I love this project that has the AI tech develop a detailed 20-30 page specification based upon a few claims and short description. https://information.patentepi.org/issue-2-2021/natural-language-generation-and-patents-be-ready.html
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.
Till then, keep reading Patently-O.
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.
— Dennis Crouch (@patentlyo) December 16, 2021
This is a good move.
Read more and provide comments here:
Update: Others have noted that USPTO computer servers went down for several hours on the day of this announcement.
by Dennis Crouch
Ex parte The Procter & Gamble Co., Appeal 2021-002928, APN. 16/388,898 (PTAB 2021) [2021002928_Mail_Decision]
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:
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:
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:
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:
See you in January.
The USPTO has joined forces with the Department of Justice (DOJ) and National Institute of Standards (NIST) in creating a new draft policy statement on licensing of standards-essential patents (SEP) subject to voluntary F/RAND commitments. The draft seeks further public comments.
The 2021 follows a long history of policy discussions on competition implications of patents in the standards market.
In 2013, a statement indicated that an “exclusionary remedy … may be inconsistent with the public interest” for F/RAND licensed patents. The 2019 statement rejected that approach and instead explained that a F/RAND commitment should not “bar any particular remedy.” The new proposal reverts back to 2013 and goes further — indicating that a patent holder who commits its patent as part of a standard-setting negotiation is making a promise that “it will not exercise any market power obtained through standardization.”
Opportunistic conduct by SEP holders to obtain, through the threat of exclusion, higher compensation for SEPs than they would have been able to negotiate prior to standardization, can deter investment in and delay introduction of standardized products, raise prices, and ultimately harm consumers and small businesses.
2021 Draft Statement. At the same time, the new statement also indicates that implementers must also participate in good faith.
Regarding injunctive relief, the 2021 proposal interprets eBay and Federal Circuit holdings as follows:
Where a SEP holder has made a voluntary F/RAND commitment, the eBay factors, including the irreparable harm analysis, balance of harms, and the public interest generally militate against an injunction.
2021 Statement.
Comments due first week of January 2022 via regulation.gov. The agencies propose the following questions to spur comment:
Over the past several years, the USPTO has been battling trademark applications that use fake specimens to establish a claim. Often these are low-quality photoshopped images, but can be more sophisticated.
This week, the UPSTO announced a final order for sanctions against the China-based law firm Shenzhen Huanyee Intellectual Property Co., Ltd. and the firm’s director Ms. Yusha Zhang associated with about 15,000 trademark applications many of which included “false and fraudulent submissions.”
Respondents have engaged in the unauthorized practice of law, provided false domicile information for applicants, impermissibly entered the signature of the named signatory on declarations and verifications, and violated other USPTO Rules and the USPTO’s website terms of use.
The sanctions are quite firm:
One part of the sanction that folks need to consider has to do with violation of TEAS terms of service and sharing USPTO.GOV accounts.
Respondents registered and shared access to at least three separate uspto.gov accounts including the name of Yusha Zhang. Respondents used these accounts to make submissions on behalf of others through TEAS in thousands of trademark matters. Given that many of the submissions were often filed through TEAS in rapid succession from the various accounts, it is clear that the accounts were used by multiple people, not just Ms. Zhang.
Final order.
Guest Post by Samuel F. Ernst, Professor of Law, Golden Gate University School of Law.
Can you register a famous person’s name as your trademark without their consent? The Lanham Act seems to say no, and the U.S. Patent and Trademark Office interprets this to mean no, never, no matter what. 15 U.S.C. § 1052(c) provides, in pertinent part, that the PTO must deny federal registration to a trademark if it “[c]onsists of or comprises a name, portrait, or signature identifying a particular individual except by his written consent….” Unlike registration denials under Section 1052(a), the PTO denies registration without any inquiry into whether the mark suggests a false connection between the mark and the famous person. Nor does the PTO inquire into whether the famous person also sells the goods or services in question, as it does with private individuals under Section 1052(c). Rather, with respect to celebrities and world famous political figures, registration is denied based solely on the determinations that (1) “the public would recognize and understand the mark as identifying a particular living individual”; and (2) the record does not contain the famous person’s consent to register the mark.[1] Under this provision, the PTO routinely denies registration to marks that appear calculated to capitalize on the famous person’s name to sell products. For example, the PTO denied registration under Section 1052(c) to ROYAL KATE as applied to watches, cufflinks, jewelry, and other luxury products based solely on the determination that “ROYAL KATE identifies Kate Middleton whose identity is renowned.”[2] Id. And the PTO denied registration to OBAMA PAJAMA in connection with pajamas based on the examining attorney’s “excellent job marshalling a variety of press excerpts to demonstrate the obvious – namely, that President Barack Obama is extremely well known.”[3]
But the PTO also denies registration to marks under this provision even if they constitute political commentary, parody, or other public discourse at the heart of the First Amendment. For example, in 2020 the PTO denied registration to the mark TRUMP TOO SMALL in connection with T-shirts, even though the applicant argued that the mark was “political commentary about presidential candidate and president Donald Trump that the relevant consumer in the United States would not understand to be sponsored by, endorsed by, or affiliated with Donald Trump.”[4] In particular, the mark “is political commentary about [Trump’s] refutation at the March 3, 2016 Republican debate of presidential candidate Marco Rubio’s insinuation that Donald Trump has a small penis”; and “is also political commentary about the smallness of Donald Trump’s overall approach to governing as President of the United States.”[5] The applicant appealed the PTAB’s denial to the Court of Appeals for the Federal Circuit, which is now deciding whether Section 1052(c) is unconstitutional in violation of the First Amendment,[6] as that court and the Supreme Court have already decided with respect to the provisions in the Lanham Act barring registration of scandalous, immoral, or disparaging marks.[7]
Unlike the bars on registration at issue in Tam and Brunetti, the PTO’s ban on registration under Section 1052(c) does not discriminate against speech based on the viewpoint expressed. Rather, the PTO bars registration whether the mark praises, criticizes, ridicules, parodies, or is neutral toward the famous person. Nonetheless, the bar is a content-based restriction because “its reach is defined simply by the topic (subject matter) of the covered speech”[8] – here, the topic being the famous person in question. And even if viewed as a regulation of purely commercial speech – and therefore not subject to strict scrutiny – the restriction would at least have to pass muster under the Supreme Court’s test in Central Hudson Gas & Electric Corp. v. Public Service Commission, which asks, in pertinent part, whether the regulation burdening speech directly advances a substantial government interest, and whether the regulation “is not more extensive than necessary to serve the interest.”[9] Section 1052(c), at least as broadly interpreted by the PTO, fails this test and is, therefore, unconstitutional.
