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29 June 2023Big PharmaLiz Hockley

US appeals court upholds decision on wrinkle treatment

Board did not violate procedure regarding ‘preliminary guidance’ say Federal Circuit judges | Medytox’s substitute claims found to be ‘unpatentable’.

On Tuesday (June 27) the US Court of Appeals for the Federal Circuit quashed a bid by Medytox to revive an invalidated patent related to treating wrinkles, in a precedential decision that dealt with the substitution of claims.

Judges Dyk, Reyna and Stark upheld the view of the Patent Trial and Appeal Board ( PTAB) that the South Korean biotech firm should be denied its motion to substitute certain claims of US Patent No. 10,143,728. The patent covers an animal-protein-free botulinum toxin composition that has both cosmetic and non-cosmetic uses.

They found that the board’s claim construction of the responder rate limitation and finding of lack of enablement for the substitute claims were “reasonable and supported by substantial evidence”. This handed a victory to Swiss pharma firm Galderma, which had requested the post-grant review that invalidated the patent back in 2021.

Motion to amend

Galderma, which develops dermatology products, requested post-grant review of the ‘728 patent. In response, Medytox filed a motion to amend, seeking to cancel certain claims and substitute others. Galderma opposed the motion, arguing among other things that the claims added new matter.

In its “preliminary view”, the PTAB found that Medytox’s proposed responder-rate limitation did not add new matter, stressing that the views expressed in the preliminary guidance were “subject to change” and “not binding on the board” regarding its final written decision.

Medytox then filed a revised motion to amend. In its final written decision, issued in July 2021, the board ultimately found that the substitute claims “impermissibly introduced new matter” and were “unpatentable for a lack of written description”.

It concluded that the full scope of the claims was not enabled and that a skilled artisan would not have been able to achieve higher responder rates under the guidance provided in the specification without undue experimentation.

'Arbitrary and capricious'

In its appeal to the Federal Circuit, Medytox challenged the PTAB’s findings on claim construction, written description, and enablement. The firm argued that the specification does not need to include a working example of “every possible embodiment to enable the full scope of the claims”.

However, the appeals court found no error in the board’s findings that Medytox had failed to demonstrate enablement because a skilled artisan “would not have been able to achieve” responder rates higher than the limited examples provided in the specification.

It also challenged the board’s ‘Pilot Program’ concerning motion to amend practice and procedures, which it said it complied with in good faith. There was no reason or explanation to suggest the board might later rule differently, Medytox argued, and that its “inconsistent conclusions on a nearly identical record” rendered its decision “arbitrary and capricious”.

In her capacity as intervenor in the case, director of the US Patent and Trademark Office Kathi Vidal rejected this challenge, asserting that the preliminary guidance was “initial, preliminary, [and] non-binding” on whether the patent owner has demonstrated a reasonable likelihood that it met the requirements for filing a motion to amend.

The judges found Medytox’s arguments “unpersuasive” and determined no violation of due process regarding the board’s preliminary guidance, affirming the denial of Medytox’s revised motion to amend substitute claims.

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Big Pharma
20 July 2021   The Patent Trial and Appeal Board has ruled that a Medytox patent for its wrinkle treatment should not have been granted.
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30 January 2020   The US Court of Appeals for the Federal Circuit has revived patent infringement litigation brought against Teva by dermatological company Galderma, a former subsidiary of Nestlé Skin Health.

More on this story

Big Pharma
20 July 2021   The Patent Trial and Appeal Board has ruled that a Medytox patent for its wrinkle treatment should not have been granted.
Americas
30 January 2020   The US Court of Appeals for the Federal Circuit has revived patent infringement litigation brought against Teva by dermatological company Galderma, a former subsidiary of Nestlé Skin Health.

More on this story

Big Pharma
20 July 2021   The Patent Trial and Appeal Board has ruled that a Medytox patent for its wrinkle treatment should not have been granted.
Americas
30 January 2020   The US Court of Appeals for the Federal Circuit has revived patent infringement litigation brought against Teva by dermatological company Galderma, a former subsidiary of Nestlé Skin Health.