Overcoming 103 Rejections for Biotech and Chemical Patents: Leveraging Recent Decisions and USPTO Guidance
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
- work Practice Area
Patent
- event Date
Thursday, December 8, 2022
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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This CLE course will guide patent counsel in overcoming Section 103 rejections for biotech and chemical patents. Biotech and chemical claims continue to be embroiled in lead compound arguments and rebutting prima facie cases of obviousness based on, for example, ranges. The panel will review recent judicial and PTAB case law and offer insights to address 103 rejections. In particular, the panel will discuss the rise of inherency arguments in an obviousness context, as well as several Federal Circuit decisions reminding the PTAB and lower courts that conclusions of obviousness must be sufficiently supported and cannot be conclusory and merely stated to be based on "common sense."
Ms. Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.
Her patent experience covers a variety of complex and innovative inventions involving small molecule drugs, biologics, cell-based technologies, compositions, drug formulations and drug delivery systems, immunotherapeutics, medical devices, diagnostic tests, nanotechnology, and immunology, particularly vaccines and antibodies. Ms. Brougher also has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act.
Mr. Irving has 47 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.
Mr. Jacobstein focuses on strategic client counseling, including due diligence, patent prosecution, and post-grant proceedings, with an emphasis on biotechnology and the life sciences. His experience includes prosecuting and appealing applications within the USPTO, as well as post-grant proceedings and larger portfolio management, licensing, and opinion work. He has conducted numerous evaluations for diligence, clearance, and freedom-to-operate assessments, and has extensive experience providing patentability, validity, enforceability, and infringement opinions.
Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.
Obviousness can be a significant hurdle for patent applicants in securing a patent on biotech and chemical inventions. An obviousness determination can be complicated, and examiners regularly reject patent claims as obvious under Section 103, often combining the prior art.
For clients who receive a 103 rejection, counsel's response should be part of a well thought out strategy that anticipates the possibility of later court and PTAB challenges. For example, counsel should try to craft the response to minimize or eliminate prosecution history estoppel without jeopardizing enablement and/or written description positions.
Further, in light of AIA post-grant proceedings such as post-grant reviews and inter partes reviews, counsel should carefully consider submitting evidence, including comparative data, scientific arguments, and supporting declarations, in reply to the rejection to build the prosecution record. Efforts during prosecution will help to raise the bar a petitioner will face persuading the PTAB to find that the claims are unpatentable more likely than not.
Listen as our authoritative panel of patent attorneys examines how the courts have treated 103 rejections and the USPTO's guidance on 103 rejections. Based on decades of experience, the panel will offer their own war stories on overcoming 103 rejections and arguments. The panel will also discuss the distinct challenges for biotech and chemical inventions and best practices for patent counsel to address 103 rejections in biotech and chemical patent applications.
- Current guidance on Section 103 patent claim rejections
- Lessons from recent court decisions
- USPTO guidance
- Distinct challenges for biotech and chemical inventions
- Overcoming 103 rejections in biotech and chemical patent applications
The panel will review these and other key issues:
- What evidentiary support should counsel provide to bolster its assertion of validity/patentability?
- What tactics should patent counsel implement to overcome 103 rejections for biotech and chemical patents?
- How can patent counsel guide applicants during patent application drafting to reduce the likelihood of rejection?
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