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.
To Collect Damages for Patent Infringement, a Patentee Must Affirmatively Provide (1) Constructive Notice by Marking Products or b) Actual Notice to the Accused Infringer
WHDA Blogging Team | March 11, 2020
ARCTIC CAT, INC. v. BOMBARDIER RECREATIONAL, INC.
February 20, 2020
Lourie, Moore, and Stoll (Opinion by Lourie)
Summary
Arctic Cat sued Bombardier for patent infringement. Despite the court’s holding that Bombardier “willfully” infringed, Arctic Cat was unable to collect any damages for pre-trial sales, much less treble damages due to the courts holding that Arctic Cat did not provide proper notice as required under 35 U.S.C. 287, whether provided (a) constructively through proper patent marking or (b) actually through direct notice to Bombardier. The Federal Circuit also emphasized that the facts that Bombardier had actual knowledge of the patents and even willfully infringed were immaterial, and explained that affirmative notice by the patentee is statutorily required.
Background
a. Factual Setting
Arctic Cat, Inc. (Arctic Cat) sued Bombardier Recreational Products, Inc. (Bombardier) for infringement of U.S. Patent Nos. 6,793,545 and 6,568,969 related to steering systems for personal watercraft.
Artic Cat only sold product via its licensee, Honda. According to the terms of the licensee agreement, Honda was expressly not required to provide patent marking to provide constructive notice of the ‘545 or ‘969 patents to which the licensed products applied.
b. Procedural Background
Arctic Cat initially sued Bombardier in the Southern District of Florida for infringement of the ‘545 and ‘969 patents. The district court held that Bombardier willfully infringed. Additionally, the district court also held that Bombardier failed to meet its burden to prove that unmarked products sold by Honda practiced the claimed invention.
Bombardier previously appealed to the Federal Circuit, and the Federal Circuit previously affirmed the district courts holding of willful infringement. However, the Federal Circuit previously remanded the case back to the district court on the issue of patent marking, explaining that the burden was on the patentee to prove that the identified products do not practice the claimed invention once the alleged infringer identifies a product alleged to practice the claimed invention.
On remand, the district court held that Arctic Cat was unable to recover any pre-complaint damages for failure to provide constructive or actual notice to Bombardier.
The Federal Circuit’s Decision
Patent Marking Statute
In the opinion, the Federal Circuit explains that “[i]n this appeal, we are tasked with interpreting the marking statute, 35 U.S.C. § 287. Statutory interpretation is a question of law that we review de novo.”
Under 35 U.S.C. 287, “patentees, and persons making, offering for sale, or selling within the United States any patented article for or under them, or importing any patented article into the United States, may give notice to the public that the same is patented … by fixing thereon the word “patent” … . In the event of failure so to mark, no damages shall be recovered by the patentee in any action for infringement, except on proof that the infringer was notified of the infringement and continued to infringe thereafter, in which event damages may be recovered only for infringement occurring after such notice. Filing of an action for infringement shall constitute such notice.”
Requirements under the Patent Marking Statute
The Federal Circuit explains that under 35 U.S.C. 287, “a patentee who makes or sells patented articles can satisfy the notice requirement of § 287 either by providing constructive notice—i.e., marking its products—or by providing actual notice to an alleged infringer,” and explains that “[a]ctual notice requires the affirmative communication of a specific charge of infringement by a specific accused product or device.”
Constructive Notice
With respect to the requirement of “constructive notice,” Arctic Cat argued that such notice wasn’t required because after initially selling unmarked products, Honda ceased sales. As a result, Arctic Cat asserts that such cessation of sales excuses non-compliance with the notice requirement in a similar manner to how a patentee that does not make any sales is not required to provide such notice. However, the Federal Circuit explained that after an unmarked product is sold into the market, such products “remain on the market, incorrectly indicating to the public that there is no patent,” and held that “once a patentee begins making or selling a patented article, the notice requirement attaches, and the obligation imposed by 35 U.S.C. 287 attaches and is discharged only by providing actual or constructive notice.”
Actual Notice
With respect to the requirement of “actual notice,” Arctic Cat argued that the defendant had actual knowledge of the patent and, thus, had actual notice of the patent. Moreover, Arctic Cat argued that such actual knowledge was also evidenced by the district court’s holding of “willful” infringement. However, the court explained that “whether a patentee provided actual notice must focus on the action of the patentee, not the knowledge or understanding of the infringer, and that it is irrelevant whether the defendant knew of the patent or [even] knew of his own infringement.”
