In a Federal Register Notice published January 6, 2022, the USPTO announced a new pilot program that will permit certain applicants to temporarily defer responding to subject matter eligibility (“SME”) rejections. The program...more
In a Director’s Forum blog post published December 10, 2021, the USPTO announced plans to issue proposed rule changes relating to the format in which U.S. patents are issued, making electronic patents the norm, with something...more
The USPTO has announced changes to the “technical and scientific qualifications that may typically make applicants eligible” to take the patent bar exam. The changes are being implemented after consideration of public...more
In Eli Lilly and Co. v. Teva Pharmaceuticals International GmbH, the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board decision upholding Teva’s patents directed to specific methods of treatment using an...more
In Minerva Surgical, Inc. V. Hologic, Inc., the Supreme Court limited the equitable doctrine of assignor estoppel that prevents an assignor from subsequently challenging the validity of the patent he or she assigned. The...more
In an unusual Federal Register Notice, the USPTO “reminded” applicants that “patent applications must properly present examples in a manner that clearly distinguishes between prophetic examples that describe predicted...more
Under current USPTO Patent Term Adjustment (PTA) rules, an Applicant can be charged a Patent Term Adjustment (PTA) deduction for “applicant delay” before examination commences if the application is not “ready for examination”...more
As much of the United States is taking steps towards “getting back to normal,” the USPTO continues to implement programs to encourage investment and innovation in technologies addressing the COVID-19 pandemic. Recently, the...more
Earlier this year, two new laws were enacted that impact patent listings in the Orange Book (drugs) and Purple Book (biologics). The Orange Book Transparency Act primarily codifies current FDA practices, but adds a new...more
The USPTO has issued a request for comments on proposed changes to requirements for admission to the patent bar. Last week I had an opportunity to speak with Commissioner for Patents Drew Hirshfeld, who currently is...more
In Chudik V. Hirshfeld, the Federal Circuit upheld the USPTO’s determination that a Patent Term Adjustment (PTA) award for “C” delay is not available when an examiner reopens prosecution after an Appeal Brief is filed,...more
One year into the COVID-19 pandemic, and its affects still are impacting patent prosecution, especially as it relates to the difficulty of obtaining paper copies of official documents. While the USPTO rarely requires...more
While I stand by my view that the doctrine of obviousness-type double patenting is one of the most complicated aspects of U.S. patent law, regulations governing the ability to claim “Small Entity” status and pay reduced USPTO...more
As a non-precedential decision on claim construction, Horizon Pharma, Inc. v. Dr. Reddy’s Laboratories Inc., may not be relevant to any other case, but it caught my attention as an example of the perils of claim drafting....more
The doctrine of obviousness-type double patenting is one of the most complicated and most confounding aspects of U.S. patent law. Although a Terminal Disclaimer can overcome most obviousness-type double patenting rejections,...more
In a Director’s Forum blog on the importance of interview practice to the patent examination process, the USPTO announced that the First Action Interview Pilot Program is going to end on January 15, 2021, largely due to...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. the Federal Circuit decided that, for the purpose of establishing venue in ANDA litigation, the place “where an act of infringement has occurred”...more
The Federal Circuit decision in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., is getting attention for potentially “endangering” the practice of skinny labelling. Indeed, the Federal Circuit held that Teva’s skinny...more
The USPTO has published proposed guidelines on the types of courses and activities that will qualify for USPTO CLE credit, which practitioners may voluntarily report in the mandatory biennial registration statements that will...more
In a decision that is not very surprising but nonetheless worth taking note of, the Federal Circuit found that a reasonable jury could have found claims reciting methods using a recombinant polypeptide to be anticipated by...more
In Phytelligence, Inc. v. Washington State University, the Federal Circuit held that the agreement terms at issue constituted “an unenforceable agreement to agree” that did not convey the license rights at issue. While...more
In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...more
9/18/2020
/ Certifications ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Investigational Device Exemptions ,
Investigational New Drug Application (IND) ,
Patent Applications ,
Patent-Eligible Subject Matter ,
Pilot Programs ,
Premarket Approval Applications ,
USPTO
The Federal Circuit decision in Bio-Rad Laboratories, Inc. v. 10X Genomics Inc., addresses several interesting issues. This article focuses on the affirmance of the district court decision that the “tangentiality” exception...more
In Dana-Farber Cancer Institute, Inc. v. Ono Pharm. Co., Ltd., the Federal Circuit agreed with the district court that two inventors should be added to a family of PD-1 cancer treatment patents, even though their...more
In a Federal Register Notice dated August 3, 2020, the USPTO published a final rule on fee changes that take effect October 2, 2020. The final rule implements fee changes we first learned about in August of 2018, with some...more