Biogen Int’l v. Mylan Pharmaceuticals (Fed. Cir. 2022) (en banc denial)
Back in December 2021, the Federal Circuit invalidated Biogen’s U.S. patent 8,399,514–affirming the lower court’s ruling of invalidity for lack of written description. 35 U.S.C. §112(a).
The claimed method has one step: administering “a therapeutically effective amount [of] about 480 mg” of DMF per day along with an excipient for treatment of multiple sclerosis.
The specification’s only reference to that dosage is in a prophetic example reciting “an effective dose of DMF … can be from … about 480 mg to about 720 mg per day; or about 720 mg per day.”
The appellate majority noted that this was the “sole reference,” the “one and only reference”, a “single passing reference” to 480 mg/day and that it appeared “at the end of one range among a series of ranges.” The court also contrasted the 480 mg/day disclosure with the specification’s disclosure of 720 mg/day that was specifically identified and elsewhere in the patent shown to be effective. Although the patentee’s prophetic example recited effectiveness, at the time the patentee did not actually have evidence that the 480 mg/day dosage was effective. Thus, the Federal Circuit concluded that “a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF dosage range and not listed as an independent therapeutically efficacious dose.” We know now that 480 mg/day is effective — but that knowledge is based upon post-filing research that cannot be added back into the written description.
The original opinion was penned by Judge Reyna and joined by Judge Hughes. Judge O’Malley (now retired) wrote in dissent.
After losing, the patentee then petitioned for en banc rehearing with two written description questions (paraphrased below):
Must a “written description” prove the invention’s efficacy?
Is there a need to repeatedly emphasize elements of the invention in order to satisfy the written description requirement?
The Federal Circuit has now released its 6-3 decision denying the en banc petition. Since Judge O’Malley is retired, she did not participate in the rehearing petition. Judges Stoll and Cunningham also did not participate.
Judge Lourie wrote in dissent, joined by Chief Judge Moore and Judge Newman. The trio argued that this case is a true outlier.
[I]n all [the] history [of the written description requirement], this case, in which every claim limitation is expressly described in the disclosure of the patent specification, is at the farthest end of the spectrum of cases where written description has not been found. It is an outlier.
Judge Lourie dissenting from the en banc denial. The dissent particularly argues that the decision “blurs the boundaries between the written description requirement and the other statutory requirements for patentability. In doing so, the court has contributed to the muddying of the written description requirement.”
From my point of view, the majority was wrong to place so much emphasis on the fact that 480 mg/day was only mentioned once in the specification. A single reference is certainly sufficient to satisfy written description.
However, I am also drawn-in by claim language that expressly requires that the 480 mg/day dosage be “therapeutically effective.” The patentee expressly claimed the therapeutic effectiveness, but did not include enough in the specification to demonstrate that it actually was effective at the 480 mg/day dosage.
Today, the Federal Circuit also denied an en banc petition in another written description case focusing on claimed ranges, Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2022). In my post on the case, I wrote “Four points are not A range.” The basic holding: although the specification described several embodiments covered by the claims, it did not describe the full-scope of the claimed invention. No dissent in the Indivior denial. Judge Lourie dissented in Biogen in favor of the patentee, but wrote the majority opinion invaliding the claims in Indivior.
After a failed negotiation, Sarepta petitioned for Inter Partes Review of Nippon Shinyaku’s patents. But, the two parties had a prior agreement to litigate patent disputes in Delaware courts (i.e., not before the PTAB). After Sarepta petitioned for IPR, Nippon Shinyaku responded with an action in Delaware Federal Court for breach of contract seeking a preliminary injunction that would force Sarepta to withdraw its IPR petitions based upon the forum selection clause. The Delaware court (Judge Stark) sided denied preliminary relief and instead sided with the patent challenger – finding (1) evidence of breach was lacking and (2) the real irreparable harm would come from barring the IPR. On appeal the Federal Circuit reversed based upon its own plain language interpretation of the contract. The result then is that the district court should enter the preliminary injunction on remand.
Sarepta has now petitioned for en banc review: asking two procedural questions, including one on the Erie Doctrine.
The petition asks two questions paraphrased as follows:
Does the Erie Doctrine require this Court to apply state substantive law when deciding an issue of contract interpretation under state law? [Under Delaware law a contractual waiver of a statutory right (such as right to file an IPR) requires that waiver be clearly and affirmatively expressed. Kortum v. Webasto Sunroofs, Inc., 769 A.2d 113 (Del. Ch. 2000)]
Should the court have vacated-and-remanded rather than reversed? [Although Fed.Cir. found the movant had established the first two gateway factors for preliminary injunction, the district court still should “reevaluate and balance the four preliminary injunction factors before entering any injunction.”]
Do you remember Erie Railroad Co. v. Tompkins (1938)? In that famous decision, the Supreme Court held that federal courts sitting in diversity must apply state substantive law rather than principles of federal common law. The lawsuit here asserts diversity jurisdiction for the state law contract claim and federal question jurisdiction over a separate set of declaratory judgment claims (asserting several Sarepta patents are invalid or not infringed). In a mixed situation like this, the standard approach is that Erie applies to the claims whose jurisdiction are based upon diversity grounds.
The Federal Circuit’s opinion in the case does not cite Erie, but does purport to be answering “a question of contract interpretation under Delaware law.” So far so good. The problem arises as you delve into further opinion. It quickly becomes clear that a good portion of the court’s conclusions are based upon “general principles” with no regard to Delaware law. Another name for those general principles is Federal Common Law — the exact approach rejected in Erie.
