Orange Book Transparency Act/Purple Book Continuity Act: Shifting the Balance for Generics and Biosimilars

Thirty-seven years after enactment of the Hatch Waxman Act 2, it remains difficult for Congress, and the drug supply chain industry to strike the appropriate balance of legal rights between brand name and generic drug manufacturers as it relates to patent protection versus encouraging generic drug entry. 3  Similarly, eleven years after enactment of the Biologics Price Competition and Innovation Act (BPCIA), 4 patent abuse issues have stifled biosimilar competition with some estimating $7.6 billion in lost savings. 5 Generics and biosimilars are less expensive than brand counterparts and help reduce total drug spend. This article discusses two new laws affecting the intersection of Hatch Waxman and the BPCIA with Orange and Purple book patent listing.
   
New Rules for Patent Listing
   
In January 2021, two laws were enacted to update the patent listing requirements for generic drugs in the Orange Book 6 (The Orange Book Transparency Act) (H.R. 1503) and biologics in the Purple Book (The Purple Book Continuity Act) (H.R. 1520).  The intent of these laws is to standardize patent listing in the Orange and Purple Book databases on the Food and Drug Administration (FDA) website and prevent future patent listing errors that delay generic drug and biosimilar approvals. One major beneficial provision of the new law is that patents that have been invalidated by a court decision or a ruling of the Patent Trial and Appeal Board will need to be removed promptly from the Orange Book.  Removal of these patents paves the way for generic approval.  Correspondingly, the Purple Book Act codifies and clarifies the requirements for listing of patents of approved biological products, similarly to the Orange Book. Patents for unapproved uses will not be permitted to be listed.
   
Situation Prior to the New Rules
   
Orange Book patent listing provides a 30 month stay of FDA approval of any generic version via an Abbreviated New Drug Application (ANDA). Listing by brand manufacturers of certain patents (e.g. drug delivery devices) has blocked generic drug competition, ultimately costing patients to pay a higher copayment or co-insurance who, for example, are prescribed insulin pens.  Such patients are not given the benefit of cheaper devices because of patent protection. The new law set out to clarify the timing of ANDAs.  
   
The old set of laws unwittingly encouraged delay in the development of generics, for fear of patent infringement.  Prior to these laws, brand drug patents were listed in the Orange Book solely on the drug manufacturer’s representation to FDA, with FDA merely acting in a ministerial role in overseeing the listing of such patents. Under the new law NDA holders must notify the FDA within 14 days of a Patent and Trademark Appeal Board (PTAB) or court decision cancelling or invalidating any claim of the listed patent. FDA will then promptly remove that patent from the Orange Book.
   
The new Orange and Purple Book Laws are helping to facilitate generic drug and biosimilar entry, shifting the balance of Hatch Waxman for the generic drug industry, and removing impediments to biosimilar development.
 
Pursuant to the Orange Book Transparency Act, the FDA will be required to solicit public comments as to which patents should be listed and how such listing will affect generic drug entry to the market. This is a great opportunity for generic drug manufacturers to document how inappropriate patent listings have harmed generic drug approvals which ultimately harms patients, Plan Sponsors and increased the cost of healthcare.
 
How Frier Levitt Can Help
 
Frier Levitt’s team of FDA, Intellectual Property and Regulatory attorneys collectively have over forty years of Hatch Waxman experience and represent both small generic and start-up pharmaceutical/medical device companies. Our services range from Paragraph IV work to patent invalidity opinions. Contact us to speak to our legal team today.
 
 
2
 P.L. 98-417. Sept. 24, 1984.
3
 Rumore MM. The Hatch Waxman Act- 25 Years Later: Keeping the Pharmaceutical Scales Balanced. Pharmacy Times. 2009. https://www.pharmacytimes.com/publications/supplement/2009/GenericSupplement0809/Generic-HatchWaxman-0809.
4
 42 U.S. Code Sec. 262.
5
 Biosimilars Council. Failure to Launch. Patent Abuse Blocks Access to Biosimilar’s for America’s Patients. June 2019.
6
 Also known as Approved Drug Products With Therapeutic Equivalence Evaluations.
 
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