Paragraph IV Disputes

Connect over coffee and a light breakfast at this pre-conference think tank for in-house counsel. This closed-door meeting will be by invitation only. Led by members of ACI’s Hatch-Waxman Advisory Board, and senior counsel from leading brand and generic pharmaceutical companies, this breakfast presents a unique opportunity to benchmark with other in-house legal teams and fine-tune strategies on the 3Cs. Attendance is limited to 15 in-house counsel attendees.

To apply: Details to come

• “Cost”: Insights on monitoring legal spend and balancing a budget
• “Competency”: Best practices for overcoming talent limitations with demonstrable advice
• “Communication”: Engaging attendees in the art of communicating value and fostering collaboration between corporate legal counsel and outside

In recognition of the 40th Anniversary of the Hatch Waxman Act, this session will analyze the current state of play for small molecule patents, Paragraph IV litigation, and pending political threats to industry. Panelists will examine shifts in the small molecule market. This will be followed by a discussion on the levers and tools being used by the Biden Administration to lower drug prices. Delve into the strategic presuit considerations and anticipate the future use of these methods after the November 2024 election.

Part I: Special Focus on Loper Bright Enterprises v. Raimondo

• Analyzing how the Loper Bright decision will affect federal agencies and the application of statutes impacting the life sciences industry
• FDA
• FTC
• USPTO
• Anticipating future litigation challenging federal agency interpretations of statutes
• Devising IP strategies in a landscape where federal agencies are no longer shielded by the Chevron Deference Doctrine

Part II: IRA, Orange Book Delistings, Bayh Doyle Act

• Analyzing trends in small molecule patent filings and Paragraph IV litigation
• Assessing the extent to which innovator companies are shifting the focus of the business to biologics/biosimilars
• Scaling the next ledge of the patent cliff with market erosion expected through 2030
• Pending legislation influencing pharmaceutical patent rights
• PREVAIL
• PERA
• BIOSECURE Act
• Understanding how the presidential invocation of Bayh Doyle march-in rights, FTC’s delisting strategy, and IRA form a trifecta attack on pharmaceutical patents
• Assessing what this means for the future of Hatch Waxman
• Monitoring ongoing legal challenges over the constitutionality of the Inflation Reduction Act
• Assessing the potential impact of drug pricing negotiations under the IRA on IP patent litigation
• Negotiating settlements prior to the IRA process
• Evaluating the impact on innovation and the pursuit of additional orphan indications
• Examining draft guidance on prerequisites to exercise March-in rights on “high-priced” federally funded drugs

Cellect has filed a petition for certiorari with the Supreme Court following a district court decision that held that statutory patent term adjustment could be invalidated on ODP grounds through earlier expiring patents. The petition for en banc rehearing was denied. The Supreme Court will now consider whether to grapple with the question of the ODP doctrine and its ability to override the congressional guarantee of PTA. This session will parse the Cellect case, and the implications for patent portfolios moving forward.

• Analyzing the impact of the Federal Circuit’s holding in recent Hatch-Waxman cases
• Comparing Allergan case to In re Cellect
• Using the In re Cellect decision to audit patent portfolios for ODP concerns
• Navigating loss of exclusivity for a product
• Devising strategies in drafting claims for first filed and subsequent continuation applications to avoid OTDP concerns
• Adapting approaches to patent prosecution and litigation

Innovators are flagging concerns over clinical trials being used against them as prior art in the district courts and IPR. In Salix Pharms., Ltd. v. Norwich Pharms. Inc., the federal circuit upheld a district court decision to invalidate method of treatment claims for obviousness, making it an important time to discuss best practices for managing disclosures and protecting IP.

• Distinguishing between publication of clinical trials and how that creates publication-based prior art; and whether the clinical trial itself is public-use prior art
• Determining whether patient confidentiality and other confidentiality agreements amongst clinical investigators eliminates the public use prong of prior art
• Examining how generics are using clinical trial summaries as evidence of obviousness to challenge patents through IPR and the district courts
• Understanding how patent examiners view clinical trials published on ClinicalTrials.gov
• Reconciling IP protection with FDA disclosure rules for clinical trials
• Devising filing strategies to maximize patent term while managing risk of invalidation
• Considerations for dosing regimen patents
• Reviewing the Federal Circuit’s analysis of:
• Janssen v. Teva, Salix v. Norwich Pharms. Inc., Vanda Pharms. Inc. v. Teva Pharms. USA Inc.
• Determining if an ongoing clinical trial can be connected to a reasonable expectation of success in the unpredictable arts

This panel will delve into the inner workings of two vitally important in-house legal functions and the importance of the relationship between the two. Join Chief IP Counsel and General Counsel from both brand and generic manufacturers for a discussion on how they work together to enforce IP, develop strategy, and navigate an increasingly unpredictable political landscape, alongside Hatch-Waxman concerns. Panelists will also share dos, don’ts, and other key considerations for outside counsel.

• Exploring the critical relationship between General Counsel and Chief IP Counsel: brand and generic perspectives
• Identifying in-house criteria for selecting outside counsel
• Understanding how to provide value to in-house and build better relationships
• Overcoming litigation funding challenges
• In-house best practices for managing budgets in different litigation scenarios
• Exploring alternative fee arrangements
• Examining brand and generic considerations for Hatch-Waxman settlements

• Analyzing how the district courts are applying directives from the Supreme Court ruling on Amgen v. Sanofi
• Developing strategies to make use of the full scope of the invention without creating exposure
• Generic insights on how this influences future patents being targeted under PIV
• Satisfying the enablement standard
• Determining whether to use functional claiming in view of the Supreme Court ruling
• Recent USPTO guidance on means plus function claiming
• Navigating the interplay between written description and enablement when drafting claims

Less than a year after the U.S. Supreme Court Decision on Amgen v. Sanofi, comes a similar result at the UPC. The Munich Central Division ruled that Amgen’s patent for a cholesterol-lowering drug is not valid, marking a successful challenge for both Sanofi and Regeneron. This session will offer a continuation of our conversation §112 concerns and how to approach written description and enablement in other jurisdictions. Hold the UPC’s analysis up against the US Supreme Court decision and reconcile strategies for global portfolios.

• Comparing the UPC decision with the U.S. Supreme Court’s findings
• Examining the concept of plausibility vis-a-vis enablement
• Understanding how the UPC’s final ruling may affect your global small molecule patent strategies
• Brand and generic outlook

In this special presentation, a distinguished panel of Magistrate Judges will offer perspectives on Paragraph IV litigation docket s as well as decision making practices. This ‘views from the bench’ panel will provide practical insights for both patent holders and patent challengers.

India is the world’s generic drug capital, and no stranger to the US Hatch Waxman schematic. This session will address how changes in IP law as well as supply chain dynamics in the developing world and API procurement are matters of concern, not only for generics, but for brands as well.

• Assessing the potential for US brand companies to seek injunctive relief in Indian Courts to block the manufacture/export of ANDA products to the USA
• Examining how recent changes to the MADE In America Act may now permit Indian companies to make constituent or whole products in India that can be sold to the US government
• Analyzing the impact of FDA inspections on the manufacture and export to the US market
• Forecasting potential post-election action on pharmaceutical API and the manufacturing of pharmaceutical products
• Using litigation in India and other jurisdictions to inform US strategies