The PTO’s asserted justification for this total ban on registration is “to protect the intellectual property right of privacy and publicity that a living person has in his/her identity.”[10] Putting aside whether the PTO has a legitimate interest under the Lanham Act in protecting intellectual property rights that are creatures of state law, these justifications plainly fail on their merits.
With respect to the right of privacy, the government does not have a legitimate interest in protecting public figures, such as former President Trump, from speech that criticizes, ridicules, or even praises them. Rather, the First Amendment recognizes “a profound national commitment to the principle that debate on public issues should be uninhibited, robust, and wide-open, and that it may well include vehement, caustic, and sometimes unpleasantly sharp attacks on government and public officials.”[11]
And even if the government has a legitimate interest in guarding the state right of publicity, the Lanham Act’s absolute bar on registering the name of a famous individual absent written consent is far more extensive than necessary to serve that interest. No state recognizes such a sweeping right of publicity that it is subject to zero countervailing First Amendment protections. As Jennifer Rothman observes, “[a]t least five balancing approaches have been applied to evaluate First Amendment defenses in right of publicity cases.”[12]:
Accordingly, the PTO’s absolute ban on the registration of marks such as TRUMP TOO SMALL is far more extensive than necessary to protect the right of publicity, which would not prevent the use of TRUMP TOO SMALL under any state’s right of publicity regime.
These various free speech defenses to the right of publicity have been criticized by scholars for providing an inadequate, misleading patchwork of First Amendment protections.[23] But the PTO’s application of Section 1052(c) is even worse: the PTO takes no countervailing interests into account before denying registration to a mark. The PTO fails to consider: whether registration of the mark would likely cause consumer confusion; whether it would cause dilution of the public figure’s brand; whether the mark suggests a false connection with the person (as separately provided by other provisions); whether there is unjust enrichment or any other type of unfair competition; whether the use of the famous person’s name constitutes news, political commentary, parody, or entertainment speech at the heart of the First Amendment; and indeed without considering any First Amendment defense or legitimate Lanham Act policy whatsoever.
Hence, the PTO’s interpretation of Section1052(c) is a First Amendment-free zone. But what remedy should the Federal Circuit provide? Should the statute be construed so as to require source confusion, dilution, or a false connection with the celebrity before denying registration?[24] Such an interpretation is not plausible because there are separate provisions preventing registration under these circumstances, such that this interpretation would render Section 1052(c) duplicative of Sections 1052(a), (d), and (f).[25] Should the Federal Circuit remand with instructions that the PTO apply one of the First Amendment defenses to the right of publicity detailed above before declining to register a mark, even though those defenses are roundly criticized by scholars?; or perhaps one of the First Amendment defenses that are recommended by scholars?[26] Which one? Is the PTO capable of applying First Amendment balancing tests such as transformative use or fair use in routine registration decisions?; determinations that befuddle and confuse Article III federal courts? Is the PTAB the right body to make such determinations? Do we really want the PTO to be judging distinctions between political speech and purely commercial speech, or might that result in new speech discrimination issues? If the PTO cannot apply a First Amendment test in a reliable, predictable way, must the statute be invalidated because it is impermissibly vague with respect to what speech it burdens?[27]
Or have we gotten this whole question exactly backwards? Perhaps the prohibition on registering famous persons’ names serves in some way to protect political speech. After all, if the PTO registers a mark that is political commentary about a famous person, this gives the registrant certain nationwide rights allowing the registrant to burden other speakers from using the political speech in commerce to the extent it would result in likely confusion. Hence, in some circumstances registration of famous person’s names could perhaps result in less political speech, not more. One thinks of a potential 2024 Marco Rubio presidential campaign that seeks to sell T-Shirts saying TRUMP TOO SMALL, but is burdened by the national registration of that mark by Mr. Elster. As Judge Reyna wrote in dissent in In re Tam, “if the expressive content of the mark precludes regulation, on what authority may the government grant Mr. Tam the exclusive right to use this mark in commerce?”[28] Perhaps the courts should analyze statutes such as this one in the flexible way Justice Breyer suggests in his partial dissent in Brunetti: by focusing on “the interests the First Amendment protects” and considering whether the harm to those interests is “disproportionate in light of the relevant regulatory objectives.”[29] But these are mere dissents, not the law. The government has not met its burden of advancing such a pro-speech rationale. If protecting political speech were the true government interest behind Section 1052(c), it is a wholly insufficient vehicle for protecting that interest. It is insufficient protection because it still allows the political figure himself to register the political speech including his name, thereby burdening others from using that speech in commerce. Moreover, the PTO can register all kinds of marks that constitute political speech so long as they do not contain the name of a famous person without his consent. The binding precedent of the Federal Circuit and the Supreme Court requires the conclusion that denying the benefits of national registration to marks constituting political speech under these circumstances constitutes an impermissible burden on free speech in violation of the First Amendment.
