For Biotech, “Method of Preparation” Claims May Survive §101
John Kong | April 15, 2020
Illumina, Inc. v. Ariosa Diagnostics, Inc.
March 17, 2020
Lourie, Moore, and Reyna (Opinion by Lourie; Dissent by Reyna)
Summary
In a patent infringement litigation between the same parties that were involved in the earlier case, Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (diagnostic patent deemed patent ineligible under 35 U.S.C. §101), the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) found the claimed “method of preparation” of a fraction of cell-free fetal DNA (“cff-DNA”) enriched in fetal DNA to be patent eligible, reversing the district court’s grant of summary judgment of patent ineligibility. A dissent by J. Reyna (author of the earlier Ariosa decision) asserts that there is nothing new and useful in the claims, other than the discovery that cff-DNA tends to be shorter than cell-free maternal DNA, and that use of known laboratory techniques and commercially available testing kits to isolate the naturally occurring shorter cff-DNA does not make the claims patent eligible.
Details
Illumina and Sequenom (collectively, “Illumina”) appealed a
summary judgment ruling of patent ineligibility by the United States District
Court for the Northern District of California.
The two patents at issue, USP 9,580,751 (the ‘751 patent) and USP
9,738,931 (the ‘931 patent), are unrelated to the diagnostic patent held
ineligible in the 2015 Ariosa decision. While the earlier litigated patent claimed a
method for detecting the small fraction of cff-DNA in the plasma and serum of a
pregnant woman that were previously discarded as medical waste, the present
‘751 and ‘931 patents claim methods for preparing a fraction of cff-DNA that is
enriched in fetal DNA. A problem with
maternal plasma is that it was difficult, if not impossible, to determine fetal
genetic markers (e.g., for certain diseases) because the proportion of circulatory
extracellular fetal DNA in maternal plasma was tiny as compared to the majority
of it (>90%) being circulatory extracellular maternal DNA. The inventor’s
“surprising” discovery was that the majority of circulatory extracellular fetal
DNA has a relatively small size of approximately 500 base pairs or less, as
compared to the larger circulatory extracellular maternal DNA. With this discovery, they developed the
following claimed methods for preparing a DNA fraction that separated fetal DNA
from maternal DNA from the maternal plasma and serum, to create a DNA fraction
enriched with fetal DNA.
‘931 Patent:
1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
(a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 500 base pairs, wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
(c) analyzing a genetic locus in the fraction of DNA produced in (b).
‘751 Patent:
1. A method, comprising:
(a) extracting DNA comprising maternal and fetal DNA fragments from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory fetal and maternal DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 300 base pairs, wherein the DNA fraction after (b) comprises extracellular circulatory fetal and maternal DNA fragments of approximately 300 base pairs and less and a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA fragments; and
(c) analyzing DNA fragments in the fraction of DNA produced in (b).
The Federal Circuit had consistently found diagnostic claims patent ineligible (as directed to natural phenomenon) (Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333 (Fed. Cir. 2019); Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019); Cleveland Clinic Found. v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017)). In contrast, the Federal Circuit had also held that method of treatment claims are patent eligible (Endo Pharm. Inc. v. Teva Pharm. USA, Inc., 919 F.3d 1347 (Fed. Cir. 2019); Natural Alternative Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019); and Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018)). However, this is not a diagnostic case, nor a method of treatment case. This is a method of preparation case – which the Federal Circuit found to be patent eligible.
The natural phenomenon at issue is that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in the mother’s bloodstream. However, under the Alice/Mayo Step 1, the Federal Circuit held that these claims are not directed to a natural phenomenon. Instead, the claims are directed to a method that utilizes that phenomenon. The claimed method recites specific process steps – size discrimination and selective removal of DNA fragments above a specified size threshold. These process steps change the composition of the normal maternal plasma or serum, creating a fetal DNA enriched mixture having a higher percentage of cff-DNA fraction different from the naturally occurring fraction in the normal mother’s blood. “Thus, the process achieves more than simply observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon.”
In distinguishing the earlier Ariosa case, the Federal Circuit stated, “the claims do not merely cover a method for detecting whether a cell-free DNA fragment is fetal or maternal based on its size.”
