Patent Docs

USPTO Increases Limit on Accepted Requests for Track I Examination

By Donald Zuhn --

In a notice published in the Federal Register (84 Fed. Reg. 45907) last week, the U.S. Patent and Trademark Office issued an interim rule in which it increased the limit on the number of prioritized (Track I) examination requests that may be accepted in a fiscal year from 10,000 to 12,000.  The increase in accepted requests took effect on September 3, 2019.

The Office implemented the prioritized examination provisions of the Leahy-Smith America Invents Act in September 2011 (see "USPTO Implements Prioritized Examination Track under AIA").  The AIA had set forth a prioritized examination fee of $4,800 (since reduced to $4,000), which applicants must pay in addition to filing, search, and examination fees (including any applicable excess claims and application size fees) and processing and publication fees (the prioritized examination fee for small entities is reduced by 50%).  In addition, the AIA specified that to be eligible for prioritized examination, an application must contain (or be amended to contain) no more than 4 independent claims and no more than 30 total claims.  The AIA also limited the number of requests for prioritized examination that the Director may accept to 10,000 per fiscal year.

When originally implementing prioritized examination, the Office noted that it would accord prioritized examination applications special status and place them on the examiner's special docket, and that the following actions taken by the applicant would terminate prioritized examination:

• Filing a request for continued examination (RCE);
• Filing a petition for an extension of time to file a reply;
• Filing a request for a suspension of action; or
• Filing an amendment that results in more than four independent claims, more than thirty total claims, or a multiple dependent claim.

The Office also noted that to participate in the Track I program, applicants had to fulfill the following requirements:

• File a new original utility or plant nonprovisional application under 35 U.S.C. § 111(a) (the procedure does not apply to international, design, reissue, or provisional applications, or reexamination proceedings, but can be used for continuing applications);
• File an application that is complete under 37 C.F.R. § 1.51(b), including the oath or declaration, and payment of the filing, search, and examination fees, any applicable excess claims fee, and any applicable application size fee at the time of filing;
• File the application via the Office's electronic filing system (EFS-Web);
• The application cannot contain more than four independent claims and thirty total claims or any multiple dependent claims;
• Request prioritized examination (preferably by using Form PTO/SB/424); and
• Pay the required fees for requesting prioritized examination at the time of filing (i.e., the prioritized examination fee set forth in 37 C.F.R. § 1.17(c), the processing fee set forth in 37 C.F.R. § 1.17(i), and the publication fee set forth in 37 C.F.R. § 1.18(d)).

In March 2014, the Office published an interim rule indicating that the time periods for meeting certain requirements for filing a request for Track I prioritized examination could be expanded while maintaining the Office's ability to timely examine the patent application (see "USPTO to Permit Delay in Meeting Certain Prioritized Examination Requirements").  The requirements for which the time periods were expanded were:  the submission, upon filing, of an inventor's oath or declaration and all required fees, as well as an application containing no more than four independent claims, thirty total claims, and no multiple dependent claims.  In particular, the Office changed the rules to (1) postpone the requirement to file an inventor's oath or declaration if an application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is present upon filing, (2) provide a non-extendable one-month period (following notification of noncompliance from the Office) to file an amendment to cancel any independent claims in excess of four, any total claims in excess of thirty, or any multiple dependent claim, and (3) no longer require the payment of excess claims fees or the application size fee upon filing.

In its latest notice, the Office notes that the number of requests for prioritized examination has increased steadily over the last few years to the point that the limit of 10,000 requests for prioritized examination that may be accepted in any fiscal year will be reached if the limit is not increased.  The Office also notes that the number of applications accepted for prioritized examination will remain a small fraction of the approximately 650,000 applications and requests for continued examination that the Office examines per fiscal year.  Thus, the Office has determined that the Track I program may be further expanded to permit more applications to undergo prioritized examination while maintaining the ability to timely examine all prioritized applications.

The Office is accepting written comments regarding the most recent interim rule until November 4, 2019.  Comments can be sent by e-mail addressed to [email protected]; submitted by regular mail addressed to:  Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Kery Fries, Senior Legal Advisor, Office of Patent Legal Administration; or sent via the Federal eRulemaking Portal website (http://www.regulations.gov).

CRISPR Interference: Motion Practice

By Kevin E. Noonan --

In their Order of August 26th, the Patent Trial and Appeal Board authorized the University of California/Berkeley, University of Vienna, and Emmanuelle Charpentier, Junior Party (abbreviated "CVC") to file a miscellaneous motion that its Priority Statement be filed under seal.  The Board set an expedited schedule to be filed September 5th and withheld authorizing the Broad to file an opposition until it considered CVC's motion.

Last week, CVC filed its motion, and this week the Board authorized the Broad to file an opposition.  CVC's motion begins, as it must under PTAB Rules (37 C.F.R. § 42.54), with a section on the precise relief requested.  This relief is to be able to file its Priority Statement under seal under the terms of a protective order filed with the motion.  The protective order is limited to "45 days until after judgment, or indefinitely, as circumstances dictate."  CVC also contemplates the 45 days to provide an opportunity to file a motion to expunge.  In the alternative, CVC requests the Board to enter the protective order until after the Board enters a scheduling order for the priority phase (which the motion contemplates would permit CVC to file a renewed motion to seal or motion to expunge, e.g. if the count is changed, depending on the status of the proceedings at that time.)

