Category: USPTO

Recently Created USPTO Precedential Opinion Panel to Decide Joinder Issues in First Review

Recently Created USPTO Precedential Opinion Panel to Decide Joinder Issues in First Review

In September, the United States Patent and Trademark Office (USPTO) revised its Standard Operating Procedures 2, addressing among other things, the new Precedential Opinion Panel and the processes the panel will follow during any review. The newly created panel recently accepted its first case where it will consider issues of party and subject matter joinder as part of a larger review of patentability of patents directed to fracking technology. Proppant Express Investments v. Oren Technologies, IPR2018-00914, Paper 24 (PTAB Dec. 3, 2018). This blog post will provide an overview of the Precedential Opinion Panel and the issues it will address in its first review. USPTO Standard Operating Procedures 2, “sets forth the composition of the Precedential Opinion Panel, describes the mechanisms for invoking Precedential Opinion Panel review of a Board decision recently issued in a pending case, and explains the Precedential Opinion Panel review process.” The panel will typically consist of the USPTO Director, the USPTO Commissioner for Patents, and the Chief Judge of the Patent Trial and Appeal Board (PTAB). The resulting decisions will be precedential and have binding authority. Under USPTO procedures, there are three ways to obtain a rehearing from the Precedential Opinion Panel: “The Director may...

Federal Circuit Affirms PTAB Finding That CRISPR-Cas9 Inventions Are Patentably Distinct

Federal Circuit Affirms PTAB Finding That CRISPR-Cas9 Inventions Are Patentably Distinct

The Federal Circuit in Regents of the University of California v. The Broad Institute weighed in on the disputed inventorship of the breakthrough CRISPR-Cas9 technology, holding that the University of California (“UC”)’s invention of the mechanism in vitro did not render obvious Broad’s claims to the mechanism in eukaryotic cells. Gibbons previously reported on the technical background of CRISPR-Cas9. This post will focus on the inventorship issue and the implications of the Federal Circuit decision. In August 2012, UC researchers published an article showing that the CRISPR-Cas9 system, derived from prokaryotic cells like bacteria, could be used in vitro in a non-cellular experimental environment. Several research groups independently applied CRISPR-Cas9 in eukaryotic cells within months of UC’s disclosure. In February 2013, Broad researchers published an article describing the use of CRISPR-Cas9 in a human cell line. Both UC and Broad sought patent protection. UC, the senior party, claims the CRISPR-Cas system without referring to a particular cell type or environment. Broad, the junior party, claims the CRISPR-Cas system limited to use in eukaryotic cells, i.e., plant and animal cells. The Patent Trial and Appeal Board (PTAB) determined there was no interference-in-fact because, given the differences between eukaryotic and prokaryotic systems, a person...

Surveying the CRISPR-Cas9 Patent Landscape in the United States

Surveying the CRISPR-Cas9 Patent Landscape in the United States

This post will discuss the patent landscape of the groundbreaking CRISPR-Cas9 systems in the United States, including pending legal disputes. A CRISPR-Cas9 system is a combination of protein and ribonucleic acid (“RNA”) that can alter the genetic sequence of an organism. CRISPR-Cas systems occur naturally in bacteria and help the bacteria target and cut identified virus deoxyribonucleic acid (“DNA”). The CRISPR-Cas9 system is being developed as a powerful tool to modify specific DNA in the genomes of more complicated organisms, including plant and animal cells. For the purpose of this overview, the mechanism of CRISPR-Cas9 is explained in the Patent Trial and Appeal Board (PTAB)’s Broad Institute v. The Regents of the University of California interference decision. As the decision explains, the CRISPR-Cas9 system comprises three effective parts: a guide-RNA sequence, an activator-RNA sequence, and a protein called Cas9. CRISPR-Cas9 alters a target DNA molecule by first binding the guide-RNA sequence to a specific sequence in the DNA of interest. The activator-RNA sequence then interacts with the Cas9 protein, and the Cas9 protein cuts the target DNA at a specific site. By linking a DNA-cutting protein (Cas9) to a specific site on the target DNA, the CRISPR-Cas9 system achieves specific targeted...

