A Look At Abbott's Citizen Petition Against The Biologics Price Competition And Innovation Act

28 June 2012 PharmaPatents Blog

I am pleased to introduce Taylor Corbitt as a new author for PharmaPatentsBlog. Taylor is an associate in our Chemical, Biotechnology & Pharmaceutical Practice and works out of our Chicago office. ~Courtenay Brinckerhoff

When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the “Biologics Act”) may have breathed a sigh of relief. However, the Biologics Act is not out of the woods, because Abbott recently filed a Citizen Petition with the FDA, seeking to block its implementation of the law as unconstitutional.

The Biologics Act

The Biologics Act creates a path to market entry for biological products that is similar to (but substantially different from) the path provided to small molecule drugs by the Drug Price Competition and Patent Term Restoration Act of 1984 (generally known as the “Hatch-Waxman Act”). (A copy of the law is available through the FDA’s Biosimilars webpage.) Key differences in the regulatory approval provisions of the Biologics Act reflect the complex nature of biologics and the safety and efficacy concerns surrounding biological products that may not be chemically identical to the approved reference product.  The Biologics Act also has a completely different mechanism for treating patent issues than those set forth in the Hatch-Waxman Act. (This article provides a more detailed discussion of the Biologics Act.)

Like the Hatch-Waxman Act, the Biosimilars Act arose from a desire to facilitate market entry of lower-cost “generic” versions of biological drugs.  For example, at the Biosimilars 2007 Conference, Representative Henry Waxman remarked that “biotech drugs are the future of medicine.” In 2006, the last year for which data is available, biotech sales grew by 20% to $40.3 billion, while sales of traditional, small molecule pharmaceuticals increased by only 8%. With skyrocketing pharmaceutical costs and increased consumer demand, lower-cost alternatives are understandably a priority. However, the demand for “generic” versions of biologics must not take precedence over the need to ensure the safety and efficacy of approved pharmaceutical products and must be balanced against the need for sufficient market exclusivity for innovator products to incentivize continued research and development.

The Biologics Act attempts to balance these competing interests by providing timeframes of exclusivity to innovator (reference) biologic drug products. For example, an application for FDA approval of a biosimilar product can be filed four years after approval of the reference product, but the application may not be approved until 12 years after approval of the reference product. (Approval of a biosimilar may be further delayed if patent infringement claims are still pending.)

Abbott’s Citizen Petition

Abbott Laboratories filed a Citizen Petition with the FDA on April 2, 2012, asserting that if the FDA approves a biosimilar of its Humira® product under the Biologics Act, the agency will be engaging in an unconstitutional taking of the company’s intellectual property. Specifically, Abbott argues that much of the analytical, preclinical, clinical, and manufacturing data and information from Abbott’s extensive testing and development of Humira® is eligible for trade secret protection and may not be relied upon by the FDA to support a biosimilar application of a third party. Abbott asks that the FDA not consider any application that cites Humira® as a reference product. (Abbott’s main patent on Humira® is set to expire in December 2016).

Abbott’s petition follows that of Genentech filed in 2004. Genentech asserted that the agency should not even issue a guidance document relating to the data requirements for biosimilar applications, since such guidance would benefit from knowledge gleaned from patentees such as Genentech. The FDA ultimately denied the Genentech petition, stating that the guidance did not “violate any protections available to applicants by relying, either ‘directly or indirectly,’ on Genentech’s or any other entity’s confidential information. . . [,] [did] not disclose any trade secret or confidential information, and [that] FDA did not impermissibly use or rely upon any such information in developing them.” (See this article for an overview of the FDA’s draft guidance document.) Abbott’s petition raises a harder question, because a biosimilar application would, by definition, rely upon the data supplied by the reference sponsor.

A Long Road Ahead

It is likely that the issues raised in Abbott’s Citizen Petition ultimately will have to be decided by the courts. The final outcome could impact the viability of the biosimilar framework, and have far-reaching effects on the biotechnology industry, as well as on healthcare costs and patient care.  As the U.S. struggles with these issues, it is interesting to watch how they have played out in other countries. For example, the European Union’s EMA has had a biosimilar approval process since 2003, and fourteen biosimilar products have been approved to date. While parties on either side of the Patient Protection and Affordable Care Act debate whether we should have a European-style healthcare system, parties on either side of the Biologics Act may debate whether we should have an EMA-type biosimilars system.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services


Ten Minute Interview: M&A Challenges & Opportunities
23 November 2022
Sujata “Sue” Sachdeva and Koss Corp.
23 November 2022
Cannabis Company Cops to SEC Accounting Fraud Charges
22 November 2022
Legal News: Cannabis Industry
Foley Automotive Report
22 November 2022
Dashboard Insights
CLE Weeks
5-16 December 2022
Milwaukee, WI
Foley Sponsors Ernst & Young Entrepreneur of the Year® Program
1 December 2021 - 30 November 2022
Michigan and Northwest Ohio Region
2022 Distressed Investing Conference
28 November 2022
New York, NY
Meet and Greet and Panel Discussion with E. Martin Estrada and Cuauhtemoc Ortega
28 November 2022
Los Angeles, CA