February 8, 2023


Move Step By Step

Push-Down on Drug Patents and Drug Pricing

2 min read

by Dennis Crouch

Over the previous a number of months, the USPTO and FDA have been collaborating with the aim of selling competitors and decrease drug costs within the US.   This week (Jan 19), the USPTO is holding a 7-hour joint listening session hosted by USPTO Director Kathy Vidal and FDA Commissioner Robert Califf.  [Register and see the Agenda here]

The session has three key substantive areas:

  1. The extent and affect of pharmaceutical and biotech corporations appearing in a two-faced method: Arguing to the USPTO that their remedies signify main adjustments from what was beforehand carried out (and thus patentable); whereas concurrently arguing to the FDA that then later arguing that these similar remedies are fairly comparable to what’s already in the marketplace (and thus protected to be used).
  2. The extent that pharmaceutical and biotech corporations are improperly gaming the patent system after which utilizing these video games to justify robust protections beneath Hatch-Waxman and the BPCIA.
  3. How can the Orange Ebook course of be improved to guard innovation whereas concurrently bettering competitors?  Prof. Jay Thomas’s remarks listed here are on level: “Regardless of their [extraordinary] affect, Orange Ebook patent listings obtain no FDA oversight.”  PTO-P-2022-0037-0010.

The thrust of this complete gambit from the administration degree is to cut back drug costs.  However, as soon as we drop right down to the PTO/FDA degree, the shut business relationship suggests to me that company officers shall be keenly conscious of the potential detrimental impacts of any motion on pharma innovation.

The important thing leadoff speaker is Hastings Legislation Professor Robin Feldman whose work argues that the system is damaged in myriad methods.  George Mason Prof. Adam Mossoff will present a high-level counterargument, and a number of other others will speak by way of problems. Particularly, I at all times study loads listening to from Corey Salsberg (Novartis), Sean Tu (WVU), and Jay Thomas (G-City)

Whereas it is a joint occasion, each companies (together with a number of different federal companies) are additionally working unilaterally to handle the excessive price of healthcare in America.  Particularly, the FTC/DOJ are utilizing antitrust instruments to push in opposition to monopoly-level pricing even for drug merchandise whose use is protected by patents.

Though no direct motion gadgets are anticipated to return out of this occasion,  I see all of this as fairly a giant deal as the varied gamers work to determine their narrative.



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