Licensees
With respect to sales through licensees, the Federal Circuit explained that “[a] patentee’s licensees must also comply with § 287.” While licensees have such an obligation, the court further explained that “courts may consider whether the patentee made reasonable efforts to ensure third parties’ compliance with the marking statute.” However, the court noted that in this case Arctic Cat’s “license agreement with Honda expressly states that Honda had no obligation to mark.”
Takeaways
- With respect to “constructive notice,” an important take away is to remember that constructive notice can be provided at any time by starting proper patent marking. Thus, in the event that a patentee initially does not provide proper patent marking, proper patent marking can be correctively initiated at a later date.
- With respect to “actual notice,” an important take away is to remember that an alleged infringer’s “actual knowledge” of the patent (and even “intentional” or “willful” infringement of that patent) is irrelevant to the notice requirement under 35 U.S.C. 287, which is entirely dependent on the actions of the patentee.
a. For example, if an infringer is aware that the patentee’s product is not marked, the infringer could potentially continue infringement without concern of potential damages until receipt of actual notice from the patentee.
- With respect to sales of patented products through licensees or third parties, an important take away is to remember that such licensees or third parties “must also comply” with 35 U.S.C. 287. However, the court indicates that “a court may consider whether the patentee made reasonable efforts to ensure third parties compliance with the marking statute.” Accordingly, another important takeaway is to ensure that licensing agreements include reasonable requirements for marking by the licensee.
- With respect to the requirement of patent marking, the opinion also provides some other helpful reminders that:
a. The patent marking requirement does not apply in the context of “process” or “method” claims. Notably, this provides another reason to consider inclusion of “method” or “process” claims.
b. The patent marking requirement also does not apply in the event that a patentee never makes or sells a product. Notably, this provides some advantage to non-practicing entities (NPEs).
Should’ve, Could’ve, Would’ve; Hindsight is as common as CDMA, allegedly!
Adele Critchley | March 5, 2020
Acoustic Technology, Inc., vs., Itron Networked Solutions, In.
February 13, 2020
Circuit Judges Moore, Reyna (author) and Taranto.
Summary:
i. Background:
Acoustic owns U.S. Patent No., 6,509,841 (‘841 hereon), which relates to communications systems for utility providers to remotely monitor groups of electricity meters.
Back in 2010, Acoustic sued Itron for infringement of the ‘841 patent, with the parties later settling. As part of this settlement, Acoustic licensed the patent to Itron. As a result of the lawsuit, Itron was time-barrred from seeking inter partes review (IPR), of the patent. See 35 U.S.C. § 315(b).
Six years later, Acoustic sued Silver Spring Networks, Inc., (SS) for infringement, and in response, SS filed an IPR petition that has given rise to this Appeal.
Prior to and thereafter filing the IPR, SS was in discussions with Itron regarding a potential merger. Nine days after the Board instituted IPR, the parties agreed to merge. It was publicly announced the following day. The merger was completed while the IPR proceeding remained underway. SS filed the necessary notices that listed Itron as a real-party-in-interest.
Finally, seven months after Itron and SS completed the merger, the Board entered a final written decision wherein they found claim 8 of the ‘841 patent unpatentable. Acoustic did not raise a time-bar challenge to the Board.
ii. Appeal Issues:
ii-a: Acoustic alleges the Boards final written decision should be vacated because the underlying IPR proceeding is time-barred under 35 U.S.C. § 315(b).
ii.b: Acoustic alleges the Boards unpatentability findings are unsupported.
iii. IPR
35 U.S.C. § 315(b)
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 CAFC held that “when a party raises arguments on appeal that it did not raise to the Board, they deprive the court of the benefit of the Board’s informed judgment.” Thus, since Acoustic failed to raise this issue to the Board, the CAFC declined to resolve whether Itron’s pre-merger activities rendered it a real-party-in-interest. Concluding, the CAFC stated that “[A]lthough we do not address the merits of Acoustic’s time-bar argument, we note Acoustics concerns about the concealed involvement of interested, time-barred parties.”
iv. Unpatentability
The sole claim at issue is as follows:
8. A system for remote two-way meter reading comprising:
a metering device comprising means for measuring usage and for transmitting data associated with said measured usage in response to receiving a read command;
a control for transmitting said read command to said metering device and for receiving said data associated with said measured usage transmitted from said metering device; and
a relay for code-division multiple access (CDMA) communication between said metering device and said control, wherein said data associated with said measured usage and said read command is relayed between said control and metering device by being passed through said relay.