[1] In re Nieves & Nieves LLC, 113 USPQ2d 1629, 2015 WL 496132, *12 (TTAB 2015).
[2] Id. at *12-*14.
[3] In re Hoefflin, 97 USPQ2d 1176, 2010 WL 5191373, *3 (TTAB 2010).
[4] In re Elster, No. 20-2205, Doc. 43 (Corrected Joint Appendix) at 111 (Response to Office Action of Feb. 19, 2018) (Fed. Cir.) (available on Pacer).
[5] Id.
[6] See In re Elster, No 20-2205 (Fed. Cir.).
[7] See In re Tam, 808 F.3d 1321 (Fed. Cir. 2015) (en banc) (holding that 15 U.S.C. § 1052(a) is unconstitutional with respect to the bar on disparaging marks), aff’d, Matal v. Tam, 137 Sup. Ct.1744 (2017); In re Brunetti, 877 F.3d 1330 (Fed. Cir. 2017) (holding that 15 U.S.C. § 1052(a) is unconstitutional with respect to the bar on immoral and scandalous marks), aff’d, Iancu v. Brunetti, 139 Sup. Ct. 2294 (2019).
[8] In re Tam, 808 F.3d at 1334 (citing Reed v. Town of Gilbert, 135 S.Ct. 2218, 2230 (2015)).
[9] 447 U.S. 557, 566 (1980). See also Matal, 137 Sup. Ct. at 1764 & n. 17 (opinion of Alito, J.) (“[W]e leave open the question whether Central Hudson provides the appropriate test for deciding free speech challenges to provisions of the Lanham Act” because “the disparagement clause cannot withstand even Central Hudson scrutiny”); Brunetti, 139 Sup.Ct. at 2298 (The Court in Tam held that viewpoint discrimination is unconstitutional but “could not agree on the overall framework for deciding the case”); In re Tam, 808 F.3d at 1364-68 (Dyk, J., concurring in part and dissenting in part) (purely commercial speech can be regulated subject to the Central Hudson test).
[10] In re Hoefflin, 2010 WL 5191373, *1.
[11] New York Times Co. v. Sullivan, 376 U.S. 254, 270 (1964).
[12] Jennifer Rothman, The Right of Publicity 145 (Harvard U. Press 2018).
[13] C.B.C. Distribution & Mktg., Inc. v. Major League Baseball Advanced Media, L.P., 505 F.3d 818, 823 (8th Cir. 2007).
[14] Id. at 824.
[15] Doe v. TCI Cablevision, 110 S.W.3d 363, 374 (Mo. 2003) (quoting Mark S. Lee, Agents of Chaos: Judicial Confusion in Defining the Right of Publicity-Free Speech Interface, 23 Loy. L.A. Ent. L. Rev. 471, 500 (2003)).
[16] Id. at 374.
[17] Comedy III Prods., Inc. v. Gary Saderup, Inc., 25 Cal. 4th 387, 404 (2001) (internal citations and quotation marks omitted).
[18] Id. at 409-10.
[19] See, e.g., Davis v. Electronic Arts., 775 F.3d 1172 (9th Cir. 2015).
[20] Id.
[21] Restatement (Third) of Unfair Competition § 47. Rothman refers to this as the “relatedness test.” Rothman, Right of Publicity 146.
[22] Rogers v. Grimaldi, 875 F.2d 994, 1004–05 (2d Cir. 1989).
[23] See, e.g., David Franklyn & Adam Kuhn, Owning Oneself in a World of Others: Towards a Paid-for First Amendment, 49 Wake Forest L. Rev. 977, 1011 (2014) (“The right [of publicity] is growing unchecked, and attempts to balance it against the First Amendment have resulted in a patchwork of misleading potential defenses.”); Rothman, The Right of Publicity at 145 (“The uncertainty of what a speaker can do has itself chilled speech because content creators do not want to risk litigation or liability.”); Stacey L. Dogan & Mark A. Lemley, What the Right of Publicity Can Learn from Trademark Law, 58 Stan. L. Rev. 1161, 1162 (2006) (“[T]he courts have developed no meaningful counterweight to this ever-expanding right [of publicity]. Instead, they have created a few ad hoc exceptions in cases where the sweeping logic of the right of publicity seems to lead to results they consider unfair.”); Eugene Volokh, Freedom of Speech and the Right of Publicity, 40 Hous. L. Rev. 903, 930 (2003) (“[T]here is good reason to think… that the right of publicity is unconstitutional as to all noncommercial speech, and perhaps even as to commercial advertising as well.”)
