Holding

In Apotex, Inc. v. Auspex Pharms., Inc., IPR2021-01507, Paper 9 (P.T.A.B. March 9, 2022) (“Institution Decision”), the Patent Trial and Appeal Board (“PTAB”) exercised its discretion under 35 U.S.C. § 325(d) to deny institution of Apotex’s petition for inter partes review (“IPR”).

Background

Apotex (hereinafter “Petitioner”) filed an IPR petition challenging claims 1-3 of Auspex’s (hereinafter “Patent Owner”) U.S. Pat. No. 8,524,733. Claims 1 and 2 are compound claims, while claim 3 is a composition claim. The claims are directed to “a specific deuteration pattern in tetrabenazine that … does not involve deuteration of the carbon-hydrogen bonds of the carbonyl group, the isopropyl group, or any other carbon-hydrogen position in the molecule.” Institution Decision at *6 (emphasis in original).

Petitioner raised three obviousness grounds based on seven references, four of which were allegedly new. Id. at *8. None of the seven references asserted in the Petition disclosed “deuteration - in any pattern - for tetrabenazine or any other drug in its class of benzoquinoline inhibitors.” Id. at *6 (emphasis in original).

Patent Owner argued that the PTAB should exercise its discretion under 35 U.S.C. § 325(d) to deny the petition, since they had overcome similar obviousness rejections during prosecution with expert declarations explaining how one of ordinary skill in the art would have understood the effect of deuterium substitution to be unpredictable. Id. at *20.

PTAB Decision

Under 35 U.S.C. § 325(d), the Director may decline to institute a petition when “the same or substantially the same prior art or arguments previously were presented to the Office.”[1] Advanced Bionics LLC v. Med-EL Elektromedizinische Geräte GMBH,[2] designated precedential on March 24, 2020, organized the Becton, Dickinson[3] factors into a two-part framework for the PTAB to apply when faced with § 325(d) considerations. First, the Board must assess “whether the Examiner considered the same or substantially the same prior art or arguments asserted in the Petition” and, if so, the Board must then “resolve whether Petitioner shows sufficiently that the Examiner erred in a manner material to the patentability of the challenged claims.” Institution Decision at *23 (citing Adv. Bionics).

The PTAB applied the Advanced Bionics framework and exercised its discretion under 35 U.S.C. § 325(d) to deny institution of the petition.

Three References Were the Same or Substantially the Same as References Previously Presented to the Office

Patent Owner argued that three of the seven references identified by Petitioner were the same or substantially the same as references previously presented to the Office. Petitioner acknowledged that two of the references were “cited during prosecution and considered by the Examiner,” but argued that the other reference, though cited during prosecution, was “not substantively considered by the Examiner.” Institution Decision at*25 (emphasis altered). Citing Advanced Bionics, the PTAB held that a reference submitted, even if not substantively discussed during prosecution, still qualifies as prior art previously presented to the Office. Id. Furthermore, the PTAB agreed with Patent Owner that the disclosures Petitioner was relying on from the third reference were also taught in one of the other two references. Id. at *25-26. Therefore, the PTAB found that these three references were previously presented to the Office during Examination. Id. at *26.

Four References Were Cumulative of a Reference Previously Presented to The Office

The PTAB held that while the other four references identified by Petitioner were not before the Examiner and no arguments were made during prosecution regarding those teachings, those four references were identical or similar to the disclosure of an eighth reference, Foster 1985, which had been considered. Institution Decision at *29. Specifically, Petitioner had cited the four references to address the specific deuteration pattern in tetrabenzine claimed in the patent in which both of the two adjacent methoxy groups are deuterated. Id. at *26. But during prosecution, the Examiner considered the Foster 1985 textbook containing “an entire section” “on the benefits and drawbacks of deuteration of methoxy groups in drugs.” Id. at *26. Therefore, the PTAB held the other four references were cumulative of the Foster 1985 textbook previously presented to the Office. Id. at *29.

Petitioner Raised the Same or Substantially the Same Arguments Previously Presented to The Office

Patent Owner argued that the arguments raised by Petitioner were the same or substantially the same arguments previously made during prosecution. Institution Decision at *30. Citing Advanced Bionics, the PTAB stated that when assessing a request for denial under § 325(d), the PTAB focuses on “‘the extent of the overlap between’ arguments made during examination and those presented in a petition for review.” Id. The PTAB examined the obviousness arguments Petitioner raised and found that these arguments were “substantially the same argument regarding the predictability of deuteration considered extensively by the Examiner.” Id. at *31.

Petitioner Did Not Show Any Material Examiner Error

Petitioner argued that the Examiner made three material errors:

  1. The Examiner materially erred by failing to consider “any reference disclosing the benefits of deuteration at methoxy groups.” Institution Decision at *32 (emphasis in original).
  2. The Examiner materially erred by “’inexplicably’ changing position after the first Office action,” arguing that the Examiner had no rational basis for reversing position on obviousness. Id. at *32-33.
  3. The “new data supporting the reduced side effects presented by the Patent Owner in support of unexpected results ‘are legally erroneous.’” Id. at *33.

Regarding the alleged first material error, the PTAB found that “the Examiner possessed a firm understanding of Foster 1985 and its relevant subject matter” disclosing the benefits of deuteration at methoxy groups. Thus, Petitioner did not show a material Examiner error. Id. at *32.

In response to the alleged second material error, the PTAB found that the Petitioner did not show that the Examiner “inexplicably” changed position. Rather, the Examiner responded to the Patent Owner’s submission of evidence of unexpected results, a second expert declaration, and a telephone interview. Id. at *33.

Lastly, regarding the alleged third material error, the PTAB held that the Petitioner did not demonstrate sufficiently that the Examiner committed a material error in evaluating the expert declaration or the prior art during prosecution. Id. at *35.

The PTAB concluded with a comment on the showing required to support a finding of material Examiner error that would “tip the balance” in favor of granting institution rather than exercising discretion to deny review:

We understand that Petitioner disagrees with the Examiner’s treatment of the prior art and the Bradbury Declarations in resolving the issue of the dose and dosage form discrepancies during patent prosecution. But in the absence of any showing that the Examiner relied upon materially false or incomplete statements during prosecution, or otherwise failed to properly apply the standard for assessing unexpected results, we find Petitioner’s information insufficient to support a finding of material Examiner error. ... Significantly, we apply the principle that, “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments” by the Examiner, then “it cannot be said that the Office erred in a manner material to patentability.”

Id. (emphasis added)

Takeaways

This case reminds petitioners who are relying on the same or a similar reference previously considered during prosecution or in another USPTO proceeding to be prepared to show that the grounds presented in the Petition amount to more than just a disagreement with the Examiner’s ultimate conclusion. Petitioners must proactively address the second part of the Advanced Bionics framework: showing the examiner erred. Also, this case demonstrates how solid patent prosecution supports obtaining a PTAB denial under 35 U.S.C. § 325(d). It may dissuade potential petitioners from even filing an IPR or PGR in the first place.