Source: https://patentlyo.com/patent/page/2
Timestamp: 2019-04-24 18:21:36+00:00

Document:
Trump Int’l. Ltd. v. DTTM Operations LLC,  EWHC 769 (Ch).
In a decision today, the High Court of Justice (Chancery Div.) has upheld the UK Intellectual Property Office (UKIPO) decision siding with DTTM and finding that Trump Int’l. had filed its opposed trademark application in bad faith and also acted in bad faith during the proceedings.
A quirk here regarding the names –– DTTM most likely stands for “Donald Trump Trademarks” and is a holding company owned by President Trump and/or his family. Trump International Limited is not related to President Trump in any way and is rather owned by Michael Gleissner an “infamous trademark troll.” To avoid confusion, I’ll use the name Gleissner rather than Trump Int’l.
A few days before the 2016 election, Gleissner applied to register ‘TRUMP TV” — DTTM opposed. The UK IPO Hearing Officer sided with DTTM. The High Court has now affirmed that judgment (1) rejecting the argument that the hearing officer was biased — finding it “obviously unsustainable”; and (2) agreeing with the bad-faith finding.
the issue of bad faith. It made it less likely that the inference of bad faith could be refuted.
Consideration of such evidence in the Registry proceedings accorded with the overriding objective of deciding cases justly.
Thus, a key holding in this case is that a pattern of bad-faith trademark filing is admissible as evidence that a new filing was also done in bad faith.
The people of the UK can also rest easier knowing that TRUMP TV will not be controlled by a notorious troll.
This case focuses on patents covering the opioid drug oxymorphone that Endo sells as Opana ER. In 2017, the FDA requested that (reformulated) Opana ER be removed from the market in response to the high risk of its illicit use. Endo had previously pulled Opana ER from the market in 2012 and then re-launched in a “non-crushable form.” However, that form continued to be abused (including by liquefying and injecting). In response to a new FDA request, Endo again removed the reformulated version from the market. The appeal here is focused on one a subset of the patents covering Opana — a fight between Endo and generic manufacturers who want to start distributing the drug once again.
“Administering” the drug with dosage calculated based upon the patient’s creatine clearance rate (using a particular formula).
The inventors here were concerned about renal impairment experienced by some folks taking oxymorphone. In their research, they discovered that some folks clear the drug faster (and have fewer kidney problems). The inventors here used the metabolite creatine as an easier to measure proxy for measuring drug clearance (creatine clearance rate) since it comes out in the urine.
These discoveries in hand, the inventors came up with the scheme of giving lower dosages of oxymorphone to individuals with lower clearance rates.
[T]he asserted claims are not directed to patent-ineligible subject matter. On the contrary, the claims are directed to a patent-eligible method of using oxymorphone … to treat pain in a renally impaired patient. . . .
The claims at issue here are legally indistinguishable from the representative claim in Vanda. Both claims recite a method for treating a patient.
Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease. Furthermore, the administering step in Mayo is distinguishable from the administering step in the [Endo] patent because the administering step in Mayo is the first step in the method that simply describes giving the drug to a patient with a certain disorder. By contrast, the administering step in the ’737 patent is the step that describes giving a specific dose of the drug based on the results of kidney function testing.
Question for those of you doing software – What is your equivalent of a “method-of-treatment” claim.
Mario and Jose Villena have thus far been stymied in their attempt to obtain patent protection for their claimed “system for distributing real-estate related information.” The pair filed an international PCT application in 2004 followed by a U.S. non-provisional in 2005 that has been abandoned, and finally the present application in 2011. U.S. Patent App. No. 13/294,044.
Question: Is it remotely plausible under any noncapricious administration of the Alice/Mayo test that five separate claim limitations can be completely unknown and nonobvious under Titles 35 U.S.C. §§ 102/103, yet at the same time be well-understood, routine, and conventional individually and as an ordered combination under an Alice/Mayo § 101 analysis?
Does a requirement of “invention” and “improvement” under the Alice/Mayo framework violate the statutory language of Title 35 U.S.C. § 101, legislative intent, and the Supreme Court’s repeated edict … that preemption, not invention or improvement, is the sole criteria for determining exceptions to patent eligibility?
USPTO” an abuse of discretion.
wherein each AVM value is pre-processed such that an AVM value for the at least one residential property pre-exists before a user query of the respective property is performed and wherein the one or more computers update each of the AVM values without requiring a user query.
Conrad’s invention is a urine-deflector — especially useful when toilet-training low-accuracy children. The main idea is to block the opening between the toilet seat and the toilet bowl with a bendable deflector that “lacks a folding seam” — a design element added to avoid incidental urine collection and resulting malodor. The product is sold as the P-Flector.
