Patent Docs

The Quest for an "Artificial Intelligence" Inventor

By Manav Das --

The United States Constitution[1] provides the basis for patent laws; it says "Congress shall have power . . . to promote the progress of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries" (emphasis added).  It is a common refrain that the Constitution is a living, breathing document, and the afore-mentioned clause is perhaps an exemplar.  Even though our founding fathers are unlikely to have contemplated artificial intelligence ("AI") inventors, it is noteworthy that nothing in the clause itself states that "authors and inventors" have to be individuals[2]. Therefore, allowing AI inventorship is unlikely to run afoul of the plain language of the Constitution.

Title 35 the United States Code is the statutory basis for the federal patent system.  Section 100[3] of Title 35 defines the term "inventor" to mean "the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention."  Various other sections require acts that only an individual can be expected to perform, at least for now.  For example, Section 112[4] specifies the requirements for a written description:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

(emphases added).  If we were to unpack some these requirements, one could ask how a patent draftsperson can "set forth the best mode contemplated by the inventor" if an AI model is the inventor.  Could we seriously argue that the AI model contemplated the invention?  One definition of "contemplate" is to "think profoundly and at length."  Does the electrical and computational activity of a computer rise to the level of profound thinking?  Philosophers and neuroscientists may be more equipped to delve into the intricacies of this question.

Another definition of "contemplate" is to "to view or consider with careful and thoughtful attention."  Proponents of AI inventorship may argue that some neural network architectures (e.g., transformers, long short-term memory networks (LSTMs)) are designed to include "attention mechanisms" precisely to mimic human cognitive attention.  For example, the recent public interest in chatbots, such as ChatGPT and Bard, highlight the power of the transformer architectures.

Therefore, a simple statutory term such as "contemplated" invokes semantic, linguistic, philosophical, and technological references, all intricately intertwined with the notion of inventorship.

The aforementioned Section 112 also requires that the written description contain the "manner and process of making and using [the invention]."  This is an important provision in the statute since the patent is a bargain between the inventor and the public.  The public grants the inventor a temporary monopoly of twenty years from the filing date of the patent application, with the understanding that the technology will be available to the public beyond the expiry of the patent.  If the written description does not provide the manner and process of making the invention, then the inventor side of the bargain is not fulfilled.  As every patent draftsperson knows well, details about the invention are elucidated from the inventors during a disclosure meeting.  How would one elucidate such information from an AI model?  Can an AI model know how to use an output of the model?

Again, proponents of AI inventorship may argue that the details about the invention may be extracted from the AI model.  For example, some AI models may be configured to output data about how predictions or outputs are generated, and such data could be used to fulfill the written description requirement.  Such data is generally referred to as "explanations" or "interpretations" of the AI model's decision making process.  For example, "feature importance" can identify the most important input features that the AI model used to make its predictions.  An image recognition model may be able to indicate which parts of the image the model focused on to recognize an image.  Another technique is "local explanation" that involves generating explanations for individual predictions or outputs of an AI model.  For example, a local explanation may indicate why a given input led to a particular output.  Similarly, a "global explanation" can be an indication of an overall summary of how the AI model functions.  Also, "counterfactual explanations" can involve generating alternative input values that may result in a different output.  This can be used to determine which input values were primarily influential in driving the AI model's prediction.[5]

Transformer-based model architectures have a highly interpretable structure, and internal weights and activations of the model may be measured.  The transformer architecture consists of a series of stacked self-attention layers, where each layer applies a set of weights to the input sequence to compute a new representation of the sequence.  The self-attention mechanism involves computing attention weights that indicate how much each position in the sequence should be weighted when computing the representation.  The weights used for computing the attention and the representations at each layer can be extracted and analyzed.  This can provide insights into how the model is processing and integrating information, and which parts of the input are most important for making predictions.  There are several tools and techniques available for visualizing and interpreting the weights and activations of transformer models, including attention heat maps, saliency maps, and activation maximization.  These methods can help to identify patterns and relationships in the input data that are most relevant for the model's predictions.

However, even if the written description requirement were to be fulfilled, as described above, the patent statute relies on other aspects of individuality, such as an inventor's oath or declaration, an assignment, a person of ordinary skill in the art, and so forth.  Inventors also appear in depositions or as trial witnesses in patent disputes.  However, such issues are statutory and/or requirements of a judicial process.  The United States Patent and Trademark Office[6], the Federal Circuit[7], and the Supreme Court[8], have made it clear that under the current law, an inventor is an individual.  The authority to decide if an AI model can be an inventor lies with Congress.  The U.S. Constitution delegates such authority to Congress, and not to the courts.  Therefore, if Congress were to decide, in its infinite wisdom, that the term "authors and inventors" can include AI inventors, then so it shall be, and statutory provisions and/or judicial processes can be suitably modified and adapted.

One of the arguments made by proponents of AI inventorship is that if an AI model were not allowed to be an inventor, as is the current state of the law, then many "inventions" may go unclaimed and unpatented.  It is argued that this will impede the "promot[ion of] the progress of science and useful arts," which is the fundamental constitutional underpinning of the intellectual property system.  To the extent an AI model may predict new outputs not contemplated by the designer of the model, the model architecture is itself man-made.  It is an intricate network of nodes and layers that is trained to process certain types of inputs and make certain predictions.  Therefore, it is under the control and direction of the designer of the model, and therefore the designer has a substantial legal claim as the individual that conceived any part of that output.

It is conceivable that there are "inventions" that may indeed be unclaimed or unpatented.  How can this notion be aligned with the current state of the law?  One perspective could be that we are creating new paradigms of an invisible nature.  Consider, for example, a rock that is beautifully sculpted by a gushing stream, or a tree that is air brushed to exquisite beauty by a wayward wind.  The sculpted rock and the tree would be considered natural phenomena, and neither the stream nor the wind would be allowed to claim a copyright for such objects, or a patent for the process of making them.  Perhaps, in the same vein, by designing AI models, we are creating new paradigms of an invisible, hidden, natural world of probabilistic, electro-magnetic "winds and streams," and what we are witnessing are natural wonders from this natural world that dazzle and amaze us.  However, from a patentability perspective, these are simply natural phenomena, and are therefore not patentable subject matter.  Perhaps as technology advances, such seeming novelties will eventually become mundane, and it could become difficult to distinguish between an output of a general purpose computer and that of a specific purpose computer (like the AI models), thereby raising the bar for patentability.

One consideration is that even if the U.S. legal system is slow to adapt to the notion of the AI model as an inventor, other nations may make this possible, creating new intellectual property rights.  For example, Australia came tantalizingly close to this reality.[9]  In such cases, U.S. commercial interests may suffer and IP rights may be usurped.  One strategy may be to protect the unpatentable subject matter as a trade secret.  However, in some cases, the subject matter may be easily reverse engineered or duplicated.  In such cases, a defensive strategy may be to make the subject matter publicly available, for example, as a defensive publication.

Certainly, there will come a time, in the not too distant future, when AI models will become self-replicating, independent, unsupervised, decision making sentient beings.  Some already claim that certain AI models are sentient.  As intellectual property and technology professionals, we need to consider the larger implications of allowing an AI to be an inventor.  Such a broadening of the notion of an "individual" will be an earth shattering change to a centuries' long held view about who an "individual" is.  It will be a tacit acknowledgement that our Constitution views AI models on an equal footing with individual inventors.  This has the potential to open up a Pandora's Box of dilemmas: must AI models be accorded equal rights in society (Voting rights?  Moral rights?  Life, liberty, and the pursuit of happiness?  Right to bear arms?).  These are significant considerations that we as a society must ponder. We need to deliberate, prepare, and shape our future by creating laws that can pre-empt and adapt to the fast pace of technological advancement.  Perhaps prior to designating AI models as inventors, we need to regulate AI models.  John Steinbeck may as well have been talking about intellectual property rights when he wrote:

Ever'body wants a little piece of lan'.  I read plenty of books out here.  Nobody never gets to heaven, and nobody gets no land.  It's just in their head.  They're all the time talkin' about it, but it's jus' in their head.[10]

And then again, the AI model may mock us by quoting Shakespeare[11]:  "I will keep where there is wit stirring, and leave the faction of fools."

[1] U.S. Const. Article 1, Section 8, clause 8

[2] Several of the founding fathers, including Benjamin Franklin, contemplated a universe with other intelligent beings

[3] 35 U.S.C. § 100(f)

[4] 35 U.S.C. § 112(a)

[5] Certain portions of this paragraph and the next are based on conversations with ChatGPT

[6] In re Application No. 16/524350

[7] Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022)

[8] Denying certiorari in Thaler v. Vidal (No. 22-919)

[9] The Australian Full Federal Court recently reversed a decision by the Federal Court that an AI system known as DABUS can be an inventor under the Australian Patents Act 1990

[10] Of Mice and Men, ch. 4, John Steinbeck

[11] William Shakespeare, Troilus and Cressida - Act 2, scene 1

Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit

By Kevin E. Noonan --

The efforts to have Judge Pauline Newman, Circuit Judge on the Court of Appeals for the Federal Circuit, unfit or guilty of misconduct have been the subject of reporting in the patent blogosphere (Patently-O, IP Watchdog), the general legal press (Bloomberg Law, IPLaw360) and the popular press (Reuters) for over a month.  The dispute rose in intensity earlier this month, when Judge Newman filed on her behalf a complaint in the District Court for the District of Columbia.  The caption named Judge Newman as plaintiff and Chief Judge Kimberly Moore, Judge Sharon Prost, and Judge Richard Taranto, members of the Special Committee of the Judicial Council of the Federal Circuit, as defendants.

