Last month, in January 2021, the United States Patent and Trademark Office (“USPTO”) published a memorandum (the “January 2021 Memorandum”) clarifying how it will analyze claims for indefiniteness in AIA post-grant proceedings before the Patent Trial and Appeal Board (“PTAB”), namely patented claims in PGRs and CBMs and proposed substitute claims in IPRs.  Prior to the January 2021 Memorandum, the PTAB applied two different approaches: the Packard approach and the Nautilus approach. According to the January 2021 Memorandum, the USPTO will now exclusively use the Nautilus approach, as further explained below.  This aligns the PTAB with the courts in civil actions.

To satisfy the definiteness requirement, a specification must have “one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.”  35 U.S.C. §112(b).

Under the Packard approach, a claim was indefinite if it contained “words or phrases whose meaning is unclear.” In re Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir. 2014) (per curiam). By contrast, the Nautilus approach requires an arguably higher threshold, finding a claim indefinite only if the claim fails to identify the inventive subject matter with “reasonable certainty.”  Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2130 (2014).

The USPTO has traditionally followed the Packard approach, while district courts apply the Nautilus approach. According to the Federal Circuit, the USPTO could properly apply the Packard approach, in the pre-issuance context, because “Congress assigned to the USPTO the responsibility to examine applications to ensure compliance with the statutory criteria” for patentability. More importantly, the applicant plays an “interactive” role pre-issuance and can therefore clarify any initially perceived problems. 751 F.3d at 1311-13. The Federal Circuit later declined to opine on whether the Packard threshold could additionally be applied to AIA post-grant proceedings. See Tinnus Enterprises, LLC v. Telebrands Corp., 733 F. App’x 1011, 1018 (Fed. Cir. 2018).

The question of indefiniteness has been considered “inextricably intertwined” with the claim construction analysis. Cox Commc’ns, Inc. v. Sprint Commc’n Co., 838 F.3d 1224, 1232 (Fed. Cir. 2016). Previously, the USPTO applied the “broadest reasonable interpretation” to the claim construction analysis, while the district courts applied the analysis set forth in Phillips. See Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). In 2018, the USPTO announced that starting November 2018, it would be applying the Phillips claim construction standard for interpreting claims in trial proceedings before the PTAB in order to be consistent with the district courts and to “promote fairness, balance, predictability, and certainty in the patent system.”

Even with the claim construction standard aligned with the district courts, the PTAB and parties were still unclear about whether the indefiniteness analysis should also follow the district courts. Parties began to argue—and the PTAB began to analyze—indefiniteness under both Packard and Nautilus, finding a claim either indefinite or not indefinite under both approaches. See, e.g., Shure Inc. v. ClearOne, Inc., PGR2020-00079, Paper 1 at 29 (PTAB July 28, 2020) (arguing indefiniteness under both Nautilus and Packard); Nippon Suisan Kaisha Ltd. v. Pronova Biopharma Norge AS, PGR2017-00033, Paper 37 at 12 (PTAB Jan. 16, 2019) (finding the claims indefinite under either the Nautilus approach or the Packard approach); Supercell Oy et al v. GREE, Inc., PGR2018-00039, Paper 42 at 42 (PTAB Sept. 6, 2019) (determining the claims are not indefinite under the Nautilus standard or the Packard standard).

In the January 2021 Memorandum, the USPTO clarified that the Nautilus approach is the proper approach for analyzing indefiniteness in AIA post-grant proceedings. The memorandum explained that because the claim construction standard in AIA post-grant proceedings now aligns with the standard used by district courts, and because indefiniteness questions are generally considered as part of the claim construction process, the PTAB’s approach to indefiniteness in AIA post-grant proceedings should similarly align with the analysis used by the district courts and therefore follow the Nautilus approach. As with the claim construction standard, aligning the indefiniteness approach in AIA post-grant proceedings with the courts will “promote consistency and efficient decision making among coordinate branches of government that decide similar issues in co-pending proceedings.”

After November 2018, when many decisions applied both the Packard approach and the Nautilus approach, the percentage of instances in which patented claims were found indefinite decreased compared to when Packard was viewed as the controlling standard. With the USPTO’s January 2021 Memorandum clarifying that the standard in Nautilus is the proper approach, we may see a continued decrease and fewer claims invalidated by the PTAB for indefiniteness.