CVC's argument is that "CVC's priority statement in this case will contain sensitive research and development information that CVC has otherwise kept confidential."  The importance to CVC of keeping its priority statement confidential is that "CVC has several third-party competitors in the field of CRISPR-Cas9 gene editing technology," including Harvard College (USSN 15/042,573), General Hospital Corp. (USSN 14/211,117), ToolGen (USSN 14/685,568), Vilnius University (USSN 16/148,783) and, seemingly most importantly, Sigma-Aldrich (USSNs 15/188,911; 15/188,924; and 15/456,204), which CVC notes "has petitioned the Office to declare an interference between Sigma-Aldrich's pending applications and CVC's involved applications" (see "Sigma-Aldrich Wants Its Piece of CRISPR Pie").  CVC sets forth the significance of these competitors and the sensitivity of their priority statement by saying:

If CVC's priority statement is made publicly available, then the access that these third parties will have to CVC's confidential research and development information will prejudice CVC in any potential interferences that are declared between CVC and these parties.  Typically, parties to an interference must submit their priority statements without knowledge of the opposing party's alleged dates.  . . .  This ensures that the allegations in the priority statements are not tainted by hindsight, and increases the likelihood that they correspond to dates that the parties may attempt to prove.  A party that has advance notice of its opponent's priority allegations may use that imbalance of information to its advantage, either in influencing the scope of the count or crafting its own allegations.  That leads not only to unfair leverage in settlement negotiations, and but also increases the costs of the proceedings to both the parties and the Patent Office.  Moreover, that undermines the purpose of the priority statement, viz., "to obtain from each party an honest statement of the essential facts and dates upon which they may have to rely to prove priority of invention." [citations omitted]

CVC supports its motion by noting that its motion and protective order "compl[y] with all applicable rules and regulations" (citing specifically 37 C.F.R. § 42.54(a)(7) and 37 C.F.R. § 41.204) as well as the lifting of the protective order 45 days after judgment in inter partes review, post-grant review, and covered business method patent reviews (and analogizing these proceedings to interference practice).  CVC also points out to the Board that the proposed protective order is the "default" order provided in the Federal Register Vol. 77, No. 157 (August 14, 2012) Rules and Regulations at 48760; Appendix B and 37 C.F.R. § 42.54.

CVC's more significant arguments in support of its motion involved the "substantial risk of prejudice" it would suffer if its priority statement was not kept confidential.  CVC emphasized in its motion that parties filed their priority statements in ignorance of the opposing party's dates of conception and reduction to practice or whether the opposing party's priority allegations will antedate a reference.  Such ignorance "ensures that priority statements are based on a party's perceptions of its own proofs, untainted by the hindsight of its opponent's positions" according to CVC's argument.  CVC once again in this section of its motion raises the risk it could face (presumably in future interferences) from Sigma-Aldrich or ToolGen or Vilnius University, each of which have patent applications pending having a priority date "within about ten months" of CVC's priority date.  Also meriting a mention were licensing agreements between some of these competitors and The Broad, which warrants a protective order and not just a decision by the PTAB not to make the priority statement on the Interference Web Portal.  "Where a party has the advantage of knowing the alleged dates of conception and reduction to practice of its opponent, it can allege earlier dates, giving it not only an upper hand in the proceeding, but undermining the integrity and purpose of the priority statement process" according to CVC, citing 37 C.F.R. § 41.204(a)(3).  And this concern is not hypothetical or speculative according to CVC, in view of public statements by some of its competitors that pending claims in their patent applications constitute interfering subject matter (and indeed, in Sigma-Aldrich's case, a motion filed to expedite the PTO's determination that such claims are in condition for allowance so that an interference declaration can be contemplated).

CVC also contends that granting its motion and imposing a protective order would not prejudice the public, particularly because the Board authorized the Broad to file a motion to substitute the count, raising the possibility that "CVC will have revealed its preliminary assessment of bases for entitlement to a judgment on priority for a count that is never adjudicated."

Finally, CVC contends that imposing its protective order would not prejudice the Broad.  CVC is perfectly content with the Board imposing a protective order on both CVC's and the Broad's priority statements.  CVC argues that the Broad has provided no allegation of prejudice, and its only basis (during the teleconference between the Board and the parties) for opposing CVC's protective order was "an internal 'policy of public disclosure'" and that the parties' priority statements were not tiled under seal in the earlier interference between the parties (Interference No. 106,048.  To this CVC states that:

Broad's claim of an internal policy of public disclosure may govern its behavior regarding its own information, but there is no reason that so-called policy should entitle Broad to publicize the confidential research and development information of its opponents.  The Broad's policy should be given no weight or relevance by the Board in its decision.  Moreover, while CVC did not file a motion to seal its priority statement in the '048 Interference, the Board did not make the priority statements in that case publicly available, and CVC did not expect that Broad would publish CVC's confidential information.  Additionally, that Interference involved a different count, and took place against a different competitive landscape.  That Interference has little relevance to the disposition of this motion other than to highlight that Broad previously made public CVC's confidential information.  . . .  CVC has identified an interest in protecting the information in its priority statement, and identified a risk of publication.  There is therefore no basis to deny CVC's motion.

The Board issued an order authorizing the Broad to file its opposition motion to CVC's motion for a protective order, due September 20th.  In addition the parties entered a stipulation changing the times for Time Periods 1 through 6, as follows:

TIME PERIOD 1                                                  October 4, 2019
File motions                                                     October 14, 2019
File priority statements
(but serve one business day later)

TIME PERIOD 2                                                  October 25, 2019
File responsive motions to motions                    November 7, 2019
filed in TIME PERIOD 1

TIME PERIOD 3                                                  December 6, 2019
File oppositions to all motions                           January 9, 2020

TIME PERIOD 4                                                  January 17, 2020
File all replies                                                  March 5, 2020

TIME PERIOD 5                                                  February 28, 2020
File request for oral argument                           March 16, 2020
File motions to exclude evidence
File observations

TIME PERIOD 6                                                   March 20, 2020
File oppositions to motions to exclude                March 26, 2020
File response to observations

TIME PERIOD 7                                                    April 3, 2020
File replies to oppositions to
motions to exclude

DEFAULT ORAL ARGUMENT DATE                         TBD

Senate to Hold STRONGER Act Hearing

By Kevin E. Noonan --

It would be understandable to have the impression that Congress is considering patent eligibility reform as the major (or even sole) patent-related legislation this session (see "Biotech Prospects for Patent Reform"; "What We Learned at Patent Reform Hearings"; "Senators Tillis and Coons Release Statement on Recent Patent Reform Hearings"; "Senate Subcommittee on Intellectual Property Holds Hearings on Proposed Revisions to 35 U.S.C. § 101"; "Senate Proposal for Section 101 Reform: Effect on Biotech/Pharma Inventions"; "Congress Proposes Draft Bill to Change 35 U.S.C. § 101"; and "Congress Releases Framework for Section 101 Reform").  That impression would be incorrect (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").  Another effort coming from the Subcommittee for Intellectual Property of the Senate Judiciary Committee (Sen. Tillis (R-NC), Chair, and Sen. Coons (D-DE), Ranking member) is the STRONGER Act (see "The STRONGER Patents Act of 2019: Weakening Post-Grant Proceedings"), a somewhat controversial attempt to mitigate the perceived inequities created by the Leahy-Smith America Invents Act.