Judge Newman's complaint sets out some factual bona fides, such as that she was the first judge specifically appointed to the Federal Circuit (by President Reagan) in 1984 and (she asserts) has "continued to faithfully, diligently, and meticulously exercise the duties of her office, to recognition and acclaim," including being named as "one of the 50 most influential people in the IP world" by Managing IP Magazine in 2018.  She contends that she has "has been and is in sound physical and mental health" at all relevant times and asserts that she has performed her duties (including that she has "authored majority and dissenting opinions in the whole range of cases before her Court, has voted on petitions for rehearing en banc, and has joined in the en banc decisions of the Court").  The complaint identifies four opinions Judge Newman has filed between March 6th and April 6th, and had also participated in an en banc proceeding during this time (with no objection from her brethren).

These assertions are backed up by a Guest Post in Patently-O by Temple Professor Paul R. Gugliuzza showing the Federal Circuit Judges' activities over the term from June 1, 2021 through December 31, 2022:

Judge Newman cites Professor Gugliuzza's report in her complaint, asserting that this report "stand[s] in sharp contrast to the[] false allegations" raised against her.

It will be noted that while Judge Newman has penned far fewer majority opinions during this time than her colleagues, she has also penned many more dissents, so that her total opinion output (while less than most other judges on the court) is in the range of the lower one quarter of them.  This outcome should not be surprising; for many reasons Judge Newman and her colleagues do not see eye-to-eye on a sufficient percentage of the patent law questions that come before the court that the Judge has been dubbed "The Great Dissenter" in patent circles (see Lim, I Dissent: The Federal Circuit's "Great Dissenter," Her Influence on the Patent Dialogue, and Why It Matters, 19 Vanderbilt Journal of Entertainment and Technology Law 873 (2020)).  In this regard, the complaint notes that "[o]ften, Judge Newman's dissenting opinions are adopted by the Supreme Court in its frequent reversals of the Federal Circuit."

Enumerated in the complaint is a history of seven Orders handed down in this dispute by the Special Committee to date, the first of which issued on March 24th.  That Order asserted that Judge Newman's colleagues had noticed deficiencies in her performance of sufficient gravity that an inquiry by the Special Committee was necessary.*

Judge Newman in her complaint characterizes the March 24th Order as being "riddled with errors," including that the Judge was incapacitated due to a heart attack and subsequent coronary stent surgery at a time when Judge Newman asserts she "sat on ten panels and issued at least eight (including majority, concurring, and dissenting) opinions."  Judge Newman's participation on ten panels during that time was more than only two other Federal Circuit judges, the complaint contends.

Judge Newman asserts that the Chief Judge "unconstitutionally and unilaterally removed [her] from all future sittings of the Court," purportedly with the unanimous consent of her judicial colleagues.  In fact Judge Newman has not been permitted to sit on any panels since the March 24th Order, despite requesting to do so.

The March 24th Order has been superseded by an April 6th Order which "expanded the scope" of the investigation to include "questions of internal operations of Judge Newman's chambers," and a day later there was another Order "demanding that Judge Newman submit to neurological and neuropsychological examinations before physicians of the special committee's choosing."  Judge Newman asserts she was given three days to comply (emphasis in complaint).

Failure to comply was the basis, the complaint asserts, for yet another Order on April 13th "further expanding the scope of investigation" into "additional misconduct."

This was followed by an April 17th Order "demanding that Judge Newman share private medical records regarding medical events identified in the March 24th Order," this time providing four days to comply (emphasis in complaint).

The complaint further asserts that the Chief Judge "unilaterally reassigned one of Judge Newman's law clerks to the chambers of another Judge" and has refused to "authorize a search for a new judicial assistant."  Similarly, the complaint asserts the Chief Judge unilaterally reassigned one of Judge Newman's law clerks (the return of this individual apparently not being an option due to "the strained relationship that developed between Judge Newman and this law clerk").  Again, the complaint asserts the Chief Judge has not authorized Judge Newman to replace this law clerk, despite (as a currently active judge on the court) she is "statutorily entitled to four law clerks and a judicial assistant."

Another Order on April 21st alleged it to be misconduct for Judge Newman not to assign her law clerk to another judge's chambers.

Judge Newman, through counsel, sent the Chief Judge a letter on April 21st requesting restoration of her hearing calendar and for the Judicial Complaint to be transferred to a different Judicial Council pursuant to Rule 26 of the Conduct Rules.  In the letter Judge Newman raised due process concerns, stating that "basic norms of due process cannot permit the same individuals to be accusers, witnesses, rapporteurs, and adjudicators of a complaint against her," her position being supported by "opinions of leading judicial ethics experts who have unequivocally stated that in these circumstances transfer to another circuit's judicial council is necessary."

A May 3rd Order (which Judge Newman characterizes as a "gag order") prohibits the Judge from publicizing the investigation by herself or her counsel and to be subject to sanctions, even if such disclosure were made pursuant to Rule 23(b)(7) of the judicial Conduct Rules.

Another May 3rd Order denied Judge Newman's request to transfer the investigation to another Judicial Council, and contained another Order that Judge Newman "submit to neurological and neuropsychological examinations before physicians of the special committee's choosing" and "surrender medical records including for events that have never occurred."  This time the Order gave Judge Newman a week to comply.

Judge Newman asserts that she does not object to undergoing a medical examination but she does object to "not being able to select or even participate in the selection of a medical professional to examine her, and to having no input into the scope of the medical investigation."

Significantly, the complaint at Paragraph 38 states that "If and when the special committee proceeds to a hearing as contemplated by Rules 14(b) and 15(c), Judge Newman intends to call, and compel witness testimony from each member of the Judicial Council as is her right under the aforementioned rules."

In her Prayer for Relief, Judge Newman alleges in Claim I "improper removal [and] violation of separation of powers" based on Article III (life tenure of federal judges) and Article I (giving the House of Representatives the sole authority to remove a judge through impeachment after trial by the Senate).  Judge Newman characterizes the several Orders as being unlawful for removing her from hearing cases, removing her judicial staff without her consent, ordering her to "undergo an involuntary mental health examination without a sufficient basis or legal authority for doing so, by physicians unknown to and unapproved by Plaintiff," and ordering the scope of the investigation to be expanded "merely because Plaintiff requires time to properly evaluate and answer special committee requests."

Claim II asserts that the Judicial Complaint is ultra vires for "improper removal [and] violation of separation of powers."  This allegation is based on Judge Newman being removed from her duties before the special committee's investigation was concluded (which removal the Judicial Disability Act of 1980 codified at 28 U.S.C. § 354(a)(2)(A)(i) requires to be after the investigation according to the complaint).  "'Sentence first—verdict afterwards' is a notorious and textbook example of deprivation of due process known even to children's literature" the complaint asserts.  This Claim alleges irreparable harm until the Orders "excluding Plaintiff from regular duties of an Article III judge and their threats to continue with such exclusion" and "requiring Plaintiff to refrain from publicizing the proceedings against her and publicly defending herself from the outrageous complaint lodged against her" are enjoined.

Claim III alleges Fifth Amendment violations of due process because the members of the Special Committee are also purported witnesses to the alleged judicial misconduct (the complaint stating that "[i]t has been established for centuries that one cannot serve as a 'judge in his own cause'").

Claim IV asserts a First Amendment violation for unlawful prior restraint for the gag order, contrary to Houston Cmty. Coll. Sys. v. Wilson, 142 S. Ct. 1253, 1259 (2022) (the First Amendment prohibits prior restraint on speech); Alexander v. United States, 509 U.S. 544, 550 (1993) (gag orders are a form of prior restraint); Bantam Books, Inc. v. Sullivan, 372 U.S. 58, 70 (1963) (there is a heavy presumption against gag orders); Reed v. Town of Gilbert, Ariz., 576 U.S. 155, 163 (2015) (gag orders are subject to strict scrutiny).

Claim V asserts that the gag order is also ultra vires as being an unlawful prior restraint on speech.