In Kannuu Pty Ltd. v. Samsung Electronics Co., Ltd., No 19-civ-4297 (S.D.N.Y Jan. 19, 2021), the parties’ forum selection clause in their non-disclosure agreement did not prevent Samsung Electronics Co., Ltd. (“Samsung”) from challenging Kannuu Pty, Ltd.’s (“Kannuu”) patent in an IPR proceeding.  The court held IPR petitions did not fall within the scope of the agreement’s forum selection clause.

Kannuu filed a suit against Samsung for patent infringement and breach of contract.  The parties had entered into a non-disclosure agreement years earlier when Samsung inquired about Kannuu’s search-and-navigation technology.  A confidentiality clause limiting the use of disclosed information and a forum selection clause requiring any proceeding “arising out of” or “relating to” the agreement be brought in a court of New York were included in the agreement.

After Kannuu filed suit asserting five of its patents, Samsung petitioned the PTAB for IPR of all asserted claims of the patents.  The IPR petitions for two of the patents were instituted.  In the district court, Kannuu filed a motion for preliminary injunction to restrain Samsung from proceeding before the PTAB in light of the agreement’s forum selection clause.

The court recognized that it may grant such a preliminary injunction if the forum selection clause is valid and enforceable.  This would require that: (1) the clause was reasonably communicated to the party resisting enforcement; (2) the clause is mandatory; and (3) the claims and parties involved in the suit are subject to the forum selection clause.  The first two requirements were not in dispute, but the parties disputed whether the claims were subject to the forum selection clause.

The court ruled that the IPR proceedings do not fall within the scope of the forum selection clause.  The court applied a plain and ordinary meaning when determining what actions “arise out of” or “relate to” the agreement because no definition defining the scope of these terms was present in the agreement.  The agreement concerned the confidentiality of disclosed information and did not grant intellectual property rights or a license to either party.  With this framework, the court noted the IPR proceedings determine the validity of Kannuu’s patents, which do not affect whether Samsung impermissibly used confidential information in violation of the agreement.  The court recognized that some of the information that arose from the discussions after the non-disclosure agreement may be relevant to the IPR proceedings, but found that connection to be too attenuated to be within the plain meaning of “relating to” the agreement.  Finding the likelihood of success on the merits against Kannuu, the court denied the preliminary injunction.

In 2017, Cytonome filed suit in the Western District of Wisconsin (“the District Court”), accusing ABS of infringing six of its patents, including US Patent No. 8,529,161 (“the ’161 patent”). Subsequently, in October 2017, ABS filed for inter partes review (“IPR”) of the ’161 patent, and the Patent Trial and Appeal Board (“the Board”) issued a decision in April 2019 that invalidated certain claims of the ’161 patent while also finding that ABS had failed to demonstrate several other claims as unpatentable.

Shortly after the Board’s decision, the District Court granted in part a motion for summary judgment by ABS, finding that ABS’s products did not infringe any of the ’161 patent’s claims. Nevertheless, nearly two months later, ABS appealed the Board’s decision. At the beginning of January, the Court of Appeals for the Federal Circuit (“the CAFC”) issued a precedential decision in ABS Global v. Cytonome/St, LLC, dismissing ABS’s appeal as moot.

On appeal, Cytonome argued that ABS lacked standing because Cytonome had disclaimed an appeal of the District Court’s finding of non-infringement. ABS, however, argued that a patent-specific exception to the mootness doctrine articulated in Fort James Corp. v. Solo Cup Co., 412 F.3d 1340 (Fed. Cir. 2005) should govern and hence preclude dismissal. The CAFC disagreed with ABS, holding instead that the question of mootness under these circumstances should be guided by Already, LLC v. Nike, Inc., 568 U.S. 85 (2013) and the voluntary cessation doctrine.

In Already, a case of trademark infringement, the Supreme Court stated that a defendant attempting to moot a case by voluntary compliance “bears the formidable burden of showing that it is absolutely clear the allegedly wrongful behavior could not reasonably be expected to recur.” The Court explained:

  1. Respondent Nike had the burden of showing it “could not reasonably be expected” to continue to enforce its trademarks against Already, which Nike showed by entering a covenant not to enforce; and
  2. Once this hurdle had been cleared by the defendant, the burden shifted to Petitioner Already to show “it engages in or has sufficiently concrete plans to engage in activities not covered by the covenant,” which Already failed to show with sufficient specificity.

