On July 20, 2017, the United States Court of Appeals for the Federal Circuit in In re OptumInsight denied OptumInsight’s petition for writ of mandamus on privilege waiver. The court held that the District Court for the Northern District of California did not clearly abuse its discretion in evaluating the proper scope of waiver.

The ‘897 patent reexamination. In June 1994, Symmetry Health Data Systems, Inc. (Symmetry) responded to a request for proposal (RFP) from Aetna Life Insurance Co. and offered to license its healthcare analytics software, Symmetry Episode Treatment Group (ETG) Program, to Aetna. More than a year later, Symmetry filed a patent application that claims and describes the ETG Program. During prosecution, Symmetry did not disclose its RFP response regarding the software license to the patent office. Symmetry’s application eventually issued as U.S. Patent No. 5,835,897.

Continue Reading Federal Circuit Says PTO Submissions can Waive Privilege to Future Communications

In a first of its kind decision with important ramifications for patentees, the U.S. International Trade Commission (“ITC”) denied a petition to suspend or temporarily rescind remedial orders issued in Investigation No. 337-TA-945 pending appeal of the Patent Trial and Appeal Board’s (“PTAB”) separate finding that the patent claims at issue are invalid.  The ITC has therefore decided to continue to exclude products it found to be infringing certain patents, regardless of the PTAB invalidating the very patents the exclusion order is based upon in separate IPR proceedings.  While this decision aiding patentees may surprise some, it is consistent with the ITC’s practices regarding stays and of giving little deference to IPR proceedings.

Continue Reading ITC Denies Suspension or Temporary Rescission of Remedial Orders after PTAB Invalidates Patents at Issue

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court ruling that claims of a patent directed to the Velcade® cancer treatment drug compound were invalid as obvious. The Court held that the District of Delaware clearly erred by finding U.S. Patent No. 6,713,446 (the ‘446 patent) prima facie obvious to one of skill in the art, and by misapplying the secondary indicia of unexpected success and long-unmet need.

Continue Reading Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

In EmeraChem Holdings LLC v. Volkswagen Group of Am. Inc., the Federal Circuit reminded the PTAB that it must abide by the APA’s requirements of adequate notice and an opportunity to respond when conducting a post-grant review.  While affirming certain challenged claims as being obvious under pre-AIA 35 U.S.C. § 103(a), the Court reversed the PTAB’s obviousness determination on a trio of claims and remanded them for further consideration and clarification.  The PTAB’s conclusion that claims 3, 16 and 20 were obvious was based on the inclusion of a reference that was not properly identified in the petition or Institution Order and which the patent owner never had the opportunity to address during the inter partes review proceeding.

Continue Reading Federal Circuit Puts the Brakes on PTAB Final Written Decision For Procedural APA Violation

On June 19, 2017, the U.S. Patent and Trademark Office (USPTO) announced that it would be extending the Cancer Immunotherapy Pilot Program, which permits patent applications pertaining to cancer immunotherapy to be examined in an expedited fashion.  As earlier discussed in this blog, the Pilot Program was established in support of the Obama White House’s National Cancer Moonshot initiative.  The goal of the Pilot Program is to complete examination of an application within 12 months of special status being granted.  Patent applications that qualify for the Pilot Program will be advanced out of turn for examination without meeting all the current requirements for accelerated examination.

Continue Reading Extension of U.S. Patent and Trademark Office’s Cancer Immunotherapy Pilot Program

On May 17, 2017, the International Trade Commission (ITC) reversed an ALJ’s ruling and found a violation of Section 337 in Certain Air Mattress Systems, Components Thereof and Methods of using the Same (“Certain Air Mattress Systems”), Inv. No. 337-TA-971, due to the importation of certain air mattresses, and components of air mattresses, by the named respondents.  The public version of the Commission opinion has been released and provides future ITC litigants  with guidance regarding the proper allocation of expenses for domestic industry purposes, and how the Commission  views certain types of products for public interest consideration.

Continue Reading ITC Issues Public Commission Opinion Clarifying Methodology for Allocating Domestic Industry Expenses and Issuing Exclusion Order against Product with Medical Applications

In a move that could drastically change the patent law landscape, the United States Supreme Court recently granted certiorari in Oil States Energy Services LLC v. Greene’s Energy Group LLC, No. 16-712, to answer the question whether the inter partes review (IPR) process violates the U.S. Constitution by “extinguishing private property rights through a non-Article III forum without a jury.”