[24] See Brunetti, 139 Sup.Ct. at 2304 (Breyer, J., concurring in part and dissenting in part) (“Our precedents warn us against interpreting statutes in ways that would likely render them unconstitutional”).
[25] See In re Brunetti, 877 F.3d at 1355 (“It is thus permissible to construe a statute in a manner that preserves its constitutionality only where the construction is reasonable.”); Brunetti, 139 Sup. Ct. at 2302 & note * (declining to narrowly construe the bar on registering scandalous marks to avoid unconstitutionality).
[26] See, e.g., Franklin & Kuhn; Dogan & Lemley, supra note 23.
[27] See In re Tam, 808 F.3d at 1358 (O’Malley, J., concurring) (opining that the disparagement provision of Section 1052(a) should be invalidated because it is impermissibly vague in violation of the Fifth Amendment).
[28] In re Tam, 808 F.3d at 1378 (Reyna, J., dissenting).
[29] Brunetti, 139 Sup.Ct. at 2306 (Breyer, J., concurring in part and dissenting in part).
by Dennis Crouch
Inter partes review (IPR) is an incredibly powerful process for cancelling patent rights. We have a set of expert judges who are not afraid of digging into the details of a complex obviousness analysis. Still, IPR petitions are strictly limited to petitions based upon obviousness and anticipation theories and “only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. 311(b).
Successful IPR petitions always focus on prior art as the central basis for cancelling the patent claims. And yet, the petitioner usually also presents additional evidence to contextualize the prior art — most typically this comes in the form of expert testimony.
In its new petition for certiorari, Baxter Corp. argues that the statute does not permit supplemental evidence such as expert testimony. Question presented:
Whether the Federal Circuit’s practice of allowing IPR petitioners to rely on evidence other than patents and printed publications, such as expert testimony, to fill in gaps in the prior art violates the plain text of § 311(b).
Baxter Corp. v. Becton, Dickinson and Co. (Supreme Court 2021) (petition).
In this case, the PTAB sided with the patentee and upheld the validity of Baxter’s U.S. Patent No. 8,554,579. The Federal Circuit reversed that judgment on appeal. Although the prior art did not show all of the claimed elements, BD’s expert witness testified that the missing material would have been obvious. The Federal Circuit found the testimony credible and unrebutted and therefore rendered the claim obvious.
The case here comes down to one of statutory interpretation. On the one hand, Baxter argues that 311(b) bars IPR petitioners from asserting of any evidence beyond the prior patents and publications in their original challenge grounds. A broader approach would interpret the statute as purely focusing on available prior art, but then permitting other forms of evidence directed toward other elements of the obviousness or anticipation analysis (such as level of skill in the art; likelihood of success; etc.).
(b) Scope. A petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.
35 U.S.C. 311(b).
Baxter also raises a second question in its petition focusing on the Federal Circuit’s approach here of imposing its own view of the facts:
Whether the Federal Circuit’s practice of resolving contested issues of patentability on appeal from Board decisions—rather than remanding those issues for the agency to decide in the first instance—violates the “ordinary remand rule.”
Petition, Question 2. Here, the “ordinary remand rule” is an approach to appellate review of agency decisions. The approach is that a rejected agency decision “should
typically return the matter to the agency to address any outstanding questions in the first instance.” Petition; See, e.g., INS v. Orlando Ventura, 537 U.S. 12, 16-18 (per curiam); Christopher J. Walker, The Ordinary Remand Rule and the Judicial Toolbox for Agency Dialogue, 82 Geo. Wash. L. Rev. 1553 (2014).
by Dennis Crouch
Astrazeneca AB v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2021)
This case helps show that patent law has arrived at Nerdsville. Actually, I’ve been here for a while and so welcome to all you newcomers. In my view, the case also suggests that our claim construction doctrine has gone too far attempting to discern meaning where none exists. Rather, I would suggest that the issues here are really about infringement rather than claim construction.
The claims require “0.001%” of a formulation be the inactive ingredient PVP K25. The allegedly infringing formulation is slightly different — lets say 0.0008% — but it is within standard rounding error if 0.001% is seen as having one significant digit (0.0005 to 0.0014). Mylan argued that 0.001% should be given a narrower range — “the precise number, with only minor variation.” Mylan’s outcome would result in a range of something like 0.00095 to 0.00104.
The district court sided with the patentee — holding that standard scientific notion indicates that a physical measure such as this includes the rounding error according to the number of significant digits shown. If they had wanted a more precise number, then scientific notation permits the addition of more significant digits — such as 0.0010%. On appeal though the majority rejected that approach based upon statements from the specification comparing 0.001% against 0.0005% (a value that should be within the rounding error).
