Patent Docs

St. Regis Mohawk Tribe (and Allergan) File Motion to Preclude PTAB Final Written Decision in IPR

March 12, 2018

By Kevin E. Noonan —

The St. Regis Mohawk Tribe and Allergan filed a joint motion late last week before the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB), arguing that its Notice of Appeal divested the Board of jurisdiction over the inter partes review proceedings related to the Tribe's patents obtained by assignment by Allergan, and thus that the Board can no longer proceed to Final Written Decision in any of these IPRs. In the alternative, the Tribe argues that the Board should suspend the IPRs under 37 C.F.R. § 42.5(a) pending Federal Circuit review, because "the issues raised in [these proceedings] are important matters of first impression not contemplated by the statutory scheme."

On the divestiture argument, the Tribe's brief in support of its Motion first establishes its right to immediate appellate review under the collateral order doctrine, citing Osage Tribal Council ex rel. Osage Tribe of Indians v. U.S. Dep't of Labor, 187 F.3d 1174 (10th Cir. 1999); Wisconsin v. Ho-Chunk Nation, 512 F.3d 921, 928 (7th Cir. 2008); and In re Board of Regents of The Univ. of Tex. Sys., 435 F. App'x 945, 947-48 (Fed. Cir. 2011), all to the effect that denial of tribal sovereign immunity in an administrative agency proceeding is immediately appealable. The Tribe cites the Supreme Court standard, that interlocutory review of an order is immediately reviewable if it "conclusively determine[s] the disputed question, resolve[s] an important issue completely separate from the merits of the action, and [is] effectively unreviewable on appeal from a final judgment," citing Justice Brennan's concurring opinion in Mitchell v. Forsyth, 472 U.S. 511, 543 (1985). The Tribe is entitled to having immunity decided before final judgment, according to the Tribe's interpretation of Supreme Court precedent, because if properly immune, the Tribe should not be subjected to judgment at all. It is "immunity from suit rather than a mere defense to liability[]" that is at issue, and "[the immunity] is effectively lost if a case is erroneously permitted to go to trial," according to the brief, citing Burlington N. & Santa Fe Ry Co. v. Vaughn, 509 F.3d 1085, 1090 (9th Cir. 2007) (emphasis in original).

The brief counters Petitioners' position that, inter alia, precedent related to immunity is inapposite because an IPR is not a trial but rather a specialized administrative agency proceeding by contending that an IPR is an "adjudicatory process" and the Tribe is asserting absolute immunity from being subjected to it. Also, sovereign immunity is a jurisdictional issue that can be raised at any time, according to the brief, and the Tribe asserts that it raised it "at its first opportunity to do so – the day it acquired the patents."

As a consequence, the Tribe argues that its appeal divests the Board from jurisdiction over the IPR unless and until the Federal Circuit decides the appeal, citing Forsyth and Apostol v. Gallio, 870 F.2d 1335, 1338 (7th Cir. 1989), to the effect that "[t]he justification for the interlocutory appeal is that the trial destroys rights created by the immunity." The brief also cites precedent from several Circuit Courts of Appeal as well as the Supreme Court that a notice of appeal divests a district court of jurisdiction. Closer to home, the brief cites Federal Circuit (In re Graves, 69 F.3d 1147, 1149 (Fed. Cir. 1995)) and Board (Smart Microwave Sensor GmbH, IPR2016-00488, 2017 WL 3669083, at *1 (Aug. 24, 2017)) cases on this point ("The general rule is that the Board is divested of jurisdiction when either party files a notice of appeal to the Federal Circuit."). The brief also sets forth the equitable basis for its position: "If this Board went forward despite the appeal, the Tribe will be forced to choose between appearing before the Board, thereby losing its immunity, or risk losing its substantial property rights in absentia." Hardly seems fair. And the argument that the Tribe's interests can be adequately represented by Allergan begs the question, because whether or not that is the case is "'inextricably tied' to the question of immunity" that is the subject of the Tribe's appeal to the Federal Circuit.

The brief then ups the ante, by contending that the Board is without authority to ignore these procedural requirements or to have determined that Allergan could adequately represent the Tribe's interests in the IPR:

The Tribe will further argue that PTAB has no authority to create equitable or common law rules to facilitate the exercise of its Congressional mandate through its written decisions and orders in IPRs; only the Director has rulemaking authority under the AIA. 35 U.S.C. § 316(a); Am. Library Ass'n v. FCC, 406 F.3d 689, 698 (D.C. Cir. 2005) (noting agencies have no constitutional or common law authority, only authority granted by Congress). PTAB has no implied authority to create ad hoc rules and new forms of PTAB standing to facilitate what it perceives to be its mission. The Supreme Court has held "[r]egardless of how serious the problem an administrative agency seeks to address, [an agency] may not exercise its authority in a manner that is inconsistent with the administrative structure that Congress enacted into law." Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 125 (2000) (internal quotation omitted). Doing so "would deal a severe blow to the Constitution's separation of powers." Utility Air Regulatory Group v. E.P.A., 134 S. Ct. 2427, 2446 (2014). Thus, on appeal, the Tribe will argue that the Board erred when it deemed Allergan the "effective owner" in order to avoid the Tribe's immunity as an impediment to Board jurisdiction.

