|
|
|
|
|
Greenblum & Bernstein, P.L.C. PHARMA/BIOTECH NEWSLETTER Recent News in Intellectual Property |
|
|
April 2018 |
|
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” Contact Us: Walter
Schlapkohl, Ph.D., Esq. wschlapkohl@gbpatent.com 703-716-1191 (phone) 703-716-1180 (fax) |
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.[1]
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.[2] 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.[3] 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. |
