MAIN CONFERENCE DAY ONE

7:00am Registration and Breakfast

8:00am

Opening Remarks from Chairs

8:15am

Global Patent Prosecution Think Tank: Cost Effective Strategies for Procuring and Enforcing Life Sciences Patents Worldwide

In this session, leading patent practitioners will provide you with a comprehensive and in-depth global life sciences overview to assist you in protecting your IP and minimizing risk when filing patents internationally.

• Reviewing the major patent prosecution developments around the world and how they can help expand your global portfolio:

» E.g., the substantial patent reforms in Canada throughout 2022

• Comparing patent procurement and maintenance costs in China, UK, the EU, Japan, and Brazil

• Analyzing the scope of existing patent protection in various jurisdictions, including the availability of the doctrine of equivalents and preliminary injunctions

» How is each jurisdiction reacting to the new Unified Patent Court?

9:30am

UPC Roundtable: Weighing Risks and Rewards for Life Sciences IP Practitioners Entering into the Unified Patent Court

• After delays and detours, examining what UPC procedures, including appeals, will look like going forward

• How will UPC judges approach areas of law where there is inconsistency across jurisdictions?

• How will the UPC judges align on handling conundrums including preliminary injunctions, timing/ urgency, evidence and the application of discretion?

• How will licensing work within the context of a unified patent?

• Whether to opt in or out

» License agreements and joint development agreements

10:30am Networking Break

10:45am

Patent Term Adjustments, Extensions, and the European Supplementary Protection Certificates: Masterful Practice Notes for Extending Global Patent Portfolios

Spc Case Law And Referrals

• Examining the impact of recent SPC case law and latest referrals for preliminary rulings on the interpretation of Article 3(c) of the SPC Regulation

• Unitary SPCs

» Examining how existing SPCs will operate under the Unified Patent Court, and how the new Unitary Patent will affect SPC filing strategies

» Exploring how the current status of reforms and the plans of the European Commission regarding the introduction of a Unitary SPC

• Comparing European standards to American standards for extensions and adjustments

Patent Term Adjustments And Extensions

• When is it beneficial to seek a PTE on the compound patent in the US?

• Overcoming the hurdle of different definitions of active ingredient at the FDA compared to the USPTO

» What is the active ingredient in a cell-based or gene-therapy based formulation?

• Understanding when and how an extension may undermine claims of prima facie infringement in Australia

• Understanding China’s new patent term extension laws

12:00pm

Obviousness-Type Double Patenting: Safeguarding Life Sciences Ownership Now and Facilitating the Success of Future Patent Applications

• Review of recent Federal Circuit cases related to obviousness-type double patenting

• Unpacking In Re Cellecte and:

» Whether PTA and PTE should be treated alike for the purposes of OTDP

» Whether it is valid for the patent office to apply OTDP rejections to expired challenged patents that had different expiration dates solely due to PTA periods.

» Examining when a terminal disclaimer can be utilized to overcome an OTDP rejection

1:00pm Networking Lunch

2:15pm

Drug Prices and Patents: Legislative and Policy Trends You Cannot Ignore

• Unpacking the Inflation Reduction Act and its influence on patent litigation and market entry strategies for both brand and generic companies.

• Responding to concerns that patent term extensions and double-patenting creates patent thickets

• Revisiting the Bayh Dole Act and march-in rights as the COVID pandemic continues

• Update on the TRIPS waiver and why the US is no longer supportive

• Tracking the expansion of the 340B Drug Pricing Program

3:30pm Networking Break

3:45pm

Skinny Labelling Claims and Safe Harbor Exemptions Around the World: Bullet-Proofing Your Patent Portfolio

The life sciences IP community has been closely following the GSK v Teva saga, with Teva planning to take the case to the U.S. Supreme Court. Until then, brand IP practitioners continue to develop strategies to argue against generic carve outs of non-patented or off-label indications, and this session will get you up to speed on the newest tactics to prevent such carve outs. Topics of discussion include:

• Reviewing recent case law to understand how courts read drug labels for evidence of intent to induce infringement and how generics attempt to carve out indications

» Using the Amarin v Hikma as a roadmap for brand companies to structure their labelling for better chances of success in future skinny labelling cases

» Will Teva serve as an example for future litigation in light of the decision in Hikma?

» Updating your Orange Book listings for the strongest protection against carve outs

• Contrasting the differences in drafting strategy when the skinny label pertains to a patent covering a new indication as opposed to a method of use.

4:45pm

The Freedom to Operate: Evaluating Current Strategies to Avoid Future Findings of Infringement

• Understanding how extensive search sequencing should be during FTO

• Evaluating the most effective process for FTO analysis

» Should it be in the hands of inhouse or outside counsel?