In the only portion of the brief resembling a carrot or peace offering, the Tribe argues in the alternative that there is a mechanism for the Board to suspend proceedings in anticipation of the Federal Circuit's ultimate ruling on the tribal sovereign immunity question. Under 37 C.F.R. § 42.5(a), the Board is empowered to "determine proper course of conduct in a proceeding for any situation not specifically covered" and to "set times by order." Sovereign immunity is just such an issue that is "not specifically covered" or anticipated by the statute, and thus the Tribe argues in its brief that it is entitled to the "extraordinary relief" contemplated by Rule 42.1(a). In addition, the brief reminds the Board that the statute already permits the time limit for a Final Written Decision to be extended by six months and (as here) in cases of joinder, citing 35 U.S.C. § 316(a)(11). The brief mentions that failure to adhere to the statutory time limit is without penalty, and then recites three "distinct and important issues" raised in this case that justify resorting to the extension of time provisions of the statute:

• Tribal immunity from suit before the PTAB;
• The "schism" between the Board's decision regarding tribal immunity and State sovereign immunity in Ericsson Inc., et al v. Regents of the Univ. of Minn., IPR2017-01186, Paper 14 at 4 (Dec. 19, 2017); and
• The panel split over jurisdiction as applied to the tribe in this case and to state actors (universities) in Covidien LP v. Univ. of Fla. Research Found. Inc., IPR2016-01274, Paper 21 at 19 (Jan. 25 2017); Neochord, Inc. v. Univ. of Md. et al, Case IPR2016-00208, Paper 28 at 6-7 (May 23, 2017); Reactive Surfaces Ltd, LLP v. Toyota Motor Corp., Case IPR2016-01914, Paper 36 at 7-8 (July 13, 2017); Minnesota Order at 4-6.

The brief ends with a warning: "If necessary, the Tribe and Allergan intend to seek emergency relief from the Federal Circuit no later than March 16, 2018."

In addition to the legal issues addressed in the Tribe's brief, another question arises: by filing this motion is the Tribe (or at least their counsel) playing with fire? Recall that after filing a motion for discovery regarding, inter alia, whether the PTAB would "stack the panel" by adding members to "ensure consistency with Office policies" (see "Skeptical St. Regis Mohawk Tribe Requests Discovery Regarding Panel Selection Circumstances"), the PTAB in a sharply-worded Order precluded the tribe or their counsel from filing any additional papers in the IPR without express authorization from the Board (see "The PTAB Strikes Back — Issues Order Prohibiting St. Regis Mohawk Tribe from Filing Any Additional Papers in IPR"). That Order also included the following warning:

As a final note, we caution counsel for the Tribe that failure to comply with an applicable rule or order, abuse of discovery, and abuse of process are all grounds for sanctions. 37 C.F.R. § 42.12(a)(1), (5), (6). We strongly advise counsel for the Tribe to review our rules and caution that any further actions that demonstrate a disregard for our process will not be tolerated. See 37 C.F.R. § 42.12(b).

This prohibition does not apply to the Notice of Appeal, of course, filed at the end of last month (see "St. Regis Mohawk Tribe and Allergan Appeal Denial of Motion to Dismiss on Sovereign Immunity Grounds"). But this Motion once again contains a flavor of mistrust, that the Board will attempt to forestall the Tribe's appeal by mooting it and issuing a Final Written Decision before the Federal Circuit can decide the issue. Perhaps provoking the kind of response from the Board that the Tribe did with its earlier discovery motion is intentional, the aim being to use any similar response to support a motion to the Federal Circuit for a writ precluding the Board from acting peremptorily. It is clear that the Tribe and its counsel are willing to use the kind of zealous tactics common in district court litigation against the Board, and that the Board is not used to and does not appreciate being treated in this fashion. But the stakes here, for both Allergan and the Tribe (and all tribes; see "Amicus Briefs Filed in Mohawk Tribe's Motion to Dismiss IPRs") are apparently sufficiently high to justify ruffling a few Administrative Patent Law judge's feathers in the process and the Tribe and its counsel show no reluctance to ruffle.
Exergen Corp. v. Kaz USA, Inc. (Fed. Cir. 2018)

March 11, 2018

By Kevin E. Noonan —

The tortured path that the Federal Circuit has taken (a path also trodden by the U.S. Patent and Trademark Office and the district courts) of applying the patent eligibility decisions under Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corp. v. CLS Bank Int'l. is illustrated in a 2-1 decision handed down by the Federal Circuit on March 8th in Exergen Corp. v. Kaz USA, Inc. In comparing the rationales used by the District Court and the majority with the dissenting opinion, this case illuminates a fundamental issue in properly applying subject matter eligibility law that, if adopted could avoid much of the confusion and uncertainty injected into the law by the Supreme Court's recent decisions.

The patents at issue, U.S. Patent No. 6,292,685 and U.S. Patent No. 7,787,938, were directed to body temperature detection apparatus and methods for detecting body temperature, respectively. Representative claims are as follows:

U.S. Patent No. 6,292,685:

48. A body temperature detector comprising:
a radiation detector; and
electronics that measure radiation from at least three readings per second of the radiation detector as a target skin surface over an artery is viewed, the artery having a relatively constant blood flow, and that process the measured radiation to provide a body temperature approximation, distinct from skin surface temperature, based on detected radiation.

