Biotech patents don’t receive protection---PTAB’s broad definition does not encompass any

Within the CBMR, the PTAB has been known to be very "aggressive, particularly with respect to its interpretation of section 101."'12 This is likely because the USPTO has a large amount of discretion in determining what patents are subject-matter eligible for a CBMR.113 Unlike IPR or PGR, "a person may not file a petition for a [CBMR] . . . unless the person or the person's real party in interest or privy has been sued for infringement of the patent or has been charged with infringement under that patent."' 14 Another key distinction is that CBMRs only apply to covered business method patents, 5 which the AIA defines in § 18(d)(1): The term 'covered business method patent' means a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions. 16

In addition to this broad definition, the AIA directs the USPTO to further define "technological invention." 117 The USPTO decides "whether the claimed subject matter as a whole recites a technological feature that is novel and unobvious over the prior art; and solves a technical problem using a technical solution." 1 8 This broad definition of "technological invention" gives the USPTO a fair amount of discretion in determining the subject matter that is eligible for instituting a CMIBR.119 Typically, CBM reviews are limited to patents that are "financial in nature," "incidental to financial activity," or "complementary to financial activity." 120 In the past, a majority of the CBMR petitions challenged claims on subject-matter eligibility. 121

Although most biotechnology uses software in research and development, the PTAB generally does not institute CBMR petitions challenging biotechnology or medical patents 122 because they are not a "financial product or service."' 123 For example, in Amneal Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc. and Roxane Laboratories, Inc. v. Jazz Pharmaceuticals, Inc., the PTAB declined to institute a CBMR because the petitioner failed to show that the claim language recited a method involving the movement of money or credit in exchange for a product or service.124 In Amneal Pharmaceuticals, the patent related to a "method for controlling access to a sensitive prescription drug prone to potential abuse or diversion, by utilizing a central pharmacy and database to track all prescriptions for the sensitive drug."' 25 In Roxane Laboratories, the patent related to a "method for treating a patient with a sensitive prescription drug and controlling access to the sensitive prescription drug, which is prone to potential abuse, misuse, or diversion, by utilizing a central pharmacy and database to track all prescriptions for the sensitive drug.' 12 6 Because the PTAB held that the patents were not subject-matter eligible for a CBMR, it could not institute the proceeding to determine the patents' validity.

The PTAB has a fair amount of discretion on the subject-matter eligibility for covered business method patents. However, Amneal Pharmaceuticals and Roxane Laboratories suggest that the PTAB has not found a way to expand the definition of a "technological invention" to encompass biotechnology subject matter. Thus, within the scope of CBMR, it is unlikely that the PTAB will have a significant impact on patent protection for biotechnology innovation.