Thus, taken as a whole, the intrinsic record supports a narrower construction of 0.001% to reflect that term’s application to the PVP concentration in particular, and the testing evidence in the written description and prosecution history showing that very minor differences in the concentration of PVP—down to the ten-thousandth of a percentage (fourth decimal place)—impact stability.
Slip Op. The court noted that the patentee could have used the term “about” to extend the range. Judge Stoll wrote the majority opinion that was joined by Judge Hughes.
Judge Taranto in dissent first noted the uncontested conclusion that the ordinary meaning follows the broader rounding range:
The significant-figure convention for real-world-measurement situations supplies an answer by giving a well-defined interval as the ordinary meaning, in the art, of a statement of a single number like the statement at issue here. Under this ordinary-meaning approach, the significant-figure interval meant by “0.001%” is 0.0005% to 0.0014%, based on rules of rounding and the single significant figure at the third decimal place.
Dissent.
Judge Taranto then argues that the proposed “minor variations” limit creates confusion because it lacks precision. Of course, we’re talking about rounding and measurement errors here and so they already lack precision.
This video was suggested by a friend as relevant:
by Dennis Crouch
Teva Pharmaceuticals, LLC v. Corcept Therapeutics, Inc., Dockt No. 21-1360 (Fed. Cir. 2021)
This is an interesting pro-pharma obviousness decision coming out of the PTAB regarding obviousness of particular drug dosages. Here, the particular drug was known to work well, but there were concerns about drug safety. And, there were a couple of particular tests that clearly would have been obvious to try. In fact, the patentee was legally required by the FDA to conduct the tests in order to ensure drug safety. Still, the outcome of the tests were not predictable. Nobody knew whether the particular dosage being was going to turn out to be “safe.” (Here “safe” is interpreted as having “an acceptable risk-benefit profile.”) The patentee ran the tests, found the dosage to be safe, and then patented a method of administering that safe-dosage to patients. Teva challenged the patent, but the PTAB and the Federal Circuit both sided with the patentee. They held that the unpredictable outcome of the test meant that the outcome was not obvious since there was no “reasonable expectation of success.”
I expect that the Supreme Court would reject the hard line drawn in this case in the same way that it rejected the TSM requirement in KSR v. Teleflex. I.e., obviousness is a flexible, open analysis asking “is there an invention here?” Former Kennedy clerk J.C. Rozendaal handled the appeal for Teva, and so I won’t be surprised to see a petition for writ of certiorari in 2022.
The rest of the story: Corcept’s patent covers a method of treatment of some Cushing’s syndrome symptoms with the drugs mifepristone and ketoconazole (a “strong CYP3A4 inhibitor”). U.S. Patent No. 10,195,214. The basic problem is that these two drugs can interact in problematic ways, and the patent calls for a reduced dose of mifepristone when being taken alongside ketoconazole. When taken alone, mifepristone is prescribed in dosages of up to 1,200 mg per day; but when taken with ketoconazole, the patent calls for reduction of down to 600 mg per day.
The prior art all comes from earlier interaction between Corcept and the FDA. Initially, Corcept filed a New Drug Application (NDA) seeking to market mifepristone in dosages of 300, 600, 900, and 1,200 mg per day. The FDA gave its approval, but suspected interaction with ketoconazole. That suspicion led to the two key prior art references:
When I think about these two references, I see a strong suggestion of an interaction between the drugs, and also a strong motivation to look into that interaction. In fact, the first two research questions implicitly demanded by the prior art is (1) whether a 300 mg dose interacts with CYP3A and (2) whether a 600 mg dose interacts with CYP3A. Yet, while the two references expressly call for research, the references do not suggest the outcome of the 600 mg test. If anything, the original label suggested that 600 mg dose would be a problematic — since the FDA limited dosage to only 300 mg if also taking the other drug.
The PTAB followed these lines of analysis and eventually concluded that the references failed to prove obviousness. In particular, the Board hung its hat on “reasonable expectation of success” — finding that the references did not suggest that 600 mg would be a safe dosage.
On appeal, the Federal Circuit has affirmed — holding that invalidating the claim would require proof of “a reasonable expectation of success in achieving the specific invention claimed, a 600 mg dosage.”
Because there was no expectation of success for any dosage over 300 mg per day, there was no expectation of success for the specific 600 mg per day dosage.
Slip Op. Affirmed.
Note – Mifepristone is new name for the drug RU-486.
I’m looking forward to being part of the revitalized Colorado IP&SKI this winter in Vail. The program is chaired by Scott Alter (Michael Best) and David Bernstein (Debevoise). I’ll be speaking there along with a bunch of greats — including Judges Chen (CAFC) and Andrews (D.Del); Erika Arner (Finnegan); Dale Cendali (K&E); Deanne Maynard (MoFo); and William Jay (Goodwin); David Gooder (Comm’r for TM); and more.
by Dennis Crouch
In re: accessiBe Ltd., Docket No. 22-113 (Fed. Cir. 2021) (non-precedential)
This mandamus petition has been denied, although the Federal Circuit has suggested that Judge Albright reconsider his denial of venue transfer. [2021.10.29 56 Public Version – Memorandum Opinion]
AudioEye sued accessiBe for patent infringement (US10423709, et al.) as well as claims under the Lanham Act (false advertisement & product disparagement) and under New York State Law (product disparagement, tortious interference, etc). But, instead of suing in New York, AudioEye sued in W.D. Tex. The focus here is on screen-reader used to help individuals with disabilities better access the internet. The software particularly helps to fix non-compliant websites to make them more accessible.