49. The body temperature detector of claim 48 wherein the artery is a temporal artery.

U.S. Patent No. 7,787,938:

14. A method of detecting human body temperature comprising making at least three radiation readings per second while moving a radiation detector to scan across a region of skin over an artery to electronically determine a body temperature approximation, distinct from skin surface temperature.

24. The method of claim 14 wherein the artery is a temporal artery.

The claimed detectors calculate a person's body temperature "by detecting the temperature of the forehead directly above the superficial temporal artery." The device then calculates the body temperature by applying a "constant coefficient" to skin and ambient temperature readings. The temperature is detected by scanning the forehead to detect a peak reading that indicates the location of the temporal artery and hence provides the most reliable temperature reading.

Kaz sold competing temperature-sensing apparatus; two other defendants, Brooklands Inc. and Thermomedics Inc., were also sued in parallel proceedings, with the District Court consolidating the lawsuits solely for claim construction purposes. Not dispositive here but providing an interesting counterpoint to the decision in this case, certain claims of both the '685 and '938 patents were held to be invalid on the basis of lack of subject matter eligibility under § 101 in these other lawsuits. In this case, a jury found the patents to be infringed and not invalid and assessed damages (in a total amount in excess of $15 million). The District Court denied Kaz's summary judgment motions and motions for JMOL that the claims were invalid under § 101, as well as that the '685 patent was not infringed and for a new trial on damages, and granted Kaz's summary judgment motion of no willful infringement. Both parties appealed the adverse judgments against them.

The Federal Circuit affirmed the decision on § 101, reversed denial of JMOL on infringement of the '685 patent, vacated judgment for damages as a result of its decision on '685 patent infringement, and remanded for the District Court to recalculate damages, in a decision by Judge Moore joined by Judge Bryson; Judge Hughes dissented.

The majority set forth the now canonical two-prong test for subject matter eligibility under Mayo and Alice: the claims need to be "directed to" a law of nature, natural phenomenon or abstract idea, and there must be "something more" amounting to an "inventive concept" that is not merely "routine, conventional, and well-understood" in the prior art. Here, the majority spends little time on the first prong, accepting without comment that the claimed invention is dependent on the "natural law" that body temperature can be measured from skin temperature at the forehead. The District Court had relied on Diamond v. Diehr, 450 U.S. 175 (1981), for the principle that claims can recite "additional steps" that "transformed the underlying natural laws into inventive methods and useful devices that noninvasively and accurately detect human body temperature." These steps, which included "(1) moving while laterally scanning ('685 patent claims 7, 14, and 17; '938 patent claims 17, 24, 33, 60, and 66); (2) obtaining a peak temperature reading ('685 patent claim 7; '938 patent claims 60 and 66); and (3) obtaining at least three readings per second ('938 patent claims 17, 24, 39, 40, 46, and 49)" were known in the prior art but that was not enough. According to the District Court "simply being known in the art did not suffice to establish that the subject matter was not eligible for patenting" because "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made," citing Diehr. The distinction (and in some ways the distinction missing from much of § 101 jurisprudence post-Mayo) is that these methods were used for a different purpose in the prior art, in this case detecting "hot spots" indicative of tumors, fractures, or other injuries (and in at least some testimony, used in horses not humans). In addition, the invention here newly provided a "calculated coefficient for translating measurements taken at the forehead into core body temperature readings" which was not routine, well understood or conventional in the prior art.

The majority considered these findings, regarding what was routine, conventional and well understood in the prior art, to be findings of fact, and thus entitled to the deferential "clear error" standard of review. The opinion explains that, although the question of subject matter eligibility is one of law it is (or at least can be; the opinion is careful to state that it isn't always) reliant on underlying facts, analogizing this question to indefiniteness, enablement, and non-obviousness. To illustrate this point, the opinion goes on to say that "[s]omething is not well-understood, routine, and conventional merely because it is disclosed in a prior art reference," setting forth the hoary precedent of In re Hall wherein although the presence of a "thesis written in German and located in a German university library" was sufficient to qualify as prior art because it was available to the public, it would not without more be enough to satisfy the requirement that something be routine, conventional and well understood in the prior art. The opinion further distinguishes both Mayo and Ariosa v. Sequenom on the basis that the methods recited in those claims were undisputedly routine, conventional and well understood.

The opinion states that "[t]his case is different," and it is informative to consider the basis for this determination:

Following years and millions of dollars of testing and development, the inventor determined for the first time the coefficient representing the relationship between temporal-arterial temperature and core body temperature and incorporated that discovery into an unconventional method of temperature measurement. As a result, the method is patent eligible, similar to the method of curing rubber held eligible in Diehr.

Finally, the panel refused to consider Kaz's arguments that it had a Seventh Amendment right to have patent eligibility decided by a jury (saying that is "a question which awaits more in-depth development and briefing than the limited discussion in this case"), based on at least three instances ("before, during, and after trial") where Kaz waived the issue.

