reference Sheet Identifying Abstract Ideas.” Under the revised guidance, the USPTO outlined… Read more »

Electronic Priority Document Exchange (PDX)

December 18, 2018

What is the Electronic Priority Document Exchange (PDX)? The Electronic Priority Document Exchange (PDX) is a program that provides for electronic transmission of priority documents to and from participating foreign Intellectual Property (IP) Offices. There is no fee for this service. For many foreign IP Offices, the USPTO exchanges priority documents via the Priority Document… Read more »

Federal Circuit Upholds PTAB Ruling that Tradeshow Catalog is a Printed Publication

October 22, 2018

Despite previously affirming the ITC’s decision that a dental tradeshow catalog was not publicly accessible, the Federal Circuit recently upheld the PTAB’s opposite conclusion.1 The Federal Circuit explained that it was not bound by its prior affirmance of the ITC’s judgment because it was based on a different factual record with a different burden of proof,… Read more »

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