Greenblum & Bernstein, P.L.C.
Recent News in Intellectual Property
In This Issue:
· Actelion Pharms v. Matal: Lessons Regarding Patent Term Adjustment and Express Requests to Begin National Stage Examination
· Evergreening Pharmacuetic Patents and Post-Grant Review
· CAFC Criticizes PTABs Dismissal of “Teaching Away” Evidence as “Subjective Preferences”
Walter Schlapkohl, Ph.D., Esq.
Actelion Pharmaceuticals, Ltd. v. Matal – The Importance of an Express Request to Begin National Examination Procedures
-- by Jeffrey Bousquet
In a recent decision by the Court of Appeals for the Federal Circuit (CAFC), Actelion Pharmaceuticals learned that failure to check a box expressly requesting national stage examination can come with a high cost. Actelion filed a U.S. national stage application four days before the 30-month deadline for commencing the national stage. Although the application as filed met all of the 35 U.S.C. §371(c) requirements, and thus was eligible for early commencement of the U.S. national stage, Actelion did not check the box on the accompanying PTO transmittal form that states, “This is an express request to begin national examination procedures.”
Failure to check the box in this instance would turn out to have a very relatively small impact on the patent term adjustment (PTA) granted to the application but presumably a very costly impact to Acetelion’s bottom line.
Actelion’s patent application eventually issued with a total accrued patent term adjustment (PTA) of 41 days. Upon Actelion’s request, the USPTO recalculated the amount of PTA, and reduced it to 40 days. The original calculation of 41 days of PTA used January 16, 2012, i.e., the 30-month date, as the starting date of the 14-month period to issue a qualifying Office Action before PTA began accruing. However, because January 16, 2012 was a federal holiday, the USPTO determined that the commencement date did not actually begin until January 17, 2012.
Actelion filed a petition for reconsideration of the recalculated PTA, asserting that the patent was entitled to 45 days of PTA based on the completion of all of the §371(c) requirements four days before the 30-month date, or at least 41 days of PTA based on the January 16, 2012 30-month date. The USPTO denied the petition, and Actelion filed suit in the Eastern District of Virginia. The Eastern District of Virginia granted summary judgment in favor of the USPTO. Actelion appealed this decision to the CAFC.
On appeal Actelion argued that an express request to begin national examination was not required to fulfill all the requirements of section 371 and thus begin the 14-month period for calculating PTA. Actelion also argued that even if an express request was required, a similar statement made by Actelion in a Preliminary Amendment on the day of filing was sufficient. However, the CAFC disagreed. The CAFC pointed out that even when viewed most favorably to Actelion, the request that was made in the Preliminary Amendment was precatory and failed to reference §371(f), the PCT, or the national stage. Combined with the unchecked “express request” box of the PTO transmittal form, the CAFC found that the request was at least inconsistent or ambivalent and perhaps amounted to an express election not to commence the national stage early.
Actelion also argued that at the latest, commencement of the national stage began on January 16, 2012, despite the fact that this date was a federal holiday. The CAFC again agreed with the USPTO, holding that national stage commencement cannot occur on a federal holiday and instead begins on the next workday. The CAFC observed that Actelion’s arguments were premised on the assumption that any time period of inaction that is not attributed to the applicant should inure to the applicant’s benefit in the form of PTA. The Federal Circuit went on to point out that the PTA statutes only restore “undue delays in patent examination caused by the PTO,” and that inaction on a holiday is also not attributable to the PTO.
It is not evident from the Federal Circuit
decision whether the failure to check the box for the “express request” on
the PTO transmittal form was a clerical error, a failure to understand relevant
PTA statutes and rules, or something else entirely. However, pharmaceutical
companies and the patent practitioners that represent them should recognize
from this case that expending a little bit more time and expense on the front
side of filing the application to ensure that potential PTA is not being
jeopardized could go a long way in avoiding substantially higher expenses on
the back side to try to challenge the USPTO’s PTA determination.
A final take away from this case is that if a patent is likely to still have value at the terminal portion of its patent term, the PTA calculated upon the issuance of the patent should be closely reviewed. The PTA indicated on the letters patent is calculated by USPTO software, which has been known to be prone to errors, and which sometimes results in a calculation of less PTA than the patentee is legally entitled, and sometimes results in a calculation of more PTA (as seen in this instant case). The USPTO only hand calculates the PTA if the original calculation is challenged.
Evergreening Pharmaceutical Patents and Post-Grant Review
-- by Christopher Wright
Collegium Pharmaceutical Inc. recently asked the Patent Trial and Appeal Board (PTAB) to cancel an opioid-related patent, U.S. Patent No. 9,693,961, granted to Purdue Pharma LP in a request for a post-grant review (PGR). The case may indicate potential new niches for using post-grant review to challenge pharmaceutical patents, as opposed to more traditional routes such as an inter partes review (IPR).