Supreme Court To Review Whether Non-Public Sales Are Invalidating Under Post-AIA Section 102

Supreme Court To Review Whether Non-Public Sales Are Invalidating Under Post-AIA Section 102

The Supreme Court recently agreed to review Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., a case with broad implications for the pharmaceutical industry. In the opinion below, the Federal Circuit held that after the America Invents Act (“AIA”), “if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale” for the sale to be invalidating under Section 102. The Court granted Helsinn’s petition for certiorari to answer “[w]hether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.” Before the AIA, § 102(b) barred the patentability of an invention that was “patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent.” By enacting the AIA, Congress amended § 102 to bar the patentability of an “invention [that] was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before...

Senator Hatch Proposes Legislation Forcing Challengers to Choose Between Filing a Hatch-Waxman Action or Filing an IPR

Senator Hatch Proposes Legislation Forcing Challengers to Choose Between Filing a Hatch-Waxman Action or Filing an IPR

On June 13, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (“IPR”) process for pharmaceuticals. The senator published a press release summarizing and explaining the proposed legislation. The amendment, titled the Hatch-Waxman Integrity Act of 2018, intends to “restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development” by “prevent[ing] alternative procedures for challenging drug patents from tilting the playing field contrary to Hatch-Waxman’s design.” The proposed legislation would amend Sections 505(b)(2) and 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 355(b)(2) and 355(j)(2)(A) respectively) to require the applicant to certify to the FDA that “neither the applicant nor any party in privity with the applicant, has filed, or will file, a petition to institute inter partes review” in order to be eligible for abbreviated regulatory approval under the Hatch-Waxman Act. The applicant would further need to certify that it “is not relying in whole or in part on any decision issued by the Patent Trial and Appeal Board in an [IPR]” in making the certification that the relevant listed patent is invalid or will not be infringed. According to Senator...

USPTO Proposes a New Rule to Use Narrower Phillips Standard During Claim Construction in AIA Trial Proceedings

USPTO Proposes a New Rule to Use Narrower Phillips Standard During Claim Construction in AIA Trial Proceedings

On May 9, 2018, the United States Patent and Trademark Office (USPTO) proposed to amend the current rules to change the claim construction standard used in America Invents Act (AIA) reviews and bring it in line with the standard used in district court and ITC proceedings. Under the amended rules, the Patent Trial and Appeal Board (PTAB) would no longer use the broadest reasonable interpretation (BRI) standard for claim construction, and instead would use the narrower Phillips standard. The proposed rules would apply to claim interpretations occurring in inter partes review (IPR), post-grant review (PGR), and covered business method (CBM) patents proceedings. The Board currently construes unexpired patent claims and proposed claims in AIA trial proceedings using the BRI standard, as directed by 37 CFR 42.100(b), 42.200(b), and 42.300(b). Each of these sections currently provides that “[a] claim in an unexpired patent that will not expire before a final written decision is issued shall be given its broadest reasonable construction in light of the specification of the patent in which it appears.” This standard differs from the Phillips standard used by district courts. Under the proposed changes to these sections, the PTAB will adopt the Phillips standard and construe claims “given their...

Rule Change Alert! The Bayh-Dole Act Has New Time and Reporting Requirements

Rule Change Alert! The Bayh-Dole Act Has New Time and Reporting Requirements

On April 30, 2018, The National Institute of Standards and Technology (NIST) issued rule changes regarding the Bayh-Dole Act. The Bayh-Dole Act was enacted in 1980 as the Patent and Trademark Law Amendments Act (Pub. L. No. 96-517), amended in 1984 by the Trademark Clarification Act of 1984 (Title V of Pub. L. No. 98-620), and again in 2000 by the Technology Transfer Commercialization Act of 1999 (Pub. L. No. 106-404). The Bayh-Dole Act created a uniform policy that allows small businesses and nonprofit organizations the option to retain title to inventions made under government contracts, grants, or cooperative agreements that are for the performance of experimental, developmental, or research work. The implementing regulations are found at 37 C.F.R. Part 401 and Federal Acquisition Regulation (FAR) Subpart 27.3. The April 30, 2018 revisions to the Bayh-Dole Act are categorized as follows: No time limit for government to request title. Since implementation, the government had 60 days within which it could request title to any inventions. The new rule removes the 60 day notice period. Quicker timeframe to prosecute patent applications. Previously, contractors and grant recipients had to notify the agency who granted them money of their intent to prosecute a...