The Subcommittee is holding hearings at 2:30 pm (ET) on Wednesday, September 11th in the Dirksen Senate Office Building, with a panel of witnesses comprising legal academics and patent counsel from (predominantly) high-tech industry representatives.  The hearings will be available for later viewing on the Subcommittee's website.

It is impossible (not to say foolhardy) to try to predict the fate of this or any of the patent-related bills percolating in the House of Representatives as well as the Senate.  While conventional wisdom counsels that Congressional consideration of patenting matters is both consistent with its proper role (after all, the Patent Clause is in Article I of the Constitution) and a welcome relief from judicial fiat regarding patents, the STRONGER Act (and the perceived need for it) just as strongly suggests that the patent community sometimes needs to be careful about what it collectively wishes for; after all, the AIA was the culmination of more than a decade of Congressional efforts to reform U.S. patent law and these efforts have had not entirely welcome consequences.  As always, the best advice for patent-savvy citizens is to contact your Congressional representatives, in each House.  At least you will know you did your part to change U.S. patent law for the better.

Allergan Sales, LLC v. Sandoz, Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

Late last month, the Federal Circuit affirmed a District Court grant of a preliminary injunction based on claim construction involving the effect of two "wherein" clauses in Allergan Sales, LLC v. Sandoz, Inc.

The litigation involved Allegan's U.S. Patent Nos. 9,770,453, 9,907,801, and 9,907,802, which are directed to the ophthalmic drug Combigan®.  As explained in the opinion, the claimed invention is "topical ophthalmic use of brimonidine in combination with timolol . . . for treatment of glaucoma or ocular hypertension . . . preferably formulated as 0.01 to 0.5 percent by weight brimonidine and 0.1 to 1.0 percent by weight timolol solution in water at a pH of 4.5 to 8.0, e.g. about 6.9," where the formulation described in the claims is Combigan® and generic versions of it.  Claim 1 of the '453 patent is representative:

A method of treating a patient with glaucoma or ocular hypertension comprising topically administering twice daily to an affected eye a single composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate, wherein the method is as effective as the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day and wherein the method reduces the incidence of one o[r] more adverse events selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence when compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times daily.

At issue were the two "wherein" clauses italicized in the claim.  According to the Federal Circuit, these clauses found support in Example II of the common specification between these related patents.

The District Court construed each of the wherein clauses as being limiting, i.e., that they were "material to patentability and express the inventive aspect of the claimed invention."  This aspect was the ability of Combigan® to reduce frequency of administration from three times (TID) to twice (BID) per day without a reduction in efficacy and with a decrease in adverse side effects.  Sandoz argued that these clauses were merely a statement of intended results and were not so limiting, inter alia, because the only affirmative steps recited in the claim were to administer the drug formulation.  Under the District Court's construction, the Court held that Allergan had shown a reasonable likelihood of success in showing infringement by Sandoz' generic product, and granted the injunction.  This appeal followed.

The Federal Circuit affirmed in an opinion by Judge Wallach, joined by Chief Judge Prost and Judge Newman; the Chief Judge also wrote a concurring opinion.  Regarding claim construction, the panel reviewed the plain meaning of the claim language, the specification, and the prosecution history; because the District Court did not consider extrinsic evidence their review was de novo.  While the opinion notes "some overlap" between the language of the wherein clauses and the results set forth in the specification of administering the formulation, the panel opined that proper claim construction requires the claim language to be considered in view of the specification as a whole, citing Sinorgchem Co., Shandong v. Int'l Trade Comm'n, 511 F.3d 1132, 1145 (Fed. Cir. 2007), and Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1363 (Fed. Cir. 2016).  The specification describes experimental comparative results of the formulation administered according to the asserted claims on the patents-in-suit and the prior art, demonstrating the disclosed formulation to be "superior."   In the Court's view, "the specification demonstrates that Allergan believed the increased efficacy and safety of the claimed methods to be material to patentability."  The panel found evidence of similar reliance on these superior properties in the prosecution history, the opinion citing specific passages where patentee argued that the claims were patentably distinct from the prior art based on the properties recited in the wherein clauses.  Finally, the opinion states that the Examiner relied on the distinctions found in the wherein clauses to find the claims "novel and non-obvious over the prior art."  Accordingly, the Federal Circuit affirmed the District Court's claim construction and the grant of summary judgment, explaining in a footnote that the parties agreed the correctness of that decision would "stand or fall" on the claim construction issue.

The Chief Judge wrote separately in concurrence because while agreeing with the panel decision her reasoning regarding the limiting nature of the "wherein" clauses took a different logical path.  She characterized the posture of the case as being "unusual," due to the reliance by all on the claim construction issue.  The Chief Judge found no fault with the panel's application of the claim construction rubrics established by case law that she says constitute "a well-established set of legal standards governing claim construction," and also stating that "the majority has already ably articulated those standards in detail."  To this able articulation, the Chief Judge added "one narrow but crucial point" that bears consideration in her view.  And that is that the plain meaning of the language of the claims, which is mentioned almost summarily in the main opinion, "on its face confirms that these clauses give meaning and purpose to the other manipulative steps of claim 1."  The Chief Judge then makes her case that the claim, written in "open" claim language ("comprising") has no basis for limiting the combination of components, expressly recited or encompassed by "comprising," with any language other than the "wherein" clauses:

Without the "wherein" clauses, the only other limitation guiding the physician is that the drug is administered "twice" per day.  . . .  Sandoz provides no basis for us to conclude with any certainty that the safety and efficacy requirements of the "wherein" clauses would always result from two doses of (1) any formulation of the combination at (2) any interval in a 24-hour period.

The Chief Judge used these circumstances to conclude that in these claims the "wherein" clauses bear the burden of limiting the formulations and administration of those formulations to those that satisfy the limitations recited in the "wherein" clauses (which is an operable definition of what a claim limitation does).  She also found that these clauses each recite with specificity and particularity what is required to satisfy them, in contrast with wherein clauses in other contexts that operate (as Sandoz unsuccessfully argued here) merely to recite an intended result.  And as in the main opinion, the Chief Judge found these conclusions are supported by both the specification and the prosecution history.

