Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

by Knobbe Martens
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Knobbe Martens

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for.  Patents for Humanity is open to patents and applications that address humanitarian challenges, and recognizes the winners with publicity and expedited examination or appeal of any application in which the winner has an ownership interest.  Patents 4 Patients, also known as the Cancer Immunotherapy Pilot Program, offers expedited examination to patent applications that pertain to cancer immunotherapy.

The Patents for Humanity initiative is accepting applications now through December 8, 2017.  This initiative offers recognition in five categories: (1) Medicine, (2) Nutrition, (3) Sanitation, (4) Household Energy, and (5) Living Standards.  Previously, awards have been granted to companies and universities in the drug & vaccine, diagnostic, clean tech, industrial biotechnology, agricultural, and medical device spaces.   Owners and licensees of utility patents and applications are eligible for the program, and can apply by submitting a five-page statement on how their claimed invention is being used to address a humanitarian issue, how the technology is being made available for this purpose, and what impact it is having on people’s lives.  In addition to actual humanitarian use, technologies may also qualify if they represent research tools and/or impact the research of others with a humanitarian purpose.

Winners of the Patents for Humanity initiative will receive a certificate that can be used for accelerated examination, reexamination (provided they are the patent owner), or ex parte appeal to the Patent Trial and Appeal Board (PTAB), but not inter partes review, post grant review, covered business methods, supplemental examination, interferences, or inter partes reexamination.  The certificate is not transferable, but can be used on any application in which the winner has an ownership interest (not just the application or patent that wins the competition).  These certificates may be particularly interesting to biotech entities, which may need to accelerate a high-value appeal before the PTAB.  For example, earlier stage companies may need to get a tough case allowed on appeal in order to secure a funding milestone, while universities can offer value to a licensee with the potential to accelerate PTAB proceedings, and large companies may wish to swiftly resolve an appeal of an ex parte reexamination on a key patent.  The USPTO states that the Patents for Humanity initiative will have up to roughly 10 winners each year.  There were four winners in 2016, and seven in 2015.

The Patents 4 Patients initiative offers expedited examination similar to prioritized examination (“Track One”) for cancer immunotherapy patent applications, but does not charge the petition fee.  In contrast, the fee for Track One is currently $4000 for large entities, and $2000 for small entities. Patents 4 Patients aims to offer a final examination decision for cancer immunotherapy applications within one year, and places these applications on the Examiner’s special docket in order to expedite the examination process. 

In order to qualify, Applicants must certify that their application contains a claim to a method of treating cancer using an immunotherapy, and must request early publication of their patent application.  The USPTO does not appear to offer an explicit definition of what constitutes a “method of treating a cancer using an immunotherapy,” but based on the language of the certification, it would appear that “method of treatment” claim formats are eligible, while “product” claim formats may not be.  However, an application containing claims to both an immunotherapy product (such as an antibody or modified immune cell) and a method of using this product to treat cancer would appear to meet the criteria for the program.

A petition for expedited processing under Patents 4 Patients is a fillable form, which can be filed prior to receipt of a first office action, with a Request for Continued Examination (RCE), or for any application for which the claimed immunotherapy has entered Phase II or Phase III clinical trials, provided the application is not under final rejection.   From June 2016 to June 2017, over 80 petitions were filed, and 9 patents were granted under the initiative.  The Patents 4 Patients initiative is currently in effect through December 31, 2018.

As these initiatives offer benefits and do not incur additional official fees, biotechnology patent applicants may wish to review their portfolios and/or confer with patent counsel to determine if they have any pending applications or issued patents that would be candidates for either or both initiatives.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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