In 2017, the Biologics Price Competition and Innovation Act (BPCIA) may be affected by a partial or complete repeal, or a revision, of the Affordable Care Act (ACA). The BPCIA is a set of laws enacted in March 2010 that became Title VII of the ACA. The Trump administration has indicated that it is interested in repealing parts of the ACA; however, it is unknown whether there is a plan to replace the regulatory pathway and litigation framework that underlies the BPCIA. Therefore, it is highly unlikely that patent attorneys will immediately change how they pursue approval for biochem patents, negotiate settlements, and engage in litigation.
The BPCIA allows a shortened approval path for biologics, medicines made from living cells. The process is called abbreviated Biologics Licensing Applications, or aBLAs. The BPCIA also affects litigation regarding biosimilars, biological products that are interchangeable with FDA-licensed biological products. The BPCIA requires a maker of a biosimilar and the company that created the original biologic to engage in pre-suit exchanges of information. These exchanges, called the “patent dance,” begin with the biosimilar maker providing the regulatory application and manufacturing information to the biologic maker. These documents allow the biologic maker to determine whether the biosimilar maker has infringed upon the biologic maker’s patent and, thereby laying the groundwork to sue.
The American Bar Association supports the idea of the patent dance. The organization takes the position that the dance benefits both parties before the drugs have reached the market. Court rulings have clarified vague and ambiguous parts of the BPCIA. For example, in early July 2016, the U.S. Court of Appeals for the Federal Circuit held that a biosimilar maker must provide the biologic maker with 180 days’ notice before the biosimilar maker begins to commercially market the biosimilar.
The number of lawsuits regarding biologics and biosimilars is set to increase in 2018 and 2019. It is unclear how the BPCIA will affect intellectual property rights going forward. Many portions of the BPCIA are being challenged in court.
For example, the U.S. Supreme Court is determining whether it will grant certiorari in Amgen Inc. v. Sandoz Inc. A ruling would determine whether the patent dance is mandatory or optional. SCOTUS invited the Solicitor General to file a brief in the lawsuit to express the opinion of the United States. The Solicitor General’s brief recommended cert be granted, which is a strong suggestion that SCOTUS will take up the case. The Solicitor General also disagreed with the 180-day notice set forth by the Federal Circuit. If the Court does take up the case, issues are expected to be briefed by early 2017 followed by arguments in April and a decision anticipated by June.
In addition, it is unclear whether Congress will pass legislation to reduce the period of exclusivity for biologics. Currently, the FDA will not approve a biosimilar’s application for 12 years after a biologic has been licensed.
Another question is what role the FDA will play in issuing guidance on patient safety issues for biosimilars. At this point, the FDA has not issued a great amount of guidance to ensure that biosimilars are safe and effective. The FDA has also not developed standards for labeling biosimilars. Further, it has not explained circumstances in which biosimilars can be considered interchangeable with biologics. If the FDA is able to clarify such information, this may assist parties to resolve patent issues without litigation. Federal guidance should lead to more understanding and less conflict.
Following how the BPCIA will change biochem patent litigation requires tracking multiple lawsuits, federal legislation regarding the BPCIA, and the FDA’s progress in the outgoing and incoming administrations. Keep a close watch on media that covers all of these matters. Doing so will help you stay informed and aware of how the BPCIA will affect you or your portfolio.