Apotex Inc. v. Cephalon, Inc. (Supreme Court 2022)
In its petition for writ of certiorari, Apotex asks the Supreme Court to revisit motivation to combine, obvious to try and whether the non-obvious contribution needs to be an improvement over the prior art. The petition argues that KSR v. Teleflex (2007) requires a flexible analysis, but that “over the ensuing decade-and-a-half, the Federal Circuit has … reverted to its old rigid ways.” The petition also complains that the Federal Circuit has again masked its jurisprudence via Summary Affirmance without opinion.
The accused infringers here were seeking to market a drug treatment for chronic lymphocytic leukemia covered by several Cephalon patents and sold as Bendeka. The defendants challenged the patent claims as obvious, but the district court sided with the patentee — finding a lack of motivation to combine the references with a reasonable expectation of success. This test has become the sina non quo of post-KSR Federal Circuit obviousness decisions. See, for example, Accorda Therap. v. Roxane Labs., 903 F.3d 1310 1328 (Fed. Cir. 2018) (“motivation to modify or combine with a reasonable expectation of success”); In re Stepan, 868 F.3d 1342, 1345-46 (Fed. Cir. 2017) (“requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art … and that the skilled artisan would have had a reasonable expectation of success in doing so.”), etc. Apotex’s petition explains this as follows:
[T]he Federal Circuit seems to believe that if there is any uncertainty about whether an obvious-to-try approach will succeed, that potentially compromises the motivation to try an obvious solution to a pressing problem, and therefore produces patent monopolies for what is obvious to try. Indeed, so ingrained has the motive-to-try-what-is-likely-to-succeed test now become in the Federal Circuit’s obviousness psyche, that the Federal Circuit now sometimes includes motivation as a fifth Graham factor.
I also write about this same issue in the Federal Circuit’s recent decision in Teva v. Corcept (Fed. Cir. 2021). Cephalon’s response is due in about 2 weeks.
Although patents are a form of private property, they are also expressly a tool of public policy. When a private patent lawsuit of interest reaches the Supreme Court, the Court regularly turns to the President’s administration for its views on how a decision may impact patent law and innovation writ large. That request for an amicus brief from the government is termed a CVSG – Call for the Views of the Solicitor General. One problem with CVSGs is that they typically add several months to the certiorari process because the DOJ spends substantial time collecting input from various government branches and outside interests before drafting and filing its brief. In patent cases, a Gov’t amicus brief is often the most important at the certiorari stage — or at least the most predictive of the outcome.
We are currently waiting CVSG amicus briefs in two patent cases pending before the Supreme Court:
American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, et al., No. 20-891 (patent eligibility); and
PersonalWeb Technologies, LLC v. Patreon, Inc., et al., No. 20-1394 (res judicata)
Of these, the Personal Web request is fairly recent, but American Axle has been spinning since May 3, 2021 – just over 8 months.
To get a sense of timing, I looked back at the past 30 CVSG requests – this stretches back to 2019 and calculated the number of months the USDOJ took to file its brief. The median timing was 5 months, and all the briefs were submitted in less than 9 months. What this means is that the DOJ still has a few more weeks to complete its task and still be within these historic guideposts.
I truly do not know what the DOJ is going to say in its American Axle brief. Back in 2019, the Solicitor General filed a powerful brief in Hikma v. Vanda arguing that Mayo and Alice led to substantial confusion, especially when attempting to reconcile prior cases such as Diehr. But, the Gov’t brief in Hikma was filed by President Trump’s SG (Noel Francisco) and the big question is whether President Biden’s Solicitor Elizabeth Prelogar (and the Biden Admin generally) will follow the same course. Although the top-signatories have changed, the folks actually researching and writing the brief are largely the same, including Thomas Krause who was PTO Solicitor and is now the PTO’s Acting GC. In addition, Malcolm Stewart remains the Deputy SG at the Department of Justice (as do others).
I have a new draft article on the Kessler Doctrine co-authored with my former student Homayoon Rafatijo and welcome comments and suggestions before it is formally published later this month.