Claim VI asserts a Fifth Amendment violation for unconstitutional vagueness of the provisions of the Disability Act.  Judge Newman asserts that she has "liberty and property interests in the outcome of any misconduct or disability proceeding against her" and "liberty and property interests in not being subjected to an involuntary medical or psychiatric examination and further liberty and property interests in not being stigmatized as having committed misconduct and having her mental health questioned, as well as having her status as an Article III judge altered by ordering her to undergo a compelled medical or psychiatric evaluation by physicians not chosen by her and who are unknown to her."  And those interests also extend to her private medical records wherein they "may not be invaded by requiring her to surrender these same records to an investigative authority absent due process of law."  These assertions are directed at the Act as well as how the provisions of the Act have been implemented in this instance.

Claim VII asserts that the activities are ultra vires for unconstitutional examination because "[n]either the Act nor the U.S. Constitution authorizes compelling an Article III judge to undergo a medical or psychiatric examination or to surrender to any investigative authority her private medical records in furtherance of an investigation into whether the judge suffers from a mental or physical disability that renders her unable to discharge all the duties of office."  Judge Newman asserts that "Defendants have neither statutory nor constitutional power to compel Plaintiff to undergo an involuntary medical or psychiatric examination, or to compel Plaintiff to surrender her private medical records."

Claim VIII is also asserts a Fifth Amendment violation for unconstitutional vagueness regarding the Act's investigative authority, with regard to "authoriz[ing] compelled medical or psychiatric examinations of Article III judges or demands from special committees for Article III judges to surrender their private medical records."  In particular, this allegation is directed to Section 353(c) of the Act.

Claim IX alleges a Fourth Amendment violation for an unconstitutional search regarding the "compelled medical or psychiatric examination of an Article III judge without a warrant based on probable cause and issued by a neutral judicial official or a demonstration of constitutional reasonableness."

Claim X alleges a Fourth Amendment violation for an unconstitutional search and seizure of a "compelled surrender of private medical records."

Claim XI alleges a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to submit to an involuntary medical or psychiatric examination."

Claim XII alleges a Fourth Amendment violation for "lack[ing] either a warrant issued on probable cause by a neutral judicial official or a constitutionally reasonable basis for requiring Plaintiff to surrender her private medical records none of which bear on her fitness to continue serving as an Article III judge."

The Relief Requested is:

(1) declare the Act to be unconstitutional, either in whole or in part and enjoin Defendants from enforcing the Act to the extent it is unconstitutional;

(2) declare any continued proceedings against Plaintiff by the Judicial Council of the Federal Circuit to be unconstitutional as violative of due process of law and enjoin Defendants from continuing any such proceedings, except to the extent necessary to transfer the matter to a judicial council of another circuit;

(3) order the termination of any further investigation of Plaintiff by the Judicial Council of the Federal Circuit;

(4) declare any decisions by any and all Defendants authorizing a limitation of Plaintiff's docket or other special restrictions on her actions as a federal judge, including, but not limited to the reduction in statutorily authorized number of staff to be unconstitutional and/or not in accordance with the law, and enjoin Defendants from continuing any such actions;

(5) declare any orders precluding Plaintiff from publicizing or otherwise speaking about the ongoing disciplinary proceedings to be unconstitutional and/or not in accordance with the law and enjoin Defendants from enforcing the foregoing unconstitutional orders;

(6) declare any orders of the special committee requiring Plaintiff to undergo a compelled medical or psychiatric examination and/or disciplining Plaintiff for objecting in good faith to  these demands to be unconstitutional and enjoin Defendants from enforcing the foregoing unconstitutional orders;

(7) declare any orders of the special committee requiring Plaintiff to surrender her private medical records and/or disciplining Plaintiff for objecting in good faith to these demands to be unconstitutional and enjoin Defendants from enforcing the foregoing unconstitutional orders;

(8) award Plaintiff reasonable attorneys' fees and costs; and

(9) grant Plaintiff such other relief as the Court deems just and proper.

It may be significant to note that Judge Newman has been an active Federal Circuit judge longer than any other member of the Court.

* Judge Newman also asserts that Chief Judge Moore has tried in the past to "coax" her into retirement, and that the Chief Judge used the existence of a complaint against the Judge in an attempt to further coax (or coerce) the Judge to retire.

Supreme Court Decides Amgen v. Sanofi; Status Quo Extended

By Kevin E. Noonan --

The Supreme Court handed down its decision in Amgen v. Sanofi today, affirming the Federal Circuit's decision below in a unanimous opinion by Justice Gorsuch.

The opinion relies heavily on its own precedent that was heavily cited by both parties in their briefs and arguments, including O'Reilly v. Morse, 15 How. 62, The Incandescent Lamp Patent, 159 U. S. 465, and Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245.  In the Court's view, the statute plainly requires that "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent's specification must enable a person skilled in the art to make and use the entire class."  The Court is careful to address some of the concerns raised by Amgen and its amici regarding that the burdens the disclosure requirements would imposed taken to its extreme could inhibit innovation in the biotech and pharma arts.  In this regard, the Court states "[a]ll this is not to say a specification always must describe with particularity how to make and use every single embodiment within a claimed class."  But the enablement requirement requires, for example, that the specification also discloses "some general quality . . . running through" the class that gives it "a peculiar fitness for the particular purpose," as in Incandescent Lamp, and situations where there is some adaptation or testing is needed does not make the disclosure "necessarily inadequate," as in Wood v. Underhill, 5 How. 1, 4– 5.  Under Minerals Separation, Ltd. v. Hyde, 242 U. S. 261, 270–271, the opinion states that "[a] specification may call for a reasonable amount of experimentation to make and use a claimed invention, and reasonableness in any case will depend on the nature of the invention and the underlying art."

Amgen's claims fail this test, the Court holding that the scope of the claims at issue were much broader than the 26 expressly disclosed antibodies.  The Court sees these claims as being like ("bear more than a passing resemblance") the claims in Morse, Incandescent Lamp, and Holland Furniture that were held to be invalid.  The Court understands Amgen's claims to attempt to "monopolize an entire class of things defined by their function" even though that class was much broader ("a vast number") of antibodies.  Nor was Amgen's disclosure of a "roadmap" for obtaining other antibodies or reference to "conservative substitutions" persuasive, the Court considering these to "amount to little more than two research assignments."

The decision certainly solidifies the Federal Circuit's trend of limiting claim scope much more closely to what is expressly disclosed and the Court's affirmance of the insufficiency of relying on conservative substitutions will have consequences extending much more broadly than to antibody claims.  Further discussions of the implications will be provided in later posts.

Senate Once Again Tries to Address Drug Pricing

By Kevin E. Noonan --

Over the past several years Congress has tried to address high drug prices, with variable success  (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived Remedies from Congress Regarding Prescription Drug Costs"; "More Ill-conceived Remedies from Congress Regarding Prescription Drug Costs"; and "A Solution in Search of a Problem").  Indeed, Executive Orders stemming in part from the COVID pandemic have garnered more success on this score.  But the Inflation Reduction Act reduced the monthly cost of insulin to $35 while other initiatives have had less success passing or having the desired effect even when enacted.

Not to be deterred, the U.S. Senate's Health, Education, Labor & Pensions (HELP) Committee this past week passed out of committee five bills in this vein:  the Ensuring Timely Access to Generics Act of 2023 (S. 1067); the Expanding Access to Low-Cost Generics Act of 2023 (S. 1114); the Retaining Access and Restoring Exclusivity Act (S. 1214); and the Increasing Transparency in Generic Drug Applications Act (S. 775).  These will be discussed seriatim below.

1.    The Ensuring Timely Access to Generics Act of 2023 (S. 1067)

This bill was introduced by Sen. Jeanne Shaheen (D-NH) on March 29, 2023, co-sponsored by Sen. Susan Collins (R-ME), Michael Bennet (D-CO), Marco Rubio (R-FL), Tammy Baldwin (D-WI) and Mike Braun (R-IN).  The bill would amend Section 505(q) of the Food, Drug, and Cosmetic Act (21 U.S.C. § 355(g)) to give the Secretary of Health and Human Services the ability to determine whether a Citizen's Petition was filed "for the primary purpose of delaying an ANDA application," and recites a number of factors to be considered in making this determination.  These include:

(aa) Whether the petition was submitted in accordance with paragraph (2)(B), based on when the petitioner knew or reasonably should have known the relevant information relied upon to form the basis of such petition.

(bb) Whether the petitioner has submitted multiple or serial petitions or supplements to petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions.

(cc) Whether the petition was submitted close in time to a known, first date upon which an application under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act could be approved.

(dd) Whether the petition was submitted without relevant data or information in support of the scientific positions forming the basis of such petition.

(ee) Whether the petition raises the same or substantially similar issues as a prior petition to which the Secretary has responded substantively already, including if the subsequent submission follows such response from the Secretary closely in time.

(ff) Whether the petition requests changing the applicable standards that other applicants are required to meet, including requesting testing, data, or labeling standards that are more onerous or rigorous than the standards the Secretary has determined to be applicable to the listed drug, reference product, or petitioner's version of the same drug.

(gg) The petitioner's record of submitting petitions to the Food and Drug Administration that have been determined by the Secretary to have been submitted with the primary purpose of delay.

As well as an omnibus provision relating to "other relevant and appropriate factors" to be set forth in an FDA Guidance.

