By J.B. Fitzgerald & Simone Raess
Regular readers of Life Science Leader know all too well the time and costs associated with bringing a drug to market (10 to 15 years, $1 billion to $5 billion). They are also very familiar with the role patents play when it comes to safeguarding and recouping their investment.
PATENT OFFICE DELAYS AND APPLICANT DELAYS
Under the PTA statute, each day of delay by the Patent Office while an application is pending results in one day of extended patent term. Delays by the Patent Office include, among others: (a) failing to respond to an application within 14 months of its filing date, and (b) failing to issue a patent within three years of the filing of the application. Applicant delays are characterized by the PTA statute as an applicant’s failure to engage in “reasonable efforts” to conclude the prosecution of the application. For each day that an applicant delay is assessed, PTA is reduced by one day.
Under a Patent Office rule corresponding to the PTA statute, supplemental replies filed by an applicant after the applicant’s initial reply reflect the applicant’s failure to engage in “reasonable efforts.” The most common supplemental reply occurs when an applicant files an Information Disclosure Statement (IDS) submitting references to the Patent Office subsequent to filing a substantive response, such as a response to an office action.
APPLICANT DELAY AFTER GILEAD AND SUPERNUS
Two recent Federal Circuit cases — Gilead Sciences Inc v. Michelle K. Lee, 778 F.3d 1341 (Fed. Cir. 2015), decided in February 2015, and Supernus Pharmaceuticals v. Andrei Iancu, 913 F.3d 1351 (Fed. Cir. 2019), decided in January 2019 — have reviewed the Patent Office rule related to filing supplemental replies. These cases address the conditions under which a supplemental reply, such as an IDS, does or does not constitute an applicant delay.
In Gilead, the Federal Circuit held that filing a supplemental response after filing a response to an office action can constitute a failure to engage in “reasonable efforts” whether or not the submission extends the duration of prosecution. It is irrelevant whether any actual delay occurs in the processing of the application as a result of the supplemental response.
In Supernus, however, the Federal Circuit clarified that the PTA statute only allows an applicant delay to be assessed based on the filing of a supplemental response when there is a finding that the applicant failed to engage in “reasonable efforts.” In Supernus, there was a 546-day period between the time the company filed an initial response and when it became aware of information that it filed in an IDS. Because the company did not have knowledge of this information during the 546-day period, it was improper to assess an applicant delay that covered the period. In other words, there was no failure to engage in “reasonable efforts” during the time period from the filing of the initial response until the time the company became aware of the information that it filed in the IDS. Thus, after Supernus, an applicant delay should not be assessed for the period in which an applicant has no knowledge of documents or information that are later filed as part of a supplemental response.
Taken together, these cases show that a supplemental filing can trigger applicant delay regardless of whether any actual delay occurred. However, applicant delay cannot be assessed if the applicant engaged in “reasonable efforts” to submit a supplemental filing immediately upon learning or receiving the underlying materials. Effectively, the Supernus decision restricted the ability of the Patent Office to assess an applicant delay, when a supplemental response is filed.
IMPLICATIONS OF GILEAD AND SUPERNUS FOR PHARMACOMPANIES
To maximize patent term and profits for patented drugs, pharmaceutical companies might consider adjusting their record-keeping and patent prosecution practices for filing supplemental responses in light of the Gilead and Supernus decisions. Certain best practices are suggested and outlined below.
When possible, pharmaceutical companies may want to avoid filing supplemental responses such as IDS filings that occur after filing a response to an office action. As a general practice, companies or their patent practitioners might submit references in an IDS concurrently with a response to office action. The need for supplemental responses can be reduced or eliminated by conducting a thorough review of prior art documents in the company’s possession prior to filing any other paper required by the Patent Office.
There are times, though, when supplemental responses cannot be avoided. However, being guided by the Supernus decision, pharmaceutical companies can limit the risk of applicant delay when filing a supplemental response. As a starting point, companies may be well-served to record the date they receive or become aware of any patent-related documents, including prior art references. As part of a supplemental reply to the Patent Office, companies or their patent attorneys may wish to prominently note the date of receipt as well as the length of time between the last submission to the Patent Office and the date of receipt. Doing so may aid the Patent Office in avoiding any improper reduction of PTA when a supplemental reply is submitted. Additionally, unless there are countervailing strategic considerations, companies may wish to file documents in a supplemental response as soon as possible after they are received. For example, if the supplemental response involves filing references in an IDS, the IDS should be filed immediately after the receipt of the references.
To maximize patent term on drugs, pharmaceutical companies may wish to avoid supplemental responses when possible. Additionally, because the Supernus decision limited the assessment of applicant delay under certain circumstances, companies may wish to adjust their strategies for filing supplemental responses during patent prosecution. Doing so could result in additional patent term for drug patents and, therefore, a windfall of additional profits to the companies that develop and patent these drugs.
KEY TAKEAWAYS FROM GILEAD SCIENCES INC V. MICHELLE K. LEE AND SUPERNUS PHARMACEUTICALS V. ANDREI IANCU
J.B. FITZGERALD is an attorney at the law offices of Snell & Wilmer focusing on intellectual property and technology law.
SIMONE RAESS is an attorney at the law offices of Snell & Wilmer focusing on intellectual property and technology law.