Search Results for: "sas institute"

PTO Asks for Comments on Improving Patent Quality

Patent

The PTO is on a mission to “improve the quality of the overall patent examination and prosecution process, to reduce patent application pendency, and to ensure that granted patents are valid and provide clear notice.”

To that end, the PTO recently released a Request for Comments (RFC) on Enhancement in the Quality of Patents. [PDF]. The RFC asks for public comment on ideas that the PTO can implement (without changes in the rules or laws or much increased expenditure) that improve patent quality and the quality of the examination process. Generally, the office is looking for practical suggestions of ways to obtain measurable quantites that are linked to meaningful outcomes.  The suggestions should all be directed toward the PTO’s goal of providing the strongest quality patent possible in the shortest time permits.

The RFC identifies seven categories of inquiry:

  1. How should the office measure quality of the examination process as well as quality of the final product (issued or abandoned patent)?
  2. What stages of the prosecution process should be most closely monitored for quality problems?
  3. Are there ways to reduce pendency while increasing quality? (How has the flux of continuations and RCE’s impacted quality and pendency?)
  4. What pilot prograrms are working: Peer-to-Patent; Pre-Appeal Brief Conference; First Action Interview; CLE for Practitioners? Ideas for pilots?
  5. How should customers be surveyed for their information regarding patent quality?
  6. Are there specific tools (software, processes, etc.) that the PTO should be using to increase quality?
  7. Incentives: Are there ways to provide incentives to both applicants and examiners to improve quality?

The RFC additionally identifies “areas of particular USPTO interest”

  1. Prior Art: How to identify the “best” prior art in ways that it can be used by an examiner.
  2. Higher Quality Patent Applications: Are there ways that the USPTO can help (or push) applicants to write better applications that do a better job of describing the invention and that include claims in the initial application that actually take the prior art into consideration?
  3. Comprehensive First Office Action: How can we measure whether examiners are doing a good job in their initial office actions? Are there better ways for examiners to communicate rejections?
  4. Interviews: How should interviews be used in a way that improves quality and pendency?

Please e-mail comments to patent_quality_comments@uspto.gov by February 8, 2010.

In the context of this inquiry, a “quality patent” has been defined as:

A patent: (a) For which the record is clear that the application has received a thorough and complete examination, addressing all issues on the record, all examination having been done in a manner lending confidence to the public and patent owner that the resulting patent is most likely valid; (b) for which the protection granted is of proper scope; and (c) which provides sufficiently clear notice to the public as to what is protected by the claims. The present quality improvement effort has, as one goal, reduction of overall application pendency and is thus also directed towards identifying quality issues that give rise to process inefficiencies. The term ‘‘quality patent’’ as used herein does not include the economic value of the resulting patent, which is a result of market conditions and not the patent process itself. Rather, providing the strongest quality patent possible in the shortest time permits making the best use of a patent, given any set of marketing conditions.

Read the full RFC here before you add your comments: PDF.

The Increasing Role of Published Applications in Patent Examination

Academic Studies, Patent

In 2001, the USPTO began publishing pending patent applications at approximately 18-months after the application's priority date. Over the past eight years, this publication rule has slowly become more integrated with the examination system. As the first chart shows below, most issued patents now cite to at least one US publication. (Patents issued January 1, 2009 – June 23, 2009 cite 4.2 US published applications, on average).

Moving toward Transparency in Prior Art: Patent applicants have historically been frustrated by prior art defined under Section 102(e) of the Patent Act. That section defines a class of "secret prior art" that was not publicly available at the time of an applicant's filing, but that was already on-file with the patent office. By opening-up the application files at an earlier date, the potential unfairness of secret 102(e) prior art is beginning to be reduced because the early publication makes the prior art searchable by the public. Although not directly proving this point, the second chart categorizes the cited US published applications according to their prior art classification. As time moves forward, more applications have become 102(b) prior art (published for more than one year before the applicant's filing) and the percentage of cited applications categorized as 102(e) prior art continues to drop.

Notes:

  • This study is based on an analysis of all US patents issued between January 1, 2000 and June 23, 2009.
  • A cited published application was counted as 102(e) prior art if the publication date of the cited application was later than the filing date of the issued patent that cited the application.
  • A cited published application was counted as 102(b) prior art if the publication date of the cited application was more than one-year prior to the filing date of the issued patent that cited the application.  The graph shown limits the analysis to only issued patents that do not claim a priority date based on a prior patent filing.  Patents that claim an earlier priority date tend to eliminate a portion of 102(b) prior art.
  • See also Dennis Crouch, Published Applications as Prior Art, Patently-O, https://patentlyo.com/patent/2009/07/published-applications-as-prior-art.html (July 28, 2009).

   

   

   

   

  

Patently-O Bits and Bytes No. 110

Articles and Publications, Bits and Bytes, Patent, ,
  • Tom Bakos and Mark Nowotarski have posted their own inventions on the Peer-to-Patent site. You can review them and add prior art: Invention 1, a Risk Assessment Company; Invention 2, SoberTeen Driving Insurance
  • I am expecting an announcement of the next PTO director on Friday (May 8). Jim Pooley is being nominated as deputy director of WIPO and is apparently out of the running for the job of PTO director. The two leading candidates thus appear to be Todd Dickinson and David Kappos.
  • If Kappos is nominated, the Peer-to-Patent system (originally funded by IBM) will receive a boost.
  • Speaking of WIPO, the US has proposed “comprehensive” PCT Reform “which would result in the establishment of a new Patent Cooperation Treaty, PCT II. The new treaty would serve to better facilitate workload sharing between the patent offices.
  • I just looked at Prof. Margo Bagley new article on First-to-Invent published in the Berkeley Technology Law Journal. Her conclusions: “The US First-to-Invent system may be unique in the world but it offers significant benefits to small entity entrepreneurs and others.” Bagley sees these benefits as primarily coming through the “robust grace period.” When should FITF be adopted? “Only when such a move will provide a clear advantage for small entities by facilitating the adoption of a one-year grace period outside of the US.” See The Need for Speed (and Grace).
  • Bagley’s short article is well received. My one quibble is that she perpetuates the idea that a desire to end interferences is a major motivation in the debate. She says “Eliminating interferences and the uncertainty associated with them appears to be a prime motivation for the FITF legislation.” Lets be clear, in the US, proponents of the first to file legislation want to make it easier to invalidate patents by creating more prior art.