In distinguishing the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), the Federal Circuit noted that the “Supreme Court in Myriad expressly declined to extend its holding to method claims reciting a process used to isolate DNA” and that “in Myriad, the claims were ineligible because they covered a gene rather than a process for isolating it.” Here, the method “claims do not cover cell-free fetal DNA itself but rather a process for selective removal of non-fetal DNA to enrich a mixture in fetal DNA.” This is the opposite of Myriad.
As for whether the techniques for size discrimination and selective removal of DNA fragments were well-known and conventional, those considerations are relevant to the Alice/Mayo Step 2 analysis, or to 102/103 issues – not for Alice/Mayo Step 1. The majority concluded patent eligibility under Step 1 and did not proceed to Step 2.
J. Reyna’s dissent focused on the claims being directed to a natural phenomenon because the “only claimed advance is the discovery of that natural phenomenon.” In particular, referring to a “string of cases reciting process claims” since 2016, the “directed to” inquiry under Alice/Mayo Step 1 asks “whether the ‘claimed advance’ of the patent ‘improves upon a technological process or is merely an ineligible concept.’” citing Athena, 915 F.3d at 750 and Genetic Techs., 818 F.3d at 1375. “Here, the claimed advance is merely the inventors’ ‘surprising[]’ discovery of a natural phenomenon – that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream.” J. Reyna criticizes the majority for ignoring the “claimed advance” inquiry altogether.
Under the claimed advance inquiry, one looks to the written description. Here, the written description identifies the use of well-known and commercially available tools/kits to perform the claimed method. Checking for 300 and 500 base pairs using commercially available DNA size markers and kits does not constitute any “advance.” There is no improvement in the underlying DNA processing technology, but for checking the natural phenomenon of sizes indicative of cff-DNA.
J. Reyna also criticized the majority’s “change in the composition of the mixture” justification. “A process that merely changes the composition of a sample of naturally occurring substances, without altering the naturally occurring substances themselves, is not patent eligible.” Here, one begins and ends with the same naturally occurring substances – cell-free fetal DNA and cell free maternal DNA. There is no creation or alteration of any genetic information encoded in the cff-DNA. Therefore, the claims are directed to a natural phenomenon under Alice/Mayo Step 1.
J. Reyna also found no inventive concept under Alice/Mayo Step 2.
Take Away
- Until there is an en banc rehearing or a Supreme Court review of this case, this case is an example of a patent eligible method of preparation claim.
- For defendants, the “claimed advance” inquiry could help sink a claimed method under Alice/Mayo Step 1.
Tags: 101 > biotech > diagnostics > eligibility > Mayo/Alice Test > preparation > treatment
FACEBOOK’S IPRs CAN’T FRIEND EACH OTHER
Michael Caridi | April 10, 2020
FACEBOOK, INC. v. WINDY CITY INNOVATIONS, LLC.
March 18, 2020
Prost, Plager and O’Malley (Opinion by Prost)
Summary: Plaintiff/Patent Holder Windy Citysuccessfully cross-appealed against Facebook on the issue of improper joinder of IPRs under 35 U.S.C. § 315(c). Facebook had filed IPRs within one year of Windy City’s District Court complaint and then joined later filed IPRs adding new claims. The PTAB had allowed the joinder. The CAFC vacated the Board’s joinder finding that Facebook could not join their own already filed IPRs.
Background:
In June 2016, exactly one year after being served with Windy City’s complaint for infringement of four patents related to methods for communicating over a computer-based net-work, Facebook timely petitioned for inter partes review (“IPR”) of several claims of each patent. At that time, Windy City had not yet identified the specific claims it was asserting in the district court proceeding. The four patents totaled 830 claims. The Patent Trial and Appeal Board (“Board”) instituted IPRs of each patent.
In January 2017, after Windy City had identified the claims it was asserting in the district court litigation, Facebook filed two additional petitions for IPR of additional claims of two of the patents. Facebook concurrently filed motions for joinder to the already instituted IPRs on those patents. By the time of filing the new IPRs, the one-year time bar of §315(b) had passed. The Board nonetheless instituted Facebook’s two new IPRs, and granted Facebook’s motions for joinder.