Kessler is a 1907 Supreme Court decision that we argue should be seen as simply implementing defensive issue preclusion. At the time, the case involved some additional novelties having to do with confusion over both the new appellate federal court structure and the scope of potential anti-suit injunctions. Meanwhile, the scope of issue and claim preclusion have expanded with the merger of law & equity, creation of the Federal Rules Rules of Civil Procedure, as well as the expansion of Declaratory Judgment jurisdiction.
As issue and claim preclusion expanded, Kessler fell from fashion and was basically unneeded and unused for several decades. But, since 2014, the Federal Circuit has steadily expanded Kessler as a patent law specific form of preclusion that is separate and distinct from the traditions of claim and issue preclusion. We argue argue this approach is wrong.
The cat: We parallel our article alongside a short parable from Paulo Coelho titled the “Importance of the Cat in Meditation.” The basic punchline is that once people started thinking the cat was an important element of mediation, it was easier for them to scientifically explain the importance rather than let go of the meaningless attachment. We argue that the Kessler Doctrine is following the same pathway, the Federal Circuit’s explanations do not make sense, and that it is time to resorb the doctrine into the general law of preclusion.
The following comes from Chief Justice John Roberts’ end-of-year Report on the Federal Judiciary for 2021.
The third agenda topic I would like to highlight is an arcane but important matter of judicial administration: judicial assignment and venue for patent cases in federal trial court. Senators from both sides of the aisle have expressed concern that case assignment procedures allowing the party filing a case to select a division of a district court might, in effect, enable the plaintiff to select a particular judge to hear a case. Two important and sometimes competing values are at issue. First, the Judicial Conference has long supported the random assignment of cases and fostered the role of district judges as generalists capable of handling the full range of legal issues. But the Conference is also mindful that Congress has intentionally shaped the lower courts into districts and divisions codified by law so that litigants are served by federal judges tied to their communities. Reconciling these values is important to public confidence in the courts, and I have asked the Director of the Administrative Office, who serves as Secretary of the Judicial Conference, to put the issue before the Conference. The Committee on Court Administration and Case Management is reviewing this matter and will report back to the full Conference. This issue of judicial administration provides another good example of a matter that self-governing bodies of judges from the front lines are in the best position to study and solve—and to work in partnership with Congress in the event change in the law is necessary.
Olaf Sööt Design’s pending petition for certiorari centers on the age-old division between issues-of-fact and issues-of-law. The U.S. Constitution generally requires due process, and particularly protects litigants’ rights to a jury trial in common law cases. One quirk–the right to a trial by jury does not cover issues-of-law, and only extends to some issues-of-fact.
This bifurcated system results in an odd dynamic in patent law — regularly seen with regard to infringement and claim construction:
Patent infringement is an issue-of-fact tried by a jury under the Seventh Amendment. Typically, a jury is asked to decide whether the evidence shows that the defendant is performing the claimed invention.
Claim construction is treated as a question of law (or mixed question of fact and law), decided by a judge. In contemporary patent litigation, a judge will typically be asked to decide whether the legal scope of the claims extend to cover the defendant’s actions.
With this setup, the whole case can be decided at either stage, but claim construction typically comes first and so often steals-the-show. One problem though, is the potential of unduly undermining the Constitutionally protected jury system.
One case pending before the Supreme Court focuses-in on these issues: Olaf Sööt Design, LLC v. Daktronics, Inc., et al., No. 21-438 (Petition). Sööt asks the following question:
In Markman v. Westview Instruments, Inc., 517 US 370 (1996), this Court held that the meaning of terms in a patent “claim” stands as a question of law and must be construed by the court. Under the Seventh Amendment, if requested by the patent owner, the jury must make the factual determination as to whether the defendant infringed the patent in light of the court’s claim construction. Consistent with the Seventh Amendment, the Markman decision leaves to the jury all factual determinations beyond the court’s construction of the claim. The question presented by this petition for writ of
certiorari is:
Whether the Seventh Amendment allows the Federal Circuit to reverse a jury verdict based on a sua sponte new claim construction of a term the district court concluded was not a term of art and construed to have its plain and ordinary meaning; where the Federal Circuit’s sua sponte claim construction essentially recasts a specific infringement factual question, previously decided by the jury, as a claim construction issue, to be decided de novo by the appellate court.