Suing a Non-Resident for Patent Infringement: In TC Heartland, the Supreme Court severely limited the scope of “proper venue” in patent cases. Generally, the patentee can only sue a defendant in either (1) its state of incorporation or (2) some venue where it has a regular-and-established place of business. These limitations stem back more than 100 years, and the “limitation” offered in TC Heartland might be more properly seen as a rejection of venue-expansion by the Federal Circuit. One gap in the Supreme Court’s analysis in TC Heartland is how to treat foreign companies. The answer though is pretty clear under Brunette Machine Works, Ltd. v. Kockum Industries, Inc., 406 U.S. 706 (1972). In Brunette, the Supreme Court held that the more-expansive rules of the general law (Section 1391) apply when the defendant is not a US entity. In particular, the statute states plainly that venue is proper in any judicial district:
(3) a defendant not resident in the United States may be sued in any judicial district …
28 USC 1391(c)(3). Obviously, the court must also satisfy the constitutional requirement of personal jurisdiction. And, the defendant may also pursue a change-of-venue based upon inconvenience under 28 USC 1404(a).
Motion to Transfer: accessiBe moved to transfer the case to W.D.N.Y. as a “clearly more convenient forum” under section 1404(a). But, the statute only permits transfer to a venue where the case “might have been brought.” In his decision, Judge Albright concluded that the movant had not shown personal jurisdiction was proper in NY state court — and therefore denied the transfer motion. The mandamus motion indicates that neither party had argued that particular issue and instead that Judge Albright had “go[ne] out of [his] way to contrive a basis for denying accessiBe’s request for a transfer.” [Petition for Mandamus]
The Federal Circuit has now denied the mandamus petition, but has suggested that the petitioner first request reconsideration from the district court:
To obtain mandamus relief, this court must be satisfied that a petitioner has no “adequate alternative” means to obtain the desired relief. Mallard (1989). Here, we cannot say that it would be futile for accessiBe to ask the district court to first reconsider its decision in light of its arguments. We therefore deny the petition without prejudice to refiling after accessiBe first asks the district court for reconsideration. Any new petition for a writ of mandamus from the district court’s ruling on reconsideration will be considered on its own merits.
Slip Op.
Personal Jurisdiction: At the district court, the defendant had also argued for dismissal of the non-patent claims for lack of personal jurisdiction. A court needs personal jurisdiction over the parties before moving forward. Due process fails absent personal jurisdiction — and that’s a Constitutional violation. The Supreme Court has offered three paths for finding personal jurisdiction in a court housed in a particular state: (1) waiver (the plaintiff is generally thought to waive personal jurisdiction by filing the lawsuit; defendants also waive by not immediately complaining); (2) general jurisdiction (defendant is truly resident in the jurisdiction); or (3) specific jurisdiction (the actions that led to the cause-of-action are directed to the state). Here, the theory is specific jurisdiction.
Specific jurisdiction over the patent claims is easier to show. The defendant has Texas-based customers and is alleged to infringe the patent by providing services to those folks. In other words, intentional infringement of the patent in TX ==> personal jurisdiction over the patent claims in TX.
The difficulty though with specific jurisdiction is that we also look at specific jurisdiction on a claim-by-claim basis. The defendant argues that the NY State claims are based upon actions that are somewhat separate from just selling software (alleged tortious interference activity beyond just selling software). Still, Judge Albright found that “accessiBe’s website is sufficient to establish specific personal jurisdiction over accessiBe in Texas” with regard to most of the Lanham Act claims. The court then decided to exercise “pendent personal jurisdiction” over the New York state law claims since they “share a common nucleus of operative fact.” The defendant did not petition for mandamus on the personal jurisdiction questions and so that issue appears dead until a post-judgment appeal.
Recent Headlines in the IP World:
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You should be able to easily answer these questions:
Prof. Crunch stays fit with his rebounder (a mini-trampoline). These already exist, but Crunch has designed a new model that includes a handle (for stability) and also a touchscreen control that can be used to stream audio/video instructions. (These are shown in the figure below). He plans to sell a higher end model that includes displaying the bouncing-tempo on the screen and also energy-exerted (using movement-sensors in the rubber-bands or springs).
Crunch recently filed a utility patent application (February 2021) with the USPTO seeking to patent the following two claims:
1. An exercise apparatus comprising: a mini-trampoline; a support handle secured to the mini-trampoline that includes a grip-bar; and a touch-screen electronic device attached to the support handle and configured with software for displaying real-time exercise instructions. 2. The apparatus of claim 1, further comprising motion sensors attached to the mini-trampoline and configured to provide data to the touch-screen electronic device and wherein the touch-screen electronic device is configured to use the data provided to calculate and display energy-exerted by a user in real-time.