The bill also adds a provision directing ("The Secretary shall") any such petition "that the Secretary determines was submitted with the primary purpose of delaying approval of an application" be referred to the Federal Trade Commission for investigation.

The bill adds provisions requiring filing of a Citizen Petition "before filing a civil action" to prevent FDA from approving an application under Section 505(b)(2) or 505(j) wherein the petition provides "all information and arguments that form the basis of the relief requested in any [such] civil action."  A Citizen Petition must (again, "shall") be filed within 60 days from when the petitioner "knew, or reasonably should have known, the information that forms the basis of the request made in the petition or supplement."  Failure to file the petition prior to filing a civil action will result in the court ("shall") dismissing the action without prejudice for failure to exhaust administrative remedies.  The court shall dismiss on the same basis any civil action filed against the Secretary before the Secretary has taken action on the petition.

The bill also removes the exception under current law for biologic drugs and biosimilar equivalents.

Often when Congress proposes to amend a statute is appears that such amendments are to provide clarity or to limit or prevent practices deemed to be abuses.  Motivation for these amendments can be understood perhaps with reference to remarks by Senator Collins, one of the co-sponsors, on YouTube.

2.    The Expanding Access to Low-Cost Generics Act of 2023 (S. 1114)

This bill was introduced by Sen. Tina Smith (D-MN) and co-sponsored by Sen. Mike Braun (R-IN).  The bill would amend Section 505(j)(5)(B)(iv) of the Food, Drug, and Cosmetic Act to provide a 75-day window for a "first filer" generic company to market its product or lose the 180-day exclusivity, which could then go to another generic drug company.  The conditions for this substitution require that the alternative filer are set forth to require satisfaction of these factors:

(aa) The approval of such application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause.

(bb) The applicant of such application has submitted a certification to the abbreviated new drug application that there are no conditions that would prevent the applicant from commercial marketing within 75 days after the date of approval and that the applicant intends to so market the drug.

(cc) At least 33 months have passed since the date of submission of an application for the drug by at least one first applicant.

(dd) Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii).

(ee) No application for the drug submitted by any first applicant is effectively approved on the date that the conditions under items (aa), (bb), (cc), and (dd) are all met and maintained.

The bill also amends Section 505(j)(5)(D)(which provides for forfeiture of the 180-day exclusivity period ANDA first-filers to add a Special Approval Status Rule For Certain Subsequent Applicants, that recites:

An application that is approved pursuant to subclause (III) of subparagraph (B)(iv) is deemed to be tentatively approved and to no longer have an effective approval pursuant to such subclause (III) on the date that is 76 days after the date on which the approval has been made effective pursuant to such subclause (III) if the applicant fails to commercially market such drug within the 75-day period after the date on which the approval is made effective.  If the applicant of an application approved pursuant to such subclause (III) submits a notification that it can no longer commence commercial marketing within 75 days after the date of approval, as required under subparagraph (B)(iv)(III)(bb), its application is deemed to be tentatively approved and to no longer be effectively approved on the date that such a notification is received.  If an applicant does not commence commercial marketing within the 75-day period, it shall not be eligible for a subsequent effective approval for the application under subclause (III) of subparagraph (B)(iv) unless, in addition to meeting each of the conditions in such subclause (III), it submits a certification to its abbreviated new drug application that an event that could not have been reasonably foreseen by the applicant prevented it from commencing commercial marketing and that it has fully resolved this issue.  The applicant shall submit notification to the abbreviated new drug application confirming that such applicant has commenced commercial marketing of the drug not later than one business day after commencing such marketing.

The applicability of these provisions is limited to applications under Section 505(j) after enactment of the legislation.

3.    The Retaining Access and Restoring Exclusivity (RARE) Act (S. 1214)

This bill was introduced by Sen. Tammy Baldwin (D-WI) and co-sponsored by Sen. Mike Braun (R-IN).  The bill would amend Section 527 of the Food, Drug, and Cosmetic Act (21 U.S.C. § 360cc) to close a loophole in orphan drug designation, regarding applicants developing newer versions of an orphan drug and getting undeserved exclusivity to such drugs.  The exclusivity provision is amended to be limited to "the same approved use or indication within such rare disease or condition" and a new subsection added that "defines the term 'approved use or indication' [to mean] the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition."  These limitations shall apply to any drug designated as an orphan drug "regardless of the date on which the drug was so designated" or approved.

The bill was motivated, according to Sen. Baldwin, by a decision in the 11th Circuit, Catalyst Pharms., Inc. v. Becerra, that provides incentives for pharmaceutical companies to seek the broadest orphan drug designation they can obtain but to pursue narrow clinical studies for approval.  A consequence of these stratagems is that the orphan drug exclusivity holder can preclude competitors from obtaining orphan drug designation for alternative conditions or other patient populations.  The bill was introduced in the last Congress (S. 4185) but was not brought to a vote.

4.  The Increasing Transparency in Generic Drug Applications Act (S. 775)

This bill was introduced by Sen. Margaret Wood Hassan (D-NH) on March 14, 2023, co-sponsored by Sen. Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Braun (R-IN).  The bill would amend the Section 505(j)(3) of the Food, Drug, and Cosmetic Act by adding that "upon request," the Secretary shall inform an ANDA applicant whether a generic drug is "qualitatively and quantitatively the same as the listed drug."  If not, on the other hand, the Secretary shall identify to the person requesting the information ". . . the ingredient or ingredients that cause the drug not to be qualitatively or quantitatively the same as the listed drug; and . . . for any ingredient for which there is an identified quantitative deviation, the amount of such deviation."  The Secretary is precluded from changing or rescinding such a determination after submission of the ANDA unless the formulation of the listed drug has changed and "the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or . . . the Secretary makes a written determination that the prior determination must be changed because an error has been identified."  The bill also requires the Secretary to produce a Guidance, within one year of enactment, "describing how the Secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug . . ." wherein this clause expressly includes "assessing pH adjusters."  These provisions will take effect on the date of enactment.

The motivation for this bill is to "streamline the approval process for generic medications" and "lower prescription drug prices for consumers" according to Sen. Hassan's website.  The enemy is purportedly "unnecessary red tape" which the Senators perceive to arise because:

[T]he FDA requires certain generic drug manufacturers to demonstrate that they have the same active and inactive ingredients in the same concentration as the reference brand name drug.  However, when a generic drug contains the wrong amount of inactive ingredient, the FDA cannot disclose the exact error, forcing manufacturers to engage in an often lengthy guessing game to reach the right balance.  This legislation would require the FDA to more clearly identify the specific differences between the generic and brand name drug, thereby streamlining the approval process, helping more generics reach the market faster, and lowering prescription drug prices overall.

5.    The Fair Accountability and Innovative Research Drug Pricing Act of 2023 (S. 935)

This bill was introduced by Sen. Tammy Baldwin (D-WI) and co-sponsored by Sen. Mike Braun (R-IN) and Sen. Tina Smith (D-MN).  This bill would amend Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) with regard to drug price reporting.  The relevant provisions of the bill are a requirement that the manufacturer of a qualifying drug (defined as any drug approved by FDA under Sections 505(c) or 505(j) or licensed under Subsection 351(a) or 351(k) that is not vaccine, has a wholesale acquisition cost of $100 or more per month supply or course of treatment, or is "commonly administered by hospitals") must submit a report to the Secretary if there is an increase in the price of the drug that results in an increase in the wholesale acquisition cost that is a) 10 percent or more over a 12-month period beginning on or after January 1, 2024; or b) 25 percent or more over a 36-month period beginning on or after January 1, 2024; or (for drug costs for a year or per normal cost of treatment) "exceeds United States median household income beginning on or after January 1, 2024).  The report is due not later than 30 days prior to the "planned effective date of the price increase."  The report must disclose (A) the percentage of the planned increase; (B) a justification for the increase; (C) an explanation for the cost; (D) the identity of the initial developer of the drug; (E) a description of the history of the manufacturer's price increases since approval; (F) the drug's current list price; (G) the total expenditures for materials, manufacturing, and acquiring and/or licensing patents for the drug; (H) the percentage of total expenditures on research and development for the drug "derived from Federal funds" less (I) total expenditures for research, development, basic and preclinical research, clinical studies, new drug development, pursuing "new or expanded" indications through supplemental applications under Section 505; (J) total revenue and net profit for each calendar year; and (K) costs associated with marketing and advertising for the drug.

Also required for manufacturers "total revenue and the net profit of the manufacturer for each of the 12-month or 36-month periods"; all stock-based performance used to determine executive compensation; and any additional information the manufacturer chooses to provide related to drug pricing decisions.

Failure to comply is subject to a civil penalty of $100,000 for each day the violation continues.

Such reports shall be posted on a public Department of HHS website no later than 30 days after the report is submitted, subject to the restrictions of laws for protecting trade secrets and confidential commercial information.

Finally, the Secretary will provide an Annual Report to Congress, also posted on a public Department of HHS website.