Patently-O Bits and Bytes

Bits and Bytes, Patent, Patent Prosecution
  • Bilski is coming (OCTOBER LIKELY)
    • Chief Judge Michel is quoted: “One of the most important cases pending with the [Federal Circuit] today is In re Bilski…. ‘It’s a very interesting case and I thought all the judges worked very hard on it,’ says [Chief Judge] Michel. He adds: ‘I think it will be a very significant decision. It probably will have broader scope than either In re Comiskey or In re Nuijten”
  • FEES: I’m looking for the PTO fee schedule (filing fees, exra claim fees, extension fees, appeal fees, etc.) for the past decade.
  • PTO Allowance Rate – depends on whether the PTO counts an RCE as an abandoned application. (which it should not…). The chart below is from a presentation by the PTO’s General Counsel James Toupin. Greg A posted a link to the whole file: www.bustpatents.com/toupin.pdf.

Tafas v. Dudas: PTO Announces its Intent to Appeal

Patent

PatentLawPic291

The Patent Office has filed a notice of appeal in the case of Tafas v. Dudas. This case involves the PTO’s attempt to limit the number of continuation applications and the number of claims per patent that may be filed based on an original disclosure.  In April, 2008, District Court Judge Cacheris granted plaintiffs motions for summary judgment — finding that the new rules are an improper extension of the PTO’s statutory authority.

“Because the USPTO’s rulemaking authority under 35 U.S.C. § 2(b)(2) does not extend to substantive rules, and because the Final Rules are substantive in nature, the Court finds that the Final Rules are void as ‘otherwise not in accordance with law’ and ‘in excess of statutory jurisdiction [and] authority.’ 5 U.S.C. § 706(2).”

The appeal will be heard by the Court of Appeals for the Federal Circuit.  The basis of the original declaratory judgment action is that the PTO’s proposed rules violate the PTO’s limited rulemaking authority granted by 35 U.S.C. § 2(b). Thus, there is no question that this case arises under the Patent Act and, consequently, that the Federal Circuit has exclusive jurisdiction on appeal.

Notes:

GlaxoSmithKline vs. Dudas: An Attempt to Stop Implemention of PTO Prosecution Rules

Patent

The U.S. Patent Office does not have substantive rulemaking authority.  Thus, the office cannot change the meaning of “novelty” or “obviousness” even through a formal process of notice and comment rulemaking. The Office does, however, have the power to make rules that govern procedures within the office that are “not inconsistent with [the] law.” 35 USC 2.

GlaxoSmithKline has now sued the Patent Office to stop implementation of two new sets of PTO rules — arguing that the scope and effect of the new rules extend well beyond the PTO’s limited rulemaking authority. The main thrust of the rules is to limit the number of follow-on applications that can be filed that somehow relate to an original patent application and to limit the number of claims filed in each patent application.

Glaxo can easily show that these rule changes will harm its business — especially because the rules retroactively impact the UK company’s already pending patent applications.

The rules hit innovator pharmaceutical companies especially hard. Pharmaceutical companies typically file large original patent applications early in the drug development process. Those original applications typically disclose many variations of a class of drug along with various methods of manufacturing and using the drug. As development continues, follow on continuation applications are used to specify and claim particular subgroups. The continuations also typically include further information to prove utility and nonobviousness of the particular subgroups.  These rule changes will severely limit GSK’s ability to file these continuations and, as a consequence, will hurt its position.

GSK notes that the PTO’s exceptions to the rule is primarily mythical because it requires a strict “could not have” limitation.

  • Read the Complaint
  • The complaint was filed by my old firm of Kirkland & Ellis. This is perhaps odd since Kirkland does no patent prosecution.

Patently-O Tidbits

Patent,

A few updates while I wait for my airplane:

  • Director John Love at the PTO has released a new set of “relaxed” guidlines for implementing the rules. These address some of the fears of major corporate patent holders. This is important to read prior to November 1. [Patent Docs explain]
  • The PTO has published its new obviousness examination guidelines. The guidance on obviousness focuses solely on the Supreme Court precedent in KSR, John Deere, and other Supreme Court cases. Perhaps going beyond the requirements of the law, the PTO will require examiners to provide a full written record. A major focus is on finding the “problem” before determining whether the solution is obvious.  Predictability is the another key. [Link]
  • I’ll be in Dallas this weekend. (near Alliance Airport) Shoot me a note if you’d like to meet-up on Friday . dcrouch@patentlyo.com.
  • GlaxoSmithKline has now joined the fray — reportedly suing the PTO to stop the new rules from becoming effective.  Mike Strickland of GSK was one of the leaders of the lobbying campaign againt the new rules. [Complaint][Quinn]

Ineligible Subject Matter: 35 USC 101 Finds its Teeth (Biting into Nonobviousness)

Patent, , ,

In re Comiskey (Fed. Cir. 2007); and
In re Nuijten (Fed. Cir. 2007)

  • Comiskey’s patent application claims a method of arbitrating that does not necessarily require the use of any ‘technology.’
  • Nuijten’s patent application claims a signal containing a ‘watermark’ without being tied to a specific type of signal or any technology.

Both applications have been denied by the Federal Circuit under 35 U.S.C. Section 101 for their failure to claim patentable subject matter.

The scope of patentable subject matter is defined by Section 101 as any “new and useful process, machine, manufacture, or composition of matter.”  Any patent claim must fall within at least one of these categories.  Further limiting these categories is our precedential history that not every new and useful process constitutes patentable subject matter. See, for example, Flook & Benson.  In particular, the Supreme Court has noted that a process claim reciting an algorithm must either be (1) tied to a machine or (2) transformative of some composition of matter or device. Flook & Diehr.

Under these precedents, a claim that includes a mental process may be patentable — so long as it is otherwise tied to ‘reality.’

Comiskey: The Comiskey method of claim 1 admittedly does not require a machine, but it does require interaction with a ‘document.’  The reference to a document, however, was not enough to allow the “mental process” claim to be treated as legitimate.

“Thus, like the claims that the Supreme Court found unpatentable in Benson and Flook and the claims found unpatentable in our own cases, Comiskey’s independent claims 1 and 32 seek to patent the use of human intelligence in and of itself. Like the efforts to patent “a novel way of conducting auctions” which Schrader found to be directed to an abstract idea itself rather than a statutory category, Comiskey’s independent claims 1 and 32 describe an allegedly novel way of requiring and conducting arbitration and are unpatentable.”