Crunch admits that all of the elements of his invention were individually available in the prior art. In particular, mini-trampolines with handles were already available, as were touch screens for displaying real-time instructions. Likewise, motion sensors are available, as well as algorithms for calculating energy use while trampolining. However, he has not seen any prior art that combines everything together in this particular way.
Question 1. (100 words) Are Crunch’s claims directed toward eligible subject matter?
Question 2. (80 words) Provide a concise argument why the USPTO should reject claim 1 as indefinite.
Question 3. (300 words) Based upon what you know so far, do Sections 102 or 103 create any hurdle to patentability?
Question 4. (100 words) Five years later … Crunch has obtained his patent exactly as claimed above and business is booming. Crunch recently found that GummyBearCo is selling a product that he thinks is infringing his claim 1. The only differences are that (1) it is a large 15-foot trampoline and (2) there is no “handle” per se. Rather, the screen is simply mounted to a pole at the edge of the trampoline. Also, although the GummyBearCo product is sold in the USA, it is actually manufactured in China. Can he prove infringement?
by Dennis Crouch
Moderna Therapeutics v. Arbutus BioPharma (Fed. Cir. 2021) (20-1184 Decision) (20-2329 Decision)
Arbutus owns several patents related to a lipid-based delivery system for nucleic-acid-based treatments. U.S. Patent 8,058,069 and 9,364,435 are the two at issue here. The claims are directed to the creation of a “acid-lipid particle” that includes some RNA along with lipids to stabilize the sequence, including particular percentages of cationic lipids, non-cationic lipids, and conjugated lipids.
COVID: If you have been following the news, you know that the COVID-19 vaccines distributed by Moderna and Pfizer deliver mRNA to the cells using lipid nanoparticles. Although Arbutus has apparently not threatened Moderna with an infringement action, it has apparently requested a broader license agreement and refused to issue a covenant-not-to-sue. Moderna recognizes “a substantial risk” that Arbutus will assert the patents in an infringement lawsuit “targeting Moderna’s COVID-19 vaccine.”
Pre-COVID: Moderna had been working on mRNA delivery systems and had previously licensed the patents for research work using a milestone payment scheme. Moderna challenged the patents via IPR in 2018 and 2019 so that it could use the inventions without royalty payments or other reporting. IPR2018-00739; IPR2019-00554. This was all before COVID, but the risk and value have ramped-up exponentially. The PTAB granted the IPR petitions but substantially sided with the patent holder:
The parties appealed their respective losses, and the Federal Circuit has now affirmed on all grounds — although a portion of its decision is a procedural shortcut. Because the patents were left largely intact, we have a good likelihood of further litigation between these parties over the patents (or else a new license in the background).
The basic idea here is that this area of innovation is extremely tricky and unpredictable. Thus, although the “general conditions for a nucleic acid-lipid particle were disclosed in the prior art,” the particular claimed lipid profile would not “have been achievable through routine optimization.”
Standing to Appeal: It is pretty clear that at this point the post-COVID relationship between the parties is such that Moderna has standing in court to challenge these patents. However, as I mentioned, the IPRs were filed pre-COVID and the 2018 IPR was appealed in November 2019 — well before Moderna had an inkling that it would be making a COVID-19 vaccine. The problem for Moderna here is that the appellate court can only hear cases involving an “actual case or controversy” between the parties. And, that actual case-or-controversy must persist throughout the entire appeal (from beginning to end). What Moderna needs to show is that the patent served as a concrete and immediate threat as of that November 2019 date. I mentioned that there was a license agreement, but the court found that any payments due under that agreement too speculative to generate standing since – at the time – Moderna was not actually doing the planned research. Further, the patentee (at the time named Protiva) “emphasized that it had never initiated a patent infringement action or directly accused Moderna of infringing its patents.”
Things had changed dramatically by the time Moderna filed its opening brief in May 2020. But, as I mentioned, courts require continuous standing throughout a lawsuit, and it just wasn’t there in November of 2019. The result then is that Moderna was not permitted to appeal its loss in the ‘435 case.
Yu v. Apple (Supreme Court 2021)
A new petition for certiorari asks the court whether Parker v. Flook, 437 U.S. 584 (1978) is still good law.
Quick answer from Crouch: Yes, it is still good law.
Flook is a divide-and-conquer case that looks a lot like the Alice test itself. The claims were directed setting of “alarm limits” for a catalytic conversion process and the court identified the only novel feature to be a mathematical formula. The mathematical formula was an abstract idea, and thus offered no patentable weight. And, the remaining features were admittedly known in the art.
Respondent’s process is unpatentable under § 101 not because it contains a mathematical algorithm as one component, but because, once that algorithm is assumed to be within the prior art, the application, considered as a whole, contains no patentable invention. Thus, the claim as a whole was ineligible. Although the court recognized that it had disected the claim into component parts, it also concluded that this approach still took the claim “as a whole:”
Our approach [is] not at all inconsistent with the view that a patent claim must be considered as a whole. Respondent’s process is unpatentable under § 101 not because it contains a mathematical algorithm as one component, but because, once that algorithm is assumed to be within the prior art, the application, considered as a whole, contains no patentable invention. Even though a phenomenon of nature or mathematical formula may be well known, an inventive application of the principle may be patented. Conversely, the discovery of such a phenomenon cannot support a patent unless there is some other inventive concept in its application.
