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Obviousness, 35 U.S.C. 271(e)(4)(A) and Application of Federal Rule of Civil Procedure 60...
June 10, 2024 CLE Live Webinar
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE webinar will guide patent counsel on obviousness issues and the implications of the Federal Circuit's recent decisions. The panel will discuss the obviousness analysis and offer best practices for a patent owner to present claims to assist in navigating obviousness and for a generic manufac... Read More

March-in Power and Patent Rights: Bayh-Dole Act, NIST Framework, Implications for Patent R...
April 30, 2024 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE webinar will guide patent counsel on the use of march-in rights as the mechanism to lower drug prices. The panel will review the history of the Bayh-Dole Act, lessons learned from past march-in petitions, and the proposed NIST framework. The panel will discuss the implications and concerns... Read More

Patenting Repurposed Drugs: Overcoming Subject Matter Eligibility, Prior Art, and Obviousn...
April 11, 2024 CLE CLE On-Demand, Download
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This CLE course will guide counsel on patenting repurposed drugs. The panel will examine the interplay between FDA exclusivity and patent exclusivity, key considerations when seeking to patent a repurposed drug, and addressing novelty and obviousness hurdles. The panel will discuss how to address th... Read More

Patent Listings in the Orange Book: FTC Guidance, Policy, and Enforcement; Practical Steps...
March 21, 2024 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE webinar will guide patent counsel on patent listings in the Orange Book and the U.S. Federal Trade Commission's (FTC) recent actions. The panel will examine the FTC's policy on Orange Book listings, its recent enforcement, and the options it is considering. The panel will discuss what holde... Read More

In-Licensing and Out-Licensing in the Pharmaceutical Industry
Evaluating and Conducting Due Diligence of Product and Licensing Partner; N...
February 22, 2024 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE webinar will guide IP counsel on in-licensing and out-licensing in the pharmaceutical industry. The panel will discuss the advantages and disadvantages of both as well as the key considerations when weighing whether to use either type. The panel will also address the evaluation of the produ... Read More

Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent...
February 15, 2024 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
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This CLE course will provide essential updates on FDA practice and patent law relating to biologics and biosimilars. The panel will discuss the current state of and recent changes to FDA initiatives, approvals, and exclusivities, as well as patent prosecution, post-grant proceedings, and litigation. Read More

Patent Infringement, Safe Harbor, and Drug Development: Navigating the Uncertain Boundarie...
November 30, 2023 CLE CLE On-Demand, Download
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This CLE webinar will guide patent counsel on the Hatch-Waxman safe harbor and the scope of its protection. The panel will discuss drug development and the implications of the safe harbor. The panel will offer best practices for leveraging the safe harbor. Read More

Labeling and Induced Infringement in Pharma Patent Litigation and Protecting IP Rights
October 26, 2023 CLE CLE On-Demand, Download
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This CLE course will guide patent counsel on the implications of recent litigation strategies and discuss strategic considerations of label language. Read More

Means-Plus-Function and Antibody Patent Claims: Preparing, Defending, and Enforcing MPF Cl...
September 14, 2023 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE webinar will guide patent counsel on means-plus-function (MPF) claims and antibody patents. The panel will discuss the benefits and risks of using MPF in the context of antibodies. The panel will offer best practices to overcome the challenges of MPF claims and leverage 112(f) and functiona... Read More

Patenting Polymorphs: Opportunities and Challenges
Proving Validity and Patentability vs. Proving Infringement in Litigation
May 2, 2023 CLE CLE On-Demand, Download
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The CLE webinar will guide patent counsel on patenting polymorphs from drafting through patent prosecution and enforcement. The panel will further examine lessons learned from the case law and offer strategies to overcome the potential challenges. Read More

Obtaining and Managing REMS Patents: What Patent Prosecutors Need to Know, USPTO and FDA P...
March 21, 2023 CLE CLE On-Demand, Download
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This CLE webinar will guide patent counsel on the issues surrounding Risk Evaluation and Mitigation Strategy (REMS) patents and listing in the Orange Book. The panel will discuss REMS patents and what patent prosecutors need to know. The panel will address the current efforts of the USPTO and FDA to... Read More

Orange Book Listing Recent Developments
Impact on Prosecution of Pharmaceutical U.S. Patent Applications, Subsequen...
February 14, 2023 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on recent Orange Book developments. The panel will discuss Orange Book listing practices and the implications for patent prosecution, listing, and litigation. The panel will examine contemporary thought about Form 3542 and pitfalls to avoid. Read More