Therefore, the Court concluded the case was moot. Applying the voluntary cessation doctrine of Already to the facts at issue, the CAFC held:

  1. Appellee Cytonome’s disclaiming its right to appeal the District Court’s finding of noninfringement showed Cytonome “cannot reasonably be expected” to resume enforcement efforts against Cytonome. The CAFC acknowledged that claiming a right to appeal is “narrower” than Nike’s covenant in Already, but the CAFC found it sufficient at least because it was “coextensive with the asserted inquiry.”
  2. Appellant ABS essentially failed to show with sufficient specificity evidence of present activity or plans to engage in activity that would create infringement liability for the ’161 patent. ABS in fact acknowledged that it faces no “specific threat” of an infringement suit under the ’161 patent.

Regarding ABS’s reliance on Fort James v. Solo Cup, the CAFC found the arguments unpersuasive. ABS argued that Fort James, a single district court proceeding, presented an exception to mootness where “a patent owner who strategically waits until after the resolution of its claim for patent infringement to offer a covenant not to sue (and not to appeal) does not moot a challenge to the patent’s validity.” The CAFC found ABS’s arguments overbroad and not necessarily applicable to parallel IPR and district court proceedings.

Finally, ABS asserted at oral argument that, if the CAFC were to find the case moot, then the proper order would be vacatur, not dismissal. The CAFC rejected this assertion, though, holding that ABS failed to timely request vacatur or adequately develop its assertion.

Therefore, the CAFC found the case moot and dismissed.

Chief Judge Prost dissented in part from the majority’s opinion, arguing that vacatur is the proper order, not dismissal.  When the party that prevails below unilaterally moots an appeal, the Chief Judge explained, then the proper course is vacatur, not dismissal, because the case was mooted by “the unilateral act of an adversary to cement its victories below.” Addressing the timeliness of ABS’s request for vacatur, the Chief Judge argued the rationale for vacatur was pronounced, that Cytonome’s theory was a “moving target,” and that courts can and sometimes should grant vacatur sua sponte. The Chief Judge concluded, “Cytonome obtained a favorable determination from the Board, took voluntary action to moot ABS’s appeal, and now will retain the benefit.”

Whether future cases will consider Chief Judge Prost’s dissent remains to be seen. However, at least one key takeaway is the importance of preserving the argument for vacatur on appeal, particularly when parallel proceedings are involved.

In 2017, Twitter, Inc. (“Twitter”) filed two petitions requesting inter parties review (“IPR”) of U.S. Patent No. 9,083,997 (“the ’997 patent”), with the first petition directed to claims 1-19 and the second petition directed to claims 20-35. The Patent Trial and Appeal Board (“the Board”) issued two substantially similar Final Written Decisions (IPR2017-00829, IPR2017-00830) that found all claims of the ’997 patent unpatentable as obvious. The ’997 patent’s assignee, VidStream LLC (“VidStream”), appealed to the Court of Appeals for the Federal Circuit (“the CAFC”) on the grounds that the primary art reference cited by Twitter and relied on by the Board did not qualify as prior art.

Twitter’s IPRs

In its petitions, Twitter cited a book by Anselm Bradford and Paul Haine (“Bradford”) as its primary reference. Twitter filed copies of several pages of Bradford, and the pages contained three pieces of information relevant to Bradford’s status as prior art:

  • The legend on one page: “Copyright © 2011 by Anselm Bradford and Paul Haine.”;
  • The ISBN information on the same page as the copyright:

ISBN-13 (pbk): 978-1-4302-3861-4
ISBN-13 (electronic) 978-1-4302-3862-1; and

  • Apparent publication information stating:

Made in the USA
Middletown, DE
13 December 2015.

