Biosimilars Approvals in the US: The Path Forward - An in-depth analysis of the patent provisions of the new legislation. - BioPharm International


Biosimilars Approvals in the US: The Path Forward
An in-depth analysis of the patent provisions of the new legislation.

BioPharm International
Volume 23, Issue 9

Patent Disputes

Such choices generally have always been available to traditional BLA sponsors in connection with hundreds of patent disputes that have arisen among traditional BLA sponsors and between those sponsors and other patent holders. A fair number of those disputes have been settled or resolved through alternative-dispute-resolution mechanisms like arbitration, while others have resulted in published opinions. The latter category can be quite useful in elucidating the newly created disparity in patent-enforcement regimes across biologics sponsors.

For example, there is the "other" Avonex litigation, the patent lawsuit amongst Biogen, Schering Corporation, and Berlex. While Biogen's BLA was pending at the FDA, the agency and Biogen focused on BLA review and approval, and patent litigation ensued at the end of that review.5 Although Biogen ultimately prevailed on its non-infringement claim, it is worthwhile to consider whether the outcome might have been altered if, when the FDA accepted Biogen's BLA, Biogen had been statutorily compelled—without any discovery request, without any ability to meaningfully object, and without any court oversight—to turn over its complete BLA and its entire manufacturing process. Similarly, when Schering Corporation and Biogen were joined in patent litigation against Amgen on a Biogen patent licensed to Schering Corporation, that suit was initiated after the BLA (now held by Intermune) for Amgen's Infergen (interferon alfacon-1) was approved by the FDA.6 Amgen ultimately prevailed, but it is not unreasonable to ponder how the course of that case might have been affected if Amgen had been statutorily compelled to disclose its trade secrets in its BLA and manufacturing process at the time of BLA filing. Equally worth considering is the patent litigation that Genentech filed against Boehringer Mannheim after the FDA approved a new thrombolytic to compete against Genentech's Activase.7 Although the various reteplase infringement lawsuits ultimately were resolved under unique circumstances (after Roche acquired Boehringer Mannheim, sold US marketing rights to Retavase to Centocor, and then joined Genentech's board),8 it undoubtedly would have been a fascinating situation if Boehringer Mannheim had been required preapproval and immediately post-filing to turn over its entire BLA and complete manufacturing process to Genentech.

The prospect of statutorily compelled precomplaint discovery linked to the FDA regulatory review process is merely a hypothetical prospect in these historical cases, and the question of its impact is by definition rhetorical. Nonetheless, given the patent estates and biologics at issue, these cases can be informative case studies for visualizing the impact of such a preapproval patent-resolution process. That process and its unprecedented draconian penalties are the new norm for patent disputes involving biosimilars.

The inclusion of these patent provisions creates the single greatest hurdle to the realization of the potential that otherwise would be achievable through the regulatory pathway Congress enacted. They are deterring, and probably will continue to discourage, any number of biosimilar applications that could meet the requirements of the new regulatory pathway but that either will be submitted as BLAs or simply will be abandoned. For as long as such perverse outcomes persist, the competitive impact of biosimilars will not be fully realized. The biopharmaceutical industry will not be fully subjected to the market-based competition that can both enhance access to lower cost high-quality biologics and also motivate R&D of the next generation of biologics. Moreover, the US healthcare system as a whole—which was the focal point of the broader law in which the BPCIA was enacted—will not benefit from the savings that otherwise could be achieved. As Europe has demonstrated, biosimilars that are equally as safe and effective as their originator counterparts are producing substantial savings. In the current economic climate, there is an imperative for the US to achieve that same economic outcome and the public health benefit of expanded access to biologics. It can be accomplished through a straightforward fix that, for patent-enforcement purposes, reverts to the status quo ante, eliminates patents from the PHSA entirely, and puts all BLA sponsors on the same footing.

The views presented in this article solely represent the author's personal opinions and do not constitute the views of his law firm or any of its clients.

John M. Engel is the managing partner at Engel & Novitt, LLP, Washington, DC, 202.207.3303,

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