The Chief Judge ends her concurring opinion with a discussion of the role of claim language in the claim construction exercise:

As it is, claim construction can be difficult.  For instance, litigants often encounter uncertainty over whether a claim's preamble is limiting or not.  I see no reason to inject further uncertainty into the notice provided by the body of a claim.  Given the specificity, clarity, and material limits the "wherein" clauses add to the scope of claim 1 on their face, Sandoz's position deserves rigorous scrutiny from the start.  We should not begin with the presumption that text in the body of the claim may be meaningless and can only be saved by clear statements in the specification or prosecution history.

For Chief Judge Prost, the name of the game is the language of the claim, and resort to the specification and prosecution history is only taken to ensure that the claim language has been properly interpreted.

Allergan Sales, LLC v. Sandoz, Inc. (Fed. Cir. 2019)
Panel: Chief Judge Prost and Circuit Judges Newman and Wallach
Opinion by Circuit Judge Wallach; concurring opinion by Chief Judge Prost

Conference & CLE Calendar

September 9, 2019 - "The Evolving Patent Eligibility of Life Sciences Method Claims" (Practising Law Institute) - 11:00 am to noon (EDT)

September 12, 2019 - "Inherency In Anticipation and Obviousness" (Intellectual Property Owners Association) - 2:00 to 3:00 pm (ET)

September 17, 2019 - "Best Practices for Patenting Chemical and Material Compositions" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 am to 11:15 am (CT)

September 17, 2019 - "A Primer on the Laws of Cannabis, Marijuana and CBD" (Loeb & Loeb LLP) - 1:00 to 2:00 pm (ET)

September 19, 2019 - "Trending Issues in Trade Secrets: 2019" (U.S. Patent and Trademark Office) - 9:00 am to 3:30 pm (ET), Alexandria, VA

September 20, 2019 - "Hot Topics in IP 2019" (Federal Circuit Bar Association) - 11:30 am to 4:30 pm (ET), Wilmington, DE

September 21, 2019 - Supreme Court IP Review (SCIPR) (Program in Intellectual Property Law, Center for Empirical Studies of Intellectual Property, and Institute on the Supreme Court of the United States at the Chicago-Kent College of Law) - 8:30 am to 5:30 pm (Central), Chicago, IL

October 3-4, 2019 - Paragraph IV Disputes Master Symposium (American Conference Institute) - Chicago IL

IPO Webinar on Inherency In Anticipation and Obviousness

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Inherency In Anticipation and Obviousness" on September 12, 2019 from 2:00 to 3:00 pm (ET).  Mark Feldstein of Finnegan, Paul Steadman of DLA Piper, and Robert Greene Sterne of Sterne Kessler Goldstein & Fox  will address how to avoid pitfalls in district court litigation and PTAB proceedings involving inherency, and also provide important tips for patent prosecution.

The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

Federal Circuit Issues Order Clarifying Status of Doctrine of Equivalents

By Kevin E. Noonan --

The late Gilda Radner's character, Emily Latella, would consistently misapprehend something ("violins on television," "saving Soviet jewelry"), give a guest editorial on Weekend Update, and when corrected would say "Never mind!"  While rare, all courts have such "never mind" moments, and the latest one for the Federal Circuit occurred in Amgen Inc. v. Sandoz Inc. earlier this year, regarding the doctrine of equivalents, which the Court corrected yesterday on Amgen's petition for rehearing regarding the panel opinion.

The case involved biosimilar litigation over Amgen's Neupogen® product (filgrastim), "a recombinant analog of granulocyte-colony stimulating factor ('G-CSF'), a naturally-occurring human glycoprotein that stimulates the production of neutrophils and stem cells and their release into the bloodstream" used to treat neutropenia inter alia, in patients undergoing cancer chemotherapy.  Amgen asserted two patents (after a tortured procedural course involving the proper application of the "patent dance" provisions of the Biologic Price Control and Innovation Act (42 U.S.C. § 262(l) (see "Gotta Dance? Apparently Not -- A Biosimilar Update"; "Amgen v. Sandoz"; "Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)"; and "Sandoz Inc. v. Amgen Inc. (2017)")), those patents being U.S. Patent Nos. 6,162,427 and 8,940,878.  The District Court construed the claims in such a way that Amgen conceded that Sandoz did not infringe, and Amgen appealed.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges O'Malley and Reyna.  There was nothing remarkable about the opinion, which agreed with the District Court's claim construction and that Sandoz did not literally infringe under that interpretation of the scope and meaning of the claims.  Where the opinion got interesting (and where the en banc court felt the need to grant in part Amgen's petition to rehear the case) was when the panel dismissed Amgen's argument that infringement could be found under the doctrine of equivalents by stating:

The doctrine of equivalents applies only in exceptional cases and is not "simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims" [italics added].

Citing its pre-Warner Jenkinson precedent in London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991).

Amgen took issue with this statement, and in its petition for rehearing en banc reminded the Court that the term "exceptional" has a specific meaning in the statute, as explicated in another context (35 U.S.C. § 285) by the Supreme Court in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. Earlier this week the Court issued an order where this portion of the opinion was modified to read:

The doctrine of equivalents applies only in exceptional cases and is not "simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims."

Prudence suggests the Court would have done itself a better service if it had struck the entire sentence, because the sentiment remains that the doctrine is not "readily available to extend protection beyond the scope of the claims."  Indeed, the doctrine is readily available to extent protection beyond the literal scope of the claims is warranted; if the Court wants to know why it should be readily evident by now that the reason is that the Supreme Court has said so, in Winans v. Denmead, 56 U.S. 330 (1854); Seymour v. Osbourne, 78 U.S. 516 (1870); Graver Tank & Mfg. Co. v. Linde Air Prod. Co. 339 U.S. 605 (1950); Warner-Jenkinson v. Hilton Davis Chemical Co., 520 U.S. 17 (1997); and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002).  This judicial sentiment to the contrary by the Federal Circuit is reminiscent of language that arguably was at least in part responsible for energizing the Supreme Court to review more closely the Federal Circuit's stewardship of the Court's patent jurisprudence (inter alia, in Warner-Jenkinson and Festo) and we all see where that has gotten us (see, e.g., "The Proper Role of the Federal Circuit").