When VidStream contended in its patent owner’s response that Bradford is not an available reference because its publication date of December 13, 2015, postdates the ’997 patent’s priority date of May 9, 2012, Twitter replied with:

  • A copy of Bradford from the Library of Congress marked “Copyright © 2011;
  • A copy of Bradford’s Certificate of Registration at the Copyright Office, which gave a registration date of January 18, 2012, and a date of first publication as November 8, 2011;
  • A declaration from “an expert on library cataloging and classification,” who declared Bradford was available at the Library of Congress in 2011;
  • A declaration from an attorney who stated he compared the pages of Bradford submitted with the petitions and the pages from the Library of Congress and found them to be identical; and
  • Copies of Internet Archive webpages showing Bradford listed on a publicly accessible website with the website date November 2, 2011, and website pages dated December 6, 2011, showing Bradford available for purchase from Amazon.

VidStream subsequently filed a sur-reply in response to Twitter’s reply. However, the Board eventually found Bradford was available as a prior art reference and held claims 1-35 of the ’997 patent to be unpatentable.

VidStream’s Appeal

VidStream argued on appeal to the CAFC that the Board erred by accepting and considering the documents that Twitter provided in its replies. VidStream cited to the Patent and Trademark Office’s (PTO’s) Trial Guide, which requires that Petitioner’s “case-in-chief” for an IPR must be made in the petition, and that Petitioner “may not submit new evidence or argument in reply that it could have presented earlier.”

On November 25, 2020, the CAFC affirmed the Board’s finding against VidStream. The CAFC found that the Board properly considered the evidence presented in Twitter’s replies and that, considering the evidence available to it, The Board properly found Bradford was published and publicly accessible before the ’997 patent’s priority date.

It seems two crucial points arise from this case, which has been designated as precedential:

First, new evidence may be introduced after the petition if the evidence is in “reply to evidence introduced by the patent owner, or if it is used to document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness.” Note that the 2015 publication date of the Bradford reference was apparently introduced by Petitioner Twitter.

Second, even if no one piece of evidence definitively establishes a reference’s public accessibility before the patent’s priority date, the evidence viewed as a whole may still suffice to establish public accessibility.

On November 9, 2020, the Federal Circuit vacated and remanded a decision by the United States Patent Office Patent Trial and Appeal Board (“PTAB”) in Donner Tech., LLC v. Pro Stage Gear, LLC,[1] holding that the PTAB applied an incorrect standard to determine whether a reference in the case was analogous art.  While the Court’s decision did not resolve whether the reference was in fact analogous art, it reiterated the two-part test defining the scope of analogous art and identified the particular deficiencies of the PTAB’s analysis that warranted vacatur.

Donner Tech. involved an inter partes review of U.S. Patent No. 6,459,023 (“the ’023 patent”), related to mounting boards for guitar pedals and owned by appellee Pro Stage Gear, LLC.  All of Donner’s obviousness challenges rested at least in part on U.S. Patent No. 3,504,311, or the “Mullen” patent, which related to support for electrical relays.  The PTAB had held that Mullen did not fall within the scope of the prior art because Donner had failed to prove Mullen’s electrical relay support was analogous art to the ’023 patent’s guitar pedal mounting board.

The Federal Circuit disagreed.  First citing to precedent from In re Bigio,[2] the Court identified the two required questions for establishing analogous art: “(1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.”  Acknowledging that the ’023 patent and Mullen were not from the same field of endeavor, the Court next turned to whether Mullen was reasonably pertinent to one or more of the problems addressed by the ’023 patent and the errors by the PTAB in concluding that it was not.

The Court explained that the second analogous art question “ultimately rests on the extent to which the reference of interest and the claimed invention relate to a similar problem or purpose.”  Thus, the Court stated that the reasonable pertinence question requires an identification and comparison of the problems to which both the invention and the reference relate.  Significantly, the analysis must “be carried out from the vantage point of a [person of ordinary skill in the art, or “POSA”] who is considering turning to the teachings of references outside her field of endeavor.”  Finally, the Court dismissed the argument that a POSA’s poor understanding of the whole reference would cut against finding it an analogous art.  Instead, the Court held that the “relevant question is whether the [POSA] would have reasonably consulted the reference in solving the relevant problem,” and that a POSA might reasonably consult a reference that she would not fully understand every last detail as long as she could understand the portions relevant to solving her problem enough to clean useful information.

A finding of analogous art will not end on the field of endeavor, and will depend more on the answer to the second part of the two-part test.  Counsel participating in argument over analogous art should take care to identify the relevant facts of the case addressing the problems that the patent at issue and reference seek to solve, and those facts that demonstrate the accessibility of the reference to those POSAs trying to solve those problems.