The Board agreed with Facebook that Windy City’s district court complaint generally asserting the “claims” of the asserted patents “cannot reasonably be considered an allegation that Petitioner infringes all 830 claims of the several patents asserted.” The Board therefore found that Facebook could not have reasonably determined which claims were asserted against it within the one-year time bar. Once Windy City identified the asserted claims after the one-year time bar, the Board found that Facebook did not delay in challenging the newly asserted claims by filing the second petitions with the motions for joinder.
The Board found that Facebook had shown by a preponderance of the evidence that some of the challenged claims are unpatentable, many of these claims had only been challenged in the later filed and joined IPRs. Facebook appealed and Windy City cross-appealed on the Board’s obviousness findings. Further, Windy City also challenged the Board’s joinder decisions allowing Facebook to join its new IPRs to its existing IPRs and to include new claims in the joined proceedings. Windy City’s cross-appeal on the joinder issue is addressed here.
Discussion:
In its cross-appeal, Windy City argued that the Board’s decisions granting joinder were improper on the basis that 35 U.S.C. § 315(c): (1) does not permit a person to be joined as a party to a proceeding in which it was already a party (“same-party” joinder); and (2) does not permit new issues to be added to an existing IPR through joinder (“new issue” joinder), including issues that would otherwise be time-barred.
Sections 315(b) and (c) recite:
(b) Patent Owner’s Action. —An inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent. The time limitation set forth in the preceding sentence shall not apply to a request for joinder under subsection (c).
(c) Joinder. —If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314.
The CAFC noted that §315(b) articulates the time-bar for when an IPR “may not be instituted.” 35 U.S.C. §315(b). But §315(b) includes a specific exception to the time bar, namely “[t]he time limitation . . . shall not apply to a request for joinder under subsection (c).”
Regarding the propriety of Facebooks joinder, the Court held the plain language of §315(c) allows the Director “to join as a party [to an already instituted IPR] any person” who meets certain requirements. However, when the Board instituted Facebook’s later petitions and granted its joinder motions, the Board did not purport to be joining anyone as a party. Rather, the Board understood Facebook to be requesting that its later proceedings be joined to its earlier proceedings. The CAFC concluded that the Boards interpretation of §315(c) was incorrect because their decision authorized two proceedings to be joined, rather than joining a person as a party to an existing proceeding.
Section 315(c) authorizes the Director to “join as a party to [an IPR] any person who” meets certain requirements, i.e., who properly files a petition the Director finds warrants the institution of an IPR under § 314. No part of § 315(c) provides the Director or the Board with the authority to put two proceedings together. That is the subject of § 315(d), which provides for “consolidation,” among other options, when “[m]ultiple proceedings” involving the patent are before the PTO.35 U.S.C. § 315.
The Court went on to explain that the clear and unambiguous language of § 315(c) confirms that it does not allow an existing party to be joined as a new party, noting that subsection (c) allows the Director to “join as a party to [an IPR] any person who” meets certain threshold requirements. They noted that it would be an extraordinary usage of the term “join as a party” to refer to persons who were already a party. Finding the phrase “join as a party to a proceeding” on its face limits the range of “person[s]” covered to those who, in normal legal discourse, are capable of being joined as a party to a proceeding (a group further limited by the own-petition requirements), and an existing party to the proceeding is not so capable.
Regarding the second issue raised by Windy City that the Joinder cannot include newly raised issues, the CAFC found the language in §315(c) does no more than authorize the Director to join 1) a person 2) as a party, 3) to an already instituted IPR. Finding this language does not authorize the joined party to bring new issues from its new proceeding into the existing proceeding, particularly when those new issues are other-wise time-barred.
The Court noted that under the statute, the already-instituted IPR to which a person may join as a party is governed by its own petition and is confined to the claims and grounds challenged in that petition.
In reaching these conclusions, the Court did acknowledge the rock and hard place Facebook is left in.
We do not disagree with Facebook that the result in this particular case may seem in tension with one of the AIA’s objectives for IPRs “to provide ‘quick and cost effective alternatives’ to litigation in the courts.” [Citations omitted] Indeed, it is fair to assume that when Congress imposed the one-year time bar of § 315(b), it did not explicitly contemplate a situation where an accused infringer had not yet ascertained which specific claims were being asserted against it in a district court proceeding before the end of the one-year time period. We also recognize that our analysis here may lead defendants, in some circumstances, to expend effort and expense in challenging claims that may ultimately never be asserted against them.
