On April 1, the U.S. Patent & Trademark Office published new rules for AIA proceedings before the Patent Trial & Appeal Board, including inter partes reviews (IPRs). IPRs are becoming an important tool for biosimilar manufacturers to challenge patents on biologic drugs (for example, see here, here, and here).
Some of the most notable changes to the rules include:
Pre-institution expert testimony. Patent owners will now be permitted to file expert declarations or other new testimonial evidence with a preliminary response (i.e. prior to institution of the IPR). For the purpose of determining whether to institute a trial, however, factual disputes created by such evidence will be resolved in favor of the petitioner. This new rule has the potential to significantly change the dynamics of the pre-institution IPR process, particularly in proceedings related to patents for biologic drugs in which expert testimony could facilitate the Board’s understanding of complex technical issues.
Word counts. Page limits for many filings will be replaced with word counts. IPR and derivation petitions, which were previously limited to 60 pages will instead be limited to 14,000 words. CBM and PGR petitions, previously limited to 80 pages, will now be limited to 18,700 words. Briefs previously limited to 25 pages, such as replies to patent owner responses to petitions, will be limited to 5,600 words. Petitions with claim charts containing argument will no longer require correction and resubmission, but claim charts will be subject to the word limit, and may thus be less likely to be used by petitioners under the new rules. Petitioners can move to waive the word-count limit.
Duty of candor. Akin to Rule 11 for filings in federal court, submissions to the PTAB now must include a signed certification from the party, their attorney or patent agent that the submission complies with the duty of good faith and candor. Sanctions for noncompliance are now possible.
Service and filing of demonstratives. Demonstrative exhibits must be served at least seven business days before the oral argument and filed no later than the time of the oral argument.
Motions to Amend. In moving to amend claims, a patent owner is required to show that the proposed amended claims are patentable over: a) any material art in the prosecution history of the patent; b) any material art of record in the current proceeding, including art asserted in grounds on which the PTAB did not institute review; and c) any material art of record in any other proceeding before the USPTO involving the patent. This codifies rules established in previous PTAB decisions.
Claim Construction for soon-to-expire patents. If the patent will expire within 18 months from the entry of the Notice of Filing Date Accorded to Petition (i.e. before the statutory deadline for a final written decision), then either party may request that a district court-type claim construction standard (Phillips) be used to interpret the claims, rather than the “broadest reasonable construction” standard usually applied in AIA trial proceedings. A motion under this rule will trigger a conference call with the PTAB to discuss whether the motion is appropriate under the circumstances and whether any other briefing is necessary for each party to be able to address adequately the appropriate construction standard. For instance, the petitioner may be afforded an opportunity to address a Phillips-type construction analysis before the patent owner is required to file its preliminary response.
The new rules go into effect on May 2, 2016 and apply to all AIA petitions filed on or after May 2 and to any ongoing preliminary proceedings or trial before the PTO.
Stay tuned for further coverage of PTAB proceedings from Big Molecule Watch.