USPTO backs Wands factors post-Amgen enablement loss
SCOTUS ignored Fed Circ cases and so-called Wands factors in reaching enablement decision | Pivotal question left unanswered | New guidance ‘provides clarity’ and reinforces status quo on enablement decisions.
The US Patent and Trademark Office ( USPTO) has published guidelines relating to the much-scrutinised enablement requirement following the US Supreme Court’s May ruling in Amgen v Sanofi.
The landmark case shone a sharp spotlight on this key requirement in a case concerning patents covering antibodies that were engineered by scientists to reduce cholesterol.
This requirement refers to the stipulation outlined in 35 USC 112(a) that says a “specification in a patent must describe the invention in such terms that one skilled in the art can make and use the claimed invention”.
‘One statutory enablement standard’
In Amgen, the Supreme Court unanimously held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed, were invalid due to a lack of enablement.
In doing so, it affirmed an earlier decision by the US Court of Appeals for the Federal Circuit's decision that the patents at issue failed to adequately enable the full scope of the genus of antibodies.
Commenting on the ruling at the time, Emily Savas, partner at Locke Lorde, told LSIPR that the court made it clear that there is only “one statutory enablement standard,” which requires that “the more a party claims for itself, the more it must enable”.
In its guidance, published yesterday, January 10, the USPTO outlined how its practice of evaluating enablement will remain the same as it was before the Amgen decision, and will be applied to all applications/patents regardless of the claimed technology.
More specifically, the office will continue to rely on the so-called Wands factors which emerged from In re Wands (1988).
Commenting on the guidelines, Ronald Kern, partner at BakerHostetler said that it was “interesting that in reaching its decision, the US Supreme Court Court “did not cite a single Federal Circuit decision nor did it discuss the Wands factors”.
Key question left unanswered
Instead, the court relied upon its own prior decisions. However, the decision left one pressing question for patent attorneys.
As Kern explained: “Among the questions raised by the Amgen decision is whether it applies across all technologies (as opposed to just antibodies or the life sciences space) and what standard is to be used when evaluating undue experimentation.”
In a bid to “promote consistency” during examination and in Patent Trial and Appeal Board proceedings, the USPTO guidelines say that the office will continue to use the Federal Circuit’s Wands factors when evaluating whether undue experiment would be needed to practise the claimed invention.
The guidelines also make it clear that the Wands factors will be used “regardless of the technology”, according to the test’s eight factors:
(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
In its guidelines, the USPTO stressed how the Supreme Court had emphasised in Amgen that while the case involved a new technology in the form of antibodies, the court had applied the same legal principle for more than 150 years for many different technologies.
Since the Supreme Court relied on precedent from a wide variety of technologies, there is no reason to treat the decision as limited to antibodies or biotechnology, according to the USPTO.
No need for change
Additionally, the office noted that the Supreme Court stated that the specification “is not necessarily inadequate” just because it leaves the skilled artisan to perform some measure of adaptation or testing.
While conceding that the Supreme Court did not explicitly address the Wands factors in Amgen, the USPTO observed that the court did emphasise that “the specification may call for a reasonable amount of experimentation to make and use the full scope of the claimed invention”.
Therefore, the office concluded that consistent with Amgen and the Federal Circuit's post-Amgen decisions when assessing whether the claims in a utility patent application or patent are enabled, USPTO personnel will continue to use the Wands factors—regardless of the technology.
“The Wands analysis should provide adequate explanation and reasoning for a lack of enablement finding in order to facilitate the USPTO's clarity of the record goals, as well as the USPTO's goals of providing consistency between examination and post-grant challenges,” added the guidelines.
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