By Lynn C. Tyler 
In a Federal Register Notice published in late July, the FDA scheduled a public hearing for September 4 and requested comments “on FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.” Members of our Committee attended the hearing on behalf of AIPLA and submitted draft comments for the Board’s consideration.
Previously, in a letter dated May 24, 2012, AIPLA recommended that FDA publish the date on which a biological product is or was “first licensed under subsection 351(a)” of the Public Health Service Act (PHSA), and/or the dates that are 4 years or 4 years and 6 months after such date, and the dates that are 12 years or 12 years and 6 months after such date. AIPLA further recommended that FDA publish the dates of supplementary approvals of products licensed under PHSA § 351(a) that may implicate the anti-evergreening provisions or that may affect whether a biological product licensed prior to the enactment of the BPCIA may serve as a reference product.
While the BPCIA does not mandate such publication, there is precedent in FDA’s publication of expiry dates of exclusivities in the Orange Book. FDA provides this listing of exclusivity expiry dates, even though the Hatch-Waxman Amendments to the FDCA did not mandate such publication. Likewise, FDA maintains a public, searchable database for approved and licensed products that have Orphan designations, which database includes the “Exclusivity Start Date” for each such product, even though the Orphan Drug Act did not mandate FDA to make such information about exclusivity available.
AIPLA reasoned that publishing such information would improve certainty for both reference product sponsors and subsection (k) applicants alike, and thereby foster investment and innovation. In addition, where there is disagreement or uncertainty over the exclusivity expiry dates, publication of the date of first licensure or the date exclusivities expire would provide all concerned parties the ability to resolve such disagreement or uncertainty before significant changes in position are made.
Because it had already submitted these substantive comments, in response to the current Notice the Board simply requested an opportunity to comment on any specific proposal that may arise out of the current notice and hearing:
AIPLA requests that before making changes related to the Federal Register Notice and Public Hearing, FDA consider possible implications on intellectual property rights, the patent litigation scheme provided by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and how that scheme compares with the patent litigation scheme provided by the Drug Price Competition and Patent Term Restoration Act of 1984 (referred to as the Hatch-Waxman Act). AIPLA also requests that FDA provide detailed notice of any proposed changes related to the Federal Register Notice and Public Hearing and its reasons for proposing those changes, as well as opportunity for meaningful comment from AIPLA and other stakeholders. Furthermore, taking into account the existing legislations, AIPLA further requests that the FDA undertake an analysis of the implications on intellectual property of any proposed changes that the FDA might implement, and publish the results for further public comments.
AIPLA’s 2012 comments were adopted as the Purple Book includes the date a biosimilar or biologic was licensed and whether FDA evaluated the biological product for reference product exclusivity. It also includes whether a biological product has been determined by FDA to be biosimilar to or interchangeable with a reference product.
Other parties also submitted comments in response to the most recent notice. With respect to exclusivity determinations, one party noted that FDA has yet to make an exclusivity determination for over 97 percent of products listed in the Purple Book that are eligible for exclusivity. Moreover as of August, FDA has listed first-licensure and exclusivity end dates for just five products.
Another comments suggested that FDA should update the Purple Book to clarify which products have been determined not to have exclusivity and those for which a decision is pending.
Another comment recommended the inclusion of approved indications for each biosimilar listed. The thrust of the comment was that, in cases where a biosimilar is not approved for all the same indications as the reference product, the specific indications for which it is approved should be listed to avoid any confusion.
Competing comments were submitted regarding whether or not the Purple Book should state when biosimilars have not been designated an interchangeable.
Interested parties should continue to monitor potential FDA actions related to this Notice and consider submitting their own comments and/or working through our Committee to have comments submitted on behalf of AIPLA.
 Lynn C. Tyler is a partner and registered patent attorney in the Indianapolis office of Barnes & Thornburg LLP. He concentrates his practice in intellectual property litigation and FDA counseling. He is the chair of AIPLA’s Food and Drug Law Committee.
 See 42 U.S.C. §§ 262 (k)(7) and (m)(3).
 42 U.S.C. § 262(k)(7)(C).
 Citizen Petition filed by Covington & Burling LLP on behalf of Abbott Laboratories, FDA Docket No. FDA2012-P-0317, April 2, 2012.
 Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, which is available at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.
 See, e.g., 21 U.S.C. § 355(b)(1)(A).
 Available at http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm.
 See, e.g., 21 U.S.C. § 360aa.