[1] No. 2020-1104 (Fed. Cir. Nov. 9, 2020).

[2] 381 F.3d 1320, 1325 (Fed. Cir. 2004).

On October 20, 2020, the United States Patent and Trademark Office (“USPTO” or “Office”) published in the Federal Register “Request for Comments on Discretion To Institute Trials Before the Patent Trial and Appeal Board” seeking public comments on the appropriate considerations for instituting trials before the Patent Trial and Appeal Board (“PTAB”) under the Leahy-Smith America Invents Act (“AIA”). 85 FR 66502.

As explained in the Federal Register, even in cases where a petitioner satisfied the institution standard, the PTAB may exercise its discretion to deny a petition for review under the AIA.  The USPTO has provided substantial guidance about when the PTAB will exercise its discretion to deny an otherwise potentially meritous petition in its Trial Practice Guide, 77 FR 48756 (Aug. 14, 2012) and in over 40 decisions designated as precedential or informative.[i]

The USPTO is interested in the public’s view on its current policies and practices and whether there are any modifications the Office should make to its approach. Particularly, the USPTO is focused on three areas:

(1) Serial petitions where the same petitioner is challenging the same patent;

(2) Parallel petitions when different parties file petitions at or about the same time on the same patent; and

(3) Petitions directed to patents that are or have been subject to other proceedings in other tribunals including a U.S. district court or the International Trade Commission (“ITC”).

To date, over 743 comments have been posted by individuals, inventors, patent practitioners, businesses, and associations/organizations. Below is a brief overview of some of the major viewpoints.

Serial Petitions

Some commenters request a policy of only allowing one petition per patent in order to protect small businesses from overly burdensome litigation. Some commenters support a rule similar to the USPTO’s current view of allowing one petition per patent except in certain circumstances, such as where there are many claims at issue. Others argue that there should be no specified cap on the number of petitions because a predetermined cap is arbitrary and limits meritous arguments of invalidity.

Parallel Petitions

Many commenters agree that the relationship between petitioners should be considered in limiting petitions from different parties, particularly if the different petitioners are real parties in interest or in privity. Some commenters go a step further to request that each patent is subject to no more than one trial under the AIA, and all challenges to a patent under the AIA should be filed within 90 days of the first petition or be denied.

Other Tribunals

Several commenters believe the PTAB should not consider whether the patent is subject to proceedings in other tribunals because the evidence and constructions in other tribunals are different from those before the PTAB. These commenters believe that all meritous arguments should be allowed, particularly when a patent is being heavily asserted against others. Other commenters push back on specific Fintiv factors, particularly the factor looking at the proximity of the other tribunal’s trial date to the PTAB’s projected deadline for a final written decision. These commenters argue that the timing of trial dates in other tribunals, namely district court trial dates, are often out of the litigators’ hands and are frequently pushed back after the PTAB’s institution decision relying on the trial date. In contrast, other commenters believe that all petitions should be denied where the patent is subject to other proceedings in other tribunals because of the burdensome cost of litigation on small patent owners, which could lead to bankruptcy.

Overall, most commenters appear to support promulgation of some version of a rule regarding discretionary denials of PTAB proceedings. The USPTO has shown a strong interest in increasing transparency and providing clear guidelines regarding the PTAB and USPTO’s policies practices. We can expect the Office to continue to provide meaningful guidance, perhaps including the codification of policies regarding discretionary denials.

Public comments may continue to be submitted until December 3, 2020.

[i] See, e.g., General Plastic Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, 2017 WL 3917706, at *7 (PTAB Sept. 6, 2017) (precedential) (providing a nonexclusive list of factors for “serial” petitions); Valve Corp. v. Elec. Scripting Prods., Inc., IPR2019-00062, -00063, -00084, 2019 WL 1490575, at *1 (PTAB Apr. 2, 2019) (precedential) (explaining when different petitioners challenge the same patent, the PTAB considers any relationship between those petitioners when weighing the General Plastic factors); Apple Inc. v. Fintiv, Inc., IPR2020-00019, 2020 WL 2126495, at *2 (PTAB Mar. 20, 2020) (precedential) (describing nonexclusive factors considered when a parallel proceeding is co-pending in another tribunal).