Prior art urine-deflectors included a shelf that allowed urine to collect. Conrad identified that problem and then solved-it by creating his no-seam version.
The PTO basically ignored Conrad’s own problem-solution story and instead simply followed it standard approach: look for similar prior art and ask whether there was any motivation to combine those references to form the claimed invention. On appeal, Conrad argued that the court should have given some weight to the fact that Conrad identified a particular problem and solved that problem.
In its non-precedential decision, the Federal Circuit has sided with the USPTO – confirming that the claim is obvious — and holding that the inventor’s identification of the problem need not be considered in the obviousness analysis. And that the identified references could be combined to improve structural integrity — even without ever recognizing the odor-solution.
The Supreme Court and this court … have repeatedly held that the motivation that a person of ordinary skill in the art would have had to combine prior art references need not be the same motivation that inspired the patent owner. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) (“[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.”); In re Kahn, 441 F.3d 977, 989 (Fed. Cir. 2006) (“[T]he skilled artisan need not be motivated to combine [a prior art reference] for the same reason contemplated by the [inventor]”); In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) (“As long as some motivation or suggestion to combine the references is provided by the prior art taken as a whole, the law does not required that the references be combined for the reasons contemplated by the inventor.”); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). “[T]he problem motivating the patentee may be only one of many addressed by the patent’s subject matter.” KSR, 550 U.S. at 420.
not address whether the Board must consider the discovery of an unknown problem when there exists an independent motivation to combine prior art references. Instead, those cases found that the inventor’s discovery of and solution to an unknown problem weighed in favor of non-obviousness because the proffered reason to modify the prior art did not present a specific, alternate basis that was unrelated to the rationale behind the inventor’s reasons for making the invention. Here, the examiner and the Board determined that a person of ordinary skill in the art would combine the ’009 publication with Raviendran for a reason independent from solving the problem identified by Conrad—to improve structural integrity by removing the folding seam. And this motivation to combine was not challenged by the patentee before the Board.
Steiert apparently also drafted at least one set of patent claims — something that the Supreme Court’s Presiding Disciplinary Judge also identified as unauthorized practice of law. In a separate proceeding, prosecutors in Eagle County, Colorado have charged Steiert with fraudulent advertising, criminal impersonation (of patent attorneys), and criminal “bait advertising.” That case is prepping for trial.
I’ll note here that Steiert argued that the alleged practice of law in this case was the practice of patent law. As such, the appropriate regulator is the USPTO and not the Colorado Supreme Court. The Presiding Disciplinary Judge rejected that allegation. However, Steiert’s argument has some precedential merit. In particular, Federal Judge in Missouri dismissed a somewhat similar case against LegalZoom for its patent drafting system. Janson v. LegalZoom.com, Inc., 802 F. Supp. 2d 1053 (W.D. Mo. 2011). In particular, the court held that Missouri’s laws governing unauthorized practice of law were preempted by the Patent Act and USPTO regulations.
Michael McCabe has discussed the case in several posts on his IPEthics Blog.
Network Monitoring and . . .
It appears that the Federal Circuit has sharpened its blades and is now slicing the bologna extra thin. This results-oriented decision unfortunately shades-facts and provides no clarity in its legal analysis of eligibility. While I agree that this network security invention should be eligible for patenting – the court’s analysis does not provide a convincing foundation for that result.
Contrary to Cisco’s assertion, the claims are not directed to just analyzing data from multiple sources to detect suspicious activity. Instead, the claims are directed to an improvement in computer network technology. Indeed, representative claim 1 recites using network monitors to detect suspicious network activity based on analysis of network traffic data, generating reports of that suspicious activity, and integrating those reports using hierarchical monitors. The “focus of the claims is on the specific asserted improvement in computer capabilities”—that is, providing a network defense system that monitors network traffic in real-time to automatically detect large-scale attacks. Quoting Enfish.
Writing in dissent, Judge Lourie argued that the claims are effectively data collection methods.
The claims here recite nothing more than deploying network monitors, detecting suspicious network activity, and generating and handling reports. The detecting of the suspicious activity is based on “analysis” of traffic data, but the claims add nothing concerning specific means for doing so. The claims only recite the moving of information. The computer is used as a tool, and no improvement in computer technology is shown or claimed. There is no specific technique described for improving computer network security.
Lourie drew a tight analogy to the Electric Power Group eligibility decision that invalidated claims directed toward a “method of detecting events on an interconnected electric power grid in real time over a wide area and automatically analyzing the events on the interconnected electric power grid.” Seemingly, this case here could also be seen as a close analogy to the court’s recent cases distinguishing between methods of diagnosis and methods of treatment. See Vanda and Natural Alternatives.