The most Erie-offensive paragraph from the case is excerpted below:
As a general principle, this court has recognized that parties are entitled to bargain away their rights to file IPR petitions, including through the use of forum selection clauses. For example, in Dodocase VR, Inc. v. MerchSource, LLC, 767 F. App’x 930 (Fed. Cir. 2019) (nonprecedential), we affirmed a district court’s grant of a preliminary injunction on the basis that a defendant had likely violated a forum selection clause by filing IPR petitions, even though the forum selection clause did not explicitly mention IPRs. Even in Kannuu Pty Ltd. v. Samsung Electronics Co., 15 F.4th 1101, 1106–10 (Fed. Cir. 2021), where we determined that the parties’ forum selection clause did not extend to IPRs, that determination was based on the specific language in the forum selection clause at issue in that case. Inherent in our holding in Kannuu was an understanding that a differently worded forum selection clause would preclude the filing of IPR petitions.
Nippon Shinyaku Co., Ltd. v. Sarepta Therapeutics, Inc., 25 F.4th 998 (Fed. Cir. 2022). What is the problem here: (1) the court talks about “general principles” for determining whether this is a proper element of a contract rather than a question of Delaware Law; (2) the court references its own cases to prove the point (rather than Delaware cases; (3) Dodocase involved a question of California state law rather than Delaware state law; (4) Kannuu purported to interpret New York state law rather than Delaware state law. Although these it makes sense to consider non-Delaware law cases in the attempt to make an Erie Guess in situations where there is no state precedent on-point. However the Erie Guess is focused on divining Delaware Law rather than being bound by some general principal of law that arches across the states. Here, the Delaware high courts have not faced the specific question of contractual waiver of IPR rights. However, they have addressed the larger question of contracts that appear to waive statutory rights. In particular, the Delaware court have held that waiver must be “clearly and affirmatively expressed in the agreement.” Kortum v. Webasto Sunroofs, Inc., 769 A.2d 113 (Del. Ch. 2000). The Federal Circuit decision did not attempt to contend with this principle of Delaware Law.
= = = =
Back to Timing: Although I see merit in the en banc petition, its filing is also part of a timing game. As soon as the Federal Circuit released its decision in February, Nippon Shinyaku asked Judge Stark to immediately enter the preliminary injunction. Judge Stark refused–holding that the Federal Circuit has not yet issued its mandate and thus that the Federal Circuit held jurisdiction over the preliminary injunction issues in the case. (That is a shaky decision, IMO since this was an interlocutory appeal.) As back-up, Judge Stark further explained that “even if the Court did have jurisdiction over the preliminary injunction issues, the Court would exercise its discretion to defer further letter briefing until the Federal Circuit issues its mandate.” So, Nippon Shinyaku’s only hope for quick entry of the preliminary injunction is expedited action by the Federal Circuit. In that regard, the company has has requested the Federal Circuit issue an expedited mandate – ordering entry of the Preliminary Injunction to halt the IPRs.
The PTAB cases are currently stayed (until April 24, 2022), but the motion practice regarding the en banc petition could easily extend beyond that date. Nippon Shinyaku explains:
Expedited issuance of the mandate would prevent Sarepta from, as Professor Dennis Crouch has hypothesized, using its motion for rehearing to “run-out the clock,” nullifying this Court’s decision. Dennis Crouch, Contractually Agreeing to Not Petition for Inter Partes Review, PATENTLY-O (Feb. 8, 2022), https://patentlyo.com/patent/2022/02/contractually-agreeing-petition.html. . . .
If Sarepta had not sought rehearing, the mandate would have issued on March 17. This would have provided ample time for any additional briefing in the district court and entry of the injunction by April 24, when the stay entered by the PTAB will expire.
But now that Sarepta has filed a petition for rehearing, the mandate will not issue until 7 days after the entry of the order denying rehearing. Even if no response to Sarepta’s petition is requested, issuance of the mandate could easily be delayed by 30 days or more. . . .
To avoid nullification of this Court’s decision and to avoid the irreparable harm to Nippon Shinyaku already recognized in the panel opinion, this Court should issue the mandate no later than March 17, 2022, allowing the district court to enter an injunction before expiration of the PTAB’s stay. . . .
Petition for Expedited Mandate. The Federal Circuit has ordered responsive briefing on the expedited mandate that appears to be due Monday 3/21 (If I have counted 5 days correctly).
Great litigating by folks at both Morgan Lewis and Finnegan Henderson.
Back to Erie: Despite being 84 years old, the case is still regularly cited — with about 200 citations by Federal appellate courts in the past 5 years. None of those citations came from the Federal Circuit. I’m not giving these figures to denigrate the Federal Circuit. Rather, the lack of citations are not surprising. Erie focuses on diversity cases and ordinary diversity cases are never heard by the Federal Circuit. The figure does show that the court is out of practice at thinking through the Constitutional implications of its state law interpretative questions.
The Honorable Kathleen M. O’Malley retired from judicial service on March 11, 2022. Judge O’Malley began her service on the U.S. Court of Appeals for the Federal Circuit on December 27, 2010, following her appointment by President Barack Obama and confirmation by the Senate. Prior to her appointment, Judge O’Malley served for sixteen years as a district judge of the U.S. District Court for the Northern District of Ohio. Judge O’Malley’s full biography is now available on the Federal Judicial Center’s website.
The court here affirms a PTAB conclusion cancelling claims 1-8 of Almirall’s U.S. Patent 9,517,219 as obvious. The patent claims a method of treating acne/rosacea using a particular formulation:
Active Ingredient: about 7.5% dapsone;
Solvent: about 30% to about 40% diethylene glycol monoethyl ether;
Gelling Agent: about 2% to about 6% of A/SA; and
water;
[note – I edited these for compactness]. The claim also indicates that the composition “does not comprise adapalene.” This concentration of the active ingredient was already known, the idea behind the invention here was to have a product that works well, that customers like, and that has a long shelf life. Thus, the figure submitted to the PTO shows shelf-life:
The prior art includes the commercial product (Aczone) that includes 7.5% dapsone and no adapalene. For the IPR, the PTAB looked at a patent application publication (Garrett) that described the Aczone product in detail. Garret taught a different gelling agent — Carbopol rather than A/SA as required in the patent. A different reference (Nadau-Fourcade) taught the use of A/SA agents in roughly the same concentration range for use in acne/rosacea products. The Board found the combination appropriate and concluded that the claims were invalid.