• Understanding patent exclusivity vs regulatory exclusivity

• Analyzing when during R&D third party patents discovered through FTO should be of concern

• Seeking out the current capabilities of FTO relating to biologic patents

5:45pm Day One Adjourns

About us: linkedin: ACI Pharma

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7:00am Registration and Breakfast

8:00am

Opening Remarks from Chairs

8:15am

Hedging your Bets Ahead of Amgen v Sanofi: Satisfying the Requirements of Enablement and Written Description for Genus Claims

The life sciences IP community waits with bated breath for the U.S. Supreme Court’s decision in Amgen v Sanofi. Whether the Supreme Court upholds the Federal Circuit’s decision or rejects it, life sciences patent prosecution strategies will transform and this session will prepare you for either outcome. Topics of discussion will include:

• Devising alternate strategies for drafting enforceable claims should the scope of appropriate claims for antibodies remain restrictive

• Creating new strategies for drafting enforceable claims should the Supreme Court reverse the federal court’s decision

• Understanding the nuances between written description and enablement

» Why did the Supreme Court decline to hear Kite v Juno?

» Updating prosecution portfolio and litigation strategy if the Supreme Court finds that written description is a fact but enablement a question of law

9:15am Networking Break

9:30am

The Elusive Subject Matter Eligibility Standard in Medtech, Machine Learning and Diagnostics: To Patent or Not to Patent?

• Addressing ownership and inventorship

» Considering Thaler’s petition for writ of certiorari to the U.S. Supreme Court following the decision in Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022)

• Learning the newest life sciences prosecution strategies for obtaining patents on medtech, machine learning, and diagnostics

» Understanding whether the goal is to protect the algorithms or conclusions made by your AI or software, compared to protecting the product developed by AI or software

» How to draft claims that comply with USPTO §101 guidance documents while also avoiding divided infringement

• Delineating which non-U.S. jurisdiction are favorable to granting patents involving AI and digital health tech

• Appreciating the advantages and disadvantages of trade secrecy as an alternative form of protection

» Learning how to make and keep a trade secret

10:30am

CRISPR, CAR T and mRNA: Scrutinizing Recent Life Sciences IP Controversies to Develop a New Way Forward

Securing life sciences rights to novel therapeutics and technologies like CRISPR, CAR T and mRNA and leveraging or licensing these rights appropriately is essential to successful commercialization, growth, and future development of these innovations. This session will review the current landmines and hurdles in biotech, and then provide an insightful exchange on obtaining and enforcing biotech patents.

• Reviewing the newest prosecution strategies for CRISPR, CAR T and mNRA therapies and products

» Emphasizing the importance of including a claim on any medical devices incorporated into the biotech invention

» Responding to novelty and subject matter eligibility rejections from the USPTO

• CRISPR licenses: update on the Broad Institute patent legal battle

» Best practices for licensing and collaborations with biotech

• Considering the biotech patent landscape in non-U.S. jurisdictions

11:30pm Networking Lunch

12:45pm

USPTO Keynote

1:15pm

What to Expect from the USPTO in 2024: Bolstering your Life Sciences Patent Prosecution and Litigation Strategies Following Recent Developments at the PTAB

• Addressing how non practicing entities may be treated as abusing the IPR process as in the cases of Patent Quality Assurance v VLSI and OpenSky v VLSI

» Assessing which conduct is at risk of being deemed abusive

• Anticipating what the Director’s discretionary powers mean for your IPR and PGR filing strategy moving forward

• Addressing the estoppel effect attached to IPR proceedings: Cal Tech v. Broadcom

• Whether the USPTO can assert prosecution latches as a defense in a civil action brought under 35 U.S.C. §145

• Update on the PTAB Reform Act of 2022 and unpacking its impact on life sciences patent and litigation strategies

2:15pm Networking Break

2:30pm

Novelty, Non-Obviousness and Inventive Step: Interpreting Recent Case Law and Improving Prosecution Strategies

• Comparing non-obviousness and inventive step differences in the U.S. versus the EU towards satisfying the both domestic and international statutory requirements

• Unpacking recent case law in the U.S. and abroad on prior art

» Addressing whether “applicant admitted prior art” can form the prior art basis for an IPR: Apple v. Qualcomm

• Developing new strategies for meeting the non-obvious and inventive step requirements

• Reviewing new and uncommon methods of conducting prior art searches

3:30pm

Ethics

MODULE:

Reformulating the Duties of Disclosure and Reasonable Inquiry in a New Era of Increased Transparency

Between FDA and USPTO

• Addressing Congress’s request for more transparency between the USPTO and the FDA

• Revisiting the duties of disclosure and reasonable inquiry

» Appreciating how inequitable conduct was found in Belcher Pharmaceuticals v. Hospira; Bruno Independent Living v. Acorn Mobility, and GS Cleantech Corp. v. Adkins Energy LLC

• Formulating new strategies for timing USPTO and FDA submissions should the proposed USPTO-FDA collaboration proceed

4:30pm Conference Concludes