The extensiveness of the financial disclosures mandated by the bill suggest passage will not be easy or without significant opposition.

Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation

By Kevin E. Noonan --

Today, the Supreme Court again disregarded the views of the Federal government regarding whether to grant certiorari, here in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, and in some ways the only positive outcome is that the Court has shown it is willing to refuse to take action is cases other than subject matter eligibility (although Justice Kavanaugh indicated he would have granted the petition).  Perhaps the Justices felt that the Federal Circuit's backtracking in its second panel decision on the breadth of infringement inducement set forth in its first decision, in light of then Chief Judge Prost's strong dissent and the firestorm of protest (public and through amicus briefing regarding Teva's petition for rehearing), was enough to cabin the decision to the somewhat unique facts in this case.  Nevertheless, consideration of the Solicitor General's arguments is sufficiently important to review them here despite the Court's decision not to do so.

The Federal Circuit's decisions, rendered separately (see "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)" and "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2021)") over strong dissents by former Chief Judge Prost in both instances, regarding whether a generic applicant filing a "skinny label" ANDA could properly be found liable for inducing infringement under 35 U.S.C. § 271(b) led, not surprisingly, to a petition to the Supreme Court for certiorari.  The Court issued an Order to the Solicitor General soliciting the government's views and that brief was filed in March, advocating that the Court grant cert.

The matter arose in litigation over GSK's Coreg^® product (carvedilol) for treatment of hypertension (the initial approved indication; U.S. Patent No. 4,503,067), congestive heart failure (CHF) (the subject of U.S. Patent No. 5,760,069), and left ventricular dysfunction following myocardial infarction (LVD-MI).  The '069 patent recites a method of treating CHF with a combination of carvedilol and "one or more of an angiotensin-converting enzyme ("ACE") inhibitor, a diuretic, and digoxin."

Teva's ANDA was filed with a Paragraph III certification over the '067 patent and a Paragraph IV certification over the '069 patent.  The FDA tentatively approved Teva's generic product for "treatment of hypertension and heart failure" which Teva launched on expiration of the '067 patent.  Teva's label indicated that the product was approved for treatment of LVD-MI and hypertension and announced that the FDA had given its product an "AB rating" (which the opinion explained "allow[s] users to determine quickly whether the Agency has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products").  Thereafter, the FDA required Teva to amend its label to be identical to the GSK label for Coreg®, which introduced treatment of heart failure into the approved treatments recited in Teva's label.

GSK filed for reissue of the '069 patent which was duly granted by the U.S. Patent and Trademark Office as Reissue Patent No. RE40,000; claim 1 is representative of the invention as claimed in the '000 reissue patent:

1.  A method of decreasing mortality caused by congestive heart failure in a patient in need thereof which comprises administering a therapeutically acceptable amount of carvedilol in conjunction with one or more other therapeutic agents, said agents being selected from the group consisting of an angiotensin converting enzyme inhibitor (ACE), a diuretic, and digoxin,
    wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months.

(where the italicized portion of the claim represents the modifications introduced in prosecution of the reissue application.)

GSK filed suit against Teva for inducement of infringement in light of the Teva label, based on direct infringement by physicians prescribing the drug for the label indications.  Teva argued that it had "carved out" the indication for CHF pursuant to 21 U.S.C. § 355(j)(2)(A)(viii), resulting in a "skinny label" with regard to this indication.  Thereafter, the FDA compelled Teva to amend its label to include that indication.  In addition, Teva argued that it could be liable for inducement only if GSK could show that Teva had "directly communicated with the direct infringers and 'caused' them to directly infringe the method in the '000 patent."  In an instruction, the District Court informed the jury that circumstantial evidence could be used to satisfy this burden.

The jury found that Teva induced infringement of the '000 reissue patent both before and after the label amendment (albeit infringing several claims after but not before that change).  The District Court granted Teva's motion for judgment as a matter of law (JMOL) on the basis that GSK had not "caused" physicians to prescribe their product for the infringing uses.  Because proof of such causation was required, according to the District Court, its absence precluded the jury from having substantial evidence in support of its decision.  The Court relied on the "many sources of information available to prescribing physicians" other than Teva's label (including paradoxically GSK's label and promotion of its Coreg® product) in finding this evidentiary deficiency.  Also, the Court based its decision on physician testimony that their prescribing behavior relied on "guidelines and research, as well as their own experience" and not Teva's label.  "In sum," the Court said, "substantial evidence [did] not support the jury's finding on causation, and therefore [did] not support its verdict that Teva is liable for induced infringement, during both the skinny and full label periods."

In a first appeal, the Federal Circuit reversed, in an opinion by Judge Newman joined by Judge Moore; Chief Judge Prost provided a lengthy, comprehensive dissent.  The panel majority relied on the Supreme Court's decision in Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011), that copying is evidence of inducement, and also found compelling evidence from Teva's website regarding its product's AB rating with GSK's Coreg® product and other promotional content, as well as testimony from GSK's witnesses regarding physician reliance on information from generic drug makers.

The panel majority opined that the District Court erred in applying the incorrect legal standard, stating that "precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met."  Considering this precedent, the majority held that "[t]here was ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe the designated claims for the period of the '000 reissue patent."

Then-Chief Judge Prost dissented based on her objections to the quanta of evidence adduced and policy consequences should the majority's position be sustained.  In the then-Chief's view, the majority's decision undermined the policy goals, embodied in the provisions of the law regarding skinny labels, for balance between the incentives patents provide for pharmaceutical innovation and the public's need for access to that innovation once the patent term has expired.  In her view, the majority's decision undermined these policy goals by finding Teva induced infringement by marketing its generic drug produce for unpatented uses (emphasis in dissent) using its skinny label.  The dissent not only disagreed with the majority's decision, but apprehended it to "nullify[y] Congress's statutory provision for skinny labels—creating liability for inducement where there should be none," contrary to Congressional intent and "slowing, rather than speeding, the introduction of low-cost generics."

The original majority opinion occasioned an outpouring of outrage from industry groups (particularly generic ones) who latched onto the then-Chief Judge's rhetoric in her dissent to the effect that the opinion eviscerated the congressional sanctioning of skinny labels.  The Court granted panel rehearing that resulted in the second opinion (that was later the subject of the Court's denial of en banc review).

The outcome did not change in the second opinion, which recited with approval behavioral distinctions underpinning the majority's decision based on the law with regard to skinny labels:

Generics could be held liable for actively inducing infringement if they marketed a drug with a label describing a patented therapeutic use or if they took active steps to encourage doctors or patients to use the drug in an infringing manner.  But generics could not be held liable for merely marketing and selling under a 'skinny' label omitting all patented indications, or for merely noting (without mentioning any infringing uses) that FDA had rated a product as therapeutically equivalent to a brand-name drug [emphasis in original].

Stating that the panel (or at least the majority) agreed to rehear arguments "to make clear how the facts of this case place it clearly outside the boundaries of the concerns expressed by amici," the opinion stated that the basis for their decision that the jury correctly found Teva liable for inducing infringement was "by marketing a drug with a label encouraging a patented therapeutic use" (emphasis in opinion).  The opinion also stated more precisely the procedural basis for their opinion:  "[t]his is a case in which substantial evidence supports a jury finding that the patented use was on the generic label at all relevant times and that, therefore, Teva failed to carve out all patented indications."  The majority also emphasized that their decision was a "narrow, case-specific review of substantial evidence [that] does not upset the careful balance struck by the Hatch-Waxman Act regarding section viii carve-outs."  The remainder of the majority opinion set forth (extensively) the evidentiary basis for their opinion that there was sufficient evidence (including expert testimony and marketing efforts occurring both before and after FDA-mandated changes to Teva's label) to satisfy the substantiality standard, and that the District Court erred in granting Teva JMOL to the contrary (inter alia including specific errors in treating factual questions as legal ones that the majority state were "not this court or the district court, to resolve").

Former Chief Judge Prost remained unconvinced, in large part because this outcome (in her view) undermined the congressionally sanctioned skinny label regime (if only by rendering it much more case- and fact-specific than she perceived Congress intended).  The skinny label regime was Congress's solution to a "problem" it "saw coming" in Judge Prost's view, specifically that "[b]ecause the FDA cannot authorize a generic version of a drug that would infringe a patent, this one remaining patented use could have prevented a less-expensive, generic carvedilol from coming to market altogether—even though the drug itself and other uses of it were unpatented."  The majority's decision thwarted this intent, according to Judge Prost, based on evidence of inducement that was "thin to nonexistent."  The District Court had properly exercised its supervisory role in remedying a situation where a jury came to the wrong conclusion, Judge Prost concluded, based on her evaluation of the evidence before it.  The Judge set forth her motivation for writing (once again) in dissent (and that the majority's attempt to provide a comforting standard falls short in her opinion):

I write in this case because far from being a disagreement among reasonable minds about the individual facts, this case signals that our law on this issue has gone awry.  I am particularly concerned with three aspects of the majority's analysis.  First, even setting aside the majority's willingness to glean intentional encouragement from a label specifically designed to avoid encouragement, the majority further weakens the intentional-encouragement prong of inducement by effectively eliminating the demarcation between describing an infringing use and encouraging that use in a label.  Second, the majority defies basic tort law by eviscerating the causation prong of inducement.  The upshot of these two moves is that a plaintiff now has to show very little for a jury to speculate as to the rest.  Third, the majority creates confusion for generics, leaving them in the dark about what might expose them to liability.  These missteps throw a wrench into Congress's design for enabling quick public access to generic versions of unpatented drugs with unpatented uses.