What is particularly disheartening is that this was a precedential decision, available for review by the entire Court.  Whilst comprising just 6 words in a 16-page opinion, it is unfortunate that the impact of those 6 words was unappreciated (or worse, that concerns about them were disregarded) by the members of the Court.  The precedential value (or risk) of these words in the decision is (for the time being) past, but the circumstances under which they arose in the first place may remain with the patent community for some time.

iNO Therapeutics LLC v. Praxair Distribution Inc. (Fed. Cir. 2019)

By Kevin E. Noonan --

Albert Einstein once famously (albeit perhaps apocryphally) said that "[c]ompound interest is the most powerful force in the universe."  Not to contradict the creator of 20th Century physics, but it is just as likely that the most powerful force in the universe is the power of unintended consequences.  The Federal Circuit illustrated this power in its recent decision in iNo Therapeutics LLC v. Praxair Distribution Inc. with regard to Justice Breyer's exhortation, in his Mayo Collaborative Serv. Inc. v. Prometheus Laboratories opinion, regarding the need to beware of "interpreting patent statutes in ways that make patent eligibility 'depend simply on the draftsman's art' without reference to the 'principles un­derlying the prohibition against patents for [natural laws],'" citing Flook v. Parker.

Plaintiffs iNO Therapeutics, LLC, Mallinckrodt Hospital Products Inc., and Mallinckrodt Hospital Products IP Inc. asserted U.S. Patent Nos. 8,282,966; 8,293,284; 8,795,741; 8,431,163; and 8,846,112, which the opinion "collectively [termed the] 'heart failure patents' or 'HF patents'" against Praxair Distribution Inc. and Praxair Inc.  Plaintiffs also asserted U.S. Patent Nos. 8,573,209; 8,776,794; 8,776,795; 9,265,911; and 9,295,802 which the opinion "collectively [termed the] 'delivery system infrared patents' or 'DSIR patents'" and which were directed to devices for administering nitric oxide gas.  As explained in the opinion, inhaled nitric oxide (iNO) gas had been "used to treat infants experiencing hypoxic respiratory failure" since at least the early 1990's.  However, in certain cases this treatment results in increased pulmonary edema for infants having a congenital defect, left ventricular hypertrophy.  The patents-in-suit were directed to methods and a gas delivery device to ameliorate this side-effect, as exemplified by the following claims:

The '741 patent:

1.  A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising:
    (a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;
    (b) determining that a first patient of the plurality does not have left ventricular dysfunction;
    (c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;
    (d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and
    (e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.

The '794 patent:

1.  A gas delivery device comprising:
    a gas source to provide therapy gas comprising nitric oxide;
    a valve attachable to the gas source, the valve including an inlet and an outlet in fluid communication and a valve actuator to open or close the valve to allow the gas through the valve to a control module that delivers the therapy gas comprising nitric oxide in an amount effective to treat or prevent hypoxic respiratory failure; and
    a circuit including:
    a memory to store gas data comprising one or more of gas identification, gas expiration date and gas concentration; and
    a processor and a transceiver in communication with the memory to send and receive signals to communicate the gas data to the control module that controls gas delivery to a subject and to verify one or more of the gas identification, the gas concentration and that the gas is not expired.

(where the italicized limitations are relevant to the Court's decision).  The opinion also notes that the Court had earlier affirmed the PTAB's invalidation of the '112 patent in inter partes review (see "Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd. (Fed. Cir. 2018)").

The District Court held the claims of the HF patents to be directed to patent-ineligible subject matter under 35 U.S.C. § 101, and that Praxair did not infringe the claims of the DSIR patents.  Mallinckrodt appealed.

The Federal Circuit affirmed-in-part, vacated-in-part, and remanded, in an opinion by Chief Judge Prost joined by Judge Dyk; Judge Newman concurred in part and dissented in part (but the thrust of her opinion dissented from the majority's routine and now conventional, but not capable of being well-understood, affirmance that the claims were not eligible for patenting under § 101).  The Court applied its now well-worn (and unnecessarily expansive) interpretation of the Supreme Court's Mayo/Alice test in affirming the District Court.  Dissecting the claims in furtherance of its patent-invalidating efforts, the panel majority first states that:

It is undisputed that treatment of infants experiencing hypoxic respiratory failure with iNO gas has existed for decades.  The inventors observed an adverse event that iNO gas causes for certain patients.  The patent claim does no more than add an instruction to withhold iNO treatment from the identified patients; it does not recite giving any affirmative treatment for the iNO-excluded group, and so it covers a method in which, for the iNO-excluded patients, the body's natural processes are simply allowed to take place.  Consequently, the claim here is directed to the natural phenomenon.  The claim, apart from the natural phenomenon itself, involves only well-understood, routine, and conventional steps.  For the reasons below, claim 1 of the '741 patent fails to recite eligible subject matter.

What follows is the majority's justification for this conclusion.  The natural phenomenon is "undisputed" (because the majority defines it as such), the majority saying "[a] neonate patient's body will react to iNO gas in a certain way depending on whether or not the patient has a congenital heart condition called LVD," followed by a recitation of the consequences thereof.  The panel majority then parsed the claim language to find that the claims are "directed to" an observation of the natural phenomenon they have defined, because the exclusion (from treatment) step "merely restates the natural law" (nature it seems providing a caregiver who can give the gas as well as knowing without benefit of the invention when to refrain from giving it).  According to the majority:

Properly understood, this added step [characterized by Mallinckrodt as an "exclusion" step] is simply an instruction not to act.  In effect, the claim is directed to detecting the presence of LVD in a patient and then doing nothing but leaving the natural processes taking place in the body alone for the group of LVD patients.  Accordingly, the claim is directed to the natural phenomenon.

And to avoid any correspondence with Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the majority asserted:

Indeed, Mallinckrodt cannot dispute that the patented method does not propose a new way of treating LVD patients that leverages this discovery (e.g., by titrating the iNO dose).  Instead, the claim simply requires that the patient not be treated with iNO.  This is significant because a claim not to treat—i.e., not to disturb these naturally-occurring physiological processes within the LVD patient's body—risks monopolizing the natural processes themselves.