In In re: Google Technology Holdings LLC, No. 2019-1828 (Fed. Cir. Nov. 13, 2020), the Federal Circuit elaborated on the policies underlying waiver and forfeiture of appellate arguments.  Ultimately, the court affirmed the Patent Trial and Appeal Board’s (“the Board”) obviousness rejections of the claims at issue because Google had forfeited the arguments it raised on appeal.

Google’s Patent Application No. 15/179,765 is directed to distributed caching for video-on-demand systems.  The examiner rejected the claims as obvious in view of several prior art references.  Google appealed the final rejection to the Board.  The Board was unpersuaded and affirmed the examiner’s obviousness rejections.

On appeal to the Federal Circuit, Google argued that the Board had erred because it misconstrued certain claim terms.  The Federal Circuit took issue that Google had never presented these construction arguments to the Board.  Therefore, Google had forfeited those arguments.

The Federal Circuit noted that waiver is often used to refer to both waiver and forfeiture by the courts—including its own cases—but the rules and concepts behind the separate terms are well established.  Waiver is the “intentional relinquishment or abandonment of a known right.”  Forfeiture is the “failure to make the timely assertion of a right.”

Forfeited arguments are not considered on appeal in the absence of exceptional circumstances, and such circumstances were not present in this case.  The court noted that by failing to present the arguments to the Board, Google deprived an expert body of its important role in reviewing patent application rejections.  Similarly, consideration of new arguments was not consistent with the Federal Circuit’s place as an appellate court, one charged with reviewing the Board’s decisions, not considering them in the first instance.  Furthermore, considering new arguments raised on appeal would encourage sandbagging by others attempting to gain a strategic advantage.

After determining that Google’s arguments before the Board could not be read to raise the arguments presented in the appeal, the court declined to address the merits of Google’s proposed claim constructions.  The Board’s rejections of the claims was affirmed.

Moderna, one of the global leaders in developing a safe and effective vaccine to combat COVID-19, appears poised to get through clinical trials with a vaccine that is based on mRNA technology. As was recently announced, Pfizer demonstrated a 90% effectiveness with its vaccine, which is also based on mRNA technology. If all stays on course, Pfizer and Moderna may be the first two market entrants with vaccines, using the non-traditional mRNA technology.

But in order for at least Moderna’s mRNA technology to function properly, it needs a “delivery system.” Specifically, Moderna’s COVID-19 vaccine introduces “mRNA-1273” molecules into the recipient via a delivery system that protects the mRNA in the bloodstream and allows for entry into cells. Once inside the cells, the mRNA-1273 molecules act like computer code and instruct the cells to produce the characteristic COVID-19 spike proteins. The immune system identifies the spike proteins as antigens and builds its defenses against those antigens in preparation for the potential exposure to the actual COVID-19 virus.

Arbutus Biopharma owns certain patents relating to lipid-nanoparticle “delivery systems” for mRNA molecules. These delivery systems essentially wrap the molecules in balls of fat to both disguise them, thereby preventing attack by the immune system, and to allow the target cells to readily ingest the mRNA molecules. Moderna lost its sublicense to those disputed patents in 2016 and then (before the pandemic) sought to invalidate the patents through three USPTO inter partes review (IPR) proceedings that were decided earlier this year.

This post examines the procedural history and status of those proceedings.

On July 23, 2020, the Patent Trial and Appeal Board (“PTAB”) for the United States Patent and Trademark Office issued a final written decision upholding the claims of Arbutus Biopharma Corporation’s U.S. Patent No. 8,058,069 (“the ’069 patent”) from a challenge by Petitioner Moderna Therapeutics, Inc.[1]

The PTAB specifically determined that Moderna failed to show, by a preponderance of the evidence, that claims 1-22 of the ’069 patent were unpatentable under 35 U.S.C. § 103. The ’069 patent’s claims relate to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.”[2]

Moderna sought to invalidate the ’069 patent on two grounds, each of which the PTAB rejected. On the first ground, Moderna argued claims 1-22 were anticipated or obvious by International Application Publication No. 2005/007196 (“the ’196 PCT”) and United States Application Publication No. 2006/0134189 (“the ’189 Publication”). On the second ground, Moderna contended claims 1-22 were anticipated or obvious by Arbutus’s prior disclosures in light of two pieces of non-patent literature.[3][4]

