Paragraph IV Disputes

Take a trip to the hill with our session leaders, as they explore what a second Trump presidency could mean for policies impacting small molecule IP and the practice of Hatch-Waxman Litigation. Topics of discussion will include:

• Assessing how the change in administration may affect the pharmaceutical industry and small molecule patents
• Forecasting the probability of previous proposals reemerging
• Examining proposed PTAB reform under the PREVAIL Act
• Anticipating potential reforms to the Inflation Reduction Act’s Medicare drug pricing negotiations
• Determining how the FDA proposal to create a safe harbor for skinny labeling will impact future Hatch-Waxman litigation
• Analyzing proposals requiring the FDA to disclose more information on Q1/Q2 sameness to ANDA applicants
• Monitoring legislative attempts to eliminate ‘thickets’ of patents for the same product

In this special interview-style session, one of the pioneers of the Hatch-Waxman Act will provide insights and candid observations on how this legal framework has shaped brand and generic competition.

Drawing from his recently released book “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” Alfred Engelberg will provide a retrospective on the enactment of the law—to which he was a significant contributor–while also examining current challenges within it. Mr. Engelberg, will be joined by industry leaders for an engaging exchange of perspectives on the future of the small molecule IP landscape and shifting dynamics between brand and generics.

• Determining what is and is not shielded by the safe harbor following the Federal Circuit decision on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.
• Analyzing the broad interpretation of the term ‘solely’ for regulatory purposes and the implications for patent enforcement
• Exploring Brand and Generic perspectives on the scope of conduct covered by the safe harbor
• Examining where safe harbor defenses are holding up and where they are being defeated
• Allel Biotechnology & Pharm v. Regeneron Pharm
• Protecting third party manufacturing activities for the purposes of filing an ANDA
• Comparing the US safe harbors for drug development with other key jurisdictions

Compounding pharmacies are increasingly being viewed as a threat to IP. Innovator concerns have snowballed over the past year, resulting in claims of patent infringement and calls for regulatory action over the compounded versions of blockbuster drugs known as GLP-1s.

This session will examine key questions that have arisen in the U.S. legal and regulatory landscape including, the FDA’s role in the absence of an approval process for these drugs, and whether there is an exemption from infringement. Panel leads will also explore global considerations, and how the prevalence of these practices will impact brand and generic manufacturers moving forward.

The FTC has applied significant pressure on branded pharmaceutical companies to remove what it alleges are “junk” patent listings from the Orange Book. The FTC claims wrongfully listed patents can drive up prices by undermining fair competition. In the past few years brand name drug makers have received letters from the agency urging them to delist hundreds of specific patents, many of which are drug device combinations.

These challenges are starting to gain traction in the US District courts. Most recently the District Court of New Jersey ordered Teva to delist five patents in the Orange Book.

• Making sense of the the rise of FTC scrutiny of Orange Book patents
• Identifying the type of patents the FTC alleges are “improperly” listed
• Evaluating patent portfolios for potential FTC targets
• Assessing the consequences of withdrawing, amending the patent listing, or leaving it unchanged
• Anticipating potential litigation stemming from the FTC’s calls to delist certain patents
• Forecasting future guidance on how to comply with Orange Book listing requirements from the FDA
• Preparing for delisting as a strategy in the district courts following the decision in the Teva v. Amneal case

The Inflation Reduction Act hangs in the balance, and with it, the future of the drug pricing negotiation framework for Medicare. For innovator companies the IRA presents a threat to profits and future R&D in the life sciences industry. It is unclear if the new administration will repeal the IRA, partially or in full, as well as what reforms will be presented in the year ahead.

• Monitoring constitutional challenges and summary motions in different courts
• Examining safe harbor exemptions from the IRA negotiations
• Assessing the impact on the life sciences industry and the patents being pursued
• Anticipating the impact on clinical trial dates, (orphan) indications
• Considering how this will influence investments in small molecules drugs to move to the development of biologics
• Developing strategies to mitigate the impact of drug pricing negotiations
• How IRA implementation impacts business cases and settlements
• Modelling when the projected revenue threshold will be hit to trigger negotiations
• What happens when you are in Paragraph IV litigation when the drug is selected for IRA negotiations
• Brand and generic perspective on how this will influence litigation strategies and settlements that are expected before the negotiations
• Analyzing investment risks for the generics market in the absence of a set price

In Sanho Corp. V. Kaijet Technology International Ltd., the Federal Circuit affirmed a PTAB finding that an inventor’s private but non-confidential sale does not qualify for a prior art exception under §102. Sanho raised the Supreme Court case Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., where the finding was that a private sale could be a public disclosure. This session will delve into complexities of navigating disclosures and prior art exceptions as highlighted by these cases.

This closed-door session is being offered to in-house counsel from brand and generic pharmaceutical companies only and will be limited to 20 participants.

Network, benchmark and discuss emerging concerns for industry with members of ACI’s Hatch-Waxman Advisory Board. This year’s discussion will provide an opportunity to share insights on the evolution of the small molecule IP landscape, and early developments in this brave new world. Participants are encouraged to submit specific topics for discussion in advance.

To secure your seat, contact Sara Cain at [email protected]

• Strengthening internal collaboration and communication to help navigate IP decisions and support Hatch-Waxman litigation down the line
• Enabling effective collaboration between R&D, clinical, IP with in house and outside counsel to capture, launch and protect innovation
• Exploring perspectives on securing and asserting secondary patents amid heightened scrutiny of ‘patent thickets’
• Factoring public perception about the commercial success of brand pharmaceutical companies into how you present your case

• Exploring perspectives on how generic companies can ensure portfolio sustainability
• Examining where generics are expanding to remain profitable
• Assessing how traditionally generic companies are managing new identities as they move into the branded and large molecule market through acquisitions
• Anticipating the potential for more litigation as companies evolve
• Examining how serial assertion of patents by brand pharma following the initial Paragraph IV litigation impacts generic decisions product launch and resources