Presumption of Obviousness: On appeal, the patentee argued that the Board improperly presumed obviousness based upon overlapping ranges. The basic argument is that A/SA was brought from a different reference and there should not be a presumption that its concentration would obviously be the same in the new combination. On appeal, however, the Federal Circuit affirmed the Board’s ruling — finding that the presumption was appropriate here because the evidence proved similarity between carbomers (disclosed in Garret) and A/SA agents (substituted from Nadau-Fourcade)
The Board also credited expert testimony that a person of ordinary skill in the art
would have been able to immediately appreciate that the carbomers and A/SA agents at issue perform the same function and are interchangeable. Moreover, there was no evidence that A/SA agents would have different interactions with the other ingredients of the compositions relative to carbomer. Indeed, the Board credited expert testimony that a skilled artisan “would not have expected any incompatibilities in substituting” the gelling agents.
It was this close similarity in the substitution that allowed the range disclosures to create a presumption of obviousness. In its decision, the court also notes that the stated presumption-of-obviousness is not any kind of burden shifting. Rather, it is simply shorthand for the proposition that overlapping ranges in the prior art justify a factfinder in concluding that the claimed range was known in the art. The patentee is free to provide evidence showing why its particular range is meaningful and thus non-obvious in the face of a similar disclosure range in the prior art.
Negative Limitation: The claims expressly exclude adapalene from the formulation. “[W]herein the … composition does not comprise adapalene.” The key prior art reference (Garrett) does not even mention adapalene, and so, according to the patentee, we are left wondering whether Garrett might include the substance. The Board rejected that argument as did the Federal Circuit. In particular, the court restated its prior precedent that negative limitations need not be expressly stated in the prior art. “[A] reference need not state a feature’s absence in order to disclose a negative limitation.” AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358 (Fed. Cir. 2019).
Reasonable Expectation of Success: Finally, the Court found that the Board had properly identified reasons to combine the references. In particular, the patent challenger provided evidence that gelling compounds were effective and compatible substitutes. As such, the substitution of A/SA was a “predictable design choice.” This falls within the Supreme Court’s guidance from KSR: “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”
The court also places substantial weight on whether the substitution would have “a reasonable expectation of success.” Here, though, expert testimony was provided regarding their interchangeability. Further, [a] finding of a reasonable expectation of success does not require absolute predictability of success.”
Coffey applied for a job with large poultry producer OK Foods (owned by Bachoco). The online application required her to provide substantial personally identifiable information (PII), including her name, SSN, birthdate, etc. She got the job. At some point a few years later OK Foods computer system was hacked and Coffey’s information was exposed (along with that of thousands of other employees). Coffey found out after being provided notice of the breach (as required by law).
Coffey sued OK Foods, bringing a class action for negligence, breach of implied contract, breach of confidence, invasion of privacy, breach of fiduciary duty, and breach of the covenant of good faith and fair dealing.
Concrete Injury for Data Breach: Coffey’s action suffers from the same problems seen in most large PII hacking cases — concrete harm. Here, Coffey argues that she now suffers from an increased risk of future identity theft. The defendant pointed the district court toward the 2021 decision in TransUnion LLC v. Ramirez, 141 S. Ct. 2190 (2021). In TransUnion, the Supreme Court held that “mere risk of future harm” regarding a credit alert was not sufficiently concrete to satisfy the Constitutional standing requirements.
OK Foods requested dismissal for lack of standing, but the district court found that the allegations future risk in this case was substantial and concrete enough to survive a motion to dismiss. the district court particularly distinguished TransUnion. In that case, there was no evidence that the information had been disseminated to any third-parties. On the other hand, in Coffee’s case everyone agrees that Coffee’s PII was obtained by a third party. Coffee also provided evidence of recent unknown requests for credit on her credit report. For the district court, this setup was enough to demonstrate standing. The decision here is on the cusp and other courts would have dismissed. Cases are more likely to proceed when the breach includes financial or account login information such as user_IDs and passwords.
Arbitration Agreement in Job Application: When Coffee applied for the job, she also clicked “I agree” to a set of terms that included an arbitration agreement. She argued, however, that the agreement is not binding because she was not provided a copy of the agreement to review and she does not recall ever actually signing the agreement. The district court noted two problems with OK Foods’ evidence thus far presented: (1) OK Foods did not present the “exact materials” as they appeared on here screen during the 2016 application process; and (2) the download link provided does not show the arbitration package. In addition, the evidence from OK Foods shows that a digitally signed arbitration agreement dated May 3, 2016, while Plaintiff alleges that she completed her online application in April 2016.
All these competing allegations and proofs create an issue of material fact and so the district court refused compel arbitration at this point.
Next steps in the case:
Jury Trial on whether the parties entered into a binding arbitration agreement. 9 U.S.C. § 4. Note here that jury trials on arbitrability are rarely granted. Rather, the usual approach is for the district court to decide arbitrability based upon a summary judgment standard. Here, however, the court determined that the competing evidence created a sufficient dispute.
If no arb, then a trial on Plaintiff’s claims (although D’s will likely attempt to preempt this via summary judgment).
I recently posted a chart showing that there is a significant difference in technology focus of patents tied to US-Inventors as compared with Non-US-inventors. The following chart looks at the file histories of U.S. patents and asks what percentage received a rejection prior to issuance (blue) and what percentage received a Section 101 rejection prior to issuance (issued patents 2015-2020). Overall, 83% of the patents received some sort of rejection prior to issuance. The vast majority of these rejections are based upon prior art – and are primarily Section 103 obviousness rejections. 13% of these patents were rejected on eligibility grounds prior to issuance.