The Majority opinion here attempted to distinguish Electric Power Group as in invention “using computers as tools to solve a power grid problem, rather than improving the functionality of computers and computer networks themselves.” What the majority fails to do here is to point to any particular aspects of the claimed invention that provide anything more than what other panels have identified as abstract ideas – receiving data; reporting data; and correlating data.
The appellate panel rejected the willfulness finding and, as a consequence, the resulting doubling of damages.
While the jury heard evidence that Cisco was aware of the patents in May 2012, before filing of the lawsuit, we do not see how the record supports a willfulness finding going back to 2000. As the Supreme Court recently observed, “culpability is generally measured against the knowledge of the actor at the time of the challenged conduct.” Halo, 136 S. Ct. at 1933. Similarly, Cisco’s allegedly aggressive litigation tactics cannot support a finding of willful infringement going back to 2000, especially when the litigation did not start until 2012. Finally, Cisco’s decision not to seek an advice-of-counsel defense is legally irrelevant under 35 U.S.C. § 298. . . .
We leave it to the district court to decide in the first instance whether the jury’s presumed finding of willful infringement after May 8, 2012 is supported by substantial evidence.
Cisco pursued litigation about as aggressively as the court has seen in its judicial experience. While defending a client aggressively is understandable, if not laudable, in the case at bar, Cisco crossed the line in several regards.
The appellate panel gave deference to district court conclusions on this final point and affirmed the award of fees.
Note: In a separate case, Judge Robinson had previously held the claims invalid under 102/103. However, that decision was vacated on appeal SRI International, Inc. v. Internet Security Systems, Inc., 511 F.3d 1186 (Fed. Cir. 2008). Here, interestingly, Judge Robinson sua sponte issued summary judgment that the claims were not anticipated. That holding was affirmed here on appeal.
In Bilski v. Kappos, the Supreme Court issued three separate opinions — although all the justices agreed that physicality — machine-or-transformation — offers at least an important clue for deciding the issue.
Four Justice minority opinion: Arguing that a “business method” is not a “process” under Section 101, and that physicality “is a critical clue” for determining eligibility.
Two Justice minority opinion: Explaining their view that only a “few patentable processes lie beyond” the machine-or-transformation test.
In InvestPic, LLC v. SAP America, Inc., No. 18-1199 (Supreme Court 2019), the question of physicality has been raised again. In that case, the patentee argues that the Federal Circuit has again recreated a physicality test for eligibility.
is a process that can only be performed by a computer; a human cannot perform the process. The Federal Circuit determined that the computer-executed invention does not touch the “physical realm” and therefore held it patent-ineligible.
Does the Federal Circuit’s “physical realm” test contravene the Patent Act and this Court’s precedent by categorically excluding otherwise patentable processes from patent eligibility?
The claims in McRO were directed to the creation of something physical—namely, the display of “lip synchronization and facial expressions” of animated characters on screens for viewing by human eyes. . . . Similarly, in Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), the improvement was in a physical tracking system. . . . Here, in contrast, the focus of the claims is not a physical-realm improvement but an improvement in wholly abstract ideas—the selection and mathematical analysis of information, followed by reporting or display of the results. . . . Some of the claims require various databases and processors, which are in the physical realm of things. But it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources InvestPic claims to have invented, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Note here, that the court did not give itself Bilski-style wiggle-room by suggesting that its physical-realm identity offered a “clue” to eligibility. Rather, the court held that the invention was not in the physical-realm (other than its use of computers) and therefore was abstract. Now, to be clear, I believe that the InvestPic decision could be interpreted a different way. However, the easiest reading of the case is that the court meant what it said – the claim is directed either to something abstract or something physical.
Exergen Corp. v. Kaz USA, Inc., 725 F. App’x 959, 966 (Fed. Cir. 2018) (finding a patent eligible in part because it took “years and millions of dollars” to invent).
The idea here is good — use a bootstrapping method to determine an appropriate predictive distribution of investment data rather than rely upon a predetermined distribution (such as the normal distribution). However, the abstract idea analysis here could look a lot like it did in Bilski.
Here, Sprint’s expert did address apportionment and told the jury that damages should be attributed only to “incremental profits are attributable to the patents in suit.” Further, the jury instructions indicated that damages should be based upon the value added by the patented features.
Finally, the court noted that Sprint did not propose alternative jury instructions.
Written Description: The divide between the majority opinion (Judges Bryson and Chen) and the Dissent (Judge Mayer) is based upon the second issue — written description.
The Patent Act requires a “written description of the invention, and of the manner and process of making and using it.” 35 U.S.C. 112(a). Judge Mayer concluded in dissent that description in the specification does not support the full-breadth of the asserted claims.