The Supreme Court will consider the petition next week.
Bankers’ Serv. Corp. v. Landis Christmas Sav Club Co, 273 F. 722 (3d Cir. 1921) [67_F.2d_904]
This 1921 decision centered on Merrill B. Barkley US Pat. No. 1,202,646, covering stationary for making “Christmas club deposits.” The specification explains:
There has developed recently in banking circles a wide demand for various kinds of special savings accounts, known generally as Christmas clubs, vacation accounts … and the like.
The claimed invention then is directed to a “deposit book,” with each page having a stub and detachable coupon. The customers keep the book with all the stubs showing deposits while the coupon goes to the bank to help direct the deposit.
Landis Christmas Sav Club was already selling supplies to banks, but Barkley was able to improve the system. In particular, with the Landis system, the a book of coupons was held by the bank, and individual sheets given out to the customer with each deposit. The Barkley reversal allowed the customer to keep the book and give deposit slips to the bank. Apparently Landis then copied the Barkley approach and an infringement suit followed. In essence, Barkley’s device is a reversal of the Landis approach. And, the appellate court recognized that the Barkley approach was and improvement that “could be more easily and conveniently handled.”
Despite the improvement, the courts found that they were of the time that would “naturally follow” from the prior art rather than rising to the level of an invention:
[I]t was the to-be-expected result which would naturally follow the study of men familiar with the banking and stationery business, when they set themselves to study and improve the Christmas Club system, as all bank employees would do. When such a new system was used by the thousands of keen minds, when better detail and further efficiency of such system would be the customary result of the experience that came from use, we would expect improvements, and the ideas such as Barkley worked out are, in our judgment, the steps that would naturally follow use. To take the cleverness of an improver and award the monopoly of an invention thereto would, to our minds, make of the patent law a hindrance, not a help, in the evolution of progress.
Invalidity affirmed.
Although the decision is issued prior to Graham v. John Deere, it offers an example of the level of ordinary skill in the art likely made a difference. The appellate court reflected that bank clerks are generally quite clever and diligent in their pursuit of efficiency. The court’s suggestion that the ubiquity of the prior art makes it much more likely that an improvement will naturally follow. This last bit on ubiquity is not typically used in the obviousness analysis anymore, but it does appear in Alice, step 2.
I’m doing a quick 3 minute anonymous survey on perceptions of probability in the legal system. Thanks so much for your input. Dennis Crouch. Fill out the survey below or use this link: https://missouri.qualtrics.com/jfe/form/SV_38JcSPmVJRpaPc2.
I previously wrote about the most cited Supreme Court patent cases since 1952. Today, I’ll write about the least-cited decision: Sanford v. Kepner, 344 U.S. 13 (1952).
Kepner filed his patent application in 1943 and Sanford filed his in 1945 — both directed to drop-bottom rail cars used in mining.
The USPTO interference sided with the first-filer Kepner and so Sanford took the case to Federal Court. Sanford argued (1) that Sanford should have priority as the first-to-invent and thus get the patent; and (2) even if Kepner gets priority, Kepner’s patent should still be invalidated based upon the prior art. (“Void for lack of invention.”) The Pennsylvania district court sided with the first-filer Kepner on priority grounds, and refused to decide the question of patentability. Sanford v. Kepner, 99 F. Supp. 221, 222 (M.D. Pa. 1951). On appeal, Sanford argued that the district court should have decided the validity question also, but the appellate court affirmed. Sanford v. Kepner, 195 F.2d 387, 390 (3d Cir. 1952). In particular, the 3rd Circuit explained that once the priority issues are decided, the plaintiff would need some additional justification to maintain standing: “some manifest threat … or interference with the activities of the petitioner beyond the issuance of a patent to another is required to create a controversy justiciable under the Declaratory Judgment Act.” Id. The Supreme Court then took up the case and again affirmed, with Justice Black writing a short opinion for a unanimous court. Sanford v. Kepner, 344 U.S. 13 (1952).