However, the Court gave little remedy to bearing an enormous “effort and expense” of filing IPRs to 830 claims, asserting that they are bound by the unambiguous nature of the statute.
Petitioners who, like Facebook, are faced with an enormous number of asserted claims on the eve of the IPR filing deadline, are not without options. As a protective measure, filing petitions challenging hundreds of claims remains an available option for accused infringers who want to ensure that their IPRs will challenge each of the eventually asserted claims. An accused infringer is also not obligated to challenge every, or any, claim in an IPR. Accused infringers who are unable or unwilling to challenge every claim in petitions retain the ability to challenge the validity of the claims that are ultimately asserted in the district court. Accused infringers who wish to protect their option of proceeding with an IPR may, moreover, make different strategy choices in federal court so as to force an earlier narrowing or identification of asserted claims. Finally, no matter how valid, “policy considerations cannot create an ambiguity when the words on the page are clear.” SAS, 138 S. Ct. at 1358. That job is left to Congress and not to the courts.
Hence, the CAFC concluded that the clear and unambiguous language of §315(c) does not authorize same-party joinder, and also does not authorize joinder of new issues, including issues that would otherwise be time-barred. As a result, they vacated the Board’s decisions on all claims which were asserted in the later filed IPRs.
Take Away: A loop-hole between the one-year time bar, joinder statute for IPRs and District Court timing potentially gives a Plaintiff/Patent holder the ability to render an IPR more cost inefficient to a Defendant/Petitioner. By not identifying the claims to be asserted within one year of filing a patent infringement complaint, the patent holder can place a large burden on filing an IPR. Plaintiffs/Patent holders can strategize to assert infringement ambiguously to a prohibitive number of claims early in a District Court proceeding. Defendants will need to attempt to counter such a strategy by requesting District Courts to force Plaintiffs to identify the specific claims which will be asserted within one year of filing the complaint.
When the Broadest Reasonable Interpretation (BRI) Becomes Unreasonable
Stephen G. Adrian | March 26, 2020
Kaken Pharmaceutical Co., Ltd., Bausch Health Companies Inc. v. Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office
March 13, 2020
Before Newman, O’Malley, and Taranto (Opinion by Taranto)
U.S. patent practitioners constantly need to address use of the broadest reasonable interpretation (BRI) by Examiners during patent prosecution. During prosecution, arguments and amendments are typically presented to overcome prior art and become a part of the prosecution history along with the disclosure of the invention. This decision illustrates that definitions provided in the specification in conjunction with the prosecution history can potentially save a patent from a later challenge which invokes BRI. In this case, an erroneous claim construction of one claim limitation during an inter partes review caused the CAFC to reverse and remand back to the Patent Trial and Appeal Board (PTAB).
U.S. patent No. 7,214,506 is directed a method for treating onychomycosis. Claim 1 recites:
1. A method for treating a subject having onychomycosis wherein the method comprises topically administering to a nail of said subject having onychomycosis a therapeutically effective amount of an antifungal compound represented by the following formula:
wherein, Ar is a non-substituted phenyl group or a phenyl group substituted with 1 to 3 substituents selected from a halogen atom and trifluoromethyl group,
R1 and R2 are the same or different and are hydrogen atom, C1-6 alkyl group, a non-substituted aryl group, an aryl group substituted with 1 to 3 substituents selected from a halogen atom, trifluoromethyl group, nitro group and C1-16 alkyl group, C2-8 alkenyl group, C2-6 alkynyl group, or C7-12 aralkyl group,
m is 2 or 3,
n is 1 or 2,
X is nitrogen atom or CH, and
*1 and *2 mean an asymmetric carbon atom.
Acrux[1] had successfully obtained inter partes review of all claims of the ‘506 patent, with the Patent Trial and Appeal Board (PTAB) ultimately determining that all claims are unpatentable for obviousness (based on a set of three references in combination with another set of two references for six total grounds). The first set of three references teach a method of topically treating onychomycosis with various azole compounds while the second set teaches KP-103 (an azole compound within the scope of claim 1) as an effective antifungal agent.