Some of Comiskey’s claims arguably require a computer to operate through “modules.”  That claim construction transforms those claims to be patentable subject matter.  This means that software remains patentable subject matter if a computer limitation is a proper part of the claim.

Section 101 is Safe: Comiskey appear to reinstate something akin to the USPTO’s ‘technological arts’ requirement that had been eliminated by the Lundgren decision.  For Comiskey, recitation of a microprocessor as a limitation of the claims was sufficient to overcome the patentable subject matter issue. Notably, this is a rule of formality that, in most instances, can be followed without substantively reducing claim scope.  Under Comiskey, there is no requirement that the technical link be something novel or non-obvious. 

Section 103 is Lost: Although the question of patentable subject matter does not require a determination of nonobviousness, the reverse is not true.  Nonobviousness may now require an input from the patentable subject matter stage. The most interesting lines of Comiskey are as follows:

“The routine addition of modern electronics to an otherwise unpatentable invention typically creates a prima facie case of obviousness. Moreover, there is no pertinent evidence of secondary considerations because the only evidence offered is of long-felt need for the unpatentable mental process itself, not long-felt need for the combination of the mental process and a modern communication device or computer.”

The implicit holdings here: (1) evidence of secondary considerations do not apply to portions of an invention that are not considered “patentable subject matter;” and (2) during nonobviousness analysis, any portion of an invention that constitutes nonstatutory subject matter will be considered de facto obvious.

Nuijten: The Nuijten court bit off a bit more — finding that a signal is not patentable even if tied to a transitory form (such as a radio broadcast or light pulses in a fiber optic cable).  The problem – the court could not fit a ‘signal’ into any of the four categories:

  • Process: Process is defined in Section 100 as a “Process, Art, or Method.” The ‘art’ term appears on its face different than a typically process — especially based on the constitutional statement of “useful arts.” However, the CAFC refused to expand the meaning of process to include items that do not require an action. Thus, a signal is not a process.
  • Machine: The Supreme Court has defined a machine as “a concrete thing, consisting of parts, or of certain devices and combination of devices.” Burr (1863). Under this definition, a signal is not a machine.
  • Manufacture: The court limited a manufacture to an “article” produced by man. According to the court, an ‘article’ is not transient and cannot exist in a vacuum — both qualities of a signal. Thus, a signal is not a manufacture.
  • Composition of Matter: A transient electric signal is not a “chemical union, nor a gas, fluid, powder, or solid.” Therefore, a signal is not a composition of matter.

Failing to fit within a predefined category, the only conclusion is that a signal is not a patentable subject matter.

Rules of Practice:

  • Gangrene Treatment: In the political world of the courts, this case might be seen as the CAFC’s gangrene treatment — where the Supreme Court is the disease and patent law jurisprudence is the patient.  Several toes have already been lost, and the CAFC is cutting off a foot to prevent the disease from spreading any further.
  • Morse Code: One important statutory subject matter case is that of O’Reilly v. Morse (1853) – invoving the patenting of Morse code. In that case, the Supreme Court invalidated some claims as overbroad, but found that Morse’s claim to a “system of signals” to be patentable as an ‘art.’  The CAFC, of course, does not overrule Morse, nor does it adequately explain how Morse’s patent would fit within our modern conception of the four categories.

Introduction to Patent Law Book Review

Book Review, Patent

Introduction to Patent Law An Introduction to Patent Law
by Janice M. Mueller

 

$50.00 from Amazon.com

Book Review: In this 400 page paperback, Professor Janice Mueller (Pittsburgh) lays out the basics of patent law and explains the requirements for obtaining a patent as well as considerations during litigation.  This is essentially a textbook, and covers the same material as other patent law textbooks.  The main difference is that Mueller’s writing flows and is easy to read.  In addition, she explains the foundations of patent law without getting bogged-down in unnecessary case-law and statutory interpretation.

This is a basic but thorough text covering the legal side of patents.

Who should read An Introduction to Patent Law:

  • Law students (This is a good back-up to understand what your casebook is saying).
  • Anyone entering the area of intellectual property and patent law.

Caveat:

This book is of limited use as a research end-point for an experienced patent attorney.  The book is an introduction and does not cover the topics in enough depth to be serve as a treatise. (That’s why it is called an introduction).

About Book Review Monday: On occasional Monday we review patent law related books.  Let me know if you are interested in writing a book review. (Send your proposal to crouch@mbhb.com).

India Greatly Increases Patent Coverage

Patent, Patent Legislation

Chandra Joshi, an Indian associate of mine filled me in on the recent amendments to Indian patent law. The amendments not only make Indian law TRIPs compliant, but also rationalize the procedures for patent prosecution.  These changes now allow patents on products and remove provisions relating to EMRs (Exclusive Marketing Rights).

India, as you know, had so far permitted Patents only for processes and not products. With the new amendment to the Patent Act, it would now be possible to obtain Patents for product patents in Pharmaceuticals and Agro Chemicals. Under the Product Patent regime no new–use Patents would be granted.

The ordinance seeks to strengthen opposition proceedings by allowing for both pre-grant and post-grant opposition. The ordinance also seeks to simplify and rationalize the time-frame for process of patents. The time limit for giving requests for examination has been reduced to 36 months from 48 months earlier. Security provisions will also be tightened particularly for dual-use patent applications. Such patents will now be scrutinized by the patent office.

Further, software would continue to be copyright protected, embedded software that has technical applications can now be patented.

DDC Comment: I expect the change to have its greatest impact in the pharmaceutical area — up to now, India has been a pharma maverick — producing generics almost at-will.

LKQ v. GM: Join us on June 4 at Noon (ET)

Patent

Talk about LKQ: I’m looking forward to joining Prof Sarah Burstein and others on Tuesday June 4 for an online panel discussion on the potential aftermath of the Federal Circuit’s major en banc design patent obviousness decision in LKQ v. GM.

In February 2024 we met along with Meredith Lowry (Wright Lindsey Jennings); Darrell Mottley (Howard University); and Laura Sheridan (Google) to give a preview of the case and we’re meeting again now to talk through where the pieces are falling.

Free event via Suffolk University Law School, but you need to register.  Noon Eastern Time, June 4, 2024.

The AGI Lawsuit: Elon Musk vs. OpenAI and the Quest for Artificial General Intelligence that Benefits Humanity

Patent

By Dennis Crouch

Elon Musk was instrumental in the initial creation of OpenAI as a nonprofit with the vision of responsibly developing artificial intelligence (AI) to benefit humanity and to prevent monopolistic control over the technology. After ChatGPT went viral in late 2022, the company began focusing more on revenue and profits.  It added a major for-profit subsidiary and completed a $13+ billion deal with Microsoft — entitling the industry giant to a large share of OpenAI’s future profits and a seat on the Board. 

