Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices
| February 4, 2019
Supernus Pharmaceuticals, Inc. et al. v. Iancu
January 23, 2019
Before Reyna, Dyk, and Schall. Opinion by Reyna.
Summary:
The Federal Circuit held that the PTO’s reduction of the patent term for a Supernus patent due to applicant delay (of filing an information disclosure statement after filing an RCE) is not correct because there is nothing Supernus could have done during the period of time from the filing of an RCE and the receiving of a communication from a foreign patent office to conclude the prosecution of the application.
Details:
Patent Term Adjustment (PTA) statute of 1999: 35 U.S.C. §154(b)
- §154(b)(1)(A)-(C): delays caused by the PTO
- Type A delay: the PTO fails to provide a notification under 35 U.S.C. §132 or a Notice of Allowance within 14 months of filing date.
- Type B delay: the PTO fails to issue a patent after 3 years have passed between the filing date and the date of allowance.
- Type C delay: for delays that are excluded from Type B delay due to derivation proceedings, secrecy orders, or successful appeals.
- §154(b)(2): delays caused by applicants
Supernus Pharmaceuticals, Inc. is the owner and assignee of U.S. Patent 8,747,897 (“the ’897 patent”), and United Therapeutics Corp. is the exclusive licensee of the ’897 patent.
Relevant timelines:
- 4/27/06: Supernus filed U.S. application and international application claiming priority from the U.S. application (international application gave rise to EP application).
- 8/20/10: the PTO issued a final OA.
- 2/22/11: Supernus filed an RCE.
- 10/13/11: the EPO issued the EP application as EP patent.
- 8/21/12: the EPO notified Supernus’s European patent counsel that a Notice of Opposition was filed by Sandoz to the EP patent.
- 9/11/12: Supernus received a letter from its European patent counsel regarding the EPO notification.
- 11/29/12 (79 days later from 9/11/12 and 100 days from 8/21/12): Supernus filed a supplemental IDS citing the EPO notification.
- 9/10/13: the PTO issued a first OA responding to Supernus’s RCE.
- 1/10/14: Supernus filed a response.
- 2/4/14: the PTO issued a Notice of Allowance.
- 6/10/14: the U.S. application issued as the ’897 patent (PTA of 1,260 days).
PTO
The PTO attributed 2,321 days to the PTO delay (1,656 days for Type A delay and 665 days for Type B delay). The PTO reduced 2,321 days by 175 days to account for overlapping Type A and Type B delays and 886 days for applicant delay. Out of 886 days, 646 days were assessed for the 2/22/11 filing of the RCE and the 11/29/12 filing of the IDS.
PTA of 1,260 days = 2,321 days – 175 days – 886 days.
Supernus filed a request for Reconsideration of PTA because the deduction of 646 days was improper. The PTO rejected the request because citing Gilead, filing the IDS after filing of the RCE “interferes” with the PTO’s ability to process an application.
District Court
Supernus appealed to the U.S. District Court for the Eastern District of Virginia. The district court granted summary judgment in favor of the PTO because the PTO did not err in the PTA calculation for the ’897 patent.
Federal Circuit
First of all, the Federal Circuit held that Gilead did not apply in this case. In Gilead, the patent owner brought an action challenging the PTO’s assessment of a 57-day applicant delay in calculating PTA reduction based on Gilead’s delay during examination between its reply to a restriction requirement and its submission of a supplemental IDS (disclosing other co-pending Gilead patent applications). However, the Federal Circuit held that the issue in this case is whether the PTO may reduce PTA by a period that exceeds the “time during which the applicant failed to engage in reasonable efforts to conclude prosecution.” (35 U.S.C. §154(b)(2)(C)(i)). The Federal Circuit held that Gilead did not answer this issue.
Supernus conceded that it failed to engage in “reasonable efforts” for the last 100 days of the 646-day period. However, Supernus argued that there was nothing Supernus could have done during the 2/22/11 filing of the RCE and the 8/21/12 receiving of the EPO communication.