Applications from US Inventors were significantly more likely to be rejected on eligibility than non-US Inventors (15% vs 10%). However, that difference can be fully explained by differences in the types of patents being obtained. For example, US applications are much more likely to patent in the business-method group (as well as 8 of the top-9 art unit groups most likely to receive 101 rejections). But, within the art units groups, there is typically no difference between US and Non-US inventions in terms of eligibility rejections. Thus, for my sample of business method patents, 75% of the patents in each group (US and Non-US inventors) received an eligibility rejection. The data do reveal some outliers. In 1660-plants, non-us-inventor patents received 15% more eligibility rejections than us-inventor patents; while in 2760-printers & graphics, non-us-inventor patents received 10% fewer.
Thaler v. Hirshfeld, App No. 21-02347 (Fed. Cir. 2022)
Prof. Ryan Abbott continues to push Thaler’s case on a global basis. Thaler created an AI system that he calls DABUS. DABUS created two separate inventions — a “Neural Flame” and “Fractal Container.” Thaler filed for patent protection, but refused to name himself as the inventor — although he created DABUS, these particular inventions did not originate in his mind. The USPTO rejected the applications — explaining US patents must name a human inventor. Now the case is pending before the Federal Circuit. The reality here is that Thaler could have claimed to be the inventor and the PTO would not have blinked-an-eye; and no other person or entity would have standing to challenge that result. In a forthcoming article, I argue that the PTO’s don’t-ask-don’t-tell approach is a truly problematic legal fiction. And, Thaler’s refusal to comply provides helpful exposure to the hypocrisy.
After being refused a patent, Thaler sued in district court, but the district court sided with the PTO and dismissed the case on summary judgment. Now the appeal to the Federal Circuit. Thaler argues:
The USPTO does not accept than an AI can be an “inventor.” This holding is simply inconsistent with the Patent Act’s plain language, Congressional intent, and the Constitution. The District Court improperly endorsed an interpretation of the Patent Act that, for the first time, excludes an entire category of innovation from patent law protection. The result of which will be to discourage innovation, limit
disclosure of trade secrets, and restrict commercialization of new products.
Thaler Brief. The argument begins with an analysis of the Patent Act: (1) nothing in the Act actually requires human inventors; and (2) nothing in the Act requires “conception.” Rather, the design of the system is to create an open incentive field to generally encourage innovation, disclosure, and commercialization. Barring AI-created inventions from the patent sphere discourages each of these goals of the patent system.
One catch to the Thaler argument in the US is that the 2011 America Invents Act included a new definition of the term “inventor” that requires the inventor be an “individual” and required submission of a inventorship declaration from “each individual who is the inventor or joint inventor.” 35 U.S.C. §§ 100, 115. The statute also provides a binary gender identification for inventors: “himself or herself.” These changes suggest a human-inventor requirement, but there are also a number of cases interpreting “individual” to include non-human persons. In addition, the law allows for a substitute declaration in cases where the inventor is legally incapacitated. In this case, Thaler submitted that substitute declaration on behalf of DABUS.
Briefing appears complete in the case, and oral arguments will likely be scheduled for sometime this summer.
Hoyt Fleming is a patent attorney, and former Chief Patent Counsel for Micron. He is also an inventor and builder (he has personally built three airplanes). His U.S. Patent No. RE47,474 is pretty cool: it claims a “whole-aircraft ballistic parachute, which includes a rocket, that is coupled to the fuselage of the aircraft.” In response to a deployment request, the system first “commands the autopilot to increase aircraft pitch” and then deploys the ballistic parachute.
Fleming sent a copy of his pending patent application to Cirrus who apparently then released a new aircraft embodying his patented design. Fleming began negotiations on a license, but Cirrus filed a declaratory judgment action for non-infringement and also filed two IPR petitions. This is an appeal from the first IPR — finding the challenged claims unpatentable as obvious.
On appeal, the Federal Circuit has affirmed both the obviousness determination and the Board’s denial of Fleming’s motion to amend several claims.
The Federal Circuit spells-out the crux of the obviousness case as follows:
It is well known that: aircraft autopilots are programmable; can perform flight maneuvers and deploy a parachute.
It is also well known certain maneuvers should be performed prior to deploying a whole-aircraft parachute — such as increasing altitude and stabilizing the attitude;
But, everyone agrees that the prior art does not specifically teach “commanding an autopilot to perform the claimed flight maneuvers of increasing pitch, reducing roll, or changing attitude upon receipt of a parachute deployment request.”
The Board concluded that a person of ordinary skill in the art would be motivated to reprogram the autopilot to take Fleming’s proposed actions prior to releasing the parachute in order to improve safety outcomes.
Note here that the motivation for combining here is improved safety. Fleming noted that the prior art cautioned against the use of autopilot in certain certain emergency situations because it was unsafe. The PTAB rejected that argument and the Federal Circuit affirmed on appeal: “the Board correctly explained that the obviousness inquiry does not require that the prior art combination is the “preferred, or the most desirable” configuration.” The court noted that caution against autopilot use did not necessarily extend to all aircraft — such as unmanned aircraft. “That the prior art cautioned pilots not to use an autopilot in some emergency situations on some aircraft does not mean that the skilled artisan would have been dissuaded from doing so in all emergency situations on all aircraft.” Slip Op.
Fleming also argued copying – that Cirrus had copied his invention – and that copying is a strong indicia of nonobviousness. The Board concluded that Fleming had not proven that Cirrus copied:
Fleming repeatedly provided copies of his patent application and argued that Cirrus incorporated that disclosed material into its product and also its own patent application.
However, the Board found the evidence lacking because he did not provide “any meaningful infringement analysis.” On appeal, the Federal Circuit affirmed that conclusion
In re Volkswagen Group of America; In re Hyundai Motor America (Fed. Cir. 2022)
On appeal here, the Federal Circuit delved into franchise law — holding that independently owned and operated VW/Hyundai car dealerships located in the W.D. Texas do not count as a “place of business” of the car distributors. As such, venue is improper under 28 U.S.C. 1400(b).