Here, the accused infringing systems are Voice-over-Internet-Protocol (VoIP) systems. The claims are not directed to internet protocol (IP) but rather use the broader category of “packet communication.” Why not claim IP?: the original specification does not mention internet protocol but instead is directed toward a separate packet-communication form known as asynchronous transfer mode (ATM). ATM was popular legacy telecommunications systems, but is being largely replaced by IP. Although ATM and IP both involve packet communications, they are quite different in how they work. For instance, ATM creates a virtual circuit / fixed call path while IP does not.
For Judge Mayer, the bulk of the specification is focused on the virtual circuits with no disclosure of other packet networks. He concludes that “the specification’s disclosure makes sense only in the context of ATM technology.” As such, the claims that cover non-ATM IP-switching are not supported by the written description.
[T]he specification refers to “[b]roadband systems, such as Asynchronous Transfer Mode (ATM),” a formulation that strongly suggests that the patents are not limited to ATM technology.
In addition, Sprint presented evidence that a person of skill in the art would understand the disclosure to — especially the term “broadband” — to include IP.
For the majority, the evidence here was enough to allow the patent to remain valid. Even if the result is uncomfortable, it is easier to see after considering the level of deference. The court should only overturn the jury verdict if the only reasonable conclusion is that invalidity was proven with clear and convincing evidence.
The two paragraph decision in this case is designed to serve as a reminder that patent validity/infringement is considered on a claim-by-claim basis.
On appeal, the Federal Circuit has affirmed the summary judgment of invalidity with the caveat that the district court’s opinion should be limited only to the asserted claims.
1. The judgment of invalidity of claims 14, 19, 24, 26, 27 and 30 of the ’628 patent is affirmed.
2. The case is remanded for the district court to revise its judgment to clarify that the declaration of invalidity is limited to claims 14, 19, 24, 26, 27, and 30 of the ’628 patent.
In this particular case, the patent challenger Sophos agreed that they had only challenged the asserted claims. Thus, this decision cannot be seen as creating any strict limit on challenging claims not pursued in the infringement contentions.
Congratulations to Scott Boalick and Jacqueline Bonilla for their appointments as Chief Judge and Deputy Chief Judge for the Patent Trial and Appeal Board. Judges Boalick and Bonilla have already been doing the work since September 2018 in their roles as Acting Chief and Deputy Chief. Earlier this year, Dir. Iancu also appointed Thomas Krause as USPTO Solicitor. These three individuals are each highly qualified with deep intellectual property and government experience.
These appointments round-out Dir. Iancu’s top staff so that all leadership team members are in permanent positions rather than temporary “acting” appointments.
Neither of these cases address core patent law issues and so their outcome will have little impact on patent law practice.
These four are the most likely cases to be heard by the court. However, the Solicitor General often takes a full-year to file a brief — meaning that the certiorari question may well be pending until the September 2019.
Note here that JTEKT adds the nuance of being a direct competitor while RPX is ostensibly not a competitor.
I mentioned the Berkheimer eligibility case above. An important follow-on case is TS Patents.
An additional eligibility cases goes to the core of the Supreme Court’s eligibility analysis and asks whether method-of-treatment claims are always patent eligible?
Overall, this is an interesting group of cases that address a set of important questions. Unfortunately, the two least impactful cases are the ones the court has agreed to hear.
Patent families generally require a chain of copendency. A later filed application may claim the same priority of an earlier-filed application so long as the later is filed while the earlier is still pending (not yet patented, abandoned, or otherwise terminated). This pending Supreme Court petition focuses on the situation where the earlier-filed application is amended to alter its priority claim — and asks What happens to the later-filed application’s priority claim.
I have been following the Natural Alternatives cases for the past several years. Natural’s patents cover a dietary supplement containing free beta-alanine.
1. A human dietary supplement comprising … beta-alanine [or amide thereof] that is not part of a dipeptide, polypeptide or oligopeptide.
The particular issue in the pending petition here focuses on priority claims.
When is priority established for a patent application under the Trade-Related Aspects of Intellectual Property Rights (TRIPs) so that a Patent Owner can change priority in one application without affecting the priority of applications that have already established priority?
In this case, the patent at issue is the eighth in a long series of U.S. patent applications claiming priority back to an original UK application. For each patent in the chain, a new application was filed just before the prior patent’s issuance. In each instance, the new application also included a claim to priority to all of the prior applications in the chain.
However, just before the fifth application issued, its priority claim was amended to “delete its claim of benefit from the fourth through first applications in the series back to the 1996 British application’s filing date and, instead, claimed benefit solely of a provisional application filed in 2003.” Thus, for the fifth application, the applicant gave up the 1996 filing date in favor of the 2003 date — with the result of extending the 20-year timeline. The problem for the patentee here is that the reduced priority claim in the fifth application also limited the chain of priority for the sixth, seventh, and eighth patent.