In a new lawsuit, Elon Musk alleges that OpenAI and its CEO Sam Altman have breached the organization’s founding vision. [Musk vs OpenAI]. 

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Ethical Infantilism in the Age of Technological Advancement

Patent

by Dennis Crouch

Martin Luther King Jr. received the Nobel Peace Prize in 1964, and I re-read his speech today — especially the portion contrasting development of science and technology against development of the human spirit.  The past 60 years have continued to reveal astonishing discoveries and invention. Yet King’s words and warnings continue to resonate because we have continued to neglect our internal realm.

Every man lives in two realms, the internal and the external. The internal is that realm of spiritual ends expressed in art, literature, morals, and religion. The external is that complex of devices, techniques, mechanisms, and instrumentalities by means of which we live.

King.  In his speech, King did not decry advances in technology, but argued that the level of attention paid to material advances should be matched by attention to moral and spiritual humanism.

Modern man has brought the whole world to an awe-inspiring threshold of the future. He has reached new and astonishing peaks of scientific success. He has produced machines that think, and instruments that peer into the unfathomable ranges of interstellar space. He has built gigantic bridges to span the seas and gargantuan buildings to kiss the skies. His airplanes and spaceships have dwarfed distance, placed time in chains, and carved highways through the stratosphere. This is a dazzling picture of modern man’s scientific and technological progress.

Yet, in spite of these spectacular strides in science and technology, and still unlimited ones to come, something basic is missing. There is a sort of poverty of the spirit which stands in glaring contrast to our scientific and technological abundance. The richer we have become materially, the poorer we have become morally and spiritually. We have learned to fly the air like birds and swim the sea like fish, but we have not learned the simple art of living together as brothers.

Id.

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Federal Circuit Continues to Apply Strict Obviousness-Type Double Patenting Analysis

Patent

by Dennis Crouch

This post gets into some weeds about obviousness type double patenting stemming from the Federal Circuit’s new decision in Institut Pasteur.  Although non-precedential, the decision signals that the doctrine remains strong (and strict). The decision cements that for OTDP analysis, any comparison of unexpected results or long-felt need must be made to the applicant’s own earlier patent claims, not the closest “prior art.”  The court also endorsed reliance on inherency to satisfy claim limitations not found in earlier claims.

I’ll note here en banc petition briefing continues in the OTDP/PTA case of In re: Cellect, LLC.  Cellect’s petition has been supported by 10 amicus briefs. The PTO responsive brief is due December 14, 2023.

= = =

The Federal Circuit recently affirmed a PTAB rejecting claims in a patent application filed by Institut Pasteur on the ground of obviousness-type double patenting. In re: Institut Pasteur, No. 2022-1896 (Fed. Cir. Dec. 13, 2023) (non-precedential). This case provides additional insight into the doctrine of obviousness-type double patenting and the ongoing high bar set by the Federal Circuit for overcoming such rejections.  Opinion by Judge Clevenger, joined by Judges Taranto and Stoll.

Obviousness-type double patenting is a judge-made doctrine designed to prevent applicants from extending patent rights first obtaining an earlier-expiring patent and then obtaining a later-expiring patent with claims that are obvious variants of those in the earlier patent. The policy goal is to prevent unjustified timewise extension of exclusive patent rights.  The doctrine was particularly relevant for patent applications filed prior to 1995 because patent term was calculated at 17 years after patent issuance. Today, patent term starts ticking as soon as the patent application — making it much more difficult to stagger patent rights in order to evergreen protection. (Note that one way to differentiate patent timing is through PTA — and that is being challenged in the Cellect case discussed above.) In addition, the doctrine is designed to protect potential defendants from unfairly facing multiple infringement lawsuits.

The Gap in 102 for Self-Harming Prior Art: Everyone knows that you cannot obtain a patent that merely claims an obvious variant of the prior art. 35 U.S.C. 103. Section 102 of the Patent Act defines prior art, and includes an important exception that is incredibly relevant to the OTDP situation. In particular, we know that the first-inventor-to-file provision found in 102(a)(2) spells out, as the name suggests, that a prior-filed patent application (once it becomes public) will serve as prior art against a later filed patent application. The important exception for OTDP purposes is that Congress limited the first-to-file provision of 102(a)(2) to applies only in cases where the two competing patent applications name different inventors and are owned by different entities. In other words, Congress carved out an exception such that your own earlier-filed patent application does not qualify as prior art that could invalidate your later-filed application under 102(a)(2), even after the earlier application publishes.  Although this analysis uses post-AIA statute, the limited protection for applicants against self-harming prior art also existed in the pre-AIA statute.

What we have here is a gap in the scope of prior art within the statute associated with the patentee’s own pre-filing activities. Courts have acknowledged that these filings by patent applicants are not prior art under the statute, but recognize policy concerns that justify limiting applicants’ rights anyway. Specifically, courts want to prevent applicants from unjustly extending patent protection with repetitive filings on obvious variants of their own inventions. Additionally, courts are concerned that separated patents (especially if ownership is separated) could put defendants at risk of facing multiple lawsuits asserting what is essentially the same invention.

The judge made solution then is to act in equity to bar an applicant from obtaining or enforcing to patents that are obvious variants to one another unless the patent applicant has filed what is known as a terminal disclaimer that disclaims any potential extra patent term in the later-issuing patent and that also promises to keep the two patents under the same ownership.  Applicants who fail to file such a disclaimer can find their applications refused by the PTO or found unenforceable by the courts.

Ordinarily, obviousness analysis compares a claim against prior disclosures.  OTDP is different.  In OTDP, the policy concern is focused on obtaining two patents whose claims are too close to one another.  Thus, the OTDP analysis compares the two sets of claims and asks whether one set is an obvious variant of the other.

In Institut Pasteur, the patent applicant filed a patent application in 2015 directed to methods of treating pain by administering opiorphin. The examiner rejected the pending claims as obvious over the claims of a different Pasteur patent directed to similar methods of pain treatment using the same peptides, and that had been filed the year before, in 2014.