And returning to the opinion's theme:

A closer look at the claim language as a whole confirms that the focus of the invention is not on a new way of actually treating the underlying condition of hypoxic respiratory failure.  Nor does it recite a way of reducing the risk of pulmonary edema while providing some level of treatment to those patients.  Rather, the focus of the invention is screening for a particular adverse condition that, once identified, requires iNO treatment be withheld.  A treatment step of administering a prior art dosage is also present.  But that step is plainly not the focus of the claimed invention.  Mallinckrodt concedes this step is not innovative.  Mallinckrodt does not point to "any innovation other than its [purported] discovery of the natural law," citing Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 750 (Fed. Cir. 2019).

The opinion also cites Nat. Alternatives Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019), and Endo Pharm. Inc. v. Teva Pharm. USA, Inc., 919 F.3d 1347 (Fed. Cir. 2019), in support of the majority's distinction between these claims and what it considers "method of treatment" claims.  The panel further distinguished these claims from the patent-eligible claims in Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016) (a decision also written by the Chief), again on the grounds of "a careful reading of the claim language" in those claims and these.

With regard to the second step of the Mayo/Alice test, the panel majority rejected Mallinckrodt's argument that the claims possess an "inventive concept."  Following their wont, the majority found nothing sufficiently novel to warrant satisfaction of the second step inquiry.  It is a tribute to the essential blurring of statutory lines engendered by Justice Breyer's Mayo decision (but much less understandable or forgivable when the nation's "patent court" does so) that the discussion revolves expressly on lack of novelty in performing the eligibility analysis ("This would be quite a different case if the inventors had invented a new way of titrating the dose" and, citing the District Court (which doesn't take a putatively specialized appellate court to do), "Plaintiffs cannot seriously contend that it is a new practice to exclude certain patients from treatment with a drug when those patients are at an increased risk of experiencing negative side effects from the drug").  Understandably, the majority took frank recourse to what they perceive to be the parallels between these claims and the claims in Mayo to support their decision.  And the majority characterized as a "red herring" Mallinckrodt's contentions that their claims do not entirely preempt the putative natural phenomenon, surprising in view of the role preemption plays in justifying the Supreme Court's eligibility requirements in the first place.

The majority's consideration of infringement of the DSIR patents is more legally conventional, involving Mallinckrodt's disagreement with the District Court's construction of the term "verify" in the phrase "verify one or more of the gas identification, the gas concentration and that the gas is not expired."  The majority correctly noted that the District Court didn't formally construe the word, giving it its plain and ordinary meaning.  The opinion characterizes this argument as Mallinckrodt "attempt[ing] to undo its loss on infringement by redrawing the metes and bounds of the claim" and finds this effort "unavailing."

Providing one basis for Judge Newman to agree with her colleagues, the opinion reversed a "technical error" by the District Court and remanded for correction of the Court's "clerical error" (specifically, issuing a "blanket" judgment on all the claims of the asserted patents rather than limiting it to the asserted claims).

Judge Newman's dissent is directed to the eligibility portion of the decision.  In her view, the inventors observed a natural phenomenon and then developed a treatment method that took advantage of that observation to avoid adverse events.  "The method that is described and claimed does not exist in nature; it was designed by and is administered by humans" in her view.  Procedurally, Judge Newman faults her colleagues because:

The majority improperly separates the claims into old and new steps, describes some claim steps as a "natural phenomenon" and some steps as "well-understood, routine, and conventional steps," and avoids the requirement that a claimed invention is considered as a whole.

And "[t]oday's change of law adds to the inconsistency and unpredictability of this area of patent-supported innovation."  In Judge Newman's view "the majority's ruling conflicts with extensive precedent" (which she extensively cites) as well as "the national interest":

The majority [states that] "we emphasize the narrowness of our holding today, which is limited to the particular claims at issue and is driven by the particular circumstances here."  This disclaimer appears at the end of a lengthy exposition, whose wide-ranging pronouncements of law and policy are not tied to narrow circumstances or claims.  The persistent theme of the majority's analysis is that if a claim contains limitations that concern human physiology, ineligibility arises under section 101, whether or not the claimed method of medical treatment meets the requirement of patentability.

The majority's broad pronouncement of ineligibility of medical treatment that relates to human physiology not only contravenes precedent, but contravenes the national interest in achieving new methods of medical treatment with the assistance of the patent incentive.

Reaching back more than two centuries, Judge Newman reminds her colleagues that patents do not function to "impede scientific and technologic advance," citing Whittemore v. Cutter, 29 F. Cas. 1120, 1121 (C.C.D. Mass. 1813), based on common law and statutory research exemptions, citing her dissent in Integra Lifesciences I, Ltd. v. Merck KGaA, 331 F.3d 860, 875 (Fed. Cir. 2003), and Giles Sutherland Rich in Principles of Patentability, 28 Geo. Wash. L. Rev. 393, 400 (1960) ("It should never be forgotten that patented inventions are published and become a part of the technical literature.  This publication itself promotes progress in the useful arts and it is the prospect of patent rights which induces disclosure and the issuance of the patent which makes it available.")

Returning to the majority's blessedly non-precedential opinion, it will bring cold comfort to patent-divested patentees, as well as being somewhat ironic that the upshot of the opinion leads patent prosecutors to the inevitable conclusion that the Federal Circuit is counseling exactly what Justice Breyer cautioned against in Mayo, that we should beware of the clever draftsman who attempts (or worse, succeeds) in obtaining claims that are enforceable and pass the patent eligibility test that the Federal Circuit has crafted, based predominantly on such claim-drafting cleverness.  This is not the first time that this has been the outcome of the Federal Circuit's patent eligibility jurisprudence.  For example, in In re Roslyn, Judge Dyk's opinion held patent-ineligible claims to Dolly the sheep which was, after all, just a sheep (notwithstanding being a sheep unlike any sheep that had ever lived).  But a careful review of that opinion leads ineluctably to the conclusion that, had the draftsman been clever enough (or prescient enough to realize before the fact the quantum and quality of cleverness required) to have claimed a flock of genetically identical sheep, the Court's objections to patent ineligibility would have perforce fallen, because it would be undeniable that flocks of genetically identical sheep do not occur in nature.  This state of affairs is frankly Byzantine and antithetical to Congress's purpose (uniformity and predictability in U.S. patent law) for creating the Federal Circuit, as well as being contrary to the principles of clarity and the creation of "bright line rules" that arguably prompted the Supreme Court to begin its heightened scrutiny of the Court and its opinions (if not philosophy).  The Federal Circuit's current path is contrary to the idea that patent claims should be readily understandable to well-intended business people and frank (or in current parlance, "efficient") infringers alike and also contrary to the Founders' attitudes regarding patenting as a way to encourage disclosure of new inventions for the public good.  Having such a path will give little relief to those who have lost patent rights under the current regime, but at least it provides a way for inventors to obtain patent-eligible claims no matter what other branches of government do in addressing this issue.  Innovation, especially in the diagnostic and life sciences arts, requires no more and is entitled to no less.