In a reexamination, the USPTO rejected the eighth patent after finding that the first patent in the series counts as prior art. That holding was affirmed by the Federal Circuit. To be clear, although the sixth application correctly established priority when filed, the priority claim of the sixth was undermined when the prior-filed application (the fifth) was amended.
In its petition, the patentee argues that this “nunc pro tunc” result is improper.
The Federal Circuit’s holding means this disclaimer occurs even when the later-filed application was filed before the priority claim was disclaimed. This departure from the normal tenets of property law is illogical.
The traditional property law law discussed here is the “vesting” of the priority claim — that the patentee argues occurs as soon as it is properly claimed.
This is an interesting decision here that should certainly offer pause to anyone considering priority-claim schemes.
Guest post by Jonathan Stroud (Unified Patents) and Saurabh Vishnubhakat (Texas A&M Law).
After a long wait, the Federal Circuit last month decided Momenta Pharms. v. Bristol-Myers Squibb Co. (Fed. Cir. 2019), dismissing Momenta’s appeal of an adverse PTAB decision based on standing and mootness concerns. (The PTAB had instituted Momenta’s petition for inter partes review of Bristol-Myers Squibb’s patent on certain formulations of an immunosuppressive agent, but ultimately sustained the patentability of all the challenged claims. Momenta, a biosimilar applicant, had sought inter partes review preemptively, with no prior infringement suit by BMS.) The Federal Circuit’s conclusion that Momenta lacked Article III standing has important implications for access to appeals in unsuccessful PTAB challenges.
Building on Professor Crouch’s initial analysis of the Momenta decision, we explore the Federal Circuit’s developing case law on what counts as an adequate injury for a petitioner to have appellate standing from a PTAB decision. Of particular interest is the persistent ambiguity about how potential future patent infringement and the PTAB estoppel provisions of the AIA affect standing to appeal.
Article III standing applied on appeal has always imposed an asymmetric burden on the system for administrative patent revocation. Patent owners who appeal can almost always show the requisite injury for standing in the form of adverse effects on some or all of their patent rights. Unsuccessful petitioners, meanwhile, may not be able to show enough injury through potential patent infringement. Ironically, this especially true of those very parties who benefit the most at the margins from having access to administrative review—precisely because they could not otherwise have established standing to seek declaratory relief in federal court.
In effect, the more proactive and preemptive a challenge might be, the less likely that party is to be able to prove standing on appeal, adding another reason not to act until after litigation has begun. The asymmetry of this burden is especially salient in domains like pharmaceutical drugs and biosimilars, where the incentive to test the validity of patents has important social consequences, and the complexities of those decades-long disputes create fact patterns that can be difficult to unpack.
At the time of its 2015 petition for inter partes review, Momenta was working with Mylan to develop a biosimilar counterpart to Orencia®, the branded biologic drug whose active ingredient was covered by the BMS patent. Momenta’s plan was to enter the market as a biosimilar applicant under the Biologics Price Competition Act of 2009 (more detail here), which provides a pathway to generic competition for complex biologic drugs akin to the “Hatch-Waxman” Act provisions that govern small-molecule generic drug approval. Momenta first sought inter partes review of the ‘239 patent covering a formulation of Orencia®.
Unsuccessful in inter partes review, Momenta appealed the decision in early 2017. One major issue in the case (which one of us has discussed here in greater detail) was whether Momenta, who had no active district court litigation against BMS and had faced no direct threats of infringement and had not yet manufactured a competing product, had standing to maintain its appeal.
Momenta argued in briefing and at oral argument that the inter partes review was akin to an expensive “freedom-to-operate” action that resulted in immediate harm, presenting a “fork in the road” in its development process. Momenta concluded that losing the ability to appeal would force it to abandon its research efforts and leave millions of dollars wasted. BMS replied that any such harm was speculative and that the case law does not support Momenta’s standing.
For five years now, the Federal Circuit has been actively exploring the boundaries of Article III standing on appeal from administrative action. For instance, in 2014 in the inter partes reexamination context, the court in Consumer Watchdog v. Wis. Alumni Research Found. explained that appeals based on vague public interest concerns in invalidating the patent, without a particularized or personal injury, is not enough. There, WARF had obtained a patent related to human embryotic stem cell cultures, and Consumer Watchdog challenged the patent as ineligible subject matter.