Before the Board, Pasteur argued that OTDP should not apply — arguing that its 2015 applicant claimed claimed methods that were significantly different from those in the 2014 patent. In particular, the 2015 applicant required administration of the peptides for seven days without inducing drug dependence or tolerance, whereas the 2014 patent did not specify any particular duration of treatment or recite the lack of dependence/tolerance.  The PTAB rejected that distinction and instead affirmed the examiner’s rejection, finding that the 2014 patent embraced treatment of chronic pain, so it would have been obvious to administer the therapy for over seven days. The Board also found that avoiding dependence/tolerance would be an inherent result of carrying out the methods of Pasteur’s earlier 2014 patent.

On appeal, the Federal Circuit affirmed the Board’s decision strictly applying obviousness-type double patenting. The court reiterated that when unexpected results are used to rebut a prima facie case of obviousness, those results must be shown to be unexpected compared to the closest prior art (here, Pasteur’s 2014 patent).  In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Pasteur failed to make that comparison. The court also endorsed the Board’s use of inherency to fill in the missing claim limitation of dependence/tolerance as part of the obviousness analysis.  The trick here that the court played, is that this “closest prior art” precedent comes from ordinary obviousness cases, not OTDP cases.  See Baxter.   And, as you recall, Pasteur’s 2014 patent is not prior art. Here, the court made the leap that it should effectively be treated as prior art for all aspects of the OTDP obviousness analysis, including both evidence of unexpected results and secondary considerations of nonobviousness.

Regarding secondary considerations, the Federal Circuit affirmed the Board’s dismissal of Pasteur’s long-felt need evidence. Pasteur had argued there was a long-felt need for pain medication that avoids issues of drug tolerance and dependence. However, the court endorsed the Board’s finding that any such need was already satisfied by Pasteur’s 2014 patent claims. In other words, in obviousness-type double patenting, where reference claims satisfy a long-felt need, that need does not constitute objective evidence for a later patent’s claims of non-obviousness over the reference claims.

During oral arguments, Salvatore Arrigo argued on behalf of Institut Pasteur before the panel of Judges Taranto, Clevenger, and Stoll.  Arrigo emphasized that unexpected results are an “integral part” of determining obviousness under Graham v. John Deere. He argued that the unexpected lack of tolerance and dependence when administering the claimed peptide for 7 days should be considered in the prima facie obviousness analysis, before reaching a conclusion on obviousness:

You have to look at the unexpected results first to figure out if it’s obvious. If you don’t, it’s always an expected results are always going to be inherent 100 percent of the time because you’ve already reached obviousness before considering. It’s part of the obvious analysis to get there.

The judges questioned whether the proper comparison should be to morphine or to the closest prior art, the claims of the ‘871 patent. Mr. Arrigo maintained morphine was the appropriate comparison “because the prior art is just this giant genus and no one within that genus ever did anything that would have shown this unexpected result.”  In its decision, however, the Federal Circuit rejected this analysis — holding that for OTDP analysis, any unexpected results must be in comparison to the company’s other patent being analyzed.

14,000 Words to Win It: Why Medtronic’s Appeal Strategy Backfired

Patent

by Dennis Crouch

The Federal Circuit’s new decision in Medtronic v. Teleflex delves into the old pre-AIA law of inventorship and prior art.  It also provides an important appellate procedure lesson with the court finding the appellant waived a key argument. 

Teleflex’s U.S. Patent No. RE46,116 claims methods for using a special extension for its guide catheter. Medtronic filed a pair of IPR petitions, asking the USPTO to cancel the claims. Although the PTAB granted the petitions, it eventually sided with the patentee — agreeing that one of the asserted references did not qualify as prior art.  On appeal, the Federal Circuit has affirmed.

The basic question is whether Itou (7,736,355) qualifies as prior art against Teleflex’s patent (RE46,116). The Itou application was filed about nine-months before the Teleflex application.

Under the AIA Teleflex would clearly lose. Itou was filed first and eventually published and therefore qualifies as prior art under AIA 102(a)(2).  And,  the AIA limited 1-year grace period under 102(b)(2) would not apply since Teleflex did not first disclose the invention. But, these applications are all pre-AIA.

In this situation, Medtronic wants Itou to qualify as prior art as of its application filing date.  That means that we apply pre-AIA 102(e).  35 U.S.C. 102(e) provided that a person shall not be entitled to a patent if the claimed invention was described in a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent.   Thus, Itou is prior art so long as it was filed prior to the Teleflex invention date.

Proving Invention Date.  Establishing invention date requires determining when the inventor both conceived of the complete invention and then reduced it to practice.  Conception is typically seen as the most important aspect of invention, but invention is not complete until it is reduced to practice. Conception occurs when an inventor forms a definite and permanent idea of the complete and operative invention in their mind. This is the critical inception of the invention. However, conception alone is not enough – the inventor must also reduce the invention to practice. This can occur either by actually building and testing the invention to show it works for its intended purpose (actual reduction to practice).  But, in patent law we also observe the legal fiction that filing a patent application describing the invention in sufficient detail to enable a person skilled in the art to make and use it will also qualify (constructive reduction to practice).

When proving a prior invention date, the law allows inventors to claim all the way back to their provable date of conception, so long as they also show reasonable and continuous diligence by the inventor to reduce the invention to practice.  Thus, if the inventor conceived the invention but then set it aside for a long period before filing a patent application or resuming diligent efforts to reduce it to practice, this can negate the prior invention date.  Once the invention is reduced to practice, diligence is no longer required, but the inventor must be careful not to unduly delay in filing for patent protection because it could create abandonment, estoppel, or laches issues.

In this case, the PTAB agreed with Teleflex that Itou was not prior art, finding that the invention was both actually and constructively reduced to practice before Itou’s filing. On appeal, the Federal Circuit affirmed on the grounds of constructive reduction to practice, declining to reach the issue of actual reduction to practice. Constructive reduction to practice requires (1) conception prior to the filing date of the asserted reference, and (2) reasonably continuous diligence from just before the reference’s filing until the priority application.

Here, Teleflex provided dated technical documents about the “GuideLiner” product it was developing sufficient to prove diligence and submitted declarations and other supporting evidence showing ongoing development of the invention through the filing date of the patent application.   These included records of prototypes, emails, testic documents, manufacturing prep, etc.