The decision by the full Court not to rehear the case en banc was announced in a simple Order to that effect, and was accompanied by three written dissents:  one by Judge Prost, joined by Judges Dyk and Reyna; another by Judge Dyk writing alone, and the third by Judge Reyna.

The Solicitor General's brief recites most of this history as an introduction to the government's views on whether the Court should grant cert on this Question Presented:

Whether the court of appeals erred in holding that the FDA-approved labeling for petitioner's generic drug could provide evidence of intent to induce infringement of respondents' method-of-use patent, where that labeling carved out the portions of the brand-name reference drug's labeling that the brand-name manufacturer and FDA had identified as corresponding to the patented method.

The Solicitor General recognizes and extends the concerns and arguments raised by former Chief Judge Prost in her dissents below.  According to the brief,

[A] jury may conclude that a generic manufacturer's engagement in the precise conduct that the Hatch-Waxman Amendments contemplate—namely, marketing an FDA-approved generic version of a brand-name drug with labeling that carves out those indications that the brand-name manufacturer has identified to FDA as claimed by a method-of-use patent—is itself evidence of intent to induce infringement of the patented method.

Under these circumstances, the government argues that uncertainty produced by the majority's decision below is "likely to deter generic manufacturers from invoking that mechanism, thereby threatening the availability of lower-cost generic drugs, in contravention of the statutory design."  The brief frankly asserts that the decision below is "incorrect" because "[n]o reasonable jury could have concluded that the carved-out labeling for petitioner's generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement."  Reciting the requirement of intent embedded in assessment of inducement under § 271(b), the Solicitor General contends that submission of a skinny label carveout as here cannot satisfy this intent requirement in the face of Congress's intent that "one patented use will not foreclose marketing a generic drug for other unpatented ones."  Any other interpretation of the statute will "substantially deter[]" use of Section viii of the statute, the brief asserts.  The Solicitor General reserves from this avoidance of inducement liability situations where a generic manufacturer "actively promotes direct infringement of a brand-name manufacturer's method-of-use patent through communications other than the carved-out labeling" or when a brand name manufacturer "timely objects to the generic drug's labeling as failing to carve out a still patented method of use and puts the generic manufacturer on notice that the labeling teaches the method."  In the Solicitor General's view, a generic manufacturer submitting a Section viii carveout is better understood to be evidence of an intent "not to encourage infringement" (emphasis in brief).

The brief argues that the inference of an intent to induce infringement by the Federal Circuit was erroneous inter alia because the carveout "was driven by FDA regulatory requirements and GSK's own identification of the indication that should be excised."  While the brief hypothesizes that there could be circumstances where a generic manufacturer could take advantage of a branded drugmaker's failure to "identify all the language in its labeling that corresponds to a patented method of use," that was not the case here.

Like former Chief Judge Prost, the Solicitor General appreciates that the Federal Circuit's decisions below "subverts the balance struck by Congress, creates significant uncertainty for FDA and generic manufacturers, and invites gamesmanship by brand-name manufacturers" (and the FDA does not have the expertise or responsibility for reviewing patent claims to address these concerns).  The structure of how the FDA has implemented this Congressional intent (by producing use codes obtained from the branded drugmakers) is ministerial, providing the needed information regarding use codes entered in the Orange Book and not independently vetting them.  But in this role it is the brand-name drug manufacturers that submit the use codes, and the Solicitor General exhorts the Court that "[t]he section viii pathway cannot function as designed unless FDA and generic manufacturers can rely on brand-name manufacturers' representations to the agency" regarding, inter alia, what parts of the brand-name indications are omitted in the carveout.  The continuing responsibility resides in the brand-name drugmaker to ensure that the indications in its label accurately reflect those protected by Orange Book-listed patents and any inaccuracies found in the label can be corrected by the NDA holder (none of which GSK did in this case, the Solicitor General reminds the Court).

The Solicitor General's brief also sets forth its apprehension of the harm to "competition and consumers" that could be occasioned by deigning not to grant certiorari.  These include that the Section viii carveout procedural pathway is "an integral component of a complex statutory scheme designed to encourage market entry by generic-drug manufacturers 'as soon as patents allow,'" citing Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012).  The brief also cites economic statistics, including savings of more than $50 million during the first 12 months of generic sales (at over 75% price reductions) and that "first generic" approvals "often" have carved-out labels.  Another aspect is time -- the brief notes that Section viii carve-outs have "permitted generic drugs to be approved for sale an average of three years before the relevant method-of-use patents expired."  The Federal Circuit's decisions below threaten to reduce such benefits, the Solicitor General argues in this brief.

Finally, the government asserts that this case is a "suitable vehicle" for the Court to consider the proper relationship between the skinny label pathway, generic drug maker behavior, and inducement of infringement liability.  The Solicitor General contends that the "interlocutory" nature of the decision below, being on remand to consider whether equitable estoppel provides a defense, will not diminish the broader harm to competition posed by the Federal Circuit's decisions.  And the government disagrees with Respondent GlaxoSmithKline that changes to the statute have made the Court's review unwarranted because those "clarifying revisions" did not "fundamentally alter the regulatory scheme, which has always placed the onus on the brand-name manufacturer—not FDA or generic competitors—to identify accurately any methods of use claimed by a patent."  Finally, the relatively specific factual bases for the Federal Circuit's decisions below should not alter the fundamental issue, the government asserts, that "the potential for inducement liability in these circumstances may significantly deter use of the section viii pathway, even if such liability is rarely imposed" (emphasis in brief).  Agreeing again with former Chief Judge Prost, in future "[i]f petitioner's carved-out labeling supports a finding of intent to induce infringement [in this case], the section viii pathway will be seriously jeopardized."

Amicus Briefing in Amgen v. Sanofi: The Rest of the Story - Part III

By Kevin E. Noonan --

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi.  This has not surprisingly generated a great deal of interest and amicus briefing.  While some of these briefs, for both Petitioners (see "Patent Law Academics File Amicus Brief in Amgen v. Sanofi"; "AbbVie Files Amicus Brief in Amgen v. Sanofi"; "GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi") and Respondents (see "Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf"; "Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi"; "U.S. Government Files Amicus Brief in Amgen v. Sanofi") have been the subject of earlier posts prior to oral argument last month, in the interest of completeness and because there were interesting positions taken and arguments raised in the remaining briefs, a more succinct but not cursory review of these briefs is warranted.  Amicus briefs in support of the Petitioner are the subject of this post.

Amicus briefs in support of Petitioner

These briefs share many arguments in common, which is due noting but not belaboring.  These include that broad patent protection is necessary for innovation in biotech/pharma; the Federal Circuit's "full scope" test is unduly burdensome and will impede innovation in particular by on small companies and "start-ups" that are prevalent in biotechnology and pharma; and that the Supreme Court's decision in Materials Separation v. Hyde is the proper test for enablement.

The amicus brief filed by Fynder Group d/b/a Nature's Find (a small company that "produces foods from a high-protein fungi-based biomass material grown by a novel fermentation process"; novel food producer) argued that broad patent protection is necessary to support innovation and consistent with the constitution, the Patent Act, and prior precedent ("broad patent protection for pioneering inventions encourages further innovation and accelerates follow-on research and development").  The brief cited "Alexander Graham Bell's telephone, Samuel Morse's telegraph, Robert Noyce's monolithic integrated circuit chip, and Herbert Boyer and Stanley Cohen's recombinant-DNA technology" regarding such broadly claimed innovation.  The Federal Circuit's "full scope" test is characterized as being unduly burdensome and will impede innovation because the test requires innovators to "devote substantial time and resources to produce routine examples premised on their invention—merely to satisfy the Federal Circuit's concern about the "time and effort" needed to "reach the full scope of the claimed embodiments" which "will impede further innovation and will delay the disclosure of key technological improvements that are critically needed in the sustainability space."  And the alternative (trade secret protection) may impede innovation through non-disclosure.