On appeal, however, Consumer Watchdog framed its argument in terms that the patent helped “loot taxpayer funds and force research overseas” and that a challenge benefited the public at large. As the party “seeking to invoke federal jurisdiction,” Consumer Watchdog bore the burden of establishing Article III standing, which included proving that it suffered an “injury in fact.” The court found it had not alleged facts sufficient to demonstrate such an injury.
In the 2017 Phigenix v. Immunogen case, Phigenix filed an inter partes review but failed. On appeal, Phigenix alleged harm apart from the threat of direct patent infringement—namely, that the existence of the patent was preventing others from taking a license to patents owned by Phigenix. This blocking effect, the argument went, caused economic harm that is cognizable in standing. The court allowed that alternative forms of economic harm were permissible and accepted the legal framework, but ultimately held that Phigenix had failed to meet its burden.
The court suggested that arguing possible or speculative future economic interest based on conclusory expert declarant testimony was not necessarily enough. The Phigenix decision also laid out the burdens of production and persuasion for appellate standing, suggesting that the requirements apply only to the party seeking to invoke the court’s jurisdiction: the appellant. It also allowed that such evidence can be produced for the first time on appeal.
As for standing arguments related to infringement potential itself, the Federal Circuit JTEKT v. GKN Automotive has explained that there may be certain situations in which a PTAB petitioner has no infringing product on the market at the relevant time but may still be able to show Article III standing. However, in such situations, the petitioner must establish “concrete plans for future activity that creates a substantial risk of future infringement.” On that case’s own facts, JTEKT had sold no infringing goods, had not finalized its product design, and had not shown any concrete plans for future activity that would run afoul of GKN’s patent rights. The court similarly concluded in RPX v. ChanBond that petitioner RPX was not engaged in any activity that even potentially infringed the patent being challenged. This necessary specificity of future plans means that PTAB challenges even from direct market competitors may ultimately lack standing to support an appeal.
For direct competitors, however, standing to appeal may still be available where the parties are engaged in a live commercial dispute presenting a “significant risk” of infringement based on “significant involvement in research and commercial activities” involving the subject matter of the patent. As the Federal Circuit held in DuPont v. Synvina, evidence showing that the petitioner in that case had an operating facility capable of infringing a method of manufacture was enough to confer standing.
Understood in this context, Momenta is a dispute in which the patent challenger was engaged in likely-infringing activity at the outset, but lost its direct stake through an “intervening abandonment of the controversy” by ending its collaboration with Mylan on an Orencia® biosimilar. The case is notable both for its high stakes on appeal and the fact that the biosimilar applicant was clearly engaged in an expensive, years-long dispute over a billion-dollar biologic product.
Although Momenta may still be able to receive royalties on any relevant biosimilar that Mylan may later develop, the court found this to be the sort of speculative future economic interest that proved inadequate in Phigenix. As in ChanBond, the lack of any current activity that might potentially infringe undermined Momenta’s argument for revived standing, and the lack of any concrete plans going forward meant that the safety valves of JTEKT or DuPont were of little help. In the end, the Momenta decision dodged the more contentious issue of just how much investment, how much potential for future infringement, and how much certainty there must be about that future harm, are ultimately enough to confer Article III standing.
Throughout most of these cases, there has also been a thread of discussion about whether the strong statutory estoppel of 35 U.S.C. § 315(e), applied after the final written decision issues in an inter partes review, constitutes an independent injury capable of sustaining standing. It is unclear whether the presence of estoppel “bolsters” or supports a finding of injury or is simply irrelevant. The court seems to have entertained the middle road in Momenta, never finding that estoppel alone could constitute injury, but with appellants arguing that it supports their overall arguments about the existence of a genuine Article III case or controversy.
The “petitioner” estoppel of § 315(e) estoppel has two prongs. One applies back to the PTAB itself; the other, to outside forums. The plain language of the statute bars the maintenance of either another PTAB proceeding or an argument in a federal-court or ITC action that a patent is invalid based on any ground that was actually raised or reasonably could have been raised in the initial inter partes review. Moreover, estoppel applies not only to the petitioner but also to their real parties in interest and privies.
Running through the various opinions on standing is an argument that the legal detriment of estoppel is at least a factor in, if not a deciding vote for, finding standing on appeal.
In Altaire Pharms. v. Paragon Bioteck, a case where the court found standing in a post-grant review, the court pointed to estoppel as compounding the harm. As previously noted, the court found in the non-precedential PPG Industries case that the petitioner’s “stake is enhanced by the ‘estoppel provisions contained within the inter partes reexamination statute.’” And in Momenta, the appellant argued that that “[t]he concreteness of that stake is bolstered by the estoppel provision, which the Board’s adverse decision already triggered,” citing 35 U.S.C. § 315(e).