As to the other questions before the Court, the panel decided that the claims of the '685 patent were not infringed because the accused devices reported the "oral equivalent" temperature rather than the "temperature of the body beneath the forehead" as required by the claims. Accordingly, the panel vacated the damages below (while affirming the methodology regarding reasonable royalty and lost profits calculations) and remanded for recalculation based on non-infringement of the '685 patent claims. And the panel majority also found that the District Court's grant of Kaz's summary judgment motion that infringement was not willful was not an abuse of discretion and not inconsistent with the Supreme Court's decision in Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923, 1934 (2016), setting forth the proper standard to applying the enhanced damages provisions of 35 U.S.C. § 284.

Judge Hughes' dissent was based on his view that the District Court committed clear error in not deciding that the undisputed presence in the prior art of apparatus for detecting "hot spots" was enough for the claimed methods to be routine, conventional and well understood. According to Judge Hughes, a hallmark of a patent-ineligible claim is one that "begins and ends" with a non-eligible judicial exception, citing Ariosa. He perceives that this is the case here, because the claim "begins" with the ineligible law of nature (that body temperature can be detected at the forehead due to the presence of the temporal artery), and ends with a determination of body temperature. (On this point, the analysis must be more detailed than that, otherwise any claim for a method of doing something that arises in the natural world would be per se ineligible.) As to the equations developed at such a cost that impressed the District Court and the panel majority, Judge Hughes sees these as merely deriving from the "the principle that heat generated by a person's body flows throughout the body and, eventually, into the environment" and that "[t]he prior art recognized long ago that this principle enabled the calculation of core body temperature from skin and air temperature measurements."

It is in Judge Hughes' discussion of whether the invention provides an inventive concept that is not well understood, routine, and conventional that the competing views of the eligibility issue are properly set out. Judge Hughes maintains that:

[A]side from its use of a newly discovered heat balance coefficient, Exergen's claimed invention amounts to nothing more than using a preexisting temperature detector to take a conventional and routine measurement of forehead skin temperature. Absent the patent-ineligible law of nature, the claimed invention consists entirely of elements already combined by the prior art. Thus, the claimed combination of elements lacks an inventive concept because the combination was well-understood, routine and conventional at the time of invention.

The District Court's error was that it:

[N]ever found that the combination of taking multiple measurements while scanning laterally across the forehead to determine peak temperature was not well-understood, routine, and conventional. It only found that there was "no evidence . . . that these steps were 'well-understood, routine, [or] conventional[ly]' used to detect arterial temperature beneath the skin." [alterations in original] (emphasis added). Rather than finding that the claim elements were not routine or conventional, the district court focused on whether those elements were routinely or conventionally used for the purpose of calculating core body temperature. It differentiated the claimed invention from the prior art solely on the basis that the claimed invention "solve[s] a different problem."

Judge Hughes properly notes that the Federal Circuit "rejected identical reasoning in Ariosa," which is not to say that the Court's reasoning in that case was sound, as illustrated by Judge Hughes' synopsis of the Ariosa decision:

Although the claimed methods solved a novel problem, using conventional techniques for a new purpose did not supply an inventive concept that amounted to significantly more than the natural phenomenon to which the claims were directed.

As applied to this case:

Despite recognizing that temperature detectors identical to the claimed invention already existed for other purposes, the district court reasoned that these prior detectors never used forehead skin temperature measurements to calculate core body temperature. Like in Ariosa, this reasoning implicitly relies upon the relationship between forehead skin temperature and core body temperature to supply an inventive concept. Although the invention calculates core body temperature from forehead temperature, those calculations merely reflect the natural relationship between forehead and core body temperatures. Accordingly, the district court clearly erred by finding an inventive concept based on the asserted claims' use of well-understood, routine, and conventional temperature- measuring techniques for this new purpose.

This reasoning sets forth exactly what is wrong with how the USPTO (sometimes), the district courts (too often), and the Federal Circuit (much too often in view of their mandate and purported expertise in patent law) have applied the Supreme Court's Mayo/Alice jurisprudence. This application, wherein discovery of a new phenomenon and using conventional means to detect it, when such detection is not possible in the prior art, extends patent ineligibility further than the Court has indicated it needs to go. It is one thing to take conventional activity and prevent it from being subject to patent exclusivity without the elusive "something more" and quite another to preclude beneficial method claims to detect previously unknown phenomena unless a new method for detecting is also provided.

Perhaps Judge Hughes points to a way in which the analysis can be refined to avoid this consequence, focusing on how the first prong of the Mayo/Alice test is applied:

I am not suggesting that considering the integration of a law of nature into the claimed invention is improper at every stage of § 101 analysis. Indeed, step one requires us to examine the claims holistically in order to determine whether they are directed to an ineligible concept. See Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016) ("Rather, the 'directed to' inquiry applies a stage-one filter to claims, considered in light of the specification, based on whether 'their character as a whole is directed to excluded subject matter.'" (quoting Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1346 (Fed.Cir.2015))). Upon reaching step two, however, we focus more narrowly on the claim elements other than the invention's use of the ineligible concept to which it is directed. Accordingly, the majority's analysis of the claims as a whole belongs at step one.

But of course, that hope is somewhat dashed in the next sentence:

At either step, however, for the reasons discussed above, a claimed invention's unconventionality, by itself, is not sufficient to render the claim patent eligible.

For a statutory regime purportedly aimed at innovation, it is reasonable to ask, "why not"?

