Using Data Exclusivity Grants to Incentivize Cumulative Innovation of Biologics' Manufacturing Processes

By Levi, Eric Lawrence | American University Law Review, January 1, 2017 | Go to article overview

Using Data Exclusivity Grants to Incentivize Cumulative Innovation of Biologics' Manufacturing Processes


Levi, Eric Lawrence, American University Law Review


"We try to remember that medicine is for the patient. We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been."

-George W. Merck1

Introduction

Medical innovation continues to skyrocket, giving us artificial hearts, medical imaging software, advanced prosthetics controllable with the mind, and pharmacological cures for a plethora of dangerous diseases.2 Notwithstanding our great strides to curtail certain genetic and biologic maladies, cancer and rare diseases in their various forms continue to proliferate.3 Legislators and regulators thus seek to incentivize this type of dramatic innovation while controlling patient costs and ensuring access to medicines.

This Comment attempts to explain and offer solutions for how patent and drug regulatory law address-or fail to address- commercialization and manufacturing inefficiencies when there are high barriers to biopharmaceutical product entry, particularly in the context of biologics. By working in tandem, patent law and drug regulations signal to the next generation of scientists, manufacturers, regulators, and business leaders where innovation and investment are lacking, encouraging smart innovation and investment. Designing biological products requires extensive investment and up-front development costs; similarly, biologics manufacturers require more process control compared to their small-molecule counterparts.

Therefore, so that manufacturers produce cheaper, safer, and more effective biologic and biosimilar cancer and rare-disease therapies (a.k.a. biobetters),4 Congress should provide greater incentive for manufacturing process innovation, disclosure, and societal health impact projections than those currently offered by the Biologics Price Competition and Innovation Act (BPCIA).5 Because small changes in biologics manufacturing processes require extensive comparability testing,6 manufacturers focus on comparing and mimicking biological products within tight preexisting constraints rather than developing and proving societal health benefits ancillary to manufacturing innovation.7 These alternative processes can result in anything from clinically tested child dosing regimens8 to brandnew therapeutic uses,9 illustrating how manufacturing processes can deliver return on investment (ROI) or fail to recoup costs. But innovators currently lack adequate incentives to develop and protect subsequent biologic manufacturing process improvements because the data and market exclusivity periods set forth in 42 U.S.C. § 262 are insufficient for an originator biologic manufacturer to (1) recoup its initial investment and (2) develop, test, and patent biobetter processes. By examining and correcting these deficiencies, and by offering a more flexible regulatory scheme rather than a one-size-fitsall paradigm, the signaling and notice functions inherent in patent and drug regulatory law will guide the next generation of innovators and corporations toward smarter investing in the biologics manufacturing improvements that best improve societal health.

Biologics manufacturing processes create unique opportunities for sponsors and manufacturers to leverage existing patent rights and obtain justified exclusivity while enhancing societal health. To best allow manufacturers to take advantage of these opportunities, legislative corrections must be made whereby the governmental grant of exclusivity built into the BPCIA would require showing projected societal health impact. Additionally, the societal impact should correspond with a tiered market exclusivity system such that manufacturers maintain the incentive to conduct further research and development (R&D) on existing rights while pursuing opportune protection of any supplemental high-quality innovation. The recent decision in Amgen Inc. v. …

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