Fig. 1:
Key: 16 = on-site utility meters: 14 = relay means: 12 = contro means. The relay means can communicate via CMDA (code-divisional mutliple access), which is descibred as “an improvement upon prior art automated meter reading systems that used exspensive and problematic radio frrequency transmitter or human meter-readers.”
- Novelty
The CAFC upheld both anticipation challenges.
The first, anticipation by Netcomm, Acoustic claims that the Board erred by finding the reference disclosed the claimed CDMA communication limitation. Acoustic argued that the Board based its final decision entirely upon SS’s expert Dr. Soliman, who applied an incorrect standard. Specifically, that Dr. Soliman’s statements used the word “recognize” which, Acoustic alleged, was akin to testimony about what a prior art reference “suggests”, and so goes to obvious not anticipation. CAFC disagreed with Acoustic.
CAFC held that the “question is whether a skilled artisan would “reasonably understand or infer” from a prior art reference that every claim limitation is disclosed in that single reference.” Further that, “Expert testimony may shed light on what a skilled artisan would reasonably understand or infer from a prior art reference,” and “expert testimony can constitute substantial evidence of anticipation when the expert explains in detail how each claim element is disclosed in the prior art reference.”
The CAFC held that “Dr. Soliman conducted a detailed analysis and explained how a skilled artisan would reasonably understand that NetComm’s disclosure of radio wave communication was the same as CDMA,” and “Acoustic provided no evidence to rebut Dr. Soliman’s testimony.”
The second, anticipation by Gastouniotis, Acoustic argued that “the Board’s finding is erroneous because the Board relied on “the same structures to satisfy separate claim limitations.” Specifically, Acoustic asserts that the Board relied on the same “remote station 6” in Gastouniotis to satisfy the “control” and “relay” limitations of claim 8.” CAFC disagreed with Acoustic.
Specifically, the CAFC held that Gastouniotis disclosed a system that included a plurality of “remote stations” and “that individual “remote stations” may have different functions in a given embodiment.” So, “In finding that Gastouniotis anticipated claim 8, the Board relied on separate “remote station” structures to meet the “control” and “relay” limitations.” Again, the CAFC held that “Dr. Soliman provided unrebutted testimony that a skilled artisan would understand that these remote stations disclosed in Gastouniotis” meet the limitations of claim 8.
- Obviousness
Acoustic challenged the Boards determination of obvious in view of Nelson and Roach. “Acoustic asserts two errors in the Board’s obviousness analysis: (i) that the Board erroneously mapped Nelson onto the elements of claim 8; and (ii) that the Board’s motivation-to-combine finding is not supported by substantial evidence.” The CAFC rejected both arguments.
Regarding point (i): “Acoustic asserts that the Board relied on the same “electronic meter reader (EMR)” in Nelson to satisfy both the “metering device” and “relay” limitations of claim 8.” Again, the CAFC held that the Board had correctly relied on “separate EMR structures to meet the “metering device” and “relay” limitations,” and that “Dr. Soliman provided unrebutted testimony that a skilled artisan would recognize” the metering apparatus of Nelson as meeting the limitations of claim 8.”
Regarding point (ii): “Acoustic requests that [the CAFC] reverse the Board’s finding because the Board relied on “attorney argument,” and “generically cited to [Dr. Soliman’s] expert testimony.” The CAFC held that “The motivation to combine prior art references can come from the knowledge of those skilled in the art, from the prior art reference itself, or from the nature of the problem to be solved.” That, the CAFC “have found expert testimony insufficient where, for example, the testimony consisted of conclusory statements that a skilled artisan could combine the references, not that they would have been motivated to do so.”
However, ultimately, the CAFC found that “Dr. Soliman’s testimony was not conclusory or otherwise defective, and the Board was within its discretion to give that testimony dispositive weight.” That the Board did not merely “generically” cite to Dr. Soliman’s testimony, but cited specific pages. Thus concluding that the “expert testimony constituted substantial evidence of a motivation to combine prior art references.”
Additional Note:
The subject ‘841 Patent is a continuation of U.S. Patent Application No., 08/949,440 (Patent No., 5,986,574). Acoustic filed a related appeal in said Patent on the same day as filing this Appeal. (Acoustic Tech., Inc. v. Itron Networked Solutions, Inc., Case No. 2019-1059). Oral arguments were heard in both cases on the same day, and the CAFC simultaneously issued opinions in both cases.