In ordinary civil actions, venue is proper in any district that would have personal jurisdiction over the defendant. 28 U.S.C. 1391. Thus, for most federal cases, venue is not a major hurdle. But, in the 1800s, Congress created a special statute that substantially limits proper venue in patent cases (well before the expansion seen in Section 1391. In Fourco (1957), and again in TC Heartland (2017), the Supreme Court gave weight to the patent-focused statute. Today, there are two ways to show proper venue over a US corporate defendant:
The defendant is incorporated in the state; or
The defendant committed acts of infringement in the district and also has a “regular and established place of business” in the district.
TC Heartland, interpreting Section 1400(b).
In 2020, StratosAudio sued VW Group of America (VW) for patent infringement in Judge Albright’s court located in Waco, Texas. VW is incorporated NJ and does not have its own “place of business” in the district. However, there are VW dealerships in Waco and Austin. The question is whether those can count as a “place of business” for the defendant.
The laws of most states, including Texas, prohibit auto manufacturers and distributors from operating a dealership within the state. Still, Judge Albright found sufficient control by the distributor as well as ratification by the distributors.
On mandamus, the court further defined its requirements to determine whether a dealership can count as the place of business for a manufacturer or distributor:
Is the dealership the VW’s agent?
Does the dealership conduct VW’s business?; and
Has VW ratified the dealership as its place of business?
Slip Op. These requirements stem from the court’s 2020 Google decision requiring physical presence of an “agent of the defendant conducting the defendant’s business at the alleged place of business.” In re Google LLC, 949 F.3d 1338 (Fed. Cir. 2020). In addition, the ratification requirement appears in Cray: “Thus, the defendant must establish or ratify the place of business. It is not enough that the employee does so on his or her own.” In re Cray Inc., 871 F.3d 1355 (Fed. Cir. 2017). These three elements are independent requirements that must each be met before a place-of-business maintained by a separate legal entity will “count” as the place-of-business of the defendant.
Not Agents: Here in particular, the court found that the dealerships located in W.D.Texas are not agents of VW Group of America. And, therefore, the dealerships are not a place-of-business of VW Group. The court’s approach was to follow the Restatement (Third) of Agency in focusing on the right of control/direction by the principal; and consent to the agency relationship by both the principal and agent. In the end, the court found that the dealerships had “full control over their day-to-day operations, such as sales.” Thus, the court found no agency relationship there. The court admitted some control over things such as:
who can be employed, what roles are required, and other employment requirements;
minimum inventory;
requirement of performing warranty work (warranty is promised by VW, not the dealer);
use specified tools when performing warranty and maintenance work;
use distributor-approved computer hardware and software;
compliance with distributors’ standards regarding dealership appearance and use of signs and brand logos;
maintaining working capital;
attending mandatory training and or certificates.
However, the court found that there was a lack of “interim control” once those parameters are set.
No agent, no place of business, no venue.
Fed Cir: a building that says VOLKSWAGEN, has VOLKSWAGEN signage all over it, has employees in it all wearing VOLKSWAGEN uniforms, and that exclusively sells and services VOLKSWAGEN vehicles, is not, in fact, VOLKSWAGEN’s place of business. https://t.co/f4GHOKD9Oq
The chart below provides a contrasting glimpse into the subject matter of US-originated patents compared with their foreign-originated counterparts. For each art-unit grouping, I show the percent of patents having US inventors (residence).
Broadcom petitioned the ITC to halt imports by Renesas Electronics (and others) because they infringe two Broadcom patents:
US7512752, claims 1, 2, 5, 7, 8: memory access unit with improve access to shared memory.
US7437583, claims 17–18, 25–26: gating clock signals to reduce power consumption.
But, the ITC sided fully with Renesas:
For the ‘583 patent, the ITC found no “domestic industry” to protect – a prerequisite for USITC action. In particular, Broadcom was unable to show any licensed domestic use of the invention as claimed. In addition, the ITC found no infringement of claims 25-26.
For the ‘752 patent, the ITC found infringement of claim 5, but concluded that claim 5 was invalid as obvious. (In a parallel IPR proceeding, the PTAB also found claim 5 obvious).
On appeal, the Federal Circuit consolidated the ITC case with the IPR appeals and has affirmed in favor of Renesas.
Domestic Industry: The International Trade Commission (ITC) is a branch of the U.S. government whose role is the protection of domestic industry against foreign overreach. As part of its role, a patentee can complain to the ITC about infringing imports. A prerequisite for these Section 337 cases is the existence of a domestic industry to protect.
[ITC powers over infringing imports] apply only if an industry in the United States, relating to the articles protected by the patent, copyright, trademark, mask work, or design concerned, exists or is in the process of being established.
19 U.S.C. § 1337(a)(2). Thus, the statute requires “an industry in the United States, relating to the articles protected by the patent” being asserted. The patentee can prove that the domestic industry already exists by pointing to actual products in the US market that practice at least one claim of the asserted patent. Of course, minimal domestic sales do not equate to “an industry.” Rather, the law also requires a showing that the patentee has made significant/substantial investment in equipment, labor, engineering, research and development, and/or licensing. 19 U.S.C. § 1337(a)(3).
Here, Broadcom pointed to its system-on-a-chip (SoC) in serving the domestic industry for the ‘583. However, Broadcom’s chips do not include a “clock tree driver” required by all claims of the patent, and the ITC found no domestic industry. Broadcom generally argued that aspect of the patent was integrated by clients. However Broadcom did not point to any actual instances of such integration. But, generalities regarding the domestic industry are insufficient. The court explained:
As in Microsoft, Broadcom failed to identify any specific integration of the domestic industry SoC and the “clock tree driver” firmware, or a specific location where the firmware was stored. [And therfore] the Commission’s finding that Broadcom failed to satisfy the domestic industry requirement of Section 337 was supported by substantial evidence.
Slip Op. After losing before the ALJ, Broadcom added further evidence pointing to a particular system. However, the ITC and CAFed both concluded that new argument had been waived.
