On September 10, 2021, Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. Patent and Trademark Office (USPTO), which raised several of FDA’s concerns relating to patents and competition in the pharmaceutical marketplace (“Letter”). The Letter called upon the agencies’ cooperation to address FDA’s patent-related concerns, specifying three practices by which FDA asserts pharmaceutical patentees may abuse the patent process to block or inhibit competing products.
The Letter was drafted pursuant to Executive Order 14036 (“Order”) aimed at “Promoting Competition in the American Economy.”1 The Order affirmed the policy of President Biden’s administration “to enforce the antitrust laws to combat the excessive concentration of industry, the abuses of market power, and the harmful effects of monopoly and monopsony…”2 In particular, the Order alleged that patent and other laws have been “misused to inhibit or delay – for years and even decades – competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”3 Accordingly, the Order called upon the Acting FDA Commissioner to provide, in a letter to the Director of the USPTO, “any relevant concerns of the FDA” that would “help ensure that the patent system, while incentivizing innovation, does not also unjustifiably delay generic drug and biosimilar competition beyond that reasonably contemplated by applicable law.”4
While FDA’s proposals and conclusions continue to acknowledge the traditional domains of each respective agency, FDA’s Letter is striking given FDA’s traditionally “ministerial” approach to patents.
I. FDA Raises Three Principal Concerns With Pharmaceutical Patents
In her Letter to USPTO, Dr. Woodcock raised three main concerns that FDA hoped USPTO would help address, “with the goal of increasing competition and access to affordable drugs…”5 These included (i) filing of continuation applications; (ii) patenting of “secondary” or “post-approval” modifications to approved drugs; and (iii) replacing approved drug products with modified and patented versions of the previously marketed drug.
A. Filing of Continuation Applications and the Creation of So-Called “Patent Thickets”
The Letter first raised concerns with continuation applications, which are often filed to obtain patent protection over different technical aspects of a single product.6 For example, a parent application may claim a novel active pharmaceutical ingredient. While acknowledging that continuations generally expire at the same time as their parent – and hence do not prolong the duration of patent protection – FDA fears that “the existence of multiple patents increases litigation burdens and potentially delays the approval of generics and the launch of generics and biosimilar and interchangeable biological products.”7 One widely cited example of a so-called “patent thicket” is AbbVie’s Humira (adalimumab) patent estate, which includes over 100 patents directed to a single drug. AbbVie has been sued for alleged antitrust violations in relation to creating and enforcing Humira’s vast patent estate.
B. Patenting of “Secondary” or “Post-Approval” Changes to Approved Drugs (So-Called “Evergreening”)
The Letter next raised concerns with the patenting of “post-approval” or “secondary” changes to approved drugs that are already being marketed.8 FDA asserts that these changes differ from continuation applications, which expire at the same time as a parent, by allowing brand sponsors to “effectively extend protection against competition.”9 Examples of post-approval or secondary changes may include new formulations, delivery systems, methods of use, and methods of manufacturing – facets of a drug product that brands may consider incremental yet significant improvements. FDA noted with concern that “[o]ne study of which we are aware found that 78 percent of the drug products for which new patents were listed in the Orange Book from 2005-2015 were existing drug products, not new drugs entering the market.”10 The Letter raised questions as to whether such later-listed Orange Book patents should be listed at all, and whether they represent “innovation that is meaningful for patients.”11
C. Replacing an Approved Product With a Modified and Patented Product (So-Called “Product Hopping”)
Finally, the Letter raised concerns that brand drug manufacturers may introduce slightly modified versions of an approved drug and then remove the original drug from the market before generic entry, precluding a pharmacist from making a generic substitution to the prior drug, where the modified drug is subject to new patent protection. This is a practice commonly referred to as “product hopping.”12 All states have substitution laws that permit a pharmacist to switch a brand prescription for a generic drug, but this substitution is only possible if the brand and generic are bioequivalent and therapeutically equivalent. Thus, even what is objectively an improvement to a drug’s composition or formulation could prevent a pharmacist from making a generic substitution.
II. FDA’s Proposals and Requests
In accordance with Executive Order 14036, the Letter provided four requests and/or recommendations to USPTO “with the goal of increasing competition and access to affordable drugs while respecting the need to preserve patent rights and incentives for innovation generally.”13
First, FDA proposed greater collaboration between the two agencies to promote efficiency while improving the quality of issued patents. For example, recognizing the time and resource constraints that patent examiners face, FDA proposed its own involvement in patent examination by providing training on FDA’s public databases so that patent examiners could identify relevant references and also determine whether references constitute prior art to a claimed invention. FDA also proposed collaborating with USPTO on evaluating patent term extension applications, such as by sharing “information on the scope and nature of FDA approvals to support USPTO’s ability to accurately and fairly grant patent term extensions, and to grant them only in those instances where such extensions are appropriate.”14
Second, while calling attention to “challenges that the public and the Administration face with respect to drug pricing,” FDA criticized the kinds of practices it calls creation of “patent thickets,” “product hopping,” and “evergreening” as means to “unduly extend market monopolies and keep drug prices high…”15 Accordingly, FDA requested that USPTO share its perspective on such practices, and whether it intends to do anything to curb their use.
Third, recognizing the complexity of pharmaceutical products and the attendant challenges in patentability assessments, FDA sought USPTO’s view on whether examiners could benefit from more resources or time “for patents relating to sensitive and complex subject matter, such as pharmaceutical patents…”16
Finally, FDA requested that USPTO share data it has on the impact of Patent Trial and Appeal Board (PTAB) Post Grant Review (PGR) and Inter Partes Review proceedings on Orange Book-listed patents and/or patents directed to biological products. PGRs and IPRs are relatively new USPTO proceedings used to challenge the validity of patents. Specifically, FDA proposed exploring “how the PTAB framework might be optimized to support timely availability of generic drugs.”17
Having raised the aforementioned concerns and proposals, Dr. Woodcock called upon USPTO to collaborate in a joint effort to strike a fine balance between promoting innovation in the pharmaceutical industry while providing patients with affordable access to drugs.