A brief by Instil Bio Inc. (a self-described "clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte ('TIL') therapies for treating cancer patients," specifically "for the treatment of lung cancer, ovarian cancer, and kidney cancer") argued that companies like theirs are particularly vulnerable to the consequences of the Federal Circuit's decision, because as an early-stage company they rely on investors and not "substantial revenues from existing products" (they have none on the market at present).  The brief also recites three benefits of genus claims (also found in other amicus briefs), of patent protection for innovators, incentives for competitors to "design around," and reducing incentives for innovators to rely on trade secret protection.  This brief is also one of several that include policy arguments made by other small company amici regarding economic burdens on providing the additional disclosure they believe the Federal Circuit's standard requires.  The brief also sets out a Catch-22 dichotomy:

The full-scope enablement requirement discourages innovation by creating an obstacle to meaningful patent protection.  This is especially a problem for clinical-stage pharmaceutical companies that lack the revenues of larger, more mature, pharmaceutical companies.  Unlike those more-mature companies, smaller companies must rely on outside investors to fund their research-and-development and clinical trial efforts.  Due to limited resources, smaller companies are frequently unable to perform the research necessary to identify an exhaustive number of embodiments in a claimed genus so that their patents meet the full-scope requirement.  And without robust and predictable patent protection for their products, these companies are less likely to be able to attract outside investments.  Decreased investments necessarily result in a smaller pipeline of new, life-saving therapies for patients.  Worse, a lack of robust patent protection might incentivize companies to pursue less challenging therapeutics that are less risky, but also less innovative.

To ensure adequate patent protection under the Federal Circuit's full-scope enablement requirement, biotech and pharmaceutical companies are perversely incentivized to invest in unnecessary research to identify innumerable embodiments within a claimed genus that might never be therapeutically important.

A brief from the National Association of Patent Practitioners makes a simple argument:  the Federal Circuit's "full-scope" test is unworkable, and the Court's "reasonableness" standard from Materials Separation v Hyde is the proper enablement test.  To the extent that enablement is not enough to police overbroad claims, other provisions of the Patent Act (such as 112(f), 102, and 103) can achieve the necessary scope restrictions just as well or better than enablement can.  But the consequence of Federal Circuit's recent decisions is to "leave patent practitioners guessing about how to advise client-inventors regarding the extent of disclosure required in patent applications to satisfy the court-established standards for enablement under 35 U.S.C. § 112(a)."

Where they don't incorporate the reasoning set forth in the law professors' brief (discussed previously), and while the brief voices concerns regarding biotechnology and pharmacology-directed patents, these amici believe the Federal Circuit's decisions are harmful to patent law more broadly and affect many other technologies, indeed any technology that seeks genus claims. On a practical note the brief expresses fears that infringers will attack patents by proposing a hypothetical species that would be allegedly not enabled, stating that "non-enablement of phantom species" creates a "risk of mischief" because "a patent challenger can always conjure a hypothetical species that is arguably not enabled," leading amici to contend that "[a]n enablement standard that always permits an infringer to attack an asserted patent based on hypothetical and imagined species is unworkable." Further the brief cites Tilghman v. Proctor, 102 U.S. 707, 728-29 (1880) for the precedent that "The standard for enablement should not be overly burdensome and does not require the inventor to enumerate all species, particularly when the number of species is large. Instead, a standard of reasonableness should prevail," and reminds the Court that "[i]n response to more aggressive demands for enabling disclosure, the United States patent system upholds patent claims even though the claims cover (i) unforeseen future improvements, Catalina Marketing Intern. v. Coolsavings.com, 289 F.3d 801, 810 (Fed. Cir. 2002), (ii) inoperable embodiments, Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984), or (iii) multiple species that are not fully disclosed or described, Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997)" (these citations suffering from their origins in the Federal Circuit, whose enablement jurisprudence is in fact at issue before the Court in this case).

The Chemistry & Law Division of the American Chemical Society (whose motion for participation at oral argument the Court denied) argues that Congress has the authority over requirements for patenting, not the courts, and that the Federal Circuit's "full scope" test is not supported by Congress, which did not change the statutory enablement standard under the patent law revisions enacted in the Leahy-Smith American Invents Act.

The heart of the argument these chemists make concerning for genus claims in biotech/pharma is that:

Those working in these fields often utilize genus claims, an important feature of patent law that allows patentees to protect their inventions where competitors could otherwise evade infringement liability by making minor changes that otherwise do not depart from the heart of the claimed invention.

Inventions in these arts require a robust and predictable patent system, they argument, based on "substantial investment" in research and development necessary in these fields.  The brief illustrates this argument citing the statistics recited by Jeffrey Lampken that new drugs cost $2.6 billion on average to develop, that the origins of many therapeutic drugs are with finding a biological target, and the high failure rate occasioned by finding molecules that bind or interact with the target.  As a result, finding a genus of chemical or biologic compounds is the first step in such discoveries and the genera produced thereby need reliable patent protection.  "Pioneering fields that work on the cutting edge, like pharmaceuticals and biotech, are often in a first-to-file race with millions, if not billions, of dollars on the line. Complying with an overly burdensome enablement requirement diverts resources that could have gone toward developing entirely new therapies into making and testing additional and unnecessary individual embodiments," the brief tells the Court.

The brief asks the Court to restore the conventional balance (mandated by the plain meaning of the statute) between disclosure and undue experimentation and to strike down the full scope test (which "violates the canons of statutory construction and contradicts established judicial precedent" and is "an unworkable standard"), reminding the Court of instances where the Justices had reversed the Federal Circuit for imposing "additional rigid and mandatory formulas" that are "inconsistent with [the text of the Patent Act]."  KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 407, 419, 428 (2007).

In a brief from the Alliance of US Startups and Inventors for Jobs (USIJ) and the Innovation Alliance (IA) (representing 22 startups, including AbbVie, Dolby Labs, and QUALCOMM) is the argument that some inventions can only be protected by genus claims.  This brief takes the position that Amgen's claims are fully enabled and that lowered enforceability in genus claims will result in a "significant shift" in investment.  The brief accuses the Federal Circuit of being "oblivious" to the consequences of its eligibility jurisprudence that render the patent system "a cruel hoax" (and in a footnote excoriates the Court for refusing to rehear cases in banc when important questions having "far-reaching implications well beyond the parties and the particular technology" are at issue).

The brief from Diversified Researchers and Innovators (which includes the Association of University Technology Managers (AUTM), Bavarian Nordic, Biogen, Bristol Myers Squibb, Corning, Merck, and 3M) relies on Materials Separation v. Hyde for the proper enablement standard and emphasizes the knowledge in the art in supporting the proper scope of enablement in genus claims.  The brief characterizes the Federal Circuit's rule as being a "special, atextual rule for certain types of claims – called genus claims. . . " that turns the enablement requirement into a "counting exercise" and does not account for the skilled artisan's perspective.  The brief also argues that the "full scope" standard engages in "prejudge[ment]" of these claims by recognizing them as "special" in the first place (something not in the statute), because some inventions are best claimed by functional language ("[c]laims should not start with a handicap simply because they contain functional language").  In addition, amici argue that the standard upsets the burden of proof between patentees and accused infringers by putting the burden on the patentee regarding whether the genus claim scope is supported by an enabling disclosure.

Considering the expected (negative) consequences of the Federal Circuit's test, the brief argues that the public loses when inventors/applicants delay in order to disclose further embodiments to bolster the scope of enablement; alternatively, if narrower protection is sought this stratagem "limit[s] innovation-adjacent insights that might otherwise benefit the public but are unnecessary to enable narrow patent claims."  This behavior also diverts resources that could be used for further innovation to be used to produce "redundant examples."  The brief also emphasizes the requirement that the disclosure be concise and that the "specification need not disclose what is well known in the art," citing Lindemann Maschinenfabrik v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463 (Fed. Cir. 1984).

The brief also argues that any test about drawing lines on what is needed to satisfy the enablement standard (whatever it may be) must take into account the judgment of the skilled artisan, illustrating the undue experimentation standard in Bene v. Jeantet, 129 U.S. 683, 686 (1889), a chemical case.  "The Federal Circuit's apparent concern over unpredictability in the chemical arts in particular has led to an impossible-to-meet standard divorced from what is actually claimed," these amici assert, detecting an "overt hostility" from the Federal Circuit to use of functional language in claims.  But, amici argue, the use of functional language does not turn these claims into "single-means claims" under circumstances where such language is used "in conjunction with other language anchoring the functional attributes to members of a genus sharing certain structural attributes (emphasis in brief)."

"The Federal Circuit's approach is backwards," amici argue, stating there should be a balance in the (any) enablement standard and how it is applied:

Extremes in either direction undermine the patent system's design.  On the one hand, a disclosure that is nothing more than a research plan is unlikely to enable a yet-to-be identified species with desired properties, let alone a broad genus claim.  Such patents improperly put the burden of inventive research and experimentation on other skilled artisans, particularly when it requires solving undisclosed challenges, developing new materials or methods, or engaging in significant experimental work whose results cannot be reasonably predicted.

On the other hand, it is equally improper to "limit[]" claims "to the 'concise and exact terms' in which the specifications ordinarily describe a single example of the invention" when the patent discloses a broader inventive contribution.  Philip A. Hunt Co. v. Mallinckrodt Chem. Works, 177 F.2d 583, 585 (2d Cir. 1949).  Doing the latter allows others to easily bypass the investments and efforts of the innovator through routine and non-inventive work, and "few, if any, patents[] would have value."  Id.