This is the third final written decision in a series of IPRs brought by Moderna against Arbutus patents, and it is also the first final written decision with an entirely negative result for Moderna. Moderna’s first IPR ended in success, with the PTAB invalidating Arbutus’s US Patent No. 9,404,127 (“the ’127 patent”)[5]; but Moderna’s second IPR, concluded with mixed results, with the PTAB invalidating some claims of Arbutus’s US Patent No. 9,364,435 (“the ’435 patent”) and upholding others.[6]

Importantly, Arbutus’s ’127, ’435, and ’069 patents are similar to the extent they claim stable nucleic acid-lipid particles (SNALP) and methods of delivery. These patents appear to cover liquid nanoparticle (LNP) technology, which can be used to deliver messenger ribonucleic acid (mRNA) to cells. In the past, Moderna has indirectly licensed such LNP technology from Arbutus, but it has recently begun to develop its own proprietary LNP technology.

After the PTAB’s ruling on the ’069 patent, Moderna stated it “is not aware of any significant intellectual property impediments” toward products it intends to commercialize, including mRNA-1273. Indeed, whether Moderna is infringing Arbutus’s patents during its development of a COVID-19 vaccine is unknown, but it is worth noting that Arbutus has not brought any patent infringement actions against Moderna.

The IPRs for the ’127, ’435, and ’069 patents have each been appealed to the Court of Appeals for the Federal Circuit (CAFC), and Moderna’s appeal brief for the case involving the ’069 patent is due this month. In an event that could be viewed as related to its failed challenge to the ’069 patent, Moderna stated last month it will not enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic” while the pandemic continues.[7] However, it remains to be seen whether another company could – or would – enforce its COVID-19 related patents against Moderna during this pandemic or otherwise.

[1] Moderna Therapeutics, Inc. v. Arbutus Biopharma Corp., No. IPR2019-00554, 2020 WL 4237232 (P.T.A.B. July 23, 2020).

[2] LIPID FORMULATIONS FOR NUCLEIC ACID DELIVERY, US PAT 8058069.

[3] Lin et al., Three-Dimensional Imaging of Lipid Gene-Carriers: Membrane Charge Density Controls Universal Transfection Behavior in Lamellar Cationic Liposome-DNA Complexes, 84 BIOPHYSICAL J. 3307–16 (2003) (“Lin”).

[4] Ahmad et al., New Multivalent Cationic Lipids Reveal Bell Curve for Transfection Efficiency Versus Membrane Charge Density: Lipid-DNA Complexes for Gene Delivery, 7 J. GENE MED. 739–48 (2005) (“Ahmad”). Ex. 1007.

[5] Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc., No. IPR2018-00680, 2018 WL 4362415 (P.T.A.B. Sept. 12, 2018). [Note: Protiva was a wholly-owned subsidiary of Arbutus.]

[6] Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc., IPR2018-00739 (P.T.A.B. Sept. 11, 2019).

[7] https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19

A motion recently filed by US Inventor, Inc. in the United States District Court for the Northern District of California seeks a temporary restraining order and a preliminary injunction to prevent the United States Patent and Trademark Office (“USPTO” or “Patent Office”) from instituting any new reviews of any patent until it solves the debate over the “NHK-Fintiv rule” by promulgating a rule under the proper notice-and-comment procedure of the American Procedure Act (“APA”).  US Inventor, Inc. is a non-profit association of inventors devoted to protecting the intellectual property of individuals and small companies.

Declaring the current situation “an emergency,” US Inventor argued that the relief requested – a restraining order and preliminary injunction – is “the only way to preserve the status quo for inventors” and “protect the availability of a lawful remedy” for the trial at hand.  The motion was filed in the lawsuit Apple, Inc., et al. v. Iancu,[1] in which a number of tech companies have challenged the NHK-Fintiv rule and the USPTO’s authority.  US Inventor intervened, arguing instead that the rule should be promulgated through the proper channel.