Kaken had argued that the phrase “treating a subject having onychomycosis” means “treating the infection at least where it primarily resides in the keratinized nail plate and underlying nail bed.” Kaken argued that the ‘506 patent’s key innovation is a topical treatment that can easily penetrate the tough keratin in the nail plate. This construction was rejected by the PTAB as too narrow because of the express definition of onychomycosis as including superficial mycosis, and the express definition in the specification of “nail includes the tissue or skin around the nail plate, nail bed, and nail matrix.” The PTAB concluded that “treating onychomycosis” includes treating “superficial mycosis that involves the skin or visible mucosa.”
The nail plate is defined as the “horny appendage of the skin that is composed mainly of keratin” whereas the “eponychium and hyponychium” are “the skin structures surrounding the nail.”
The CAFC reversed the PTAB’s claim construction as unreasonable in light of the specification and prosecution history as the broadest reasonable interpretation of treating a subject having onychomycosis “is penetrating the nail plate to treat a fungal infection inside the nail plate or in the nail bed under it.”
The CAFC came to this conclusion based on the specification’s characterization of onychomycosis in a way which links three other crucial passages. In particular, after defining the terms “skin” and “nail” and characterizing “superficial mycosis”, the specification stated that onychomycosis is “a kind of the above-mentioned superficial mycosis, in the other word a disease which is caused by invading and proliferating in the nail of human or an animal.” Thus, the specification conveys that onychomycosis is a disease with two basic features (1) of a disease of the nail and (2) it is a kind of superficial mycosis. As such, the BRI of onychomycosis would not include invasion of any part of what is defined as the nail other than the nail plate or nail bed, such as skin in its ordinary sense. The PTAB’s inclusion of the eponychium and hyponychium is unreasonable as the specification defined that onychomycosis is a disease involving invasion of the nail.
Other parts of the specification explain that an effective topical treatment would need to penetrate the nail plate, and the ‘506 patent explained that known topical treatments were largely ineffective. The patent further contains as objects as good permeability, good retention capacity and conservation of high activity to indicate that treating an infection of skin surrounding the nail plate alone would not require all these properties.
The prosecution history also included statements overcoming prior art as providing “decisive support” for Kaken’s claim construction. Kaken’s statements, followed by the examiner’s statements, make clear the limits on a reasonable understanding of what Kaken was claiming. The exchange between the examiner and Kaken:
“would leave a skilled artisan with no reasonable uncertainty about the scope of the claim language in the respect at issue here. Kaken is bound by its arguments made to convince the examiner that claims 1 and 2 are patentable. See Standard Oil, 774 F.2d at 452. Thus, Kaken’s unambiguous statement that onychomycosis affects the nail plate, and the examiner’s concomitant action based on this statement, make clear that “treating onychomycosis” requires penetrating the nail plate to treat an infection inside the nail plate or in the nail bed under it.”
Since the PTAB relied upon an erroneous claim construction throughout its consideration of facts in its obviousness analysis, the CAFC vacated the PTAB’s decision and remanded.
Takeaways:
Intrinsic evidence in the specification can overcome an ordinary meaning in the art (extrinsic evidence).
Although an applicant desires a broad interpretation of patent claims, too broad of an interpretation can open the patent to attacks. As such, the prosecution history plays an important role.
Some past decisions have taught patent
practitioners to avoid stating objects of the invention or discussion of prior
art. However, stating objects and providing a discussion of prior art can be
important for securing a proper claim construction, particularly in “crowded”
art areas.
[1] Acrux withdrew from the appeal, and the Director intervened to defend the PTAB’s decision.