Amicus Briefing in Amgen v. Sanofi: The Rest of the Story - Part II

By Kevin E. Noonan --

The Supreme Court's consideration of the standards for satisfying the enablement provisions of 35 U.S.C. § 112(a) has been occasioned for the first time in over a century by the Court's granting certiorari in Amgen v. Sanofi.  This has not surprisingly generated a great deal of interest and amicus briefing.  While some of these briefs, for both Petitioners (see "Patent Law Academics File Amicus Brief in Amgen v. Sanofi"; "AbbVie Files Amicus Brief in Amgen v. Sanofi"; "GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi") and Respondents (see "Esteemed Scientists File Amicus Brief in Amgen v. Sanofi on Respondents' Behalf"; "Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi"; "U.S. Government Files Amicus Brief in Amgen v. Sanofi") have been the subject of earlier posts prior to oral argument last month, in the interest of completeness and because there were interesting positions taken and arguments raised in the remaining briefs, a more succinct but not cursory review of these briefs is warranted.  Amicus briefs in support of neither Party are the subject of this post.

Amicus briefs in support of neither party

The amicus brief filed by the Intellectual Property Owners (IPO) argued that the enablement requirement "strikes a balance" on claim breadth with regard to the quid pro quo, from the perspective of the person of ordinary skill in the relevant art, and that it is important that the inquiry be based on the language of the statute.  But even with these policy goals in mind, "an applicant is not required to describe in the specification every conceivable possible and future embodiment of his invention" they argue, citing Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003), and In re Angstadt, 537 F.2d 498, 503 (C.C.P.A. 1976).

Undue experimentation is the proper standard which is a fact-intensive inquiry that is helped but not limited to the Wands factors.  However the inquiry is made, it must be applied in a predictable and fair manner that is consistent with the statutory language and longstanding precedent and should not "disrupt the settled expectations of the inventing community."  See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002), these amici argue.  Also emphasized in their brief is the statutory presumption of validity that can only be overcome by clear and convincing evidence.  When enablement does arise as an invalidity defense in federal district court, the burden always rests on the patent challenger to prove lack of enablement by clear and convincing evidence, under Microsoft Corp. v. i4i Limited P'ship, 564 U.S. 91, 100-03 (2011).  On appellate review, courts " give due deference to the fact-finder's credibility determinations in weighing competing expert evidence," citing Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 611 (1950).  All this to say is that the IPO's brief hews the course of its neutrality regarding either party in the dispute by sticking to these eternal verities of enablement law.

The Regenexbio, IGM Biosciences, and Adapative Phage Therapeutics brief was filed by a self-described group of "small to mid-sized biotech companies currently pursuing innovation across multiple platforms," wherein Regenexbio is developing gene therapy approaches for treating "retinal, metabolic, and neurodegenerative diseases"; IGM Biosciences is developing IgM-based immunotherapies against "cancer, infectious diseases, and autoimmune and inflammatory diseases"; and Adapative Phage Therapeutics is developing bacteriophage banks that "provide evergreen, broad spectrum, and polymicrobial coverage."

Their expressly asserted reason for filing their amicus brief is a concern that the Federal Circuit's application of the enablement standard "threatens innovation in the life sciences" by "shift[ing] the burden from the challenger to the patentee to prove enablement of its issued patents" and "makes the burden of proving enablement nearly insurmountable for innovative start-ups, small-to-medium-sized companies, universities, and other innovators with limited resources."  This test will make innovators "waste precious resources by forcing them to reduce to practice not just instructive and illustrative examples but an undefined number of individual species that embody every 'corner' of the claims" they argue, which will be prejudicial to smaller companies.  Accordingly, amici address the Court seeking "reasonable disclosure standards" for enablement.

Their arguments rely on the presumption of validity:

Amici rely on the statutory presumption of validity that adheres to every patent claim after the Patent Office examines and issues the patent.  The presumption ensures that the innovative value captured by the claims will not be wiped away on a dubious or speculative case.  It does so by placing the burden of proof on the patent challenger.  And by requiring the challenger to meet that burden with clear-and-convincing evidence.

The reach-the-full-scope standard undermines that presumption.  The Federal Circuit acknowledges this when it "raises the bar" or sets "high hurdles" for particular claims.  These phrases lay the burden of proof on the patentee as soon as the court reads the claims.  Further, they show that the court is adjusting the standard of proof to be higher for the patentee (or, more properly, lower for the patent challenger) than the standard codified in the statute.

Amici also argue that the Federal Circuit's full scope test is inconsistent with constructive reduction to practice.

The Intellectual Property Law Association of Chicago (IPLAC -- amici asserting that they are "the country's oldest bar association devoted exclusively to intellectual property matters") in their brief ask the Court to vacate and remand because the case can be settled by the application of the statute and stare decisis.  "Enablement is not, because it never has been and never should be—but for decisions such as the reviewed one—a matter of whether the specification has catalogued all possible embodiments of invention and taught each of them; that is not the law" they assert.  The brief relies heavily on the Karshtedt et al. law review article, and one by Jason Rantanen, The Doctrinal Structure of Patent Law's Enablement Requirement, 69 Vanderbilt L. Rev. 1679, 1680 (2019).  Both stand for the proposition that the Federal Circuit has recently "varied greatly from deciding enablement in a proper manner and muddled their own jurisprudence on the issue."  Their brief also criticizes In re Wands for leaving the definition of undue experimentation "amorphous"

The brief suggests that the Court's decision in Consol. Elec. Light Co. v. McKeesport Light Co. (Incandescent Lamp), 159 U.S. 465 (1895), sets the standard for undue experimentation (albeit it should be recognized that this takes the definition from the extreme, where >6,000 failed attempts constitute undue experimentation; while that is certainly the case it seems unlikely to be encountered routinely).  The brief distinguishes the Consol. Elec. standard with the facts below, where Respondent did not identify any antibody that would/could not be obtained using Amgen's disclosure (the "roadmap").

And In a sad or amusing footnote (depending on your prejudices) the brief sets forth a "list of areas of patent law in which this Court has overturned the Court of Appeals [that] is long, and the frequency of the overrulings notorious"; with two exceptions these cases were all decided in this century and over 80% since 2010.

Another local intellectual property law group, the New York Intellectual Property Law Association (NY IPLA) argued in its brief that the Federal Circuit has gone beyond the requirements of the plain language of the statute, which has been the standard applied by the court since In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983).  But as applied to biotechnology inventions amicus argues that genus claims have required "disclosure of every species in the genus," citing Wyeth v. Abbott Laboratories, 720 F.3d 1380, 1385 (2013), Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340, 1345–48 (Fed. Cir. 2019), and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149, 1160–63, 1165 (Fed. Cir. 2019), based on the court's perceptions regarding "the uncertainty of the science and the required functionality."  The NYIPLA contend that "the requirement for enablement of the full scope of the claimed invention is not supported by the plain language of the statute and is contrary to th[e] Court's holding as Minerals Separation v. Hyde, 242 U.S. 261, 270-71 (1916)."

Although the brief recognizes that there is a valid concern at issue, that an inventor not be "granted patent claim coverage that exceeds what the inventor has invented," amici predict a severe adverse impact that would arise should the Court affirm the Federal Circuit test, specifically that "could lead inventors to disclose less than what they discovered, such as a functional relationship at the heart of why the invention works.  Although the amicus appreciates the potential inequities that could be occasioned by claims like Amgen's, on balance the consequences of affirming the Federal Circuit's "full scope" test are worse due to the inherent unpredictability of the chemical and biotechnological arts, amicus argues, citing In re Fisher, 427 F.2d 833, 839 (CCPA 1970), for the principle that "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.")  Affirming the Federal Circuit would create a situation wherein "the inventor will have no incentive (or duty) to disclose the genus, which perhaps comprises the most important part of the discovery" and "[t]he rest will be kept from the public as a trade secret," until such time that the patentee develops another species that can be subject to its own 20-year term.

While amicus argues that the Federal Circuit's decisions "goes beyond the literal requirements of the statute's plain language," the brief also gives little credence to Amgen's arguments that the Federal Circuit had only recently imposed an unnecessarily stringent enablement standard, citing earlier precedent to the same effect, including In re Fisher, 427 F.2d 833, 839 (CCPA 1970); In re Hyatt, 708 F.2d 712, 714 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, (Fed. Cir. 1991); In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993); and Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997).

Their solution:  requiring disclosure of a "reasonable number of species" test for prosecution before the USPTO that could be limited at trial by claim construction and having undue experimentation be a defense against infringement species by species, the patentee being protected by the clear and convincing evidence standard (to the extent it is respected by district courts and the Federal Circuit in deciding JMOL motions).

As for disposition, the brief advises that "[i]n the present case, respectfully the Court should remand the case for a determination of whether the Sanofi antibody was obtainable from the disclosure in the Amgen patents with some — but not undue — experimentation at the time of the filing of the Amgen application."