The NHK-Fintiv rule stems from a line of cases where the USPTO’s Patent Trial and Appeal Board (“PTAB”) declared its discretionary authority to deny institution of American Invents Act (“AIA”) review trials based on parallel proceedings in federal district courts.  In the two precedential opinions from which the rule takes its name, the PTAB outlined a number of factors that would weigh against instituting review of a patent whose validity is already at issue in a pending district court trial.  Although the Patent Act gives the PTAB discretion to deny AIA review for any reason, it also requires that the Director prescribe regulations setting forth the standards to show sufficient grounds to institute review.  US Inventor points to the latter as its basis for arguing that the Patent Office may not develop standards like the NHK-Fintiv rule in an ad hoc adjudicative decision, and instead must promulgate regulations through the statutory process of notice-and-comment rulemaking.

US Inventor pointed to “traditional preliminary injunction factors,” such as public interest weighing in favor of granting its relief.  Specifically, US Inventor identified the harm of patentees being “deprived of a procedural protection to which they are entitled,” where the current rules lack the clarity and balance that only notice-and-comment rulemaking can provide; and that US Inventor’s members are irreparably harmed by having to formulate arguments and responses under deadlines without proper guidance as to the discretionary facts, where an adverse decision would mean a loss of their property.

The parties stipulated to and the court granted a deadline of October 12, 2020, for the USPTO to respond to US Inventor’s motion.

[1] No. 5:20-cv-06128 (N.D. Cal. Sept. 29, 2020).

On October 6, 2020, the United States Patent and Trademark office (USPTO) released a report titled “Public Views on Artificial Intelligence and Intellectual property Policy.”  The report follows the USPTO’s August 2019 request for comments on patenting AI inventions, and the USPTO’s October 2019 request for comments related to the impact of AI on other IP policy areas.

A few general themes emerged from the nearly 200 submissions, including “the fact that AI has no universally recognized definition,” “the current state of the art is limited to ‘narrow’ AI”, as opposed to artificial general intelligence akin to human intelligence, and “a general sense that existing U.S. intellectual property laws are calibrated correctly to address the evolution of AI.”  Report pp. ii-iii.

With respect to patent protection, the consensus remains that inventors must be human, but some differences arose as to what human activities should qualify as a contribution to the conception of an invention.  The Report notes that “activities such as designing the architecture of the AI system, choosing the specific data to provide to the AI system, developing the algorithm to permit the AI system to process that data, and other activities not expressly listed here may be adequate to qualify as a contribution to the conception of the invention.”  Report, p. 5.  But perhaps the USPTO will need to revisit the question of whether machines can be inventors when and if science agrees that machines can “think” on their own.

On data and new forms of IP protection, the Report acknowledges that data “is a foundational component of AI,” and “data and datasets, including their collection and compiling, have value.”  Report p. 15.  Commentators, however, were divided between the view that new IP rights were necessary and the belief that the current US IP framework was adequate to address AI inventions.  No concrete proposals were submitted on how any newly created IP right for AI and data should function, and many called upon the USPTO to further consult the public on the issue.

On the copyright front, the Report notes that existing “statutory and case law should adequately address the legality of machine ‘ingestion’ in AI scenarios,” and that mass digitization and text and data mining “may be considered copyright infringement or fair use, depending on the facts and circumstances at issue.”  Report p. 23.  Critically, however, “mass digitization for purposes of machine learning (ML) ‘ingestion’ processes-and large-scale ingestion of already-digitized works-has not yet been tested by the courts.”  Id. p. 25.  Additionally, commentators mostly found that existing laws are adequate to continue to protect AI-related databases and datasets—including copyright protection as a compilation, trade secret, contract law, and tort law—and there is no need for a sui generis database protection law, such as exists in Europe.

In view of these comments and the areas of greatest divergence, there are a few practical takeaways to keep in mind.  First, there are numerous ways a human can contribute to the conception of an AI invention—from curation of the input data to practical application of the output—and innovators should document and evaluate who was involved at every step of the AI development process as part of the inventorship inquiry for patent protection.  Second, datasets used for AI can have tremendous value, and there are multiple ways to preserve the value of datasets, such as with copyright, trade secret, and contractual/licensing protection.  As each form of protection has its strengths, it is important to choose the right avenues of protection for the right datasets and applications.  Finally, we will likely see further developments in the case law on the issue of copyright infringement through machine ingestion of data, and the applicability (or not) of the fair use defense.  The Oracle v. Google Supreme Court case on fair use may potentially touch these issues, as well as the numerous data scraping cases making their way through the courts.

Stay tuned!