On appeal, Medtronic argued that the PTAB erred in finding that Teleflex established an actual reduction to practice before Itou’s filing date. Specifically, Medtronic asserted that the plain language of Teleflex’s claims requires in vivo testing, as the claims recite steps like “advancing a distal end of a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” According to Medtronic, Teleflex’s bench testing in an anatomical model was insufficient to meet this limitation and demonstrate actual reduction to practice.  In response, Teleflex contended that actual reduction to practice allows some flexibility rather than rigidly requiring that every claim limitation be performed exactly as stated. Teleflex pointed to cases like In Re Spiller finding reduction to practice despite variations from the explicit claim language. However, the Federal Circuit panel questioned whether Spiller actually supports such flexibility, and whether the Board properly construed the precedent it relied on.

Ultimately, the Federal Circuit declined to decide the issue of actual reduction to practice, affirming solely on the grounds of constructive reduction to practice since Medtronic had seemingly waived its diligence arguments on appeal through improper incorporation by reference.

Incorporation by Reference Doesn’t Work: For anyone appealing to the Federal Circuit, the waiver aspect of this case will be the most important part.   Appellants get 14,000 words in their appeal brief. Although that word length is quite a lot — it gets eaten up pretty quickly and appellants are regularly cutting arguments that they feel could be winners. Here, Medtronic attempted to incorporate 20 pages of briefing from another case by reference that detailed its argument on lack-of-diligence.  The brief itself only included a cursory statement that if the Federal Circuit vacated the diligence finding in the parallel case, it should also vacate and remand on diligence here. But, Medtronic did not substantively argue against the PTAB’s diligence analysis in the brief proper. During oral arguments, Judge Chen offered the following remarks:

We have a 14,000 word count limit to our briefing. You’re at 13,979 and on page 41 you want to incorporate 20 pages of briefing from a separate appeal, which would obviously blow right through the 14,000 word count.  So I’m trying to figure out what to do here. We’ve got 14,000 word count limit that’s being blown through. And likewise, we have a pretty strong precedent that says you’re not allowed to incorporate by reference arguments made in other documents into your briefing. So I don’t know if we can read this as a permissible incorporation by reference.

In the decision, the court concluded that the 14,000 word count limit for principal briefs under Federal Circuit Rule 32(a) along with prior precedent prohibits incorporation by reference to ensure parties fully develop their arguments within the allotted word limits. Despite Medtronic asserting the diligence issue was fully briefed in the other case, the Federal Circuit held Medtronic waived any challenges to the PTAB’s diligence determination and affirmed on the basis of Teleflex’s constructive reduction to practice. According to the court, Medtronic made a strategic decision (a bet) regarding how to allocate its words, and could not undo that choice by asking the court to consider extra-record briefing (without a successful motion to extend the word count).  Thus, while Medtronic contested the finding of diligence before the PTAB, the Federal Circuit found this challenge waived on appeal due to inadequate briefing.

Affirmed.

Navigating Claim Construction and Broadening Amendments: Lessons from Sisvel v. Sierra Wireless

Patent

by Dennis Crouch

In 2019, Sisvel began asserting its U.S. Patent Nos. 7,433,698 and 8,364,196 against cell phone makers, wireless chip suppliers, and cellular network operators. These patents claim methods and systems for exchanging frequency information between a mobile station and a mobile switching center to facilitate switching a mobile device’s connection point within a cellular network. Several defendants petitioned the Patent Trial and Appeal Board (PTAB) for inter partes review (IPR), arguing that the challenged claims were invalid as anticipated and/or obvious based on prior art references. The PTAB instituted IPR and ultimately issued final written decisions concluding that the claims were unpatentable. See IPR2020-01070, Paper No. 31 (PTAB Nov. 8, 2021); IPR2020-01071, Paper No. 30 (PTAB Nov. 8, 2021).

On appeal to the Federal Circuit, Sisvel challenged the PTAB’s claim construction of the term “connection rejection message” and its denial of Sisvel’s revised motion to amend the ‘698 patent claims. The Federal Circuit, in an opinion authored by Judge Stark and joined by Judges Prost and Reyna, affirmed on both issues. Sisvel International S.A. v. Sierra Wireless, Inc., No. 22-1387 (Fed. Cir. September 1, 2023).

Claim Construction

The claims at issue particularly focus on the use of a “connection rejection message” to confer certain information to a mobile device.  The term is used throughout both the patent specification and the claims.  However, it is not expressly defined. The key dispute was it should be construed broadly to mean simply “a message that rejects a connection” or narrowly limited to “a message from a GSM or UMTS telecommunications network rejecting a connection request from a mobile station.”  As is usual for IPR proceedings, the patentee was asking for the narrow construction in order to avoid the prior art.

The Board and the Federal Circuit both applied the Phillips standard. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc)  Under Phillips, claims are construed according to their plain and ordinary meaning as understood by a person of ordinary skill in the art, looking at the intrinsic evidence including the claims, specification, and prosecution history. Although the specification provides guidance, limitations found within described embodiments should not be imported into the claims absent a clear intent by the patentee to limit claim scope.  Extrinsic evidence, such as dictionary definitions are less important.

On appeal, the Federal Circuit agreed with the PTAB that the plain and ordinary meaning of “connection rejection message” is “a message that rejects a connection.” It found no persuasive basis in the intrinsic evidence to restrict the term only to GSM or UMTS networks. The patentee’s argument here was that the embodiments found in the specification were all directed to UMTS or GSM networks.  But, the problem is that the specification also states that the invention is could work “in many different cellular telecommunications systems” of which UMTS and GMS are two examples. The specification goes on to state that the system work work in any system that involves sending a rejection message in the manner outlined.  Thus, although the specification only the two networks, the court found that the claims and specification were drafted broadly and did not limit the invention only to GSM/UMTS. The court  ultimately declined to confine the claims only to the disclosed embodiments and instead affirmed the broad construction.

Result — invalidity affirmed.

Motion to Amend

Sisvel also challenged the PTAB’s denial of its revised contingent motion to amend claims of the ‘698 patent. The PTAB found the proposed substitute claims impermissibly broadened the scope of the original claims, specifically by changing “based at least in part on” to merely “using” when referring to information from the connection rejection message.  The AIA explicitly prohibits broadening amendments in IPR proceedings. 35 U.S.C. § 316(d)(3) states that amended claims “may not enlarge the scope of the claims of the patent.” Similarly, 37 C.F.R. § 42.121(a)(2)(ii) provides that a motion to amend may be denied if it seeks to enlarge the scope of the claims.

Sisvel contended that when all limitations were considered together, the substitute claims were narrower overall. On appeal, the Federal Circuit explained that a claim is broadened if it is broader in any respect–even if narrowed in some other respects, if it is broadened in any respect. Here, the change from “based on” to “using” broadened the claims by removing the requirement that the frequency parameter impact the value.