In the related Appeal, Acoustics argued again that the CAFC “must vacate the Board’s final written decisions because the inter partes reviews were time-barred under 35 U.S.C. § 315(b).” For the same reasons outlined above, Acoustics were unsuccessful.
The second issue on Appeal in the related case centered on Acoustic arguing that the CAFC “should reverse the Board’s obviousness findings on grounds that the Board erroneously construed the “WAN means” term.” However, the CAFC noted that “Acoustic’s argument on appeal is new. Rather than arguing that the prior art fails to disclose a conventional radio capable of transmitting over publicly available WAN, Acoustic now argues that the prior art fails to disclose any conventional WAN radio” Thus, “[B]ecause Acoustic never presented to the Board the non-obviousness arguments it now raises on appeal, we find those arguments waived,” and so the Board’s decision was affirmed.
Take-away:
1. Ensure all arguments are presented to the Board.
2. Ensure that any arguments against an unpatentability rejection directly address the actual reasons for rejection. That is, the CAFC repeatedly stated that Acoustic had failed to rebut any of the actual reasons outlined in the expert testimony that the Board ultimately relied upon in its holding.
3. Be aware of Broadest Reasonable Interpretation. Here, Acoustic argued
What role does inherency have in an obviousness analysis?
WHDA Blogging Team | February 22, 2020
Persion Pharmaceuticals LLC v. Alvogen Malta Operations Ltd.
December 27, 2019
Before O’Malley, Reyna, and Chen (Opinion by Reyna).
Summary
The Federal Circuit affirmed the district court’s decision invalidating as obvious patents directed to method of using a hydrocodone-only formulation to treat pain in patients with hepatic impairment. Important to the obviousness determination was the concept of “inherency”. Specifically, the Federal Circuit agreed with the District Court that where the claimed method of would have been obvious from the prior art, claim limitations directed to the pharmacokinetic properties of the formulation would be inherent in the combination of the prior art.
Details
Hydrocodone is an opioid pain medication commonly prescribed to treat prolonged, severe pain. The bulk of metabolism of many opioids, including hydrocodone, occurs in the liver. People suffering from hepatic impairment (i.e., liver dysfunction) are at increased risk of opioid overdose, because their livers cannot clear the drugs from their bloodstreams as quickly and effectively as would be the case for people with healthy livers. As such, when prescribed to patients with impaired livers, dosages of opioids are often adjusted to prevent build-ups.
Persion Pharmaceuticals, LLC (“Persion”) commercializes a hydrocodone drug under the brand name Zohydro ER. The drug is an extended-released hydrocodone-only product—that is, it contains no other active ingredients. Clinical trials on Zohydro ER revealed, to its inventors’ surprise, that the concentration of hydrocodone in the bloodstream of subjects with mild and moderate hepatic impairment was not dramatically higher than in patients with unimpaired livers. The inventors of Zohydro ER filed U.S. patent applications that eventually issued as U.S. Patent Nos. 9,265,760 (“760 patent”) and 9,339,499 (“499 patent”).
The 760 and 499 patents were directed specifically to methods of treating pains in patients with mild or moderate hepatic impairment, and the claims emphasized the similar effects that the hydrocodone-only formulation had on patients with and without hepatic impairment.
The relevant claims of the two patents fell into two categories. The “non-adjustment” claims recited the lack of need to adjust the dosage for patients with mild or moderate hepatic impairment relative to patients without hepatic impairment. Meanwhile, the “pharmacokinetic” claims recited certain pharmacokinetic (PK) parameters that highlighted the similarity in the results of administering the claimed formulation to patients with and without hepatic impairment.
Claim 1 of the 760 patent is representative of the “non-adjustment” claims:
1. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.
Claim 12 of the 760 patent is representative of the “pharmacokinetic” claims:
12. A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment an oral dosage unit having hydrocodone bitartrate as the only active ingredient, wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate,
wherein the dosage unit provides a release profile of hydrocodone that:
(1) does not increase average hydrocodone AUC0-inf in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%;
(2) does not increase average hydrocodone AUC0-inf in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 30%;
(3) does not increase average hydrocodone Cmax in subjects suffering from mild hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 9%; and
(4) does not increase average hydrocodone Cmax in subjects suffering from moderate hepatic impairment relative to subjects not suffering from renal or hepatic impairment in an amount of more than 14%.
