Tag: Purple Book

Senate Bill on Patents Could Turn the Purple Book Into Something More Useful

The Biologic Patent Transparency Act (BPTA), a Senate bill introduced by Senator Susan Collins (R-ME) in March, is an independent, bipartisan attempt to address patent thickets. It does so largely by clarifying an individual biologic product’s patent situation. In achieving this, it can also create a real reason for the existence of the Purple Book.

Biologic Patent Transparency Act

Today, the Purple Book is nothing more than a listing of biologic agents, their original FDA filing dates, and whether there are any biosimilars of the originator biologic. It provides very few dates when a biologic’s exclusivity period ends. One day, it may list whether a biosimilar is interchangeable with a reference drug, but there are no designated interchangeable biosimilars today (and that seems to be the case in the near future, at least).

Under the Senate BPTA proposal, the originator manufacturer must disclose all relevant patents to the Secretary of Health and Human Services. It states that “…a ‘patent required to be disclosed’ is any patent for which the holder of a biological product license approved under subsection [351](a) or (k), or a biological product application approved under section 505 of the Federal Food, Drug, and Cosmetic Act and deemed to be a license for a biological product under this section on March 23, 2020, believes a claim of patent infringement could reasonably be asserted by the holder, or by a patent owner that has granted an exclusive license to the holder with respect to the biological product that is the subject of such license…” We assume that the patent lists will be provided via the Purple Book, which is supposed to be a reference for prospective biosimilar manufacturers.

The BPTA strives to make the patents held by a manufacturer as transparent as possible. It would require drug makers to list exclusivity periods or any exclusivity extensions received, information related to interchangeability or biosimilarity of a product, approved indications, and mandates updates every 30 days. Of course, this language does not prohibit, restrict, or redress any existing patents. Any changes in the patent law is not the addressed in this proposal.

The seven bill cosponsors (as of May 2, 2019) include a group as diverse as Tim Kaine (D-VA) to Rand Paul (R-KY).

In other biosimilar news…Sandoz announced a partnership with Taiwan-based EirGenix to commercialize the latter’s investigational trastuzumab biosimilar. This agent is currently in phase III trials. Under terms of the agreement, Sandoz will market the agent globally, except for China and Taiwan.

FDA Purple Book: Much Potential Value, Little Current Help

Under the BPCIA, the FDA Purple Book is the published agency reference on biosimilars. It lists very specific information with regard to both the reference biologics and biosimilars: (1) biologic licensing application number, (2) nonproprietary name, (3) proprietary name (brand name), (4) date of licensure, (4) reference product exclusivity expiration, and (5) whether the product is a biosimilar or interchangeable product.

FDA Purple BookHowever, the number of patents existing on a specific reference product and the complex nature of the web of exclusivities, has compelled several speakers at a September 4, 2018 public hearing on biosimilars to question the value of the current Purple Book information.

FDA Purple Book
Mariana Socal

At the FDA-sponsored hearing, Mariana Socal, MD, PhD, MS, MPP, from the Johns Hopkins Bloomberg School of Public Health, stated that the FDA Purple Book should focus more on competition, “providing both proprietary and nonproprietary information.” She believes that “the drug identification information should be expanded,” to include administration, dosage form, strength, pediatric use, and orphan drug status. She would rather the FDA Purple Book publish much more information regarding the active ingredient, “and all unexpired exclusivity periods should be published in the Purple Book.” For those patents found to be eliglible, the 12-year reference exclusivity under BPCIA should be determined and published definitively in the Purple Book.

“The Purple Book should include information on all unexpired patents that the reference manufacturers reasonably believe protects their biologic product,” said Dr. Socal. Otherwise, it forces prospective biosimilar drug makers to sift through hundreds of complex pharmaceutical patents, “making it easy to miss a key patent.”

“The FDA is authorized to do this under the Public Health Service Act,” she stated. Increasing transparency and reducing uncertainty are building blocks of the effort to improve timeliness of access to biosimilars.

According to Dr. Socal and other speakers like Michelle Cope at the National Association of Chain Drug Stores and Christine Simmon at The Biosimilar Council, the implication is that the FDA Purple Book needs to be more of an assistive tool to improving access to biosimilars rather than simply a reference on what has been approved.