Exergen Corp. v. Kaz USA, Inc. (Fed. Cir. 2018)
Nonprecedential disposition
Panel: Circuit Judges Moore, Bryson, and Hughes
Opinion by Circuit Judge Moore; dissenting opinion by Circuit Judge Hughes
Conference & CLE Calendar

March 11, 2018

March 13, 2018 – "Top Stories at the PTAB: What You Need to Know" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

March 13, 2018 – "Subject Matter Eligibility: Guidance & Examination Resources" (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

March 13, 2018 – "Apportionment in Patent Damages: What You Need to Know and Do" (The Knowledge Group) – 12:00 to 1:00 pm (ET)

March 14, 2018 – Patent Litigation Seminar (New Jersey Intellectual Property Law Association) – 12:00 to 5:00 pm, Iselin, NJ

March 15, 2018 – "On Sale and Public Use Bars to Patentability: Minimizing the Risk of Patent Ineligibility or Invalidation" (Strafford) – 1:00 to 2:30 pm (EDT)

March 15, 2018 – 2018 Business Methods Partnership Meeting (U.S. Patent and Trademark Office) – 1:00 to 4:00 pm (ET), Alexandria, VA

March 15, 2018 – Patent Administrative Law Conference (American University, the Federal Circuit Bar Association, and Unified Patents) – 12:00 to 6:00 pm (EDT), Washington, DC

March 15, 2018 – "Waymo v. Uber: DTSA Test Tube" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

March 20, 2018 – "How to Secure and Exploit Patents for Combination Therapies" (J A Kemp) – 3:30 to 4:30 pm (GMT)

March 20, 2018 – Technology Center 1700 Customer Partnership meeting (U.S. Patent and Trademark Office) – 12:00 to 2:00 pm (ET), Alexandria, VA

March 20, 2018 – "USPTO Examiner Interview Strategies: Preparing for and Conducting Interviews to Advance Patent Prosecution" (Strafford) – 1:00 to 2:30 pm (EDT)

March 22, 2018 – Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office) – Alexandria, VA

March 28, 2018 – "Patent Infringement: Structuring Opinions of Counsel — Leveraging Opinion Letters to Reduce the Risks of Liability and Enhanced Damages" (Strafford) – 1:00 to 2:30 pm (EDT)

March 29, 2018 – "The Evolving Scope of IPR Estoppel" (Federal Circuit Bar Association) – 1:00 pm to 2:00 pm (EST), Washington, DC

April 5, 2018 – "Paragraph IV Litigation and IPRs — Interplay Between Paragraph IV Litigation and IPRs, Multiple Generic Challengers, Key Issues in IPRs" (Strafford) – 1:00 to 2:30 pm (EDT)
BCP Customer Partnership Meeting

March 10, 2018

The U.S. Patent and Trademark Office will be holding its next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting on March 22, 2018 at the USPTO Headquarters (Alexandria, VA). The agenda for the meeting is as follows:

• Welcoming and Opening Remarks (10:00 – 10:10 am EDT) — Daniel Sullivan and Andrew Wang, Directors, TC1600, USPTO

• Obviousness of Biologics: Identifying the Biggest Challenges (10:10 – 11:00 am) — Carla Mouta-Bellum of Arrigo, Lee, Guttman & Mouta-Bellum LLP

• 103 KSR Rationales (11:00 – 11:50 am) — Lora Driscoll, QAS, TC1600, USPTO

• Lunch (11:50 am – 12:50 pm)

• 112(f)-New Form Paragraphs (12:50 – 1:40 pm) — Marjorie Moran, QAS, and Heather Calamita, SPE, TC1600, USPTO

• Requirements for Information Under 37 CFR 1.105 and Responses to Said Requirements (1:40 – 2:40 pm) — Amjad Abraham, SPE, and Shubo (Joe) Zhou, SPE, TC1600, USPTO

• Break (2:40 – 3:00 pm)

• Accidental Infringement: the need for additional limitations in plant utility claims directed to chemical profiles or cultivars (3:00 – 3:50 pm) — Reggie Gaudino, Chief Science Officer, Steep Hill Labs, Inc.

• Closing Remarks (3:50 – 4:00 pm) – Directors, TC1600, USPTO

Additional information regarding the BCP customer partnership meeting, including registration information for those wishing to attend the meeting or register for online participation, can be found here.
Webinar on Paragraph IV Litigation and IPRs

March 10, 2018

Strafford will be offering a webinar entitled "Paragraph IV Litigation and IPRs — Interplay Between Paragraph IV Litigation and IPRs, Multiple Generic Challengers, Key Issues in IPRs" on April 5, 2018 from 1:00 to 2:30 pm (EDT). Erin M. Dunston, Matthew L. Fedowitz, and Mythili Markowski of Buchanan Ingersoll & Rooney will discuss strategies for using IPRs in relation to Hatch-Waxman litigation, how pharmaceutical patents fare in post-grant challenges in comparison to all patents, and what the crucial issues are in post-grant challenges involving pharmaceutical patents. The webinar will review the following issues:

• Where do multiple generic challengers fit into the exclusivity scheme?
• How do pharma patents and CDER-listed biologic patents fare in post-grant challenges in comparison to all patents?
• What are the crucial issues in post-grant challenges involving pharma or biologics patents?