Biologics Price Competition and Innovation Act: Purple Book, Dispute Resolution, Exclusivi...
January 5, 2023 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on the Biologics Price Competition and Innovation Act (BPCIA). The panel will discuss the Purple Book and issues related to exclusivities and the retroactivity of the BPCIA. The panel will also address the ongoing debate over whether the BPCIA's patent dispu... Read More

Overcoming 103 Rejections for Biotech and Chemical Patents: Leveraging Recent Decisions an...
December 8, 2022 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

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... Read More

Patenting Pharmaceutical Drug Formulations: Withstanding Litigation and PTAB Challenges
September 1, 2022 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on patenting drug formulations from drafting through patent prosecution and enforcement. The panel will examine lessons learned from the case law and offer strategies to overcome the potential challenges. Read More

Patent Exclusivity Health Checks for Small Molecules: Are Your U.S. Patents Ready to Maxim...
Phase II Efficacy Trials, Phase III Clinical Trials, NDA Submission, Approv...
July 21, 2022 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will provide guidance to patent counsel on the essentials of patent exclusivity that are in critical need of independent checking. The panel will discuss crucial health checks on U.S. patent exclusivity for small molecules in Phase II efficacy trials and proceedings through large-sca... Read More

Antibody Patenting: Meeting Written Description and Obviousness Requirements, U.S. and Eur...
May 26, 2022 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on the patentability requirements in the USPTO and EPO for claiming a broad genus of antibodies, recent case law that could impact those claims, and how best to protect antibody inventions in light of the recent developments. Read More

Patent Eligibility and Engineered Natural Products: Overcoming 101 Challenges, Leveraging...
April 28, 2022 CLE CLE On-Demand, Download
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This CLE course will guide patent counsel on patent eligibility issues with engineered natural products. The panel will examine the key considerations in determining patentability and review recent case law. The panel will also address alternatives for getting IP protection for engineered natural pr... Read More

Life Sciences IP Due Diligence: Implications of Recent Decisions, Legislation, PTO Guidanc...
March 17, 2022 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide counsel for conducting intellectual property due diligence in life sciences deals. The panel will discuss recent court decisions and current and pending legislation relating to patent rights that impact life sciences analyses. The panel will offer steps companies and couns... Read More

Creative Patent Claiming Strategies in Light of FDA Approval
Lessons From Teva Pharms. v. Corcept Therapeutics, Sanofi v. Watson, and Su...
March 8, 2022 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on patent claiming and the virtues of claiming precisely what the FDA approved. The panel will discuss the recent Teva Pharms. v. Corcept Therapeutics decision, the obvious to try requirements, and the lessons from the recent decision. The panel will also hi... Read More

Pharma and Chemical Patent Applications: Meeting Written Description Requirement
Demonstrating Evidence of Possession of the Invention, Navigating the Guide...
January 6, 2022 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel to ensure chemical and pharmaceutical patent applications meet the written description requirement, outline lessons for counsel from Federal Circuit and PTAB decisions, and offer their perspectives and strategies to avoid challenges. Read More

Orange Book Listing Recent Developments
Impact on Prosecution of Pharmaceutical U.S. Patent Applications, Subsequen...
November 16, 2021 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on recent Orange Book developments, including recent cases related to Orange Book listing practices and the implications for patent prosecution, listing, and litigation. The panel will examine, in particular, contemporary thought about Form 3542 and pitfalls... Read More

Markush Claims in Patent Prosecution and Litigation: Leveraging Federal Court Guidance
October 27, 2021 CLE CLE On-Demand, Download
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This CLE course will guide patent counsel on Markush claims in the prosecution and litigation of patents. The panel will review the original case, Ex Parte Markush, and other critical cases, including recent PTAB appeal and IPR decisions. The panel will discuss the ongoing debate about what Markush... Read More

Patent Exclusivity Health Checks for Biologics: Are Your U.S. Patents Ready to Maximize RO...
September 23, 2021 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on the essentials of patent exclusivity that are in critical need of independent checking. The panel will discuss crucial health checks on U.S. patent exclusivity for biologics in Phase II efficacy trials and proceedings through large scale randomized Phase... Read More

