Congress Votes on Amending Orange and Purple Books in Effort to Encourage Generics and Biosimilars

This story has been updated.

The House of Representatives has passed pair of bills that will make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

The Orange Book Transparency Act will require that drug makers update their information with the FDA in a timely fashion; if the bill is eventually enacted, patents on small-molecule drugs that are invalidated through court litigation or by the Patent Trial and Appeal Board would have to be removed swiftly from the Orange Book, and the FDA would be required to solicit public comments on the kinds of information that should be listed.

Within a year of the bill’s enactment into law, the FDA would have to report to Congress its recommendations on the kinds of patents that should be included or removed from the Orange Book. The act also requires the General Accountability Office to analyze certain patents and evaluate to what extent listing those patents in the Orange Book impacted generic market entry.

The Congressional Budget Office has estimated that implementation of the act would cost $1 million.

The Purple Book Continuity Act will require that the Purple Book, which addresses biologics, be updated to include patent information similar in format and in requirements to what appears in the Orange Book, to disclose whether a product was deemed biosimilar or interchangeable, and to disclose whether it was considered for reference product exclusivity.

If eventually made law, the act would require the FDA to solicit public comments about the kinds of information that should be included in the Purple Book and to report on those comments within the year. It would also require that the Purple Book be available in a searchable electronic format and that it be updated every 30 days.

The CBO says that implementing the act would cost approximately $3 million by 2024.

In an interview with The Center for Biosimilars^®, Chad Landmon, JD, chair of the FDA and intellectual property practice groups at the law firm Axinn, said that the key feature that biosimilar developers hope to see in updates to the Purple Book “is having a full list of patents that may cover the innovator product or potential biosimilar product.”

Landmon explained that one of the biggest hurdles for developers today is simply locating all of the relevant patents and patent families that may be asserted to cover a biosimilar. Currently, developers use internal staff or outside counsel to search existing databases or United States Patent Trial Office records for all relevant patents, but this process is time consuming. Given the fact that some patents cover processes rather than products themselves, it may even be possible to miss an important patent. Those facts generate uncertainty for investors, who may not opt to go down the path of biosimilar development if it is unclear which patents may later be asserted.

Innovator product developers, on the other hand, are less eager to have patents listed in the Purple Book, and Landmon pointed to what he called the legitimate concern that, if they inadvertently failed to list a given patent, they may not be able to challenge infringement later.

In explaining why the Purple Book does not already include patent information in the same way that the Orange Book does, Landmon explained that “a lot goes back to how we got into the BPCIA,” or Biologics Price Competition and Innovation Act. Unlike the Hatch-Waxman Acts that govern the generic drug intellectual property landscape, the BPCIA, said Landmon, incorporates many provisions that were “pushed heavily by the innovator side.” It’s also true, he said, that when the Hatch-Waxman Acts were implemented in 1984, the regulatory milieu was far less complex.

On the Orange Book side, Landmon noted that a key feature of the act is that it provides an avenue in which to incorporate the inter partes review (IPR) process. IPRs did not exist when Hatch-Waxman was created, he noted, and this is among the first efforts to incorporate the results of IPR proceedings, insofar as they result in patent invalidation, into the Orange Book. Interestingly, this development is taking place even as there are more challenges to allowing IPRs in the pharmaceutical space. Landmon said that there has been significant pushback against allowing IPRs to be undertaken in the life sciences, so the act’s provision is notable.

As to whether the 2 bills could deliver on their stated purpose of lowering drug prices through spurring competition, Landmon said that making the Purple Book more robust could have a significant impact by helping biosimilar developers focus their efforts and make better decisions about their investment, although “it will be difficult to measure, because it’s going to play out over a number of years.”

In the days ahead, Landmon says that it will be interesting to see whether the Senate attempts to combine various pieces of legislation, such as these 2 bills, into a larger package to address drug pricing, given the apparent congressional appetite for dealing with the high cost of drugs in the United States.