USPTO Issues Guidance Applying SAS Institute to Pending and Future PTAB Trials

USPTO Issues Guidance Applying SAS Institute to Pending and Future PTAB Trials

On April 26, 2018, the United States Patent and Trademark Office (USPTO) issued a guidance, applying SAS Institute v. Iancu to the America Invents Act (AIA) trial proceedings. The U.S. Supreme Court in SAS Institute held that when the Patent Trial and Appeal Board (PTAB) institutes an inter partes review, it must decide the patentability of all claims challenged in the original petition. The USPTO guidance gives a general outline of how the PTAB will review patents in the future, and how it will handle cases that are already pending. The memo makes clear that the PTAB will no longer have partial institutions: “if the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.” For pending trials in which the PTAB has instituted trial on only some of the petitioned claims, “the panel may issue an order supplementing the institution decision to institute on all challenges raised in the petition.” The final written decision will address, to the extent claims are still pending at the time of decision, “all patent claims challenged by the petitioner and all new claims added through the amendment process.” When supplementing the institution decision, the panel has discretion to manage the...

While the PTO Director has Discretion to Institute an IPR, the Board Must Review All Petitioned Claims Upon Institution

While the PTO Director has Discretion to Institute an IPR, the Board Must Review All Petitioned Claims Upon Institution

The U.S. Supreme Court in SAS Institute v. Iancu held that when the Patent Trial and Appeal Board (PTAB or “the Board”) institutes an inter partes review (IPR), it must decide the patentability of all claims challenged in the original petition. Here, in a case with wide-reaching implications, the questions centered on the United States Patent and Trademark Office (USPTO) Director’s discretion and subsequent control of an IPR. In the underlying case, SAS filed a petition for IPR alleging that all 16 claims of a particular patent were unpatentable. The Board instituted review on nine of the challenged claims and denied review on the rest, eventually finding eight of the instituted claims unpatentable in a final written decision. The Federal Circuit rejected SAS’s argument on appeal that 35 U. S. C. §318(a) required that the Board decide the patentability of all 16 claims challenged in the petition. The Supreme Court, in a 5-4 opinion authored by Justice Gorsuch, reversed the Federal Circuit, striking down partial IPR decisions. The Supreme Court held that the plain text of §318(a) conclusively answers the question presented. The section directs that “[i]f an inter partes review is instituted and not dismissed under this chapter, the [Board]...

The USPTO Under Recently Appointed Director Andrei Iancu Will Promote Innovation and Increase Reliability in Issued Patents

The USPTO Under Recently Appointed Director Andrei Iancu Will Promote Innovation and Increase Reliability in Issued Patents

Speaking to the U.S. Chamber of Commerce on April 11, 2018, recently sworn-in USPTO Director Andrei Iancu gave an impassioned speech about his vision for the patent system. Director Iancu outlined challenges facing the USPTO and goals the agency aspires to achieve, focusing on two main objectives: (1) creating a new pro-innovation, pro-IP dialogue, and (2) increasing the reliability of the USPTO granting patents. Stakeholders should take note of the Director’s objectives and should anticipate policy changes that further strengthen the patent system. Creating a new pro-innovation, pro-IP dialogue One thing is clear from Director Iancu’s remarks: the USPTO under his leadership will strive to help the inventor and incentivize innovation. Consistent with this goal, the USPTO will “create a new narrative that defines the patent system by the brilliance of inventors, the excitement of invention, and the incredible benefits they bring to society.” “And it is these benefits,” Director Iancu continued, “that must drive our patent policies.” Much of the narrative of the patent system in recent memory has focused on curbing abuses of non-practicing entities sometimes referred to as “patent trolls.” And Director Iancu’s remarks suggest that the USPTO will actively try to change that narrative. Iancu explained...