iNO Therapeutics LLC v. Praxair Distribution Inc. (Fed. Cir. 2019)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Newman and Dyk
Opinion by Chief Judge Prost; opinion concurring in part and dissenting in part by Circuit Judge Newman

Federal Circuit Invalidates A. G. Bell's Telegraphy Patent

By Michael Borella --

June 23, 1880

WASHINGTON D.C.  In a unanimous panel ruling, the Federal Circuit invalidated a patent owned by Salem, Massachusetts inventor A. G. Bell.  On February 14, 1876, Mr. Bell was granted Letters Patent No. 174,465 to an "Improvement in Telegraphy."  This patent was challenged in various proceedings by Mr. Elisha Gray of Highland Park, Illinois as allegedly entailing subject matter ineligible for patenting.  In a long-awaited ruling, the Federal Circuit held that Mr. Bell's claims were directed to an abstract idea without significantly more and therefore invalid.

The claims of the '465 patent recite:

1.  A system of telegraphy in which the receiver is set in vibration by the employment undulatory currents of electricity, substantially as set forth.

2.  The combination, substantially as set forth, of a permanent magnet or other body capable of inductive action, with a closed circuit, so that the vibration of the one shall occasion electrical undulations in the other, or in itself, and this I claim, whether the permanent magnet beset in vibration in the neighborhood of the conducting-wire form simultaneously be set in vibration in each others neighborhood.

3.  The method of producing undulations in a continuous voltaic current by the vibration or motion of bodies capable of inductive action, or by the vibration or motion of the conducting-wire itself, in the neighborhood of such bodies, as set forth.

4.  The method of producing undulations in a continuous voltaic circuit by gradually increasing and diminishing the resistance of the circuit, or by gradually increasing and diminishing the power of the battery, as set forth.

5.  The method of, and apparatus for, transmitting vocal or other sounds telegraphically, as herein described, by causing electrical undulations, similar in form to the vibrations of the air accompanying the said vocal or other sound, substantially as set forth.

The Court began its analysis by inferring the scope of the claimed invention.  To do so, it considered the specification of the '465 patent, writing "[o]ur cases have found the specification helpful in illuminating whether a claim is truly focused on an ineligible abstract idea or significantly more than just that."  To that point, the Court observed that:

The eligibility inquiry may involve looking to the specification to understand the problem facing the inventor and, ultimately, what the patent describes as the invention.  The problem identified by Mr. Bell, as stated in the specification, is that intermittent electrical currents sent along a telegraphic wire become effectively continuous when subjected to numerous transmissions of different rates of vibration, making this technique unsuitable for accurately transmitting sounds.  Mr. Bell's solution is to represent sounds by transmitting undulatory currents instead, which are physical phenomenon mathematically similar to sinusoidal motions of air caused by these sounds.

The Court then found that "looking at the problem identified, as well as the way the inventor describes the invention, the specification suggests that the invention is nothing more than the abstract idea of communicating sounds over a wire."  The Court noted that humans have communicated audibly since time immemorial -- that such vocalization was a fundamental aspect of and long prevalent in the human experience.  Further, the use of various types of audible and non-audible waveforms for communication over a distance -- such as those involved in or generated by drumming, shouting, signal fires, mirrors, semaphores, and so-called optical telegraphs -- have been used for centuries, if not millennia.

Notably, the Court made an analogy between Mr. Bell's claims and those found invalid by the Supreme Court in O'Reilly v. Morse.  Mr. Morse's invention was directed to using electromagnetism to telegraphically transmit intelligible signals, and was found to be an abstraction -- an "idea" rather than a practical application thereof.  In that case, the Justices expressed concern that Mr. Morse's broad claims would cover any possible application of communicating at a distance via electromagnetism.  Similar to those of Morse, Mr. Bell's claims are sufficiently broad enough to be directed to a principle ("all solutions for attaining a desired result") rather than a specific implementation of that principle ("a specific embodiment that produces the desired result in a particular fashion").

While the Court acknowledged that Mr. Bell described such communication in the context of telegraphy using undulatory currents, "[t]he prohibition against patenting abstract ideas cannot be circumvented by attempting to limit the use of the idea to a particular technological environment."  Again, the language of the claims supported the Court's determination, as they were "recited at such a high level of generality that the claimed scope encompasses representing sounds of all types with electrical undulations."  In support of this determination, the Court pointed to the specification where Mr. Bell wrote "I desire here to remark that there are many other uses to which these instruments may be put, such as the simultaneous transmission of musical notes, differing in loudness as well as in pitch, and the telegraphic transmission of noises or sounds of any kind."

Thus, the Court concluded that "the claims clearly involve an abstract idea -- namely, the abstract idea of transmitting representations of sounds over a telegraphic wire."

Moving on to the next step of the patent eligibility inquiry, the Court sought to determine whether the additional elements of the claims included an "inventive concept" that would limit their coverage to be significantly more than the abstraction therein.  The Court explained this step as involving "consideration of the additional elements of the claim both individually and as an ordered combination to determine whether these elements transform the nature of the claim into a patent-eligible application."  Such additional elements cannot be "well-understood, routine, or conventional articles previously known in the relevant art."  Thus, "transformation into a patent-eligible application requires more than simply stating the abstract idea while adding the words 'apply it.'"