In its decision, the court noted that the odd setup would likely result in a weak validity challenge:
There would be no attack on the patent comparable to that of an infringement action. Here. the very person who claimed an invention now asks to prove that Kepner’s similar device was no invention at all because of patents issued long before either party made claim for his discovery. There is no real issue of invention between the parties here and we see no reason to read into the statute a district court’s compulsory duty to adjudicate validity.
Lots of the new learning in patent law over the past decade has focused on patent eligibility. But, none of the eligibility cases (new or old) show up in my list of the most cited Supreme Court cases.
Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (claim construction);
Christianson v. Colt Industries Operating Corp., 486 U.S. 800 (1988) (arising under jurisdiction);
eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006) (injunctive relief in accordance with the principles of equity);
Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966) (obviousness);
Zenith Radio Corp. v. Hazeltine Research, Inc., 401 U.S. 321 (1971) (antitrust – patent pools – waiver of defenses);
MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007) (licensee standing for declaratory judgment action);
Blonder-Tongue Laboratories, Inc. v. University of Illinois Foundation, 402 U.S. 313 (1971) (non-mutual issue preclusion in patent cases);
Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100 (1969) (antitrust – patent pools);
Holmes Group, Inc. v. Vornado Air Circulation Systems, Inc., 535 U.S. 826 (2002) (arising under jurisdiction – patent assertions in counterclaims, overruled by AIA);
Gunn v. Minton, 568 U.S. 251 (2013) (arising under jurisdiction for patent attorney malpractice);
Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997) (element-by-element, even for doctrine of equivalents);
Hoffman v. Blaski, 363 U.S. 335 (1960) (change of venue under 1404(a));
College Sav. Bank v. Florida Prepaid Postsecondary Educ. Expense Bd., 527 U.S. 666 (1999) (sovereign immunity for patent infringement);
KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obviousness); and
Kerotest Mfg. Co. v. C-O-Two Fire Equipment Co., 342 U.S. 180 (1952) (declaratory judgment and district court discretion).
The citation ranking here is based upon the cite by other cases. If we add in PTAB decisions, Briefs, and Articles, then the top four are KSR, Graham v. Deere, Markman, and Alice Corp.
Most of the cases in this list decide some trans-substantive principle and so are being cited outside of the patent context. The only core patent cases are Markman, Graham v. Deere, Warner-Jenkinson, and KSR.
The Secretary of Commerce has announced three new members of the USPTO’s Patent Public Advisory Committee (PPAC): Charles Duan, Suzanne Harrison, and Heidi S. Nebel. Congratulations! All three of these individuals care deeply about improving the patent system, and now have an official seat at the table.
The PPAC is charged with advising the PTO Director on the “policies, goals, performance, budget, and user fees of the United States Patent and Trademark Office with respect to patents.” 35 U.S.C. 5.
PPAC Members:
Steven Caltrider (Chair) – VP and General Patent Counsel, Eli Lilly and Company;
Tracy-Gene Durkin (Vice Chair) – Director at Sterne Kessler;
Jeffrey Sears – Associate General Counsel and Chief Patent Counsel at Columbia University;
Jeremiah Chan – Director and Associate General Counsel at Meta (FB);
Daniel Brown – Professor at the Segal Design Institute of Northwestern University;
Judge Susan Braden – Former Judge of the Ct. Fed. Claims;
Charles Duan – IP-focused public policy researcher at R Street Institute and formerly with Public Knowledge;
Suzanne Harrison – Percipience LLC (IP Strategy); and
Heidi Nebel – McKee, Voorhees & Sease.
These folks are all charged with receiving public input and using it in the process of building a better patent system. The next public meeting will be in February 2022.
I have written a handful of posts over the years suggesting a merger of the USPTO and Copyright Office to form a United States Intellectual Property Organization (USIPO). The current fractured structure means that we lack a coherent administrative approach to treatment of the various IP regimes, even though they obviously overlap in very important ways. Further, although trade secrets are increasingly important to US industry, no federal agency is providing any oversight or guidance. The political difficulty here, I believe, is that major copyright industry insiders feel that they have captured the copyright office and so are concerned that a transformation would harm their lobbying position.
