Jeopardizing Drug Development with Bad Policy: How to Properly Incentivize Biopharma to Get What We Need

Jeopardizing Drug Development with Bad Policy: How to Properly Incentivize Biopharma to Get What We Need

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It is no secret that the cost for prescription drugs is more than anyone wants to pay. But is the price of newly developed, FDA approved drugs really the result of patents, or a thicket of patents? While patents are often to blame for the cost of prescription drugs, the truth is far more complicated. Indeed, the FDA approval process can literally last a decade (or more) and add hundreds of millions if not multiple billions of dollars to the costs incurred by innovator pharmaceutical companies. Notwithstanding, patents remain an easy target for those concerned with the escalating cost of medicines.

Earlier this year the United States Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) held what was dubbed “a public listening session”. The purpose of this listening session and associated request for comments was to obtain public input on areas for USPTO-FDA collaboration and engagement. Among the questions specifically asked in the Federal Register Notice was: “[W]hat other steps could the USPTO and the FDA take collaboratively to address concerns about the potential misuse of patents to improperly delay competition or to promote greater availability of generic versions of scarce drugs that are no longer covered by patents?”

On top of the Executive Branch’s regulatory attempts to attack life science patents, the recently passed Inflation Reduction Act, under the guise of “negotiation” establishes for the first time, set prices for drugs under complicated conditions.

Against this backdrop this panel will discuss:

1. Does this one-two punch of the IRA and the USPTO juggernaut help or hurt?

2. Will government bureaucracy second guessing the industry over drug pricing decisions lead to more or less innovation?

3. Should the USPTO and FDA work together to address perceived or potential misuse of patents or should it even be within their purview?

4. Is the omnipresent threat of the federal government exercising march-in-rights good for innovation?

5. Does the uncertainty surrounding government approach to pharmaceuticals lead companies to focus on live saving treatments and cures, or to focus on lifestyle drugs where international agreements would not allow for patent busting?

6. Does pharmaceutical protection last long enough for those small percentage of drugs that actually make money?

7. Are investors who provide the lifeblood for life sciences companies sufficiently incentivized to take the necessary risks with their capital?

Materials

Drug Price Controls Mean Slower Cures

Penalizing Drugs Developed from Federally Funded Inventions is a Really Bad Idea

Report Reveals Danger of Proposed Price Fixing to U.S. Biopharma Innovation

Bayh-Dole Opponents Slam-Dunked Once Again

IP VIPS Send Letter to Congress Countering Calls for Government Price Controls on Drugs

 

NOTE: Gene Quinn, President & CEO of IPWatchdog, will moderate this panel.