Claim Construction Should be Well-Grounded in Intrinsic Evidence
| August 3, 2023
MEDYTOX, INC. v. GALDERMA S.A.
Decided: June 27, 2023
Before DYK, REYNA, and STARK, Circuit Judges.
Summary
The CAFC upheld a decision by the PTAB in a post-grant review involving a patent for a botulinum toxin treatment. The patent owner attempted to replace original claims with substitute claims was rejected by the Board, leading to the cancellation of the original claims and the finding that the substitute claims were unpatentable. The court affirmed the Board’s decision, emphasizing the challenges of amending claims in post-grant proceedings.
Background
Medytox owns U.S. Patent No. 10,143,728 (‘728 patent), issued in December 2018, which is directed to a method that uses an animal-protein-free botulinum toxin composition for cosmetic and non-cosmetic applications. Galderma filed a petition for post-grant review (PGR) proceedings at the PTAB to challenge the validity of ‘728 patent claims.
During the PGR proceedings, Medytox attempted to modify all 10 claims of its ‘728 patent and obtained initial feedback on proposed substitute claims under the PTAB’s amendment motion pilot program. The PTAB’s preliminary guidance revealed that Medytox did not meet the statutory requirements for submitting an amendment motion. However, the board acknowledged that the new phrase claiming “a responder rate at 16 weeks after the first treatment of 50% or greater” neither introduced new matter nor suggested a range of responder rates. Despite this, Galderma opposed Medytox’s substitute claims, arguing that the ‘728 patent’s specification only revealed responder rates up to 62% in clinical trials, whereas Medytox’s claim language encompassed a range of responder rates from 50% to 100%.
Contrary to its initial guidance, the PTAB issued a final written decision in the PGR proceedings, ruling that the substitute claims introduced new matter regarding to the responder rate limitation. Medytox asserted that the 50% responder rate was claimed as a minimum threshold and not a range. Nevertheless, the PTAB found the substitute claim language to be invalid for indefiniteness after reviewing the complete record, as “a skilled artisan would not have been able to achieve higher responder rates under the guidance provided in the specification without undue experimentation.” Ultimately, the Board cancelled the original claims 1-5 and 7-10 and also found that the substitute claims to be unpatentable.
Below, substitute claim 19 is provided as a representative of the substitute claims.
19. A method for treating glabellar lines
a conditionin a patient in need thereof, comprising:locally administering a first treatment of
therapeutically effective amount ofa botulinum toxin composition comprising a serotype A botulinum toxin in an amount pre-sent in about 20 units of MT10109L, a first stabilizer comprising a polysorbate, and at least one additional stabilizer, and that does not comprise an animal-derived product or recombinant human albumin;locally administering a second treatment of the botulinum toxin composition at a time interval after the first treatment;
wherein said time interval is the length of effect of the serotype A botulinum toxin composition as determined by physician’s live assessment at maximum frown;
wherein said botulinum toxin composition has a greater length of effect compared to about 20 units of BOTOX®, when
whereby the botulinum toxin composition exhibits a longer lasting effect in the patient when com-pared to treatment of the same condition with a botulinum toxin composition that contains an animal-derived product or recombinant human albumin dosed at a comparable amount andadministered in the same manner for the treatment of glabellar linesand to the same locations(s)as that of the botulinum toxin composition; andwherein said greater length of effect is determined by physician’s live assessment at maximum frown and requires a responder rate at 16 weeks after the first treatment of 50% or greater.
that does not comprise an animal-derived product or recombinant human albumin, wherein the condition is selected from the group consisting of glabellar lines, marionette lines, brow furrows, lateral canthal lines, and any combination thereof.
Discussion
The key issues in the case were the responder rate limitation and whether the substitute claims contained new matter not found in the patent specification. The responder rate limitation referred to the proportion of patients who responded favorably to the treatment with Medytox’s animal-protein-free botulinum toxin composition. In the appeal, Medytox contested the Board’s findings on claim construction, new matter, written description, and enablement, as well as the Board’s Pilot Program on amending practice and procedure under the Administrative Procedure Act.
The Board’s interpretation of the responder rate limitation as a range was the first issue addressed. Medytox argued that the responder rate limitation should be viewed as a binary (“yes-or-no”) inquiry, serving as a “threshold” for determining whether the animal protein-free composition has a more extended effect than BOTOX®.
According to Galderma, Medytox failed to cite intrinsic evidence supporting its suggested claim construction. Galderma also asserts that Medytox did not propose its “minimum threshold” interpretation of the responder rate limitation until after the Preliminary Guidance was released. Medytox did not substantively counter Galderma’s claim but instead insisted that extrinsic evidence supports their claim construction.
The court upheld the Board’s decision and noted that it is typically considered that intrinsic evidence, such as the specification and the prosecution history, is the most crucial consideration in a claim construction analysis. The court cited the U.S. Supreme Court’s recent landmark decision in Amgen v. Sanofi (2023) when nixing Medytox’s challenge to the PTAB’s lack of enablement determination. Under Amgen, “[t]he more one claims, the more one must enable,” and the court noted that data tables included with the ‘728 patent’s specification only disclosed responder rates of 52%, 61% and 62%. While the parties do not substantially dispute the responder rate limitation as a “threshold” or “range,” the Board’s construction of the responder rate limitation as a range in the substitute claims was ultimately affirmed.
Furthermore, the court concluded that the Board’s change in claim construction between its Preliminary Guidance and final written decision was not arbitrary and capricious and did not violate due process or the Administrative Procedure Act (APA). The court emphasized that the Board’s Preliminary Guidance, as indicated in its statement, is “initial, preliminary, [and] non-binding”, and only provides initial views on whether the patent owner has demonstrated a reasonable likelihood of meeting the requirements for filing an amendment motion. The court cited previous rulings which state that the Board must reevaluate matters based on the full record, especially when the standard changes, and that it is encouraged to modify its viewpoint if further development of the record necessitates such a change. Therefore, the Board’s decision to alter its claim construction for the responder rate limitation was not deemed arbitrary and capricious.
Takeaway
- The evolution of the record over the course of a proceeding can significantly impact the outcome, necessitating adjustments in views and decisions as the evidence develops.
- Arguments related to claim construction should be well-grounded in the intrinsic evidence, which includes the specification and the prosecution history, as these are typically the most important considerations in claim construction.
- Claims should be well-grounded in the specification.
