Pharma Industry Wants USPTO To Hit Brakes On Changes To Patent Continuation Practice
Executive Summary
AbbVie, Amgen, Genentech, Bristol-Myers Squibb and others call on the patent office to retain the current system for continuation applications in comments on the USPTO and FDA’s proposed initiatives.
Pharmaceutical companies urged the US Patent and Trademark Office not to change continuation application review procedures as the agency appears ready to do in response to concerns about patent thickets.
The patent office requested comments on its proposed initiatives to bolster the robustness and reliability of patents in an October Federal Register notice. Officials wanted feedback on a list of questions about the information needed to support patent claims and potential changes to the continuation practice, including giving greater scrutiny to continuation applications in large patent families. (Also see "Patent Process Reforms Proposed By US PTO Could Be ‘Quite Burdensome’ For Applicants" - Pink Sheet, 4 Oct, 2022.)
The agency is considering the changes in response to a June 2022 letter from six senators, who said patent thickets are primarily made up of continuation patents and posed questions about possible changes to the patent process.
They asked how eliminating terminal disclaimers would affect patent prosecution strategies and patent quality, if filing a terminal disclaimer should be considered an admission of obviousness, and whether heightened examination requirements for continuation patents are necessary to ensure minor modifications do not receive second or subsequent patents. In an unusual move, the USPTO incorporated their questions verbatim in its request for comments. (Also see "Battle Over Patents And Drug Pricing Engulfs FDA And USPTO" - In Vivo, 6 Dec, 2022.)
Genentech, Inc. said in its comments that continuation applications allow an inventor to get some claims issued while continuing to pursue the full scope of entitled protection based on its disclosure.
“If a company could not pursue patent claims in batches by using continuing applications, it would face an untenable choice in which it might have to sacrifice claims to which it should have been entitled in the interest of securing prompt issuance of a patent,” Genentech stated. “Conversely, if the company decided to pursue all the claims to which it is entitled in a single application, prosecution would slow down, because no patent could issue until the examiner considered all claims ready for issuance.”
Genentech said it was particularly concerned by the suggestion that a continuation application should be subject to special procedures, such as “heightened examination requirements” or “a second look” by a team of patent quality specialists. The company added that continuation applications are already subject to the patentability requirements established by Congress and that the patent office does not have authority to impose heightened requirements. In addition, Genentech said a second look could slow down patent prosecution, increase the period of patent term adjustment, and delay the patent’s expiration date.
Restrictions On Terminal Disclaimers
AbbVie Inc. urged the USPTO against restricting the current obviousness-type double patenting (OTDP) and terminal disclaimer practices. Terminal disclaimers tie the patent terms of two patents together.
“We believe that the restrictions on terminal disclaimers, as proposed in the RFC [request for comments], will likely compromise overall patent quality, raise serious questions of fairness and due process, and do not meaningfully address any valid policy concerns,” AbbVie stated.
“Most real-world litigation turns on a handful of ‘representative claims,’ and the availability of continuation and divisional practice promotes the broad and early invention disclosures at the heart of our patent system” – Bristol Myers Squibb
The company noted that patent applicants often file terminal disclaimers to overcome OTDP for reasons not related to the merits of the OTDP rejections. For example, AbbVie said, they are often filed for convenience in continuation applications when they are expected to have the same ownership and expire at the same time as, or even earlier than, the referent patent parent.
AbbVie said the patent office should dispel common misconceptions about continuation practice. “First, continuation applications do not extend the patent term of any patents within the family,” AbbVie stated. “Subject to limited and statutorily authorized exceptions, a patent issued from a continuation application expires 20 years from the parent application’s filing data, regardless of when the continuation application is filed.”
Real-World Litigation
Bristol Myers Squibb Company said several of the initiatives and questions posed by the patent office “appear to reflect the mistaken perception that a single patent application can or should provide adequate opportunity to protect the full range of innovation reflected in a commercial product.”
BMS said it has significant concerns about initiatives to apply greater scrutiny to continuation applications in large families or to use declaratory evidence to overcome rejections.
“Most real-world litigation turns on a handful of ‘representative claims,’ and the availability of continuation and divisional practice promotes the broad and early invention disclosures at the heart of our patent system,” BMS stated.
Amgen, Inc. described the value of filing continuation applications, saying the practice permits a patent applicant to agree to one set of claims and then continue to pursue claims of different wording, scope, and variation that were either not presented or were not agreed upon in the initial examination.
Amgen also said it was concerned about “the current trend to unnecessarily narrow the scope of claims to be less than the scope of the patent disclosure.” The company cited its case pending before the Supreme Court seeking to reverse the Federal Circuit’s application of the enablement standard to invalidate patents that claim more than the specific embodiments disclosed in the patent specification “even though the teaching of the patent disclosure enables so much more.”
The Supreme Court heard oral arguments in the case, Amgen v. Sanofi, on 27 March. At issue is the standard for determining whether a patent describes an invention so as to enable any person skilled in the art to make and use it. The case specifically concerns genus claims. Amgen is challenging the US Court of Appeals for the Federal Circuit’s ruling invalidating Amgen’s Repatha (evolocumab) patents for lack of enablement. (Also see "Supreme Court Seems Ready To Uphold Ruling Against Amgen’s Anti-PCSK9 Antibody Patents" - Pink Sheet, 27 Mar, 2023.)
Genus And Markush Claims
The patent office also asked if applicants should be required to provide a detailed analysis supporting genus or Markush claims, to identify each claim limitation that is a genus, and to explain or identify the corresponding support in the written description for each species encompassed in the claimed genus.
A genus claim is a patent that covers a group of related chemicals. Markush claims set a list of alternatives from which a selection is made.
“We are concerned about burdening applicants with adding additional requirements and do not think drawing a bright line at the claim amendment stage or creating new requirements for all genus or Markush claims makes sense,” the Intellectual Property Owners Association said.
The American Bar Association IP Law Section also recommended against requiring an applicant to explain or identify support for a priority claim or Markush claim in a present or parent application. The group said an examiner now can reject claims for lack of written description support and that increasing the burden on applicants would likely lead to substantially greater expense and increase disparity to favor more well-funded applicants.
The ABA IP Law Section also advised the USPTO not to change the current practice of amending the detailed description of continuation or divisional applications or the terminal disclaimer practice.
The Association for Accessible Medicines asserted that terminal disclaimers should be considered strong evidence of obviousness type double patenting. The generic drug trade association said the ODP doctrine ensures that a patentee receives one period of exclusivity for an invention that cannot be extended through subsequent claims covering obvious variations of the invention.
“Nonetheless, when an examiner rejects a patent owner’s claims under the ODP doctrine, the applicant may ‘revive’ and receive protection for their previously rejected claims by filing a terminal disclaimer,” AAM said.
The patent office also asked how, if at all, it should change the request for continued examination (RCE) practice. Specifically, USPTO asked if the agency should implement internal process changes once the number of RCEs filed in an application reaches a certain threshold, such as transferring the application to a new examiner or increasing the scrutiny in the examination of the application. An RCE is a request for continued examination of a patent application after the examination has ended, such as after a final office action.
IPO said it supports exploring internal USPTO process changes after a threshold number of RCEs have been filed to ensure that examination and prosecution is conducted appropriately.
“The filing of a third RCE might be an appropriate time to consider such a change, but we do not recommend setting a bright-line rule triggering changes,” the group said.