Broadcom was able to show a domestic industry for the ‘752 patent, but the court also affirmed the PTAB findings that the asserted claims were invalid. The court’s only real quibble was with regard to grammar. In a footnote, the court explained:
The Board and Commission decisions refer to what “is” obvious. Because § 103 addresses what “would have been” obvious, we recommend usage of the statutory language that looks back to the past in order to avoid the appearance of hindsight bias.
Slip Op. at Note 2. I read through the ITC decision and found the following line that appears to have raised Judge Lourie’s ire: “[T]he record evidence fully supports the FID’s finding that claim 8 is obvious over Foster alone.” [ITC Decision – 711340-1540697]. I also read through the PTAB decisions, but could not find any parallel offensive statements. Rather, the PTAB was careful to repeatedly recite the line “would have been obvious.” The PTAB did conclude that each problematic claim “is unpatentable under 35 U.S.C. § 103(a) as obvious.” However, that statement does not appear problematic to me.
As with most grammar, Judge Lourie’s opinion has some rational basis but will have the primary result of protecting self-satisfied insiders. The Supreme Court as a non-patent court doesn’t appear to care. Guess what the Court wrote in the biggest obviousness case of the past 50 years: “THE COMBINATION IS OBVIOUS.” KSR (2007)
In 1982, the USPTO began charging a surcharge for patent applications that included >3 independent claims and >20 total claims. The original surcharge was $10 per extra claim. The surcharge slowly rose up to $18 per extra claim by 2004. Then, in December of that year Congress pushed the fee up to $50 per claim–almost treble damages. Since then, the rate has continued to rise–jumping to $62 and then $80 in 2013. It now sits at $100 per claim beyond the 20-claim buffet limit.
The chart below shows the percent of patents that I call “jumbo patents”–those with >50 claims (orange) and >100 claims (dashed-blue). Both curves peak in 2005 with that year celebrating the issuance of the most jumbo patents in history. At its peak, only about 3.5% of patents issued with more than 50 claims. That number is now down below 0.5%.
I posit that the rapid decline in jumbo patents after 1995 was a direct result of the substantial rise in fee-surcharges December 2004. The impact of that change began to be felt in patents issued in 2006, and is shown much more dramatically by 2008 as the pre-2005 applications worked their way out of the system. An application with 50 claims (including 7 independent claims) went from an $850 surcharge to $2,300 surcharge. Thus, the new surcharge was substantially above the $1,000 fee for simply filing another patent, and almost covered the issue fee of $1,400 as well. In fact, the rise in jumbo patents was a key reason why the Dudas USPTO pushed for the large surcharge increase — Imagine seeing that upward trajectory in the pending applications and trying to figure out how to manage examination time.
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The following are the most-jumbo patents from the past year:
11,116,808 – 394 claims – Nielsen Biosciences – “method for treating a common wart”
10,973,440 – 354 claims – method for “determining a gait velocity” – solo inventor.
11,080,336 – 302 claims – “a commonplace of information” – solo inventor
The decision here is simple, the plaintiffs sued WM for a data breach, but failed to allege that any of WM’s actions were unreasonable. The court dismissed the case, holding that “the law does not impose strict liability for harms arising out of the storage of personal information.”
In re Waste Management Data Breach Litigation, 21CV6147 (DLC), 2022 WL 561734, at *6 (S.D.N.Y. Feb. 24, 2022) [WasteManagementDismissal].
Waste Management detected some suspicious activity on its servers in January 2021, but did not discover that there was a real breach until May 2021. By that time, hackers had obtained personally identifiable information (PII) for the company’s 40,000 employees, and tens-of-thousands of former employees. This includes name, SSN, DOB, Driver’s License, etc. 4-weeks after discovering the breach, Waste Management disclosed the breach to individuals as well as to the California Attorney General (required by statute). WM offered to pay for 1-year identity monitoring.
The current/former employees sued in a nationwide class action alleging negligence, breach of implied contract, breach of fiduciary duty, and unjust enrichment. In addition, the California plaintiffs alleged breach of various California state laws, including the CCPA. In her recent decision, S.D.N.Y. Judge Denise Cote has dismissed the case for failure to state a claim upon which relief could be granted. Fed. R. Civ. Pro. R. 12(b)(6).
Negligence: “When an employer requires an employee to submit their sensitive personal information, the employee … has a reasonable expectation that the employer will take reasonable care not to place their personal data at unnecessary risk of exposure.” However, negligence does not sound in strict liability for all hacked disclosures. Rather, negligence always requires some unreasonable action (or inaction) in breach of the duty of care. Here, the complaint did not spin-out any such story. The court provides potential examples: non-encrypted files; failure to delete old data; failure to adhere to industry security guidelines; etc. However, none of these facts were pled. Thus, the negligence claim was dismissed.
Implied Contract: The court found that the plaintiffs might be able to prove that WM entered into an implied contract regarding data security. However, the complaint alleges that the implied contract was that WM “act reasonably.” But, as in the negligence claim, the complaint failed to plead plausible facts telling the story of any unreasonable action. The court notes that the plaintiffs might have pled (but did not actually plead) an implied contract to “insure employees against any data loss.”
Fiduciary Duty: No case here because “employers are not fiduciaries of their employees.”
Unjust Enrichment: Again, an unjust enrichment claim here would require some unreasonable act by WM. Plaintiffs failed to allege such an act.
California Consumer Privacy Act (CCPA): The complaint failed here again on reasonableness grounds. In particular, the complaint failed to allege that WM had in place “reasonable security procedures and practices appropriate to the nature of the information.” Cal. Civ. Code § 1798.150(a)(1). The CCPA also creates an action for unreasonable delay, but the court found that the 24-day delay “is insufficient on its own to plausibly allege unreasonable delay.”