Apparently, Sen. Thom Tillis is thinking along these same lines, and has been meeting with industry insiders to see whether there may be a consensus approach. The proposal may be larger — taking control from the President’s hands and creating a more independent agency.
I just wrote 150 words, and so it is 3% of the way toward a 5,000 word goal. If we get to 5,000 coherent words, then I’ll make sure it gets published — probably in some fancy law journal.
I expect that most folks won’t be satisfied, but in many cases it might be sufficient. And, if the technology is sufficiently mainstream, it suggests that the patent document actually needs less disclosure.
A requirement for continuing legal education (CLE) is on the horizon for US patent attorneys and patent agents, but that horizon has been pushed back once again. The first proposed step was a voluntary certification of CLE attendance. However, Dir. Hirshfeld and OED Dir. Will Covey have pushed that back indefinitely:
On June 10, 2021, the USPTO issued a Federal Register Notice announcing that the voluntary CLE certification would commence in the spring of 2022 but that implementation of the biennial electronic registration statement would be delayed until November 1, 2024. 86 FR 30920.
At this time, based on operational priorities, implementation of the voluntary CLE certification will be delayed indefinitely. The expected implementation date for the biennial electronic registration statement remains November 1, 2024.
US courts formerly tossed around the derogatory term “paper patents” in reference to inventions that were thought experiment scribbled down on paper and never actually reduced to practice. Ordinarily, paper patents were given more narrow construction than their more well rounded cousins. But, at least they were still on-paper.
The USPTO has announced its intent to stop printing patent documents on paper as a matter of course. Rather, the patent grant will remain in electronic storage. Paper versions will still be printable on-demand — informally from the website or formally with a fee.
The USPTO is finally moving away from printing of patent documents. That move is important because it has the potential of allowing the patent system to more fully take advantage of "born digital" documents.
The PTAB recently issued an odd opinion in this case focusing on the written description requirement. The application is directed to a “package of absorbent articles.” I.e., a bag full of diapers. These particular diapers are designed to include a higher percentage of “bio-based materials” and fewer petrochemicals. As such, the claims require that the bag contain “a plurality of absorbent articles … wherein the absorbent articles are devoid of lotion, fragrance or perfume, chlorine, and green number 7 dye.”
The patent examiner rejected the claims as obvious based upon several prior art references. Those rejections were affirmed by the PTAB, but then the PTAB also added two new grounds of rejections: Indefiniteness and Failure of Written Description. Basically, the PTAB was concerned with the claim limitation that the diapers are “devoid of … green number 7 dye.”
Appellant’s Specification is silent as to what, exactly, “green number 7 dye” is, or what “undesirable” materials or features it possesses that might warrant its absence from absorbent articles. . . . Further, there is no indication that “green number 7 dye” is a well-known dye, that it has a certain meaning in the industry, or that it falls within any of a number of classifications or descriptions by which dyes are often characterized.
In addition, the specification provided no criteria for determining why “green number 7 dye” is “undesirable.” Based upon those perceived failures in the specification, the PTAB concluded that “the term ‘green number 7 dye’ … lacks adequate written description support and is indefinite.” Although I have no experience in this area, I did do a 2 minute Google search and found that Green No. 7 is a term of art for Phthalocyanine Green G.
Question: Did the applicant err by not including a better definition of Green No. 7 and by particularly explaining why it is undesirable? The decision here has clear errors, but it does beg the question of the extent that a patent specification needs to explain “why” the inventor made certain choices. P&G sells diapers both with and without Green No. 7, and I expect that its reasoning is simply that some customers will pay more for the version without.
“An abstract idea can generally be described at different levels of abstraction.” Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240 (Fed. Cir. 2016).
I really have no idea what to make of this quote from Judge Reyna’s opinion, but the PTAB Judges Appear to love it. More than 600 PTAB decisions have included the full quote over the past few years. The citation appears to come into play in two occasion: (1) when the PTAB makes a slight shift from what the examiner identified as the relevant abstract idea; and (2) when the claims appear to be directed to something very specific, but that still fails the Alice test.