Id. To be clear, the Federal Circuit treated Flook as effectively repudiated by Diamond v. Diehr, 450 U.S. 175 (1981), but that was apparently never the view of the Supreme Court. I should note here the actual question presented is as follows:
Whether, when applying the test for patent eligibility set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), a patent claim should be considered “as a whole” in accordance with Diamond v. Diehr, 450 U.S. 175 (1981), or instead, whether all conventional elements of the claim must be disregarded prior to determining its “point of novelty” as set forth in this Court’s older precedent in Parker v. Flook, 437 U.S. 584 (1978).
Read the petition here: 20211129141853759_USSCPetitionforWritofCertiorari.
On December 1, 2021, the Senate Judiciary Committee held a hearing on two of President Obama’s Biden’s patent related nominees:
Both nominees have substantial experience handling patent cases. Stark as a district court judge in the patent-heavy district of Delaware (2000+ patent cases) and Vidal as a patent attorney and patent litigator in Silicon Valley. And, importantly, I expect both nominations will be swiftly confirmed by the Senate, although Judge Stark will not be seated until after Judge O’Malley retires in March 2022. Vidal’s testimony offered some clues, suggesting that she may consider rolling back some of the pro-patentee procedural changes to IPRs implemented by Dir. Iancu. But, as is usual with nomination hearings today no concrete details were provided.
Watch it here: https://www.judiciary.senate.gov/meetings/11/24/2021/nominations
by Dennis Crouch
In his 1967 Ruschig decision, Judge Rich applied a colorful woodsman metaphor to the written description requirement:
It is an old custom in the woods to mark trails by making blaze marks on the trees. It is no help in finding a trail or in finding one’s way through the woods where the trails have disappeared—or have not yet been made, which is more like the case here—to be confronted simply by a large number of unmarked trees. Appellants are pointing to trees. We are looking for blaze marks which single out particular trees. We see none.
In re Ruschig, 379 F.2d 990, 994–995 (C.C.P.A. 1967). 
In Biogen Int’l GMBH v. Mylan Pharma Inc. (Fed. Cir. November 30, 2021), the Federal Circuit has extended that metaphor and found Biogen’s patents invalid for lack of written description. In the case, Judge Keeley (N.D.W.Va.) held a bench trial and concluded that the asserted claims Biogen’s MS treatment-method patent invalid for lack of written description. On appeal, a divided Federal Circuit then affirmed, with Judge Reyna penning the majority opinion joined by Judge Hughes, and Judge O’Malley writing in dissent.
Biogen’s U.S. Patent 8,399,514 covers a method of treating multiple sclerosis using the drug dimethyl fumarate (DMF). The claimed method has one step: administering about 480 mg of DMF per day along with an excipient. Claim 1 is reprinted below:
1. A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.
‘514 patent.
The question in the case is whether the dosage requirement (~480 mg/day) was sufficiently disclosed in the original specification so that it can be specifically claimed. For this type of analysis, the courts look to the Written Description requirement as one way to ensure that a patent’s exclusive rights are commensurate with what was actually invented. The doctrine requires that the patent application show “possession of the invention” as judged from the perspective of a person of skill in the art considering the entire original specification, including “words, structures, figures, diagrams, formulas, etc.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Originally filed claims are seen as part of the specification, and so most often it is sufficient to show that claim limitations were found in the original application. But see, Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc) (original claims can still fail). Despite Ariad, we most often see the power of written description in situations where the claims have been amended to add some limitation that is not clearly expressed in the original specification.
Here, for prior art purposes, the patentee needs to claim priority back to its original provisional application filed back in 2007. That original application is focused on use of DMF for a variety of neurological conditions, including MS and did not include the ~480 mg/day limitation within any of the included claims.
The ~480 mg/day dosage is listed once in the original specification, describing an effective dose of DMF without particularly specifying that the dosage is for MS.
For example, an effective dose of DMF … can be from about 0.1 g to 1 g per pay, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day; or from about 480 mg to about 720 mg per day; or about 720 mg per day). For example, the 720 mg per day may be administered in separate administrations of 2, 3, 4, or 6 equal doses.
On appeal, the majority classified the disclosure of 480 mg/day as a “sole reference . . appear[ing] at the end of one range among a series of ranges.” The court 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. The inventor also provided testimony that those ranges in the specification could not be extrapolated to a clinical dose. Based upon all of this, the court affirmed 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.”
Biogen later established that the 480 mg/day was effective, but by then prior art was already available and so a new application would have been ineffective.
In a recent decision, the Federal Circuit ruled that written description failed for a claim covering a range of values since the specification only disclosed several points within the range. Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2021). This case is a flip-side — the specification discloses a range, and the court rules that, without more, written description also fails for a claim directed to an endpoint of the disclosed range.
Writing in dissent, Judge O’Malley focused on a separate district court error that, she concludes, tainted its written description analysis. In particular, the district court applied the doctrine of judicial estoppel to bar the patentee from distinguishing from clinical efficacy (required for FDA approval) and therapeutic effect (as claimed in the patent). O’Malley concludes that the district court’s analysis erroneously focused on requiring a showing that 480 mg/day was clinically effective and that improperly resulted in invalidity.
