On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on June 14th, the Senate Judiciary Committee voted 16-5 to bring it to the Senate floor for a vote. Presently, generic ANDA filers can pursue challenges using both of these routes at the same time, although some courts may stay litigation pending the outcome of the AIA challenge. The proposed legislation would modify the Food & Drug Cosmetic Act (not AIA) to require the ANDA filer to confirm at the time of making its Par. IV certification that neither the ANDA applicant nor any party in privity has filed, or will file, a petition to institute an IPR or PGR challenge of any patent claiming the reference listed drug.
The PTAB has released a Frequently Asked Questions and Answers document. The Questions and Answers are grouped into the following categories:
- Effect of SAS on AIA proceedings generally
- Effect of SAS on on-going partially-instituted proceedings
- Effect of SAS on instituted challenges previously denied for statutory reasons
- Effect of SAS on future challenges that could be denied for statutory reasons
- Content of institution decisions post-SAS
- For additional questions about SAS
The PTAB has also indicated the FAQs will be updated periodically and encourages stakeholders to continue submitting questions.
In view of the Federal Circuit Decision in Aqua Products, the PTAB has de-designated as precedential MasterImage 3D, Inc. v. RealD Inc., Case IPR2015-00040 (PTAB July 15, 2015) (Paper 42) and has de-designated as informative Idle Free Sys., Inc. v. Bergstrom, Inc., Case IPR2012-00027 (June 11, 2013) (Paper 26). As a replacement, Western Digital Corp. v. SPEX Techs., Inc., IPR2018-00082, -00084 (PTAB Apr. 25, 2018) (Paper 13) has been designated as informative, which provides guidance on motions to amend. More information can be found in the USPTO press release.
We are now a little over a month since the Supreme Court issued its decision in SAS Institute v. Iancu, where the Court held that “[w]hen the Patent Office institutes an inter partes review, it must decide the patentability of all of the claims the petitioner has challenged.” As previously reported, the PTAB issued Guidance on the impact of SAS on AIA trial proceedings and immediately started implementing its interpretation of SAS Institute, including the issuance of “order[s] supplementing [an] institution decision” for partially instituted proceedings to include all challenged claims and all challenged grounds. As of the time of this post, the authors were able to identify over 300 of these types of orders – the last of which issued on May 24. At this point, it is expected the vast majority of orders modifying the scope of trial have been issued by the PTAB. Continue reading this entry
As explained in a prior client alert, two weeks ago the Supreme Court issued its decision in SAS Institute v. Iancu holding that “[w]hen the Patent Office institutes an inter partes review, it must decide the patentability of all of the claims the petitioner has challenged.” The primary significance of SAS is its impact on the Patent Trial and Appeal Board’s (“PTAB”) prior partial institution practice. See e.g., 37 C.F.R. § 42.108(a) (“the Board may authorize the review to proceed on all or some of the challenged claims and on all or some of the grounds of unpatentability asserted for each claim.”). Under SAS¸ and specifically as to claims, the PTAB is no longer able to institute on only some of the challenged claims and any final written decision must address each such claim. Continue reading this entry
Today, the USPTO announced its Notice of Proposed Rulemaking for the Claim Construction Standard used in PTAB Proceedings. As summarized in the Notice:
The United States Patent and Trademark Office (“USPTO” or “Office”) proposes changes to the claim construction standard for interpreting claims in inter partes review (“IPR”), post-grant review (“PGR”), and the transitional program for covered business method patents (“CBM”) proceedings before the Patent Trial and Appeal Board (“PTAB” or “Board”). In particular, the Office proposes to replace the broadest reasonable interpretation (“BRI”) standard for construing unexpired patent claims and proposed claims in these trial proceedings with a standard that is the same as the standard applied in federal district courts and International Trade Commission (“ITC”) proceedings. The Office also proposes to amend the rules to add that the Office will consider any prior claim construction determination concerning a term of the involved claim in a civil action, or an ITC proceeding, that is timely made of record in an IPR, PGR, or CBM proceeding.
Today in Oil States v. Greene’s Energy, the Supreme Court upheld the constitutionality of IPR proceedings, finding that they are a permissible second review of patents conducted by the administrative agency that issues them and not a violation of the right of a property owner to have adjudication of property rights by an Article III court and also comply with the 7th Amendment. The decision was issued by a majority of Justices Thomas, Ginsburg, Breyer, Alito, Sotomayor and Kagan. Justices Breyer, Ginsburg and Sotomayor also issued a concurring opinion, while Justices Roberts and Gorsuch dissented. Continue reading this entry
In connection with a recent “Chat with the Chief” webinar, the Patent Trials and Appeal Board (“PTAB”) released two studies – a study of expanded panels and a study of proceedings challenging orange book-listed patents. Practitioners may find value in reviewing these studies and the conclusions drawn by the PTAB. Continue reading this entry
On Feb. 23, 2018, the Patent Trial and Appeal Board (“Board”) ruled an assertion of Tribal sovereign immunity would not avoid challenges to certain patents that had been assigned to the Saint Regis Mohawk Tribe (“the Tribe”). See Mylan Pharm., Inc. v. Saint Regis Mohawk Tribe, IPR2016-01127, Paper No. 130 (February 23, 2018). In our earlier post entitled “Pharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review” we reported that certain Orange Book-listed patents had been assigned to the Tribe, which licensed the patents back to the original assignee, in an effort to obtain dismissal of the pending inter partes reviews (“IPRs”) against those patents. Continue reading this entry
Obtaining a remand on an appeal from the Patent Trial & Appeal Board (PTAB) is of course a win for the Patent Owner, but may result in an ultimate loss when the case is revisited at the PTAB. The Feb. 12, 2018 Federal Circuit opinion, In Re Hodges, No. 2017-1434, (Fed. Cir. Feb. 12, 2018), highlights the importance of anticipating appellate review when developing the IPR record and choosing response strategies during patent prosecution to put the Patent Owner in the best position possible for a full reversal of the PTAB’s decision rather than a remand. Continue reading this entry