In JTEKT, on the other hand, the panel rejected appellant’s argument that inter partes review estoppel constituted a separate injury in fact, an issue the appellant there has raised in a petition for certiorari to the Supreme Court. RPX Corp. argued something similar in their opposition to the motion to dismiss their appeal, and have likewise made that argument the basis of a petition for certiorari, which, it should be noted, has drawn a “call for the views of the Solicitor General” from the high Court.
These arguments appear to be grounded in Justice Kennedy’s concurrence in Lujan, where he noted that “Congress has the power to define injuries and articulate chains of causation that will give rise to a case or controversy where none existed before.” But few actual cases exist holding that a statute itself creates standing, and it seems clear that the Federal Circuit, at least, is unconvinced that this argument holds water, certiorari petitions or no.
The Federal Circuit’s conclusion in Momenta that estoppel cannot constitute an injury-in-fact when Momenta “is not engaged in any activity that would give rise to a possible infringement suit” is potentially far-reaching. Standing to appeal depends on whether there is adequate injury-in-fact at the time of appeal—but estoppel, of course, lasts indefinitely. This is a significant disparity for petitioners, one that doubles down on the asymmetric burden that petitioners already face with regard to Article III standing.
Although the opinion did not address it, it is noteworthy that Orencia® is listed in the Purple Book, which identifies what biological products the FDA has determined to be “biosimilar to or interchangeable with a reference biological product.” In another PTAB appeal decided just a few weeks prior to Momenta, the Federal Circuit in Amerigen Pharms. v. UCB Pharma (Fed. Cir. 2019) held that the listing of a patent in the FDA Orange Book (a Paragraph III certification) can constitute an injury sufficient to support Article III standing.
Accordingly, appellants confronted with administrative challenges prior to open district court litigation may be left scratching their heads and wondering just when standing kicks in and whether it continues through the life of any given appeal. That makes challenging biologics patents especially fraught with uncertainty. It also pushes would-be PTAB petitioners toward later or more reactive filing of inter partes review petitions rather than early filing of post-grant review or inter partes review challenges prior to a district court litigation. Given the complex regulatory schemes at work, it seems likely that these parallel proceedings will even further complicate ANDA and ABLA-related litigation and the related approval processes rather than streamline them.
We conclude that the Momenta decision has ultimately done little to ease concerns about who does and does not have standing to appeal. It is an important development in the ongoing evolution of Article III standing for appeals from PTAB trials, to be sure, as well as an informative survey of the relevant case law. Still, it may have created further confusion by injecting the issue of mootness into the debate. While courts have no control over the parties’ positions or the status of any particular appeal, the Federal Circuit’s decision making seems to reflect some discomfort with taking evidence on appeal in the first instance—as, for example, the D.C. Circuit does. This reluctance has led to longer briefing schedules and more complicated and uncertain appellate fact patterns. The weight of that uncertainty ultimately falls upon the parties and Federal Circuit panels themselves.
Prof. Saurabh Vishnubhakat is an Associate Professor at the Texas A&M University School of Law and the Texas A&M Dwight Look College of Engineering, and is a former USPTO advisor. Mr. Jonathan Stroud is Chief Intellectual Property Counsel at Unified Patents Inc., an Adjunct Professor at American University Washington College of Law, and a former USPTO examiner. The arguments presented here are the authors’ and should not be imputed to Unified Patents, the USPTO, or to any other organization.
Building upon judges’ views that they are bound by the Supreme Court’s new standard and their concerns that that standard is having devastating consequences, the American Intellectual Property Law Association and the Intellectual Property Owners Association believe the situation is so untenable that they have proposed that Congress overturn that standard.
Others, however, disagree. They effectively ask: To what extent have the Court’s cases shifting eligibility law actually impacted decisions to invest in the development of technology? Moreover, exactly how have these cases actually impacted investment decisions? And to the extent these cases have had a significant impact on investment decisions, has that impact proven to be positive or negative in the sense of increased or decreased investment?
Existing literature provides surprisingly little data even to begin to answer these questions. And, make no mistake, these questions are fundamental, and the accuracy of their answers is important. Answers to these questions will either support congressional intervention in the law of patent eligibility or counsel against it. Thus, the questions ought to be asked and—more importantly—answered by reference to hard data rather than gut feeling or prognostication. Quite literally, future innovation—perhaps even lifesaving innovation—hangs in the balance.
And so that is exactly what I have done: gathered data to help begin identifying accurate answers to these questions. In particular, I have conducted a survey of 475 venture capital and private equity investors to study the impact of the Court’s eligibility cases on their firms’ decisions to invest in companies developing technology. This survey is the first of its kind, and the data it has provided is sorely needed.
In an article summarizing my findings, I present detailed results of the survey and identify and consider four principal findings.