Thomas v. Hughes, 20-50671, 2022 WL 620238, at *1 (5th Cir. Mar. 3, 2022) [Opinion]
Texas attorney Lee Ann Hughes purchased Performance Probiotics, LLC from the company founder Pearcy. At the time of the purchase, Hughes was Pearcy’s attorney – a red flag. In addition to the purchase agreement, PPI agreed to license Pearcy’s proprietary formulation of probiotics at a rate of 14% of net sales with an option to purchase the rights for $100k at the end of five years. But, PPI did not pay the royalties and instead simply used the formulation without payment (a second red flag).
Percy sued in Texas state court an won a verdict of almost $1 million for trade secret misappropriation (by PPI) but just $1 against Hughes for breach of attorney fiduciary duty. But, PPI did not pay the money owed on the judgment — instead filed for bankruptcy. At that point, Percy (as well as PPI’s bankruptcy trustee Thomas) sued Hughes personally for the money owed. The veil-piercing action included allegations of fraudulent transfer pre-bankruptcy, fraud, and breach of fiduciary duty to the company — this time all against Hughes. A jury found that Hughes was liable for all of it — although by that time the interest pushed the award up to $1.5 million. In addition, the jury awarded $1.2 million in punitive (“exemplary”) damages. The district court additionally ordered:
Disgorgement of $900k in compensations Hughes received from PPI;
Injunction against Hughes and her new companies from using the trade secret formulation until the judgment is fully satisfied;
Joint and several liability against Hughes personally for the prior judgment against PPI; and
Attorney fees of $400k. (This brings the total due to about $4 million).
On appeal, the Fifth Circuit has affirmed (with only a slight modification).
Under Texas law, trade secret misappropriation requires the following three elements:
existence of a trade secret
acquisition of the trade secret through a breach of a confidential relationship or improper means; and
unauthorized use of the trade secret.
Sufficiency of the Evidence: A litigant in federal court must take particular actions at trial in order to preserve a right to appeal a verdict on sufficiency-of-the-evidence grounds. In particular, the issue must be raised first in a pre-verdict R.50(a) JMOL motion; and then the same issue must be renewed as part of a post-verdict R.50(b) JMOL motion. On appeal here, Hughes argued that there was insufficient evidence to prove that Percy’s formulation was a trade secret. Although Hughes made that argument in her R.50(b) motion, she did not make the argument in a pre-verdict R.50(a) motion. On appeal, the Federal Circuit stuck to the rules and refused to consider this particular challenge. “Because Hughes did not challenge the existence of a trade secret or improper use in her initial Rule 50(a) motion, those issues were not properly raised in her post-trial Rule 50(b) motion. We therefore decline to address them on appeal.”
Trade Secret Damages: Although you have to prove damages in a trade secret case, the Texas Supreme Court allows for “flexible and imaginative” approaches. Here though the damages were easy to calculate because they were part of the contract – 14% of net sales + 100,000 for the purchase price. On appeal, the court affirmed the award.
Injunction: Hughes argued that the money paid fully compensated the defendant and thus no injunction was appropriate. The appellate court disagreed:
While it is true that the jury awarded “legally measurable damages” to Pearcy for Hughes’s misappropriation of trade secrets, the history of this case makes clear that such damages, without more, are incapable of remedying “the situation sought to be enjoined.” The Comal County jury originally awarded damages against PPI for breach of contract and misappropriation of trade secrets. But that award did not stop Hughes and companies she controlled from misappropriating Pearcy’s trade secrets again. Moreover, the money damages awarded to Pearcy compensate for past misappropriation, while the injunctive relief was fashioned by the district court to prevent future misappropriation—until the court’s judgment is satisfied, neither Hughes nor her companies have any more right to use Pearcy’s trade secrets than they did before. We agree with the district court that “the evidence adduced at trial and supported by the jury’s verdict shows that without injunctive relief, [Hughes] could continue harming Plaintiffs, which would … defeat the entire purpose of this long, expansive litigation.”
The chart below provides one look at the role of the U.S. Gov’t in directly funding patentable research-and-development. You’ll see two curves. The bottom curve tracks the percent of U.S. utility patents assigned to the U.S. governmental (or agency of the government, such as the Navy). U.S. Gov’t owned patents has dropped precipitously over the past 40 years. The upper curve tracks the percentage that list some U.S. Government interest in the patent — typically based upon Gov’t funding of the R&D and the government interest is provided for under the Bayh-Dole Act. Overall, when these two curves are combined together, we have a slight downward trend in the percentage of patents where the U.S. Gov’t asserts some property interest.
Readers should note that the primary government interest in government-funded patents are the march-in rights outlined in 35 U.S.C. § 200 et seq., and extended to large entities by various executive orders. Although that interest appears powerful, it has never been used by the government to ignore patent owner’s exclusivity. In addition, the funding agency receives a non-exclusive license to the patents for governmental uses. “With respect to any invention in which the contractor elects rights, the Federal agency shall have a nonexclusive, non-transferrable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world.” 35 U.S.C. 202.
The U.S. Gov't disclaims copyright protection the works of authorship created by the Government.
How would the world be different if we did the same with patentable inventions?
Data available here: Dennis Crouch, Replication Data for: U.S. Government Property Interests in Patent Rights, Harvard Dataverse (March 6, 2022), https://doi.org/10.7910/DVN/8CXI6Y.
DBN Holdings (DeLorme) v. International Trade Commission (Fed. Cir. 2022)
This case is a bit complicated procedurally — the basic facts are here:
BriarTek’s brought an ITC action against DeLorme (now DBN) asserting U.S. Patent No. 7,991,380 covering “two-way global satellite communication devices.” DBN settled that dispute and agreed to stop importing the accused products.
But, DBN actually continued to import covered products and the ITC assessed a civil penalty of $6.2 million for violation of the consent decree.
After being charged with the penalty, DBN filed an action in Federal Court seeking a declaration that the patent claims were invalid. DBN won the case and the invalidity was affirmed on appeal. Once the patent was invalidated, the consent decree (by its terms) no longer barred DBN from importing products. However, DBN also wanted to escape from the $6.2 million fine for its pre-invalidation violations.