Key Takeaways

In hindsight, this is a situation where the patentee could have drafted the claims in these patents in a way that would have at least avoided the arguments raised here.  Of particular note, it often makes sense to include a dependent claims that narrow aspects of the claim to the same level provided by the embodiments. Here, the court also latched-onto throwaway language in the specification stating that the system could work on any network even though the rest of the specification focused on GSM and UMTS networks.  Still, at the time the statement likely made sense as an attempt to explain why it was proper to allow claim scope that is not limited to those networks.

Meta Claim Construction: Finding Meaning in the Meaning

Patent

by Dennis Crouch

One-E-Way, Inc. v. Apple Inc., 22-2020 (Fed. Cir. Aug. 14, 2023) (nonprecedential) (Opinion by Chief Judge Moore, joined by Judges Lourie and Stoll).

The district court sided with Apple on summary judgment, finding no infringement. On appeal, the Federal Circuit has affirmed, holding that Apple’s accused Bluetooth products do not infringe One-E-Way’s patents.  Although the parties had agreed to the construction of the “unique user code” term, they disagreed over the construction-of-the-construction.  On appeal, the court treated this meta-construction effectively as a form of claim construction — looking for the ordinary meaning rather than a contract-like interpretation that would have looked more toward discerning the intent of the parties.

One-E-Way sued Apple for infringing the claims of two patents related to a wireless digital audio system that allows private listening without interference. The system uses a transmitter connected to an audio source and a receiver connected to headphones. The transmitter contains a code generator that generates a “unique user code” associated with a specific user to allow pairing between the transmitter and receiver.

During the infringement litigation, the parties agreed to construe “unique user code” as a “fixed code (bit sequence) specifically associated with one user of a device(s).” Although Apple’s Bluetooth products do transmit a unique code to establish the connection, the code is not unique to the user, but rather it is unique to the Bluetooth device.  The district court agreed with Apple’s assessment and granted summary judgment of non-infringement.

On appeal, One-E-Way argued that the “unique user code” limitation is still met by Apple’s accused Bluetooth products. Specifically, One-E-Way contended that even though the Bluetooth address codes are associated with devices, the codes are still associated with individual users through operation of the device. In other words, One-E-Way argued that Bluetooth pairing to a particular device is equivalent to pairing with a specific user.  This argument makes the assumption that each device is limited to just “one user.” Although that assumption is not strictly true, I expect that it holds true in 99% of cases.  For a while, I shared Bluetooth headphones with one of my daughters–it did not work well at all.

The Federal Circuit rejected this argument, finding that it was inconsistent the claim construction which clearly states the code is associated with “one user.” rather than the device itself.  Even if the Bluetooth address code is associated with a user through use of the device, the code remains fundamentally associated with the device. The Federal Circuit found no evidence that the code itself becomes directly linked to the user, rather than the device, through pairing and use.

The arguments in this case are somewhat meta. The parties are not arguing about claim construction per se, but rather construction of the construction.  In the appeal, the Federal Circuit considered the “plain and ordinary meaning of the agreed-upon construction” and concluded that it required required a more direct link to a user.   As it would with ordinary claim construction, the court looked to the specification for support.  In particular, the court noted that the patent specifications “distinguish between users and devices when describing the purpose of the invention” and recognized the problem of conflict that I had with sharing Bluetooth accessories. “The patents’ consistent reference to ‘user’ and ‘device’ as distinct entities and association of the unique user code with ‘user’ supports the district court’s conclusion that ‘one user of a device’ does not mean the device itself.” Slip Op.

Non-infringement affirmed.

= = =

The patents at issue are:

– U.S. Patent No. 10,129,627
– U.S. Patent No. 10,468,047

The ‘627 and ‘047 patents share the same specification. The court treated Claim 1 of the ‘627 patent as representative.

Stumbling in the Dark: Regional Circuit Law at the Federal Circuit

Patent

Guest post by Paul R. Gugliuzza & Joshua L. Sohn

One of the oddest things about the Federal Circuit is that, in the court’s view, it’s powerless to decide many issues of federal law that arise in the appeals presented to it.

Sure, on matters of patent law, what the Federal Circuit says binds district courts, the Patent Office, and future panels of the Federal Circuit itself. Ditto for nonpatent matters the Federal Circuit considers “unique” to patent disputes.

But, on pretty much every other issue in a Federal Circuit patent appeal—whether it be transfer of venue, the permissible scope of discovery, co-pending antitrust or copyright claims, or anything else—the Federal Circuit asserts no “law-saying” power. Instead, the Federal Circuit—and district courts in cases that will be appealed to the Federal Circuit—apply the precedent of the regional circuit from which the case arose.

Recent Federal Circuit venue disputes spotlight the need for a better approach to questions of nonpatent law in patent cases.

As readers of this blog surely know, the Federal Circuit decides venue questions all the time, usually through petitions for writs of mandamus by defendants seeking to escape the Eastern or Western Districts of Texas. As a nonpatent issue, however, a court deciding a transfer-of-venue fight in a patent case must apply regional circuit law.

Yet, at the regional circuits, transfer disputes are vanishingly rare: the Federal Circuit in a single year decides as many transfer cases as the regional circuits decide in a decade. Moreover, the regional circuit cases that do exist usually involve fact patterns wildly dissimilar from patent litigation, making that precedent unhelpful in the patent context.

The paucity of relevant binding precedent has led both district judges and Federal Circuit judges to essentially guess about what “what the law is.” Judge Albright, for instance, has complained about having to choose between what he characterized as “traditional Fifth Circuit transfer law” or “the Federal Circuit’s”—erroneous, in his view—“interpretations of Fifth Circuit transfer law.”

And, in one of the Federal Circuit’s most high-profile venue mandamus grants, In re Apple, Judge Moore castigated the majority on the ground that “[n]either [the Federal Circuit] nor the Fifth Circuit has held that an accused infringer’s general presence in a district is irrelevant” to the transfer analysis. Well, of course the Fifth Circuit has never held that! With the Federal Circuit’s exclusive jurisdiction over patent cases, how could it?

Transfer isn’t the only area where we see the Federal Circuit’s choice-of-law rule leaving judges and litigants in the dark. In a forthcoming article, we provide examples from areas as varied as copyright, antitrust, and attorney-client privilege.

And we propose a simple solution: much like federal courts certify unsettled questions of state law to state supreme courts, the Federal Circuit should certify unsettled questions of nonpatent law to the regional circuits.