Post-Importation Activity can be used by the International Trade Commission for determining a violation of Section 337
Andrew Melick | March 18, 2020
Comcast Corporation v. ITC and Rovi Corporation
March 2, 2020
Newman, Reyna and Hughes. Opinion by Newman
Summary:
Rovi Corporation (hereinafter “Rovi”) filed a Section 337 complaint with the ITC for infringement of U.S. Patent No. 8,006,263 (“the ‘263 patent”) and U.S. Patent No. 8,578,413 (“the ‘413 patent”) based on importation of Comcast’s X1 set-top box used in an infringing system. Arris Enterprises and Technicolor SA imported the devices for Comcast and were also named in the complaint. The ITC found that even though infringement of the patents does not occur until after importation and when the customer connects a mobile device to the X1 set-top box, the X1 set-top boxes are still considered “articles that infringe” under Section 337. The ITC also found that Comcast induced the infringement by providing guidance and instructions to customers on how to operate the system. Comcast did not dispute direct infringement by the customer or its induced infringement. Comcast argued that the X1 set-top boxes are not “articles that infringe” under Section 337 because the boxes do not infringe at the time of importation. The CAFC agreed with the ITC affirming that the X1 set-top boxes are “articles that infringe” and that Comcast is considered an importer under Section 337.
Details:
The patents at issue are to an interactive television program guide system for remote access to television programs. The claims require a remote program guide access device such as a mobile device that is connected to an interactive television program guide system over a remote access link so that users can remotely access the program guide system. Claim 1 of the ‘263 patent is provided.
1. A system for selecting television programs over a remote access link comprising an Internet communications path for recording, comprising:
a local interactive television program guide equipment on which a local interactive television program guide is implemented, wherein the local interactive television program guide equipment includes user television equipment located within a user’s home and the local interactive television program guide generates a display of one or more program listings for display on a display device at the user’s home; and
a remote program guide access device located outside of the user’s home on which a remote access interactive television program guide is implemented, wherein the remote program guide access device is a mobile device, and wherein the remote access interactive television program guide:
generates a display of a plurality of program listings for display on the remote program guide access device, wherein the display of the plurality of program listings is generated based on a user profile stored at a location remote from the remote program guide access device;
receives a selection of a program listing of the plurality of program listings in the display, wherein the selection identifies a television program corresponding to the selected program listing for recording by the local interactive television program guide; and
transmits a communication identifying the television program corresponding to the selected program listing from the remote access interactive television program guide to the local interactive television program guide over the Internet communications path;
wherein the local interactive television program guide receives the communication and records the television program corresponding to the selected program listing responsive to the communication using the local interactive television program guide equipment.
The ITC found that the X1 set-top boxes are imported by Arris and Technicolor, and that Comcast is sufficiently involved with the design, manufacture and importation of the accused products such that Comcast is an importer under Section 337. The ITC further found that Comcast’s customers directly infringe the patents through use of the X1 systems in the US and that Comcast induced that infringement because Comcast instructs, directs, or advises its customers on how to carry out direct infringement of the claims of the patents.
Regarding Arris and Technicolor, the ITC found that they do not directly infringe the asserted claims of the patents because they do not provide a “remote access device,” and they do not contributorily infringe because the set-top boxes have substantial non-infringing uses.
The ITC issued a limited exclusion order excluding importation of the X1 set-top boxes by Comcast, including importation by Arris and Technicolor on behalf of Comcast. Comcast, Arris and Technicolor appealed the ITC decision.
Motion to Dismiss Appeal
The CAFC first addressed a motion to dismiss the appeal by Comcast, Arris and Technicolor because the patents at issue have now expired. The ‘263 patent expired on September 18, 2019 and the ‘413 patent expired on July 16, 2019. Comcast argued that the appeal is moot because after expiration of a patent, the ITC’s limited exclusionary order has no further prospective effect.
The ITC and Rovi opposed the motion to dismiss because there are continuing issues and actions to which these decisions are relevant, “whereby appellate finality is warranted because there are ongoing ‘collateral consequences.’” There are two other ITC investigations on unexpired Rovi patents that involve the X1 set-top boxes and that these investigations are likely to be affected by the decisions on this appeal as they have similar issues of importation.
The CAFC stated that “a case may remain alive based on collateral consequences, which may be found in the prospect that a judgment will affect future litigation or administrative action” citing Hyosung TNS Inc. v. U.S. Int’l Trade Comm’n, 926 F.3d 1353, 1358. The additional pending cases involve unexpired patents related to the same X1 set-top boxes and “the issues on appeal concern the scope of Section 337 as a matter of statutory interpretation. The CAFC denied the motion to dismiss because there are sufficient collateral consequences to negate mootness.