In general, if the PTAB quotes Ameranth, it finds the claims abstract. Out of 100 recent PTAB eligibility decisions quoting Ameranth, only 1 sided with the applicant on eligibility grounds.
by Dennis Crouch
The Supreme Court has not yet granted a writ of certiorari in any patent cases this term, and has denied certiorari in several dozen cases. A handful of important petitions are pending whose outcome could be transformative to the law.
Eligibility: American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, No. 20-891. The Federal Circuit concluded that American Axle’s vehicle-manufacturing claims are ineligible under the two-part tests of Alice and Mayo. U.S. Patent No. 7,774,911 (Claim 22). The claims here are directed to a method of manufacturing an automobile drive-shaft with reduced vibration. The basic idea is to insert a liner into a hollow shaft. The liner though is special — it is made of a “reactive absorber” and its mass and stiffness have been “tuned” all for the purpose of attenuating both “shell mode vibrations” and “bending mode vibrations” of the shaft. The petition asks two questions:
What does it mean to be “directed to” an ineligible concept? (Alice Step 1).
Is eligibility a pure questions of law (based upon the claims); or is it a “question of fact for the jury based upon the state of the art at the time of the patent?”
The Federal Circuit released a first opinion in the case followed by a toned-down second opinion. Both opinions were opposed by Judge Moore who explained that even the second try was an “unprecedented expansion of § 101.” The en banc petition failed, but in a 6-6 tie. The petition includes several features making certiorari more likely: Issue of historic interest to the Supreme Court; Divided lower court; Multiple amici in support of hearing the case; Multiple similar petitions in other cases; and Prior statement from US Gov’t (Trump Admin) that the Post-Alice eligibility setup needs recalibration. The Court has also shown signs of interest, including an order for responsive briefing from Neapco, and a request for the views of the Solicitor General (CVSG). We are now awaiting those views, and I expect that the SG’s brief will give us the best clue as to the likely outcome. The Supreme Court requested briefing almost 8 months ago – on May 3, 2021. The five most recent CVSG briefs took an average of 5.5 months from the request to the brief. So, we’re at the extreme end of the scale for this one.
There are two other eligibility cases pending: Yanbin Yu, et al. v. Apple Inc., No. 21-811; and WhitServe LLC v. Dropbox, Inc., No. 21-812. Neither of these are likely to garner interest.
PTAB Practice: The Supreme Court has shown extensive interest in various aspects of AIA Trials. The top pending case in this area is Mylan v. Janssen. Mylan filed an IPR petition that was denied based upon the six-factor NHK-Fintiv Rule established under Dir. Iancu. NHK-Fintiv permits the PTAB to deny IPR institution in situations where a parallel district court litigation is already well under way. Mylan appealed the IPR institution denial, but the Federal Circuit dismissed for lack of appellate jurisdiction, citing 35 U.S.C. § 314(d) (“The determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.”) In its petition, Mylan asks two questions:
Does 35 U.S.C. § 314(d) categorically preclude appeal of all decisions not to institute inter partes review?
Is the NHK-Fintiv Rule substantively and procedurally unlawful?
Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., No. 21-202. The petition has received amicus support as has a parallel petition in Apple Inc. v. Optis Cellular Technology, LLC, No. 21-118. Apple asks whether the law permits either appeal or mandamus in situations where the PTO exceeds its authority in a way that “is arbitrary or capricious, or was adopted without required notice-and-comment rulemaking.”
More Appellate Standing: A third PTAB related appellate standing case is Apple Inc. v. Qualcomm Incorporated, No. 21-746, this one focusing on standing to appeal a final written decision. The patent act is clear that any “person” other than the patentee can file an IPR petition and, if granted, participate in the trial as a party. The statute goes on to indicate that “a party dissatisfied with the final written decision” has a right to appeal that decision to the Federal Circuit. 35 U.S.C. 319. Despite the statutory right to appeal, the Federal Circuit has still refused to hear appeals in situations where the appellant cannot show concrete injury caused by the PTAB decision and redressability of that injury. The appellate court’s grounding stems from the Constitutional requirement from Article III of an actual case or controversy.