The ITC refused to relieve DBN from payment of the fine — finding it “res judicata” based upon a prior affirmance of the fine by the Federal Circuit. Back on appeal in 2018, the Federal circuit vacated that judgment — holding instead that the ITC possessed authority to rescind or modify the civil penalty in light of the invalidity of the relevant patent claims.
Back on remand, the ITC maintained the penalty — finding that the ex post invalidation did not free DBN from penalties associated with its bad faith violation of the consent orders and disrespect to the ITC. This last decision is what is on appeal now, and the Federal Circuit has affirmed.
The Federal Circuit explains:
By entering the consent order, DBN agreed to discontinue any violation of Section 337. The ITC, in turn, terminated the investigation as required. From a contractual perspective, the breach of this promise provides the ITC a distinct ground for imposing a civil penalty. DBN agreed to the terms of the consent order, and those terms “unambiguously indicate[] that the invalidation trigger—like the expiration and unenforceability triggers—applies only prospectively.” Had the consent order been written in retrospective terms, DBN might have a stronger argument that the invalidation of the asserted claims renders the consent order null and void, or that modification is required. But under the clear terms of the consent order, DBN remained potentially liable for any violations up to the time of invalidation.
Slip Op. Judge Reyna’s opinion provides a rough roadmap for accused infringers entering into consent decrees — endeavor to negotiate retrospective terms regarding invalidity. This would look like something along these lines: “Defendant agrees to no longer import or sell any products infringing the asserted claims . . . . If the patent is later found invalid, Defendant will no longer be bound by the consent decree and the court will reconsider any prior adverse judgments against Defendant in light of the new invalidation.”
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The prospective/retrospective considerations here point toward a philosophical question of whether an invalidity decision is should be seen as an action cancelling a patent or instead is merely revealing that the patent has always been invalid. The consent order in this case agreement particularly states that DBN won’t import products “that infringe claims 1, 2, 5, 10–12, and 34 of the ’380 Patent.” One argument here is that the proper interpretation of “infringe” assumes patent validity. Once we figured out that the patent is invalid, doesn’t that mean that it was always invalid?
When a patent is found invalid, we know that it never should have issued.
Arthrex, Inc. v. Smith & Nephew, Inc. (Fed. Cir. 2022).
In 2021, the Supreme Court sided with the patentee in holding that the AIA trial system violated the Appointments Clause of the U.S. Constitution. The Court concluded that PTAB judges were wielding the substantial power of the U.S. Gov’t by cancelling already-issued patent claims. The Constitution provides that officers wielding such power must be directly tied to the US President via presidential nomination and confirmation by the US Senate. But, PTAB judges are appointed by the Secretary of Commerce and do not undergo Senate confirmation. Rather than burning down the entire house, the Supreme Court partially rewrote the statute — adding the presidentially appointed USPTO director as an intermediary with power to accept or reject any PTAB decision stemming from an AIA trial.
The PTAB had originally sided with the patent challenger (Smith & Nephew) in finding the claims unpatentable. After the Supreme Court decision, the case was remanded back to the Patent Office so that the USPTO Director could have the final word from the administrative agency. Commissioner for Patents Drew Hirshfeld denied the petition for director review. Although Hirshfeld is currently the USPTO’s highest ranking official, he is not the USPTO Director, nor is he the Acting Director rather he continues in his role as Commissioner for Patents while still “performing the functions and duties of the Director.” Further, Hirshfeld was not nominated by the President or confirmed by the Senate. Rather, just like the PTAB judges found Constitutionally inadequate, Hirshfeld is an inferior officer appointed by the Secretary of Commerce.
Arthrex has now appealed its case back to the Federal Circuit — arguing that Hirshfeld’s denial does not meet the strict requirements imposed by the Constitution and the Supreme Court. The basic argument here is simple — the Supreme Court held that the PTO’s final agency decision in an IPR must come from a presidentially appointed principal officer.
One issue here is the practicalities of running an administrative agency such as the PTO in the interim following resignation of a presidentially nominated director. From the beginning of the Republic (1791), Congress has authorized temporary appointments in situations where the full nomination-confirmation process might take too much time to complete. Today, this process is generally provided for by the Federal Vacancies Reform. That law outlines mechanisms for allowing a temporary acting Director absent Senate confirmation. However, Hirshfeld does not qualify even for this statutory work-around because he was not the Deputy Director nor was he personally selected by the President.
One aspect of the appointments clause is to draw a direct link to the President. A final difficulty for Hirshfeld is that his appointment has a 5-year tenure protection and can only be removed early for cause. 35 U.S.C. 4(b)(2). These tenure protections further limit Presidential power over agency action.
In response, Smith & Nephew rely heavily on United States v. Eaton, 169 U.S. 331 (1898). In Eaton, the Supreme Court permitted approved of a non-presidential appointment of an officer “under special and temporary conditions.” However, there is a strong suggestion that Eaton was an inferior Officer rather than principal Officer case. Dir. Hirshfeld has now been standing-in as director for more than one year — on the four-year-timeline of the Presidency, this is starting to appear permanent.
Oral arguments in this round of the appeal are set for March 30, 2022.
Although it is not entirely clear, it appears to me that the original merits panel of Chief Judge Moore, and Judges Reyna and Chen will retain the case and here this petition as well. This trio decided the original case, with Judge Moore writing the opinion. The Federal Circuit and Supreme Court both agreed that the PTAB judges were principal officers if the IPR statute was strictly followed. The Federal Circuit offered a different remedy (removing PTAB judge tenure) than the Supreme Court (adding Director Review). Following the Supreme Court decision, the same panel issued the order to remand the case for Director Review. However, that remand included a statement that the “court retains jurisdiction over this appeal” and that the appellate proceedings are simply stayed. Thus, the appeal pending now is using the same docket number (18-2140) and, I expect, will be in front of the same set of judges.