Congress intended PGRs to be more popular by removing disincentives found in other administrative remedies and by giving PGRs a broader range of statutory grounds to challenge patents. For example, a petitioner in a PGR could challenge a patent under any of 35 U.S.C. §§101, 102, 103, 112, and 251, whereas IPRs are limited to challenges under 35 U.S.C. §§ 102 & 103 based on patents or printed publications. However, while drafting the Leahy-Smith America Invents Act (AIA), Congress included “could have raised” language in the estoppel provisions of the PGR. Thus, a PGR petitioner may be estopped from arguing a patent claim is invalid based on reasons that were “raised or reasonably could have raised” during the PGR. Inclusion of this language into the AIA was potentially inadvertent, at least according to Senator Leahy whose name appears in the title of the Act. Coupled with the provision that a PGR petition must be filed within 9 months of the issuance of the patent, a potential challenger might not have enough time to evaluate all of the possible avenues for invalidating a patent using a PGR.
Enter “evergreening” pharmaceutical patents. Pharmaceutical companies often try to extend the life of patent protection by patenting small changes to their products, such as changing drug delivery systems. Such “evergreening” pharmaceutical patents may provide a sweet spot for PGRs insofar as the patent landscape and a number of the issues related to patentability would not necessarily be “new” to potential challengers and could be evaluated within the 9-month window required for a PGR petition.
In the case of Collegium’s challenge to Purdue Pharma’s U.S. Patent No. 9,693,961, the patent-at-issue is directed to a gelling agent for formulating a new time-released version of OxyContin®. The new formulation avoids potential drug abuse problems with previous time-released versions and will not provide “hit” even when the pill is crushed.
CAFC Criticizes PTAB’s “Subjective Preference” Analysis in Teaching Away Case
-- by Kenneth Salen
A popular rebuttal to an obviousness rejection is that a reference “teaches away” from the claimed subject matter. However, in practice, it is rare for the USPTO to concede that a reference includes a technical explanation that diverges sufficiently strongly as to satisfy the teaching away standard. In Polaris Industries, Inc., v. Arctic Cat, Inc., No. 2016-1807, 2016-2280 (Fed. Cir. February 9, 2018), the Court of Appeals for the Federal Circuit (CAFC) recently clarified how a “teaching away” may not be disregarded even if what is expressed is a general preference.
In an inter partes review (IPR) initiated by competitor Arctic Cat, Inc., the PTAB determined that certain claims of U.S. Patent No. 8,596,405 directed to a side-by-side all-terrain vehicle (ATV) were unpatentable as obvious in view of a combination of U.S. Patent Nos. 7,658,258 to Denney and 5,327,989 to Furuhashi. Many of the claims of the ‘405 patent are directed to the placement of components such as a fuel tank, a battery, and a front driveshaft on the ATV so as to achieve a low center of gravity.
During the IPR, Polaris introduced undisputed evidence that placing a fuel tank underneath one of the seats disclosed in the asserted prior art would have required significantly raising the occupancy area. Thus, Polaris argued, such a modification would have been contrary to prior art’s teaching that, “[b]y raising the occupancy area, the center of gravity of the ATV is also raised,” which results in “a decrease in vehicle stability and subsequent increased risk of rollovers.”
But the PTAB rejected Polaris’s supposed “conflat[ion] [of] known modifications having known benefits with subjective preferences,” and held “that an obviousness analysis should focus on whether a modification is known to implement and has known benefits.” The PTAB further stated that “one of ordinary skill has the ability to weigh the various benefits and disadvantages based on ‘subjective preferences,’” and characterized the teaching of a low center of gravity in the prior art as a mere subjective preference.
The question considered by the CAFC was whether the PTAB properly considered evidence introduced by the parties in evaluating whether one of skill in the art would have been motivated to modify the prior art to meet the limitations of the claims. The CAFC found that the PTAB erred by failing to analyze whether the asserted prior art “teaches away” from the claimed subject matter by determining whether “a person of ordinary skill, upon reading [the prior art reference], would be discouraged from following the path set out in [the prior art reference], or would be led in a direction divergent from the path that was taken by the applicant.”
The CAFC concluded that the PTAB’s analysis of the claims was inadequate because the PTAB (1) failed to consider Polaris’s uncontested evidence that skilled artisans would not have been motivated to place a fuel tank under the primary reference’s seat; and (2) applied a “subjective preferences” legal analysis that not only finds no support in CAFC case law, but also runs contrary to the concept of teaching away.
In its decision, the CAFC emphasized that it has “never articulated a framework for analyzing whether claims would have been obvious that includes the phrase ‘subjective preference’ or that permits a tribunal to wholly disregard the significance of prior art teachings based on such a characterization.”
The CAFC listed three specific problems with the analysis applied by the PTAB. First, by completely disregarding certain teachings as ill-defined “subjective preferences,” the PTAB’s approach invited the “distortion caused by hindsight bias” into the fold. Second, the PTAB focused on what a skilled artisan would have been able to do, rather than what a skilled artisan would have been motivated to do at the time of the invention. Third, the PTAB’s analysis encouraged the fact-finder to outright discard evidence relevant both to “teaching away” and to whether skilled artisans would have been motivated to combine references.
On remand, the PTAB must determine whether the asserted prior art merely expresses a general preference for maintaining very low seats or whether the teachings of the prior art “criticize, discredit, or otherwise discourage” significantly raising the occupancy area of an ATV to add a fuel tank under one of the seats. Even if the PTAB determines that the prior art does not teach away because it merely expresses a general preference, the statements in the prior art are still relevant to the obviousness determination.