FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and Cosmetic Act. The platform technology program was included as part of the PREVENT Pandemics Act “to bring significant efficiencies to the drug development or manufacturing process.”¹ Specifically, a platform technology must have the “potential to be incorporated in, or utilized by, more than one drug without an adverse effect of quality, manufacturing or safety.”²

The Draft Guidance emphasizes up front that the requirement that the platform technology has the potential to be incorporated in, or utilized by, more than one drug excludes some technologies that the industry would consider “platform technologies.”³ Indeed, the influence of the response to the COVID-19 pandemic on the Draft Guidance can be seen in its examples of platform technologies, with two of the four examples of platform technologies involving lipid nanoparticles (LNPs for mRNA vaccines or gene therapy products or LNPs encapsulating different short, single- or double-stranded oligonucleotides), one involving chemically synthesized siRNA in conjugation with a chemically defined targeting moiety, and one involving the traditional platform technology category of monoclonal antibody technologies, which are particularly prevalent among biologics.⁴

The statute itself requires not only that the technology is incorporated in or used by a drug or biologic and is essential to the structure or function of such drug or biological product, but also that it (1) can be adapted for, incorporated into, or used by more than one drug or biologic sharing common structural elements; and (2) facilitates the manufacture or development of more than one drug or biologic through a standardized production or manufacturing process or processes.⁵  These requirements for applicability to more than one drug or biologic exist because the benefits of the platform technology program can include 1) leveraging batch and stability data from a prior product using the platform technology as prior knowledge for a subsequent application; 2) leveraging nonclinical safety data from a prior product using the platform technology, potentially avoiding the need for product-specific data; and 3) leveraging inspectional findings from a prior product using the platform technology.⁶ In other words, subsequent applications by the same sponsor (or another sponsor with the right to reference) can rely on data in an earlier application for the same platform application to expedite approval of the subsequent drug or biologic.

This emphasis on repeated approvals of drugs based on the same underlying technologies mirrors a seldom-used patent term extension provision that could have great utility for platform technologies. Patent Term Extension (PTE) generally extends the term of an entire patent, subject to certain limitations.⁷ For product and method-of-use patents, the extended rights are limited to uses “approved for the product.”⁸  For method-of-manufacturing patents, in contrast, the extended rights are limited not just to methods of manufacturing used to make the approved product but also to methods of manufacturing used to make other products (as long as they are approved by the FDA):

(3) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make —

(A) the approved product, or

(B) the product if it has been subject to a regulatory review period described in paragraph (1), (4), or (5) of subsection (g).⁹

That the extended rights cover both the approved product forming the basis of the PTE application and subsequently approved products becomes even more apparent when considering the history of this subsection. Originally, the extended rights for method-of-manufacturing patents under the Drug Price Competition and Patent Term Restoration Act were limited to the method of manufacturing “as used to make the approved product,” paralleling the extended rights for product and method-of-use patents:

(3) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the approved product.¹⁰

When Congress expanded its work on the topic in 1988 by passing the Generic Animal Drug and Patent Term Restoration Act, it also affirmatively expanded the scope of the extended rights for method-of-manufacturing patents — but not product or method-of-use patents — to include not just the approved product forming the basis for the PTE application but also products later approved by the FDA. And Congress further emphasized the distinction between the approved product forming the basis for the PTE and a subsequent product undergoing FDA review by adding a concluding sentence to § 156(b) indicating that approved product is a subset of all products: “As used in this subsection, the term ‘product’ includes an approved product.”

Thus, PTE for method-of-manufacturing patents can provide extended rights that cover not just the method of manufacturing used to make the originally approved drug or biologic but also the method of manufacturing used to make a subsequently approved drug. Companies with a platform technology — such as a manufacturing method used to make more than one drug or biologic — should consider using § 156(b)(3) to extend the term of a method-of-manufacturing patent so that the extended rights of the platform are applicable to all future products manufactured using that method.

One potential risk of such a strategy is that this subsection seems not to have been litigated, and some cases involving other subsections include loose language that would seem to question this interpretation. For example, in rejecting an argument that the extended rights under § 156(b)(2) regarding method-of-use patents should extend beyond the approved product because that subsection expressly says “use . . . approved for the product,” not “use . . . approved for the approved product,” the US Court of Appeals for the Federal Circuit stated, “it would make little sense for an extension — whether for a product patent or a method of treatment patent — to apply to a different product for which the NDA holder was never subjected to a regulatory review period.”¹¹ However, this statement is on its face limited to product and method-of-use patents under §§ 156(b)(1) and (2). Similarly, the case the Federal Circuit cited to support its assertion is also on its face limited to product patents under § 156(b)(1).¹²Neither of these statements addresses method-of-manufacturing patents or the express language and legislative history of § 156(b)(3).

In any event, companies uncertain about this approach can always hedge their bets regarding a platform technology PTE by filing two PTE applications. While only one PTE is available for a particular drug approval,¹³ companies can file more than one PTE application. When that happens, the PTE applicant does not need to choose which patent to extend until the US Patent and Trademark Office has made a final determination of PTE eligibility and length.¹⁴ Because this process usually takes around four years, companies with platform technology can file one PTE application on a method-of-manufacturing patent and one application (or more) on a product or method-of-use patent and defer any decision for several years. During that time, the value of the company’s platform technology, as well as the acceptance by courts of this plain-language reading of the statute, may become more apparent and better inform the company’s PTE election decision.

 

---

^[1] 21 U.S.C. § 356k.
^[2] 21 U.S.C. § 356k (b)(2) (emphasis added); Draft Guidance at 9.
^[3] Draft Guidance at 1.
^[4] Draft Guidance at 11-13.
^[5] 21 U.S.C. § 356k (h)(1); Draft Guidance at 4.
^[6] Draft Guidance at 6; 21 U.S.C § 356k (h).
^[7] Genetics Inst, LLC v. Novartis Vaccines & Diagnostics Inc., 655 F.3d 1291, 1300 (Fed. Cir. 2011) (“the term of the patent, as opposed to specific claim(s), shall be extended”); 35 U.S.C. § 156(b).
^[8] 35 U.S.C. §§ 156(b)(1) and (2).
^[9] 35 U.S.C. § 156(b)(3) (emphasis added).
^[10] 35 U.S.C. § 156(b)(3) (emphasis added) (1985).
^[11] Biogen International GmbH v. Banner Life Sciences LLC, 956 F.3d 1351, 1347-48 (Fed. Cir. 2020).
^[12] Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1547 (Fed. Cir. 1996) (“the restoration period of the patent does not extend to all products protected by the patent but only to the product on which the extension was based. Id. at § 156(b)(1).”).
^[13] 35 U.S.C. § 156(c)(4).
^[14] 37 C.F.R. § 1.785(b).

 

This informational piece, which may be considered advertising under the ethical rules of certain jurisdictions, is provided on the understanding that it does not constitute the rendering of legal advice or other professional advice by Goodwin or its lawyers. Prior results do not guarantee a similar outcome.