Here, Apple licensed a large number of Qualcomm patents as part of a portfolio license, but has only challenged a couple of them via IPR. The PTAB sided with Qualcomm and Apple appealed. On appeal, the Federal Circuit found that Apple had not provided any immediate concrete injury associated with the patent’s existence and so dismissed the appeal. In particular, (1) the court was not shown how the license would change in any way if those patents fell-out; and (2) although the license was set to expire prior to the patents, the court found that potential infringement liability a few years now was too speculative. Apple has now petitioned for writ of certiorari with the following question: Whether a licensee has Article III standing to challenge the validity of a patent covered by a license agreement that covers multiple patents. As you can see, this question attempts to tie the case directly to MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007) where the Supreme Court found standing for a licensee to challenge a patent.
Prior Art for IPRs: An interesting statutory interpretation petition was recently filed in Baxter Corporation Englewood v. Beckton, Dickinson and Company, No. 21-819. Congress was careful to limit the scope of IPR proceedings. The IPR petition may request claims “only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. 314(b). In the case, expert testimony was used to fill a gap in the prior art, and the question is whether the use of expert testimony in this manner violates the statutory provision.
Full Scope Enablement: LDL (“bad cholesterol”) is removed by LDL receptors in the liver. That’s a good thing. But, the body also makes PCSK9, a protein that can bind to the LDL receptors and destroy them. Amgen’s solution is an antibody that competitively binds to PCSK9 in a way that prevents them from binding and harming the LDL receptors. The result then is lowering of LDL in the body.
A monoclonal antibody is a type of protein made up of amino acids. Amgen’s claims at issue here do not recite the particular amino acid sequence or how the protein is structured and chemically linked. Rather, the claims are directed to a whole genus of monoclonal antibodies defined by the ability to bind with PCSK9 in a way that blocks PCSK9 from also binding with the LDL receptor.
The jury sided with the patentee on the issue of enablement, but the district court rejected the verdict on renewed JMOL. On appeal, the Federal Circuit sided with the accused infringer — holding that enablement is a question of law, and that the claims were so broad that full-scope-enablement is virtually impossible. In its petition, Amgen argues that (1) enablement should be seen as a question of fact; and (2) that the law does not require “full scope enablement” to the extent demanded by the Federal Circuit here.
A Novel form of Preclusion, the Kessler Doctrine: Finally, we get to res judicata. Lawyers all learned about claim preclusion and issue preclusion. Those two principles of law are designed to ensure finality of judgment and avoid relitigation. History shows substantial confusion about both terminology and scope, but things have been substantially clear and steady since the adoption of the Restatement (Second) of Judgments in 1982. One aspect of the historic confusion stems from the Supreme Court’s 1907 decision of Kessler v. Eldred. Kessler has been on a back-burner for decades, but in 2014 the Federal Circuit revived the case and found that it deserved to co-equal — a preclusion doctrine separate and distinct from issue or claim preclusion. That 2014 Brain Life decision was followed by a further expansion of Kessler in Speedtrack (Fed. Cir. 2015) and again in PersonalWeb Techs. (2020).
PersonalWeb’s certiorari petition the Supreme Court asks two questions:
Whether the Federal Circuit correctly interpreted Kessler to create a freestanding preclusion doctrine that [applies] even when claim and issue preclusion do not.
Whether the Federal Circuit properly extended its Kessler doctrine to cases where the prior judgment was a voluntary dismissal.
The Supreme Court has shown interest in the case, and recently called for the Solicitor General to submit a brief on behalf of the U.S. Gov’t. I have an article on the case coming out in the Akron Law Review that I’ll post in a week or so (after fixing a few citations).
Two More: Although no petitions have been filed yet, the parties in two other cases have publicly indicated their intent to file petitions by the end of 2021:
Intel Corporation v. VLSI Technology LLC (Follow-on case to Mylan v. Janssen and Apple v. Optis); and
Ikorongo Texas LLC v. Samsung Electronics Co., Ltd. (proper venue in a situation where the plaintiff holds territorially limited patent right).