The registration fee for the webcast is $297. Those interested in registering for the webinar, can do so here.
FCBA Program on IPR Estoppel

March 10, 2018

The Federal Circuit Bar Association (FCBA) will be offering a program on "The Evolving Scope of IPR Estoppel" on March 29, 2018 from 1:00 pm to 2:00 pm (EST) at the FCBA office in Washington, DC. Eldora Ellison of Sterne Kessler Goldstein & Fox, PLLC will moderate a panel consisting of Brian Walsh of Bristol-Myers Squibb Company, Andrew Trask of Google LLC, and Jonathan Strang of Latham & Watkins LLP. The panel will provide an overview of the current state of estoppels following IPRs, and also consider the impact that the evolution of the application of the AIA's estoppel provisions has had on patent owners and petitioners.

The program is complimentary for FCBA members and $50 (government/academic/retired) or $125 (private practitioner) for non-members. Those interested in registering for the webcast, can do so here.
Webinar on Opinions of Counsel

March 10, 2018

Strafford will be offering a webinar entitled "Patent Infringement: Structuring Opinions of Counsel — Leveraging Opinion Letters to Reduce the Risks of Liability and Enhanced Damages" on March 28, 2018 from 1:00 to 2:30 pm (EDT). Thomas J. Scott, Jr., Senior Vice President and General Counsel, Personalized Media Communications; April E. Weisbruch of Sheppard Mullin Richter & Hampton; and Eleanor M. Yost of Carlton Fields Jorden Burt will provide patent counsel with an analysis of the evolving role of attorney opinions in the defense of patent infringement claims and the potential use of written opinions of counsel, and also discuss the issue of waiver of the attorney-client privilege and provide best practices for developing opinions of counsel. The webinar will review the following issues:

• What is the practical impact of recent decisions on utilizing opinions of counsel in defense of willful infringement and induced infringement claims?
• How does the “totality of the circumstances” standard impact legal advice on proactive clearance analysis for product planning and strategic portfolio development?
• Under what circumstances should corporate counsel seek outside opinions of counsel to protect their client from infringement claims?

The registration fee for the webcast is $297. Those interested in registering for the webinar, can do so here.
IPO Webinar on Waymo v. Uber

March 10, 2018

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Waymo v. Uber: DTSA Test Tube" on March 15, 2018 from 2:00 to 3:00 pm (ET). Diane Danoff of Dechert LLP; James Pooley of James Pooley, PLC; and Barbara Reeves of JAMS will examine the recently-settled trade secret action Waymo v. Uber as a test case for the new federal trade secret law, the DTSA, and also analyze other recent cases in other federal courts, illustrating how the risks of using the DTSA to bring suit compares to the benefits. The panel will discuss how:

• Federal judges have been making rigorous demands for specificity of TS description, both at the pleading stage and at the gateway to discovery.
• Federal courts are more likely than state courts to challenge experts and theories of harm.

The registration fee for the webinar is $135 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Webcast on Apportionment in Patent Damages

March 10, 2018

The Knowledge Group will offer a webcast entitled "Apportionment in Patent Damages: What You Need to Know and Do" on March 13, 2018 from 12:00 to 1:00 pm (ET). John Jarosz of Analysis Group, Inc., Daniel M. McGavock of Charles River Associates, and John Scalf of NERA Economic Consulting will provide attendees with the latest updates regarding apportionment of damages in patent infringements, and also offer helpful insights and tips for patent owners faced with the same case. Key topics to be addressed by the webcast include:

• Damages Apportionment in Patent Cases
• Apportionment Requirements set by the Federal Circuit
• Most Notable Court Decisions
• Latest Trends and Developments
• Practical Tips for Patent Owners

The registration fee for the webcast is $49. Those interested in registering for the webinar can do so here.
Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2017)

March 8, 2018

By Donald Zuhn –-

At about this time last year, the Supreme Court reversed the Federal Circuit's determination that there are circumstances in which a party may be liable for infringement under 35 U.S.C. § 271(f)(1) for supplying or causing to be supplied a single component of a patented combination outside the United States (see "Life Technologies Corp. v. Promega Corp. (2017)"). This past November, the dispute between Promega Corp. and Life Technologies Corp. returned to the Federal Circuit on remand, with the Federal Circuit affirming the District Court's grant of judgment as a matter of law (JMOL) to Life Technologies and the District Court's denial of Promega's motion for a new trial.

The dispute between the two companies began in 2010 when Promega sued Life Technologies for infringement of U.S. Patent No. RE37,984 ("the Tautz patent") (as well as four other patents owned by Promega), alleging that Life Technologies had sold genetic testing kits that were not covered by a license agreement between the parties. The Tautz patent, which is owned by Max-Planck-Gesellschaft zur Förderung der Wissenschaften E.V. and exclusively licensed to Promega, claims a kit for testing at least one STR locus that contains: (1) a mixture of primers; (2) a polymerizing enzyme such as Taq polymerase; (3) nucleotides for forming replicated strands of DNA; (4) a buffer solution for the amplification; and (5) control DNA. Life Technologies manufactures genetic testing kits that provide components for carrying out a multiplex amplification of STR loci from DNA samples, wherein the kits contain (1) a primer mix; (2) Taq polymerase; (3) PCR reaction mix including nucleotides; (4) a buffer solution; and (5) control DNA. At trial, the parties moved for summary judgment on infringement and invalidity, with the District Court determining that Life Technologies' sales outside the license agreement's field of use were infringing. Following trial, the jury returned a verdict of willful infringement. Life Technologies then moved for judgment as a matter of law (JMOL) of noninfringement, and the District Court granted the motion, finding that Promega had failed to present sufficient evidence to sustain a jury verdict under § 271(f)(1), and the Court vacated the finding of infringement.