When Alvogen Malta Operations, Ltd. (“Alvogen”) filed an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Zohydro ER, Persion sued Alvogen for infringing the 760 and 499 patents.
Naturally, Alvogen sought to invalidate those patents.
The prior art at issue were Devane (US2006/0240105), Jain (US2010/0010030), Vicodin label, and Lortab label.
Devane disclosed the same formulation as Zohydro ER, and disclosed an in vivo study in which the formulation was administered to treat post-operative pains in patients following their bunionectomy surgery. Devane did not disclose patients with mild or moderate hepatic impairment.
Jain disclosed a hepatic impairment PK study on Vicodin CR, a hydrocodone-acetaminophen combination formulation. Jain reported that the PK parameters (Cmax and AUC values) for hydrocodone in Vicodin CR were similar in normal and hepatically impaired subjects.
The Vicodin and Lortab labels disclosed the dosing instructions for those drugs. Vicodin contains hydrocodone and acetaminophen. Lortab contains hydrocodone and ibruprofen. The labels did not provide any precautions or dosing restrictions for individuals with mild or moderate hepatic impairment.
The district court found that the claims were obvious over the cited prior art.
As to the “non-adjustment” claims, the district court found that a person of ordinary skill in the art would have been motivated to administer Devane’s formulation to patients with mild or moderate hepatic impairment, because Jain taught that the hydrocodone exhibited similar PK parameters in normal and hepatically impaired patients, while the Vicodin and Lortab labels did not require different dosages for patients with mild or moderate hepatic impairment.
As to the “pharmacokinetic” claims, the district court found that the claimed PK values were “inherent in any obviousness combination that contains the Devane formulation”, because Devane disclosed what was essentially Zohydro ER, i.e., the claimed formulation, and the claimed values were “necessarily present” in Zohydro ER.
On appeal, the Federal Circuit honed in on Persion’s challenge of the district court’s “inherency” determination. Persion argued that Devane did not teach administering its formulation to hepatically impaired patients, so that “the natural result flowing from the operation as taught” in Devane could not be the claimed pharmacokinetic properties.
The Federal Circuit disagreed, distinguishing between the applications of “inherency” in the obviousness and anticipation contexts:
To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that “inherency may supply a missing claim limitation in an obviousness analysis” where the limitation at issue is “the natural result of the combination of prior art elements.”
As the Federal Circuit noted, the longstanding rule is that “an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations.”
Notably, there was no dispute that if administered under the same conditions, Devane’s formulation, which was identical to Zohydro ER, would necessarily exhibit the claimed PK values.
Related was Persion’s argument that the person skilled in the art would not have combined the cited prior art as the district court had. In particular, Persion argued that the district court should not have relied on the combination formulations disclosed in Jain and the Vicodin and Lortab labels.
Here also, the Federal Circuit disagreed. The Federal Circuit focused primarily on Jain’s teachings that its hydrocodone-acetaminophen combination formulation produced similar PK results for normal and hepatically impaired patients. That is, if Jain disclosed that its combination formulation was safe for patients with hepatic impairment, then it would be reasonable to expect the acetaminophen-free, hydrocodone-only formulation to be even safer. Further, considering Jain’s reported similarity in PK results for both hepatically impaired and unimpaired patients, it would have been obvious to the person skilled in the art to forgo dose adjustments when administering the same hydrocodone formulation to patients with hepatic impairment.
Where a claim defines some property of the claimed invention, it is not uncommon to find Examiners relying on inherency for those properties to complete their obviousness analyses. Reliance may be especially prevalent in chemical arts, as it has long been established that a chemical composition and its properties are inseparable. The Persion decision seems to reinforce the idea of inherency as a powerful argument that allows a missing limitation to be supplied based on some hypothetical combination of the prior art. That said, I suspect that the reach of the Persion decision will limited, as the fact that Persion’s claimed hydrocodone formulation already existed may have made it easier for the Federal Circuit to accept the finding of inherency.
Takeaway
- If the claim is directed to a new use of a known compound, then the claim should be more specific than a single, generic step of “applying the compound”. Consider defining the specific population or subpopulation that is helped by the compound, the specific conditions under which the compound is applied, and/or combination of the compound with other ingredients.
- If one can help it, avoid reciting intended results, which continue to be a complicated strategy. Not only could such a recitation force the issue of inherency, it could also raise the question of whether the recitation is even entitled to patentable weight, which is often a difficult argument to win with Examiners.