At this point, you hopefully have lots of questions: Wouldn’t we need Congress to pass a statute to make this happen? What about Article III’s case-or-controversy requirement? Wouldn’t certifying questions just add more cost and delay? And wouldn’t it be easier to simply change the choice-of-law rule?

To see how we respond, download the article!

—–

Paul R. Gugliuzza is Professor of Law at Temple University Beasley School of Law.

Joshua L. Sohn is a Trial Attorney at the U.S. Department of Justice and former law clerk to Judge Jerome Farris, U.S. Court of Appeals for the Ninth Circuit. J.D., Harvard Law School; A.B., Stanford University.

The views expressed in this piece are those of the authors and should not be taken to represent those of the U.S. Department of Justice. 

Claim Construction and Due Process: Examining NST Global v. Sig Sauer Inc. in the Supreme Court

Patent, , , , , , ,

by Dennis Crouch

NST Global, LLC, dba SB Tactical v. Sig Sauer Inc. (Supreme Court 2023)

This case has a low chance of being granted certiorari, but it still has some interesting elements regarding claim construction and procedure.  This is a perfect case for the Supreme Court to issue a GVR (Grant-Vacate-Remand) with an order to the Federal Circuit to explain its reasoning.

The setup is common. Tactical sued Sig Sauer for patent infringement; Sig Sauer responded with an IPR petition that was eventually successful.  Tactical appealed based upon the PTAB’s sua sponte claim construction that found the preamble to be limiting, but the Federal Circuit Affirmed without opinion.

The Supreme Court petition asks three questions:

  1. Whether the claim construction finding the preamble limiting was improper.
  2. Whether the PTAB violated due process by construing the term sua sponte and failing to give the patentee with notice or an opportunity to present evidence.
  3. Whether the Federal Circuit’s use of Rule 36 violates constitutional guarantees  of due process and the statutory protections of 35 U.S.C. 144.

The Tactical patents cover a forearm stabilizing brace that can be attached to a pistol. U.S. Patent Numbers 8,869,444 and 9,354,021. Sig Sauer initially was a distributor of Tactical’s product, but later began making its own competing product. At that point Tactical sued.

In the IPR petition, Sig Sauer did not request any claim construction. Likewise, the petition decision granting the IPR stated that no claim terms needed any express construction.  “We agree—we need not expressly construe any claim term
to resolve the parties’ dispute.”  During briefing, neither party requested construction of any aspect of the claim preambles.  Eventually though, in its final written decision, the PTAB interpreted the preambles as limiting and then used that construction to conclude that the claims were invalid as obvious.

Yes, I said that the narrow construction led to the claims being found invalid.  That is unusual — usually the addition of limitations helps to avoid the prior art. In this case though the focus was on objective indicia of non-obviousness. NST’s sales; copying by Sig; praise; etc.  But, by giving weight to the preamble terms, the PTAB was able to destroy the presumed nexus between the claims and NST’s product.  The result, those secondary indicia were found wanting because NST had not provided additional evidence “commensurate with the claims” as newly construed.

For context, the claims are directed to the attachment, but the preamble recites “a handgun” and “a support structure extending rearwardly from the rear of the handgun:”

1. A forearm-gripping stabilizing attachment for a handgun, the handgun having a support structure extending rearwardly from the rear end of the handgun, the forearm-gripping stabilizing attachment, comprising: . . .

The PTAB ruled that the claims require the handgun and also the support structure  as recited in the preamble along with the forearm attachment described in the body.  The problem for the patentee is that its objective indicia evidence focused on the forearm attachment, not the whole package.  Thus, no nexus and no weight given to those secondary factors.  In its decision, the PTAB when through the whole life and meaning analysis: “we conclude that the preambles of claims 1, 3, and 5 are ‘necessary to give life, meaning, and vitality to the claim[s],’ and, as such, are limiting.”

The case was already close because there is a long history of this sort of stabilizer going back to the 19th Century, and so the absence of secondary considerations led to the obviousness conclusion.

During the IPR trial, Sig Sauer had argued that the high sales were due to an odd regulatory scheme against semi-automatic rifles, and the pistol attachment was actually popular primarily because it allowed the pistol to be shouldered.  On appeal, that was raised as an alternative justification for the judgment. But, in my view, the PTAB did not actually rule on that issue in the first place.

The patentee appealed, but the Federal Circuit panel of Judges Reyna, Schall, and Chen affirmed without opinion.

Push-Down on Drug Patents and Drug Pricing

Patent

by Dennis Crouch

Over the past several months, the USPTO and FDA have been collaborating with the purpose of promoting competition and lower drug prices in the US.   This week (Jan 19), the USPTO is holding a 7-hour joint listening session hosted by USPTO Director Kathy Vidal and FDA Commissioner Robert Califf.  [Register and see the Agenda here]

The session has three key substantive areas:

  1. The extent and impact of pharmaceutical and biotech companies acting in a two-faced manner: Arguing to the USPTO that their treatments represent major changes from what was previously done (and thus patentable); while simultaneously arguing to the FDA that then later arguing that these same treatments are quite similar to what is already on the market (and thus safe for use).
  2. The extent that pharmaceutical and biotech companies are improperly gaming the patent system and then using those games to justify strong protections under Hatch-Waxman and the BPCIA.
  3. How can the Orange Book process be improved to protect innovation while simultaneously improving competition?  Prof. Jay Thomas’s remarks here are on point: “Despite their [extraordinary] impact, Orange Book patent listings receive no FDA oversight.”  PTO-P-2022-0037-0010.

The thrust of this entire gambit from the administration level is to reduce drug prices.  But, once we drop down to the PTO/FDA level, the close industry relationship suggests to me that agency officials will be keenly aware of the potential negative impacts of any action on pharma innovation.

The key leadoff speaker is Hastings Law Professor Robin Feldman whose work argues that the system is broken in myriad ways.  George Mason Prof. Adam Mossoff will provide a high-level counterargument, and several others will talk through complications. In particular, I always learn a lot hearing from Corey Salsberg (Novartis), Sean Tu (WVU), and Jay Thomas (G-Town)

While this is a joint event, both agencies (along with several other federal agencies) are also operating unilaterally to address the high cost of healthcare in America.  In particular, the FTC/DOJ are using antitrust tools to push against monopoly-level pricing even for drug products whose use is protected by patents.

Although no direct action items are expected to come out of this event,  I see all of this as quite a big deal as the various players work to establish their narrative.