The Federal Circuit agreed with Supernus’s arguments. The Federal Circuit held that there was no action Supernus could have done to advance prosecution of the patent during the 546-day period because the EPO communication did not exist yet. The Federal Circuit held that the PTO’s interpretation of the statute “would unfairly penalize applicants, fail to incentive applicants not to delay, and fail to protect applicants’ full patent terms.”
Finally, the Federal Circuit held that the PTO’s additional 546-day assessment is contrary to the plain meaning of the statute because “the 646-day total reduction is not equal to a period of time during which Supernus failed to engage in reasonable efforts to conclude the prosecution of the ’897 patent (35 U.S.C. §154(b)(2)(C)(i)). In addition, the Federal Circuit held that the PTO’s decision is not consistent with the intent of Congress because Congress intended that the PTA statute not adversely impact applicants who could have done nothing to advance the prosecution.
Therefore, the Federal Circuit held that the district court erred in granting summary judgment in favor of the PTO.
Takeaway:
Applicant should carefully review the PTO’s PTA especially when applicant filed corresponding applications in foreign patent offices and submitted IDSs to the PTO citing communications from foreign patent offices.
Applicant should advise foreign patent counsels to forward the communications from foreign patent offices as soon as possible for a timely filing of IDSs.
Tags: information disclosure statement (IDS) > patent term > Patent Term Adjustment (PTA) > PTA reduction > Type A delay > Type B delay > Type C delay
Issuance date or expiration date as the reference point for obviousness-type double patenting?
| January 11, 2019
Novartis Pharmaceutical Corp. v. Breckenridge Pharmaceutical Inc., et al
December 7, 2018
Before Prost, Wallach, and Chen. Opinion by Chen.
Summary
The Federal Circuit reversed the district court’s decision to invalidate U.S. Patent No. 5,665, 772 based on obviousness-type double patenting because a change in patent term law should not truncate the term statutorily as assigned to the pre-URAA ‘722 patent.
Details
Novartis owns U.S. Patent No. 5,665,772 (hereafter ‘722 patent), which claims the compound everolimus, and U.S. Patent No. 6,440,990 (hereafter ‘990 patent), which is directed to some methods of treatment using everolimus and some pharmaceutical compositions including everolimus. Everolimus is an active ingredient in Zortress® and Afinitor®, which are famous drugs for treating certain cancers and preventing rejection in kidney and liver transplantations. Plaintiff Novartis sues Defendants Breckenridge for infringing ‘772 patent after Defendants sought FDA approval to market generic versions of Zortress® and Afinitor®.
The only question before the district court was whether the ‘990 patent could serve as an obviousness-type double patenting reference against the ‘772 patent? The ‘772 patent was filed on April 7, 1995 and issued on September 9, 1997. Because it was filed before June 8, 1995, the URAA’s effective date, the patent term is 17 years from the issuance date. Furthermore, Novartis obtained a five-year patent term extension under 35 U.S.C. §156 of the Hatch-Waxman Act. So the actual expiration date for the ‘722 patent is September 9, 2019. The ‘990 patent was filed on May 23, 1997 and issued on August 27, 2002. Because it was filed after the URAA’s effective date and claimed the same priority as the ‘722 patent from a September 24, 1993 PCT filing date. So the expiration date for the ‘990 patent is September 24, 2013. The following diagram illustrates the dates for each patent:
That is, the ‘990 patent issues later, but expired earlier, than the ‘772 patent. There is a terminal disclaimer filed in ‘990 patent.
Defendants relied heavily on decision in a previous federal circuit case, Gilead Sciences, Inc., v. Natco Pharma Ltd. 753 F. 3d 1208 (Fed. Cir. 2014). The following diagram illustrates the relevant dates of two patents in dispute:
Gilead held that the proper reference point for an obviousness-type double patenting inquiry is the expiration dates, rather than the issuance dates, of the patents in question. Thus, a patent (‘375 patent) that issues after but expires before another patent (‘483 patent) can qualify as a double patenting reference against the earlier-issuing, but later-expiring patent (‘483 patent). However, the Federal Circuit distinguishes this case from Gilead because the two patents in Gilead were all filed post-URAA while, in the present case, one patent was filed pre-URAA and the other patent was filed post-URAA. The URAA transition statute changed the term of a U.S. patent from 17 years from the issuance date to 20 years from the filing date of the earliest U.S. or PCT application to which priority is claimed, excluding provisional applications.