First, the investors who responded to the survey overwhelmingly believe patent eligibility is an important consideration when their firms decide whether to invest in companies developing technology. Indeed, overall 74% of the investors agreed that patent eligibility is an important consideration in firm decisions whether to invest in companies developing technology; only 14% disagreed. Likewise, investors reported that reduced patent eligibility for a technology makes it less likely that their firm will invest in companies developing that technology. For example, overall 62% of the investors agreed that their firms were less likely to invest in a company developing technology if patent eligibility makes patents unavailable, while only 20% disagreed. These results, while perhaps not surprising, nonetheless confirm one of the central premises upon which the patent system rests: that patents help to spur investment in development of technology.
Second, reduced patent eligibility correlates with particular investment behaviors in particular industries. Investors overwhelmingly indicated, for example, that the elimination of patents would either not impact their firm’s decisions whether to invest in companies or only slightly decrease investments in companies developing technology in the construction (89%), software and Internet (80%), transportation (84%), energy (79%), and computer and electronic hardware (72%) industries. But investors, by contrast, overwhelmingly indicated that the elimination of patents would either somewhat decrease or strongly decrease their firm’s investments in the biotechnology (77%), medical device (79%), and pharmaceutical industries (73%). Thus, according to these investors, on average each industry would see reduced investment, but the impact on particular industries would be different. And the life sciences industries would be the ones most negatively affected.
Third, the Supreme Court’s eligibility cases have impacted many firms’ investments and, more significantly going forward, their firm’s investment behaviors. Almost 40% of the investors who knew about at least one of the Court’s eligibility cases indicated that the Court’s decisions had somewhat negative or very negative effects on their firm’s existing investments, while only about 15% of these investors reported somewhat positive or very positive effects. On a going forward basis, moreover, almost 33% of the investors who knew about at least one of the Court’s eligibility cases indicated that these cases affected their firms’ decisions whether to invest in companies developing technology. These investors reported primarily decreased investments, but also shifting of investments between industries. In particular they identified shifting of investments out of the biotechnology, medical device, pharmaceutical, and software and Internet industries. Again, the life sciences industries represent the most negatively affected of all industries.
Fourth, investors familiar with the Supreme Court’s eligibility cases indicated different changes in firm investment behavior as compared to investors without this familiarity. As discussed above, about 33% of investors with this familiarity reported that these cases impacted their firms’ investment behavior, with these investors reporting shifting of investments away from the software and Internet industry along with the biotechnology, medical device, and pharmaceutical industries. Investors without familiarity with these cases, by contrast, overwhelmingly reported that decreased availability of patents since 2009 (prior to the Supreme Court’s eligibility cases) has not impacted their firms’ changes in investment behavior. Indeed, a full 95% indicated no impact on any change in their firm’s investments. Moreover, investors without familiarity with these cases indicated more often, as compared to investors with familiarity, that their firms have shifted investments into the software and Internet industries as compared to all other industries. In short, eligibility knowledgeable investors report the Supreme Court’s cases have resulted in reduced investment in software and the Internet, while unknowledgeable investors report increased investment in software and the Internet over the same time period. As investor’s transition from non-knowledgeable to knowledgeable (once they learn about the Court’s cases and their impact on patent eligibility), investment in software and the Internet will seemingly decrease. Thus, the life sciences industries are by no means the only industries impacted by the Court’s cases.
The results of the survey provide critical data for an evidence-based evaluation of competing arguments in the ongoing debate about the need for congressional intervention in the law of patent eligibility. Proponents of reform will no doubt tout the results of the survey as representing a clarion call for reform. The best that can be said by those that prefer the status quo is that most investors do not report changing their investment decisionmaking based upon the Supreme Court’s eligibility decisions. A significant part of this group of investors, however, represents those uninformed about the Court’s cases.
The reality is that the results of the survey highlight the importance of patent eligibility and the negative impact of the Supreme Court’s eligibility cases generally on investment, but particularly in the most important areas of technological development in terms of its impact on public health: the biotechnology, medical device, and pharmaceutical industries—the life sciences industries. That said, it is important to highlight that the results show the Court’s decisions have negatively impacted each and every area of technological development studied.
As a consequence, the results do support the idea that the time has come for Congress to at least consider overturning the Supreme Court’s new eligibility standard to prevent additional lost investment in technological development in the United States. Indeed, given the results of the survey, it seems likely that the Supreme Court’s eligibility decisions have resulted in lost investment in the life sciences that has delayed or altogether prevented the development of medicines and medical procedures.
Research funding disclosure: I prepared this Article supported by grants from Microsoft Corporation, the Tsai Center for Law, Science and Innovation, and the Clark J. Matthews, II Faculty Research Endowment Fund.

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