Articles that Infringe
Comcast did not dispute direct infringement by its customers, and did not dispute that it induces infringement by its customers. Comcast argued that its conduct is not actionable under Section 337 because Comcast’s conduct “takes place entirely domestically, well after, and unrelated to, the article’s importation.” Comcast stated that the imported X1 set-top boxes are not “articles that infringe” because the boxes do not infringe the patents at the time of importation.
The statutory basis for Section 337 investigations relevant to this case is in 19 U.S.C. § 1337(a) which states:
(1) Subject to paragraph (2), the following are unlawful . . . .
(B) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that—
(i) infringe a valid and enforceable United States patent . . . .
Comcast argued that the ITC’s authority is limited to excluding articles that infringe “at the time of importation.” The ITC and Rovi, citing Suprema, Inc. v. U.S. Int’l Trade Comm’n, 796 F.3d 1338 (Fed. Cir. 2015) (en banc), stated that imported articles can infringe in terms of Section 337, when infringement occurs after importation. The basis of the Suprema decision was that the statute defines as unlawful “the sale within the United States after importation … of articles that—(i) infringe. The CAFC cited the following passage from the Suprema Decision:
The statute thus distinguishes the unfair trade act of importation from infringement by defining as unfair the importation of an article that will infringe, i.e., be sold, “after importation.” Section 337(a)(1)(B)’s “sale . . . after importation” language confirms that the Commission is permitted to focus on post-importation activity to identify the completion of infringement.
Suprema, Inc. at 1349.
Comcast argued that based on the facts in Suprema, inducement liability must be attached to the imported article at the time of the article’s importation. The imported X1 set-top boxes are incapable of infringement until the X1 set-top boxes are combined with Comcast’s domestic servers and its customers mobile devices. Comcast stated that any inducing conduct of articles that infringe occurs entirely after the boxes’ importation.
The CAFC stated that the ITC correctly held that Section 337 applies to articles that infringe after importation. The CAFC also cited the ITC decision which pointed out that Comcast designed the X1 set-top boxes to be used in an infringing manner, directed the manufacture overseas, and directed the importation. The ITC concluded that the inducing activity took place prior to importation, at importation, and after importation. The CAFC agreed with the ITC that X1 set-top boxes imported by and for Comcast for use by Comcast’s customers are “articles that infringe.”
Importer
Comcast argued that it is not an importer of the X1 set-top boxes because Arris or Technicolor are the actual importers, and because Comcast does not physically bring the boxes into the US and it does not exercise control over the importation process.
The CAFC agreed with the ITC that Comcast is an importer of the X1 set-top boxes under Section 337. The ITC found that Comcast is sufficiently involved in the importation of the X1 boxes that it satisfies the importation requirement. The ITC pointed out that the X1 boxes are particularly tailored for Comcast and they would not work with another cable operator’s system, Comcast is involved with the design, manufacture and importation of the X1 boxes, that Comcast controls the importation of the X1 boxes because Comcast provides Arris and Technicolor with technical documents so that the X1 boxes work as required by Comcast, and that the X1 boxes are designed only for Comcast. Comcast also restricts Arris from selling the products without Comcast’s permission. The ITC also found that Comcast directs Arris and Technicolor to deliver the accused products to Comcast delivery sites. The CAFC stated that the ITC’s findings are supported by substantial evidence.
Limited Exclusion Order
Arris and Technicolor argued that the limited exclusion order should not apply to them because they were found not to be infringers or contributory infringers. The ITC said that the exclusion order is within ITC’s discretion because the order is limited to importations “on behalf of Comcast” of articles whose intended use is to infringe the patents at issue. The CAFC agreed that the limited exclusion order is within the ITC’s discretion as “reasonably related to stopping the unlawful infringement.”
Comments
An importer of goods may not be able to avoid a Section 337 violation even though the goods do not infringe at the time of importation. Post-importation activity can be used to determine the completion of infringement. In this case, the X1 box itself does not infringe the patents at the time of importation. Customers infringe the patents only after a mobile device is connected to the system which is at the direction of Comcast.
Also, even if someone else imports the goods for you and you do not physically bring the goods into the US, you may still be considered an importer of the goods under Section 337 if you have a certain amount of control over the goods to be imported or the actual importation.