On appeal, the Federal Circuit determined in Promega Corp. v. Life Technologies Corp. ("Promega I") that substantial evidence supported a jury's finding that Life Technologies infringed the Tautz patent under § 271(f)(1), and therefore reversed the District Court's grant of JMOL of noninfringement. The panel was divided as to the finding of infringement under § 271(f)(1), but the divide centered on another aspect of the statute. With regard to the issue of whether infringement under § 271(f)(1) requires that at least two components be supplied from the U.S., the Federal Circuit held "that there are circumstances in which a party may be liable under § 271(f)(1) for supplying or causing to be supplied a single component for combination outside the United States," and "based on the facts of this particular case . . . conclude[d] that substantial evidence supports the jury's verdict that LifeTech is liable for infringement under § 271(f)(1) for shipping the Taq polymerase component of its accused genetic testing kits to its United Kingdom facility."

In reversing the Federal Circuit and remanding the case, the Supreme Court, in Life Technologies Corp. v. Promega Corp., determined "that a single component does not constitute a substantial portion of the components that can give rise to liability under §271(f)(1)." As the Supreme Court noted, Life Technologies manufactured all but one component of its kits in the United Kingdom — manufacturing Taq polymerase in the United States and then shipping the Taq polymerase to its United Kingdom facility to be combined with the other four components of the kit.

On remand, the Federal Circuit noted that the Supreme Court's opinion required the Federal Circuit to reconsider two of its prior holdings: (1) its reversal of the District Court's grant of Life Technologies' motion for JMOL that Promega had failed to prove its infringement case under 35 U.S.C. §§ 271(a)3 and 271(f)(1), and (2) its vacatur of the District Court's denial of Promega's motion for a new trial on damages and infringement. In reconsidering these holdings, the panel first looked to the procedural history before the District Court, noting that the District Court did not decide how many of Life Technologies' kits, which were all assembled abroad, had been sold, offered for sale, or imported into the United States (i.e., were infringing under § 271(a)) or included a substantial portion of their respective components that were supplied from the United States (i.e., were infringing under § 271(f)(1)). In addition, while the parties stipulated at trial that Life Technologies' total worldwide sales of the accused products during the pertinent time period amounted to $707,618,247, a dispute arose with respect to the effect of this stipulation. In particular, Promega and Life Technologies disagreed as to whether Promega needed to separately quantify domestic and foreign sales. Ultimately, the District Court determined that Promega needed to prove the amount of damages attributable to infringement under § 271(a) and the amount of damages attributable to infringement under § 271(f)(1), and the Court provided Promega with a second chance to meet its burden by presenting evidence of infringing sales in its rebuttal case.

In its rebuttal case, Promega presented additional evidence of infringement, but did not present evidence or elicit testimony intended to prove a specific amount of domestic, foreign, or any other subset of total sales, relying instead on the stipulated worldwide sales figure as a potential damages base. In addition, in its proposed special verdict form, Promega sought to have the jury calculate a single damages amount rather than separate damages numbers under § 271(a) and § 271(f)(1). The jury subsequently found that all of Life Technologies' worldwide damages qualified as U.S. sales, and further, that all of Life Technologies' unlicensed sales infringed Promega's asserted patents under § 271(a) and/or § 271(f)(1).

After trial, Life Technologies filed a renewed JMOL motion, arguing that Promega was entitled to no damages because, inter alia, it had failed to present adequate evidence of an amount of infringing sales under either § 271(a) or § 271(f)(1). Promega countered that the damages verdict should stand because all of the accused products infringed under § 271(f)(1) (since all of the products included Taq polymerase, which qualified as a "substantial portion" of each of the accused products) and all of the accused products also infringed under § 271(a). The District Court granted Life Technologies' JMOL motion, holding that no reasonable jury could have found that all of the accused products infringed under § 271(a) or § 271(f)(1), and finding that Promega had waived any argument that the trial record could support a damages calculation based on an amount other than worldwide sales. The District Court also denied Promega's motion for a new trial, reiterating that Promega had waived any argument based on a subset of worldwide sales by failing to respond to Life Technologies' argument on this issue in its JMOL briefing.

Following the Supreme Court's remand, the parties submitted statements to the Federal Circuit as to how the Court should proceed post-remand. Life Technologies argued that the Federal Circuit should affirm the District Court's post-trial decisions, contending that "[t]he trial judge with her 'first-hand knowledge of witnesses, testimony, and issues' simply held Promega to its own considered strategic litigation decisions, and appropriately denied Promega's retrial request." Promega, on the other hand, argued that the Federal Circuit should reinstate the judgment of infringement under § 271(a) and order a new trial on damages, because "[t]he Seventh Amendment, the Patent Act, and precedent all require a new trial on damages under § 271(a)—not a windfall judgment of noninfringement," in view of Life Technologies' admissions that it committed infringing acts in the U.S. (the opinion indicates in a footnote that "[i]t is undisputed that Life admitted to at least some infringement," pointing out that Life Technologies "admit[ed] at trial that there had been 'an infringement' and that Promega was 'entitled to be compensated for that infringement'").