The Court determined that the additional claim elements above and beyond those reciting the abstract idea were "a receiver, a telegraphic line, and various mechanisms for generating electrical undulations in said line."  But each of these elements fell under the "well-understood, routine, or conventional" rubric.  The Court quickly observed that receivers and telegraphic lines have been used in communication systems for decades, and included those of Mr. Morse.

Moreover, the Court noted that not all of the claims explicitly recited mechanisms for generating electrical undulations, and that Mr. Bell had made admissions in the specification that any such mechanisms were already known.  For example, Mr. Bell disclosed that it was well-understood that a permanent magnet could be used for this purpose:

It has long been known that when a permanent magnet is caused to approach the pole of an electro-magnet a current of electricity is induced in the coils of the latter, and that when it is made to recede a current of opposite polarity to the first appears upon the wire.  When, therefore, a permanent magnet is caused to vibrate in front of the pole of an electromagnet an undulatory current of electricity is induced in the coils of the electro-magnet.

Mr. Bell went on to state that:

There are many ways of producing undulatory currents of electricity, dependent for effect upon the vibrations or motions of bodies capable of inductive action.  A few of the methods that may be employed I shall here specify.  When a wire, through which a continuous current of electricity is passing, is caused to vibrate in the neighborhood of another wire, an undulatory current of electricity is induced in the latter.  When a cylinder, upon which are arranged bar magnets, is made to rotate in front of the pole of an electromagnet, an undulatory current of electricity is induced in the coils of the electro-magnet.

In the Court's view, these additional elements were, by Mr. Bell's own admission, pre-existing articles.  Further, they were merely being used "for their intended purpose with no improvement made thereto."  Indeed, "Mr. Bell did not invent electro-magnets, wires, or cylinders of bar magnets, nor was he the first to observe that these items can induce undulatory currents."  Particularly, "electromagnetic induction had been discovered by the Englishman Michael Faraday nearly half a century ago, and was a well-understood phenomenon at the time of the patent's filing."

Therefore, the Court found that "[t]hese conventional components, all recited functionally at a high level and in a generic way, are no better equipped to save the claims from abstractness."  Furthermore, "when considered as an ordered combination, these elements add nothing that is not already present when looking at the elements taken individually . . . [t]here is no indication that the combination of elements improves the functioning of a receiver, the wires, or any magnets used in various claims."

Consequently, the Federal Circuit concluded that the '465 patent was invalid due to being directed to patent-ineligible subject matter, and Mr. Bell has lost exclusive rights to his invention.

Conference & CLE Calendar

September 9, 2019 - "The Evolving Patent Eligibility of Life Sciences Method Claims" (Practising Law Institute) - 11:00 am to noon (EDT)

September 17, 2019 - "Best Practices for Patenting Chemical and Material Compositions" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 am to 11:15 am (CT)

September 17, 2019 - "A Primer on the Laws of Cannabis, Marijuana and CBD" (Loeb & Loeb LLP) - 1:00 to 2:00 pm (ET)

September 19, 2019 - "Trending Issues in Trade Secrets: 2019" (U.S. Patent and Trademark Office) - 9:00 am to 3:30 pm (ET), Alexandria, VA

September 20, 2019 - "Hot Topics in IP 2019" (Federal Circuit Bar Association) - 11:30 am to 4:30 pm (ET), Wilmington, DE

September 21, 2019 - Supreme Court IP Review (SCIPR) (Program in Intellectual Property Law, Center for Empirical Studies of Intellectual Property, and Institute on the Supreme Court of the United States at the Chicago-Kent College of Law) - 8:30 am to 5:30 pm (Central), Chicago, IL

October 3-4, 2019 - Paragraph IV Disputes Master Symposium (American Conference Institute) - Chicago IL

USPTO Program on Trade Secrets

The U.S. Patent and Trademark Office will be holding a program on "Trending Issues in Trade Secrets: 2019" from 9:00 am to 3:30 pm (ET) on September 19, 2019 at the USPTO's Clara Barton Auditorium in Alexandria, VA.  Five panels will bring together experts from government, academia, the courts, and the private sector for in-depth discussions of:

• Patents or trade secrets—what is trending?
• Issues in criminal prosecutions
• Notable trade secret prosecutions
• Views from the federal bench
• Advising clients in criminal trade secret matters

Additional information regarding the program can be found here.  The program will also be available for viewing remotely via LiveStream, with a link to be posted on the USPTOP website prior to the event.  There is no registration fee for the program.  Those interested in registering for the conference can do so here.

Supreme Court IP Review

The Program in Intellectual Property Law, Center for Empirical Studies of Intellectual Property, and Institute on the Supreme Court of the United States at the Chicago-Kent College of Law will be holding its tenth annual Supreme Court IP Review (SCIPR) on September 21, 2019 from 8:30 am to 5:30 pm (Central) at the IIT Downtown Campus - Chicago-Kent College of Law in Chicago, IL.  Among the sessions being offered at the conference are:

• Review of Copyright and Trademark Cases
• Review of Patent Cases
• Analytics and Preview of 2019 Term
• Supreme Court IP Review Address -- Donald B. Verrilli, Jr., Partner, Munger Tolles & Olson, 46th Solicitor General of the United States
• Supreme Court IP Cases: The Views of Advocates
• The Views of Former Supreme Court Clerks
• Taking Stock of IP Cases at SCOTUS in the Past Decade

A complete agenda for the conference, including a list of sessions and speakers can be found here.

The registration fee for the program is $150 (attorneys and general public guest, including Chicago-Kent alumni) or $60 (outside academics).  There is no fee for Chicago-Kent faculty, current Chicago-Kent students, and current students of other law schools.  Those interested in registering for event can do so here.

FCBA Program on Hot Topics in IP

The Federal Circuit Bar Association (FCBA) will be offering a CLE program on "Hot Topics in IP 2019" on September 20, 2019 from 11:30 am to 4:30 pm (ET) at the Hotel Du Pont in Wilmington, DE.  The program will include presentations on the following topics:

• Don't Be Abstract: Section 101 Through the Legislative Lens
• Excellence in Persuasion: Advocacy from a Judicial Perspective
• Read the Signs: Supreme Court Decisions This Term and Next

Additional information regarding the program can be found here.  The registration fee for the program is $275 (BPLA members) or $295 (non-members).  Those interested in registering for the program, can do so here.