Defendants also relied on another previous case, Abbvie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust, 764 F. 3d 1366 (Fed. Cir. 2014). The following diagram illustrates the relevant dates of two patents in dispute:
AbbVie also held that claims of the ‘422 patent (second issued, second-expiring) were invalid over the ‘766 patent (first-issued, first-expiring) for obviousness type double patenting. The court explained that the patent owner had impermissibly sought an undue patent term extension for its later-expiring, patentably indistinct claims by choosing to claim different priority dates for its patent applications. However, the Federal Circuit distinguishes this case from Abbvie because the two patents in Abbvie were all filed post-URAA.
The Federal Circuit’s rationale seems to place a lot of weight on the fact that Novartis did not engage in any gamesmanship such as the structuring of priority claims among related patents to obtain the benefit of one patent gaining a later expiration date. Furthermore, the URAA transition statute expressly provides that the term of a patent issuing from an application filed before June 8, 1995 shall be the greater of the 20-year term from the earliest priority date or 17 years from grant, subject to any terminal disclaimers. Thus, the Federal Circuit applies traditional, pre-URAA obviousness-type double patenting practice to the pre-URAA patent. That is, the ‘772 patent’s issuance date is used as the reference point for the obviousness-type double patenting analysis. Since the ‘990 patent is issued later than the ‘772 patent, the ‘990 patent is not a proper obviousness-type double patenting reference for the ‘772 patent.
Furthermore, the Federal Circuit considers that the holding is consistent with the core principle underlying the double patenting doctrine: giving one invention and nonobvious variants of that invention the same patent term. Here, critically, Novartis did not seek to extend its patent rights over its invention beyond one patent term, 17 years from issuance of the ‘772 patent.
Take away
- Is issuance date or expiration date as the reference point for obviousness-type double patenting? It depends. If the challenged patent is filed before June 8, 1995, the reference point for obviousness-type double patenting is the issuance date. If the challenged patent is filed after June 8, 1995, the reference point for obviousness-type double patenting is the expiration date.
Latest Developments in Calculating Patent Term Adjustment (PTA) from the District Courts
| November 21, 2012
Exelixis, Inc. v. Kappos
Decided November 1, 2012
U.S. District Court for the Eastern District of Virginia
University of Massachusetts v. Kappos
Decided November 9, 2012
U.S. District Court for the District of Colombia
Summary
This week, rather than discuss a CAFC case, we take a look at two important District Court cases dealing with Patent Term Adjustment (PTA). According to Exelixis, under 35 U.S.C. §154(b)(1)(B), the filing of a Request for Continued Examination (RCE) has no impact on PTA determinations when filed after the three year examination guarantee has passed. Additionally, according to University of Massachusetts, under 35 U.S.C. §154(b)(1)(A), a fundamentally flawed Office Action will count towards calculating an A delay.
Tags: patent term > Patent Term Adjustment > PTA > RCE > Request for Continued Examination
CAFC holds all the claims of a patent have the same expiration date, whether the claims are drawn to the product subject to patent term extension or not
| April 11, 2012
Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.
August 23, 2011
Panel: Lourie, Plager and Dyk. Opinion by Judge Lourie. Concurrence-in-part and dissent-in part by Dyk.
Summary:
Today, we bring you the second in a series of three articles regarding an important case from last year. For part 1, click here. This article discusses the following question:
Question: Where a patent has been granted an extension of term due to regulatory review, is there a different expiration date for the claims that were the subject to the regulatory review and the claims that do not claim the approved product?
Answer: The expiration date is not determined on a claim by claim basis.
A patent, and therefore all of the claims in the patent, have the same expiration date, which is the expiration date as extended by patent term extension.
Tags: Delay due to regulatory review > Expiration > FDA > patent term > Patent Term Extension > PTE