The Federal Circuit began its discussion of the case by noting that Promega had expressly waived its right to any award based on a reasonable royalty, and instead only sought damages in the form of lost profits. The opinion explains that:

The linchpin of the district court's rulings on Life's JMOL motion and Promega's motion for a new trial is its finding that Promega waived any argument that the trial record supports a damages calculation based on a subset of Life's total worldwide sales. In Promega I, we held that all of the accused products infringed under § 271(f)(1) and that the jury's damages verdict—based on total sales—was supported by substantial evidence. It was therefore unnecessary for us to address the district court's waiver finding. However, now that it is undisputed that certain of the accused kits did not infringe under the Supreme Court's interpretation of § 271(f)(1)—specifically, kits containing only one component supplied from the United States that were assembled and sold overseas to foreign buyers without ever passing through the United States—we must address the district court's waiver finding [citations omitted].

With respect to the District Court's waiver finding, the Federal Circuit determined, after looking at the procedural history of the case before the District Court, that:

In the instant case, the district court could properly conclude that Promega abandoned any alternative damages base when it failed to rebut Life's argument in its Rule 50(b) motion that Promega did not present evidence that a reasonable jury could have relied on to award damages based on any subset of total worldwide sales. The district court's decision was all the more reasonable given that it warned Promega during trial that it bore the burden to separately prove infringement under § 271(a) and § 271(f)(1).

In affirming the District Court's grant of JMOL to Life Technologies, the Federal Circuit noted that:

Promega argues, and Life does not dispute, that the record contains evidence of admitted infringement by Life under § 271(a). It further argues that we should reaffirm our prior decision on § 271(a) infringement and order a new trial on damages. In Promega I, we held that an unspecified number of Life's accused products infringed the Tautz patent under § 271(a). We made no finding regarding the quantity of infringing acts under § 271(a), because such a finding was unnecessary in light of our holding that all of the accused products infringed under § 271(f)(1). Now that our holding under § 271(f)(1) has been reversed by the Supreme Court, and in view of the waiver finding discussed, supra, the only way Promega could preserve the jury's damages verdict is by showing that the record supports a finding that all of Life's accused products that did not infringe under § 271(f)(1) infringed under § 271(a). Promega has failed to make this showing [citations omitted].

The opinion explains that "[t]his is a case where there was a finding of waiver that carried forward as law of the case to subsequent proceedings in the litigation," adding that "[t]he nature of the waiver under the circumstances of this case had the effect of limiting the trial evidence on damages to only the parties' stipulated worldwide sales figure." And "[b]ecause there was insufficient evidence to show that all worldwide sales infringed under § 271(a) or § 271(f)(1)," the Federal Circuit concluded that "there was no evidence to support a lost profits damages calculation under the narrow damages theory Promega crafted over the course of litigation." As a result, the panel affirmed the District Court's grant of JMOL to Life Technologies.

With respect to Promega's motion for a new trial, the Federal Circuit determined that "[u]nder the law of the case doctrine, the district court properly exercised its discretion by relying on its waiver finding from its JMOL ruling to support its decision to deny Promega's motion for a new trial." The panel explained that:

If Promega wanted to argue that the evidence at trial supported a damages calculation based on anything other than worldwide sales, it should have raised such an argument at trial and in response to Life's Rule 50(b) motion, which specifically attacked Promega's damages case on that very ground. Promega did not, choosing instead to continue to solely pursue an all-or-nothing damages strategy. Moreover, the district court afforded Promega a second opportunity to supplement the record and present evidence broken out by statutory subsection and quantity. Yet Promega declined to use this opportunity to prove any lesser damages amount [citations omitted].

The panel also noted that:

The only relevant law affecting the outcome in this case that was addressed by the Supreme Court was the "substantial portion" provision of § 271(f)(1). No law stood in the way of Promega's proving liability and damages separately under § 271(a), and Promega's reading of § 271(f)(1) was untested. Indeed, the district court itself ultimately rejected Promega's interpretation of § 271(f)(1), and so did the Supreme Court. And, from the time the district court gave Promega a second chance to put in evidence at trial to prove liability separately under § 271(a) and § 271(f)(1), Promega was on notice that its untested interpretation of § 271(f)(1) might not prevail. But Promega nonetheless declined to use its opportunity to establish entitlement to an alternative, smaller damages award.

The opinion conceded that "[t]his is an unusual case," noting that "[p]atent owners who prove infringement are typically awarded at least some amount of damages." However, in this case, Promega waived its right to a damages award "when it deliberately abandon[ed] valid theories of recovery in a singular pursuit of an ultimately invalid damages theory." The Federal Circuit therefore concluded that the District Court did not abuse its discretion by declining to give Promega "multiple chances to correct deficiencies in its arguments or the record." As a result, the panel also affirmed the District Court's denial of Promega's motion for a new trial.

Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2017)
Panel: Chief Judge Prost and Circuit Judges Mayer and Chen
Opinion by Circuit Judge Chen

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