Hoffman-La Roche Inc. and Morphosys AG are among the latest patent holders to file a Patent Term Adjustment (PTA) action against the USPTO. Their complaint is somewhat unique in that it challenges the factual basis for PTA deductions based on "Applicant Delay," rather than challenging the USPTO's interpretation of the PTA statute.
The Patent At Issue
Hoffman-La Roche and Morphosys AG are the assignees of U.S. 7,794,719, directed to antibodies against amyloid Β, a protein associated with Alzheimer's disease. The patent issued on September 14, 2010, and originally was awarded 1016 days PTA. In their complaint, Roche and Morphosys seek 1412 days PTA.
The Applicant Delays At Issue
Roche and Morphosys challenge the basis for several PTA deductions for "Applicant delay:"
- 90 days charged from the day after an allegedly non-compliant response to a Restriction Requirement was filed until a response curing the alleged defects was filed.
This deduction was not included in the USPTO's original PTA calculation provided with the Notice of Allowance, but was assessed in the USPTO's Decision on Applicant's request for reconsideration of the 198 day deduction discussed below. Applicant challenged this PTA deduction in a petition and application for PTA filed within two months of the USPTO Decision.
The issue underlying this deduction is whether the Examiner should have issued a notice of "non-compliant" response when the response to the Restriction Requirement listed claims as being "withdrawn" before the Examiner himself had "withdrawn" the claims pursuant to Applicant's election.
(Now, if that's not a brilliant example of elevating form over substance and undermining all reasonable goals of compact prosecution, I don't know what is!)
- 198 days charged from the day after a response was filed, running through the filing of a supplemental response, issuance of a Notice of Non-Responsive Amendment, and filing of a response curing the alleged defects.
Applicant challenged this PTA deduction when the issue fee was paid, in accordance with 37 CFR § 1.705(b).
The issue underlying this challenge is whether the claims presented in the responses were directed to subject matter that had been elected pursuant to an election of species requirement.
- 120 days charged for filing an amendment after the Notice of Allowance, even though the only papers filed related to Patent Term Adjustment.
(As noted below, the USPTO has since corrected this error.)
The USPTO Decisions
The USPTO issued a Decision on Applicant's first request for reconsideration on June 22, 2010, over 8 months after Applicant filed the request for reconsideration. The USPTO "dismissed" the request, finding that "Applicants essentially seek to reopen prosecution after prosecution has closed." According to the USPTO, if Applicant "believed that the Notice of Non-Compliant amendment were [sic] mailed in error, applicants [sic] recourse was to file a petition seeking review of the Notice and or the Office actions pursuant to 37 CFR 1.181(a)(3)."
The USPTO issued a Decision on Applicant's second request for reconsideration on March 7, 2011, nearly four months after Applicant's request, and just shy of 180 days from the patent's grant date.
With regard to the 90 day deduction, the Decision is wholly conclusory and does not address the underlying factual basis of the "withdrawn" status of the claims:
The reduction of 90 days pursuant to 37 CFR 1.704(c)(7) is required. In response to the Restriction Requirement mailed on June 5, 2007, applicants submitted a non-compliant response on July 27, 2007. A Notice of Non-Compliant Amendment was mailed on October 18, 2007. A response to the Notice was submitted on October 25, 2007. The reduction of 90 days for the delay from the filing of the initial response on July 28, 2007, to the filing of the response on October 25, 2007, is warranted.
With regard to the 198 day deduction, the Decision reiterated the findings of the first Decision.
With regard to the 120 deduction, the Decision admitted:
A review of the record confirms that the documents submitted on October 16, 2009 were in support of the request for patent term adjustment. As such the 120 day reduction will be removed.
The Problem of "Non-Compliant" Responses
The PTA penalty for a "non-compliant" response is particularly harsh, because no matter how long the USPTO takes to notice the alleged defect in the response, and no matter how promptly the defect is corrected, the PTA rules charge Applicants with "delay" for the entire time period from the filing of the original response until the filing of a corrected response.
This deduction is set forth in 37 CFR § 1.704(c)(7):
Submission of a reply having an omission (§1.135(c)), in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed.
In this case, both the "non-compliant" and "non-responsive" notices were issued 2-3 months after the allegedly defective responses were filed. Thus, the bulk of the time associated with the deduction for "Applicant delay" was time that the application was awaiting review by the Examiner.
Allocating Scarce Resources
It will be interesting to see if the district court will hear these arguments on the merits. I understand why the Applicant may not have challenged the "non-compliant" and "non-responsive" notices at the time. For example, filing a petition as the USPTO suggested would not have stopped the time period for answering the notices, would have incurred additional attorney charges and USPTO fees, and would have delayed prosecution while the petition was decided. On the other hand, I understand why the USPTO does not want to decide these types of issues at the PTA stage, and I can see the district court being even more reluctant to dig into the "weeds" of patent prosecution issues.
It's not clear where the overall interests of compact prosecution and administrative and judicial economy fall in a case like this. Would the USPTO rather decide issues like these in every case, or only in those cases where the facts, delays, and expected long-term patent value make it worthwhile for the Applicant to pursue PTA issues?
This case also brings up the issue of therelative timing of USPTO and district court review of PTA awards. While Roche and Morphosys filed their complaint within 180 days of the patent grant date (in accordance with 35 USC § 154(b)(4)(A)), it looks like the complaint crossed in the mail with the USPTO's second Decision. Thus, Roche and Morphosys had to raise in their complaint the 120 day issue that the USPTO resolved in its Decision, and had to address the 90 day issue without knowing the USPTO's response.