In 2001, Oil States Energy Services LLC (“Oil States”) was granted U.S. Patent No. 6,179,053 for a lockdown mechanism to ensure a mandrel is locked in an operative position during fracking.  Oil States sued Greene’s Energy Group LLC (“Greene’s Energy”) in the Eastern District of Texas in 2012 for infringing this patent, and in turn, Greene’s Energy petitioned the United States Patent and Trademark Office (USPTO) to institute an IPR on the patent.  This petition was granted. After the proceedings, the Patent Trial and Appeal Board (PTAB), the administrative body of the USPTO that handles IPRs, concluded the challenged patent claims were invalid.  Oil States appealed to the Federal Circuit, which affirmed the decision, and Oil States then petitioned the Supreme Court for certiorari.

Continue Reading Supreme Court to Decide the Constitutionality of Inter Partes Review

This article is first in a series focusing on various issues related to Patent Term Adjustment.  Part 1 is a general overview of how to calculate patent term adjustment, without addressing the numerous factors that can affect patent term adjustment that will be examined in future articles.

Why PTA Exists

Under the pre-GATT regime, Patent Term Adjustment (“PTA”) did not exist in the U.S. because patent term was 17 years from issuance.  Consequently, any delay during examination, on the part of the United States Patent and Trademark Office (“USPTO”) or Applicants, was not a concern.  In fact, during this time, Applicants were in a way incentivized to, and sometimes would, delay examination to prolong their effective patent term, particularly since at the time publication of applications did not occur until issuance of the patent.  However, in 1995 GATT was adopted in an effort to harmonize U.S. patent term with the rest of the world, with patent term in the U.S. now being limited to 20 years from the earliest effective filing date.  As a result, any delays during examination would now erode a patent’s period of enforceability, which could cost Applicants millions of dollars or more.  Unfortunately, the onus was only on Applicants to avoid delays during examination, resulting in USPTO delays costing Applicants days or years of patent term without any recourse.  In an effort remedy this, Congress created PTA.

Continue Reading Calculating Patent Term Adjustment: Part 1

The Patent Trial and Appeal Board (“PTAB”) issued Final Written Decisions regarding Cisco’s U.S. Patent Nos. 6,377,577 (the “’577 Patent”) and 7,023,853 (the “’853 Patent”) on May 25, 2017 and U.S. Patent No. 7,224,668 (the “’668 Patent”) on June 1, 2017.  The PTAB found the ’577 and ’668 Patents invalid but upheld the validity of the ’853 Patent.  The Inter Partes Review (“IPR”) proceedings were brought by Arista Networks in retaliation to Cisco’s accusations of infringement brought in multiple venues, including at the U.S. International Trade Commission (“ITC”), which had just a few weeks earlier upheld the validity of these very same patents and determined that Arista infringed the ’577 and ’668 Patents, and issued exclusion and cease and desist orders accordingly.  Since the IPR decisions issued Arista has filed a petition asking the ITC to suspend its limited exclusion order regarding the ’577 Patent based on the PTAB’s decision and is expected to file a similar request with respect to the ’668 Patent.  On the other side, Cisco plans to appeal the PTAB’s decisions to the Federal Circuit.  The uncertainty created by these inconsistent outcomes is an issue for patent owners, and it will be interesting to see how these cases are resolved.  In addition, this case shows that even though the ITC does not stay its investigations for IPRs, IPRs may still impact ITC proceedings.

Continue Reading PTAB Invalidates Two Cisco Patents Found Valid and Infringed at the ITC

In a unanimous decision issued on June 12, 2017, the Supreme Court for the first time interpreted key provisions of the 2010 Biologics Price Competition and Innovation Act (“BPCIA”). See Sandoz Inc. v. Amgen Inc., No. 15-1195 (U.S. June 12, 2017). The Court’s decision grants more flexibility to biosimilar companies and filers of abbreviated Biologics License Applications (“aBLAs”), holding that (1) a reference product sponsor is not entitled to injunctive relief under federal law for an applicant’s refusal to provide a copy of its aBLA and manufacturing information during the information exchange period contemplated by the BPCIA, and (2) an applicant may provide statutory 180-day pre-launch notice of commercial marketing before its proposed biosimilar product is licensed by FDA. An overview of the parties’ oral arguments before the Court on these issues can be found here.

Continue Reading Amgen v. Sandoz: The Supreme Court’s First Biosimilars Ruling