Sect. 112 Indefiniteness in Chemical and Biotech Patent Claims
Drafting and Prosecuting Patent Claims That Will Hold Up Under Any Definite...
July 1, 2021 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on how recent Federal Circuit and Patent Trial and Appeal Board (PTAB) case law impact daily patent practice. The panel will offer best practices to navigate pre- and post-issuance scrutiny for compliance with 35 U.S.C. 112(b). Read More

Biologics Price Competition and Innovation Act: Purple Book, Dispute Resolution, Exclusivi...
May 11, 2021 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on the Biologics Price Competition and Innovation Act (BPCIA). The panel will discuss the new Purple Book and issues related to exclusivities and the retroactivity of the BPCIA. The panel will address the potential unavailability of IPR and PGR proceedings f... Read More

Biotech Patents and Section 101 Rejections: Meeting Patent Eligibility Requirements
Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections
March 25, 2021 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel through strategies for overcoming Section 101 rejections of biotech patents. The panel will review recent case law and USPTO guidance on Section 101 patent eligibility and offer strategies to address Section 101 rejections. Read More

Hatch-Waxman Litigation and 30-Month Stays: Multiple Stays, Late-Listed Patents, and More
October 29, 2020 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on the 30-month stay in Hatch-Waxman Act litigation. The panel will discuss the circumstances where the FDA will grant a stay--and those where it will not. The panel will discuss when a stay may extend beyond 30 months and when it may be shortened. Read More

Protecting Cannabis IP: Viability of Cannabis Patents, USPTO Guidance on Trademark Applica...
October 27, 2020 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide IP counsel on the protection of cannabis IP. The panel will examine the current cannabis IP landscape and discuss the impact of the legality of cannabis on IP rights. The group will also address what the FDA's cannabis regulation means for IP and offer best practices for s... Read More

Patenting Compounds, Compositions, and Methods for Viral Infections: Patent Eligibility Co...
October 7, 2020 CLE CLE On-Demand, Download
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This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will provide guidance to patent professionals and their management counterparts on the critical and essential legal issues surrounding technology directed to managing and overcoming the global COVID-19 pandemic. Specifically, they will address the patenting of compounds, compositions... Read More

Antibody Patenting: U.S. and Asian Perspectives
Meeting Patentability Requirements in the USPTO, JPO, and CNIPA
September 10, 2020 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on the patentability requirements at the USPTO, JPO, and CNIPA when claiming antibodies, recent case law that could impact those claims, and how to protect antibody inventions in light of the latest developments. Read More

Drug Substance Patents: FDA Guidance, Protecting Composition-of-Matter Patents, Drafting S...
April 30, 2020 CLE CLE On-Demand, Download
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This CLE course will guide patent counsel on solid form patents, how to patent them, and process challenges. The panel will also discuss implications of the current cocrystal guidance by the FDA and provide a survey of, and lessons from, cases relating to solid form patents. Read More

Protecting Cannabis IP: Viability of Cannabis Patents, New USPTO Guide on Trademark Applic...
August 20, 2019 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide IP counsel on the protection of cannabis IP. The panel will examine the current cannabis IP landscape and discuss the impact of the legality of cannabis on IP rights. The group will also address what the FDA's recent hearing on cannabis regulation means for IP and offer be... Read More

Application of Section 101 in Life Sciences Patents: Leveraging Revised USPTO Guidelines,...
Implications for Patent Prosecution, Litigation and Reform
August 15, 2019 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

The CLE course will guide patent counsel on patent eligibility in life sciences patents, examining the latest Federal Circuit decisions, Patent Trial and Appeal Board cases, and U.S. Patent and Trademark Office (USPTO) guidance. The panel will offer best practices for navigating the interplay betwee... Read More

Drug Substance Patents: FDA Guidance, Protecting Composition-of-Matter Patents, Drafting S...
April 25, 2019 CLE CLE On-Demand, Download
This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

This CLE course will guide patent counsel on solid form patents, how to patent them, and challenges that are in the process. The panel will also discuss implications of the current cocrystal guidance by the FDA and provide a survey of, and lessons from, cases relating to solid form patents. Read More

Developing a Life Sciences Patent Portfolio
Prosecution, Orange Book /Purple Book Listing, IP Acquisitions, Licensing,...
March 28, 2019 CLE CLE On-Demand, Download
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This CLE course will guide patent counsel on developing a life sciences patent portfolio. The panel will examine key considerations and strategies counsel should employ to build the company's patent portfolio and protect its IP. Read More