July 2018

Patent Grants

With two-months left in the fiscal year, the USPTO is on-track for another 300,000+ patent year. The chart above shows the number of utility patents issued each fiscal year for the past two decades. The current forecast for FY2018 is a bit below FY2017 – but still the second highest number of patents issued in a single year. Examiners will push to make their quotas prior to the end of the year – however those will not be reflected in issued patents in FY18 because of the lag between allowance and issuance.

Patently-O Bits and Bytes by Juvan Bonni

Recent Headlines in the IP World:

 

Commentary and Journal Articles:

New Job Postings on Patently-O:

Patent Office Updates

  • The next PPAC Meeting will be on August 2, 2018 starting at 9:00 a.m. I usually attend via webcast that works well. [Agenda and Links]
  • Former Acting PTO Director Joseph Matal has moved into the role of Acting Solicitor of the agency as well as Acting Deputy General Counsel for Intellectual Property Law.  Congratulations Joe! Former Solicitor Nathan Kelley has left the office that he joined originally back in 1993 as an examiner.
  • EPO is highlighting its new office in The Hague. The Video below is worth watching if only for the dramatic background music.

Firm DQ’d Because it “Should Have Known” a TM Client Would Sue Another for Patent Infringement the Day the Patent Issued

This is an interesting case where the court granted a motion to disqualify based on a very odd assumption.  The case is Altova GMBH v. Syncro Soft SRL, No. 17-11642-PBS (D. Mass. July 26, 2018), here.

The facts of this case are a bit unclear, but it seems like Firm A represented Syncro Soft in three trademark-related matters.  The first involved responding to a C&D letter from a third party in 2004. The second involved representing Firm A in responding to a C&D letter alleging trade dress and copyright infringement from the party moving for disqualification in this case, Altova, in April 2009 and ending in June 2009.  Then in 2010 Firm filed a trademark registration for Syncro Soft and provided other assistance through 2014. The total number of hours on these matters:  less than 50.

In October 2011, Firm A had begun to represent Altova in trademark matters and in June 2012 filed suit for Altova against an alleged trademark infringer.  In other words, although Firm A had defended Syncro Soft from claims of trade dress and copyright infringement in 2009, from October 2011 through 2014, at least, Firm A was representing both Altova and Syncro Soft though not in matters where each was adverse to the other.   The opinion is unclear whether Firm A represented Syncro Soft after 2014.

In June, 2017, Altova asked Firm A to assert a patent that Altova had obtained against Syncro Soft.  In July, 2017, Firm A sent a letter to Syncro Soft “terminating” its attorney-client relationship with it (again, it’s not clear the firm was doing anything after 2014).  The firm did not explain why.  It then filed the patent infringement suit for Altova against Syncro Soft.

Syncro Soft moved to disqualify Firm A. The court held that at the time the conflict arose, Syncro Soft was a current client of the firm.  Thus, the rule governing current client conflicts, not former client conflicts, controlled.  Under that rule, it is unethical for a law firm to be adverse to a current client of the firm.  Thus, the firm was disqualified, the court noting that most courts do not permit lawyers to drop a client like a hot potato in order to have the former client conflict rule apply, which permits lawyers to be adverse to a former client, just not in a matter that is substantially related to the work the firm performed for its former client.

So, in many ways, the case is no news.  But — and this is a “wow” statement –the court stated that the firm should have known when Altova obtained its patent that Altova was reasonably likely to sue for patent infringement, and, again, there’s no indication the firm obtained the patent for Altova or knew of its existence until Altova approached Firm A in June, 2017.  The court nonetheless wrote:

A reasonable lawyer should have known that there was a significant risk that Altova’s interests would become adverse to Syncro Soft’s concerning their competing XML products no later than November 2016 when Altova’s patent issued, and then should have obtained written, informed consent from both clients or withdrawn from representing both parties on that matter. The companies were direct competitors who sold similar XML editor software products. Sunstein knew that Altova vigorously protected its intellectual property rights. In fact, Altova had previously sent Syncro Soft a cease and desist letter related to alleged copyright infringement involving this software. For these reasons, this patent dispute is not the type of unforeseeable development contemplated by Comment 5. See Mass. R. Prof. C. 1.7 cmt. 5.

Hopefully, the case won’t be read as standing for the proposition that you need to monitor every patent one client obtains, to make sure you don’t have a conflict!

 

En Banc Federal Circuit: PTO Does Not Automatically Get Attorney Fees in Appeals and Civil Action Claims

by Dennis Crouch

In its new en banc opinion, the Federal Circuit has confirmed that the Patent Act does not require patent applicants to pay the USPTO’s attorney fees in Section 145 actions.  The USPTO had requested $100,000+ to compensate for the time of its in-house attorneys.

NantKwest, Inc. v. Iancu, 16-1794, 2018 U.S. App. LEXIS 20932 (Fed. Cir. 2018) (en banc).

35 U.S.C. 145 provides an unsuccessful patent applicant with the option of either (a) appealing the PTAB decision to the Federal Circuit or (b) filing a “civil action” in district court.  One kicker though – the statute provides that “All the expenses of the proceedings shall be paid by the applicant.”

Back in 2010, the Federal Circuit ruled that the statute allows the USPTO to collect expenses “regardless of the outcome.” Hyatt v. Kappos, 625 F.3d 1320 (Fed. Cir. 2010) (en banc).

In NantKwest, the original panel split on the meaning of “all the expenses” — with the majority holding that “expenses” include USPTO attorney fees (including in-house salaried attorney fees)..  That panel decision has now been rejected in a 7-4 decision with Judge Stoll penning the majority decision. Chief Judge PROST wrote in dissent and was joined by Judges Dyk, Reyna, and Hughes.

The court’s reasoning here is that the “American rule” on fees (each party pays for its own attorney fees) is a strongly embedded and any statutory rejection of the rule must be “specific and explicit.” The “all the expenses” language here does not meet that requirement — especially since such an interpretation would render this the only federal statute requiring “a private litigant to pay the government’s attorneys’ fees without regard to the party’s success in the litigation.”

The bottom line here is that patent applicants who challenge a PTAB decision will still be forced to pay other expenses such as printing costs and expert fees — but will not be required to pay the PTO attorney fees as a matter of course.

Trustees of Boston University v. Everlight: (Non)enablement of permutation #6

By Jason Rantanen

Trustees of Boston University v. Everlight Electronics Co., Ltd. (Fed. Cir. 2018) Download Opinion
Panel: Prost (author), Moore, Reyna

This opinion provides an example of how Section 112 can function as a commensurability requirement.  The court’s final lines say as much:

“Having obtained a claim construction that included a purely amorphous
layer within the scope of the claim, BU then needed to successfully defend against an enablement challenge as to the claim’s full scope…Put differently, if BU wanted to exclude others from what it regarded as its invention, its patent needed to teach the public how to make and use that invention. That is ‘part of the quid pro quo of the patent bargain.'”

Slip Op. at 14 (citations omitted).

I like the opinion because the court’s analysis fits neatly with my conceptual explanation of how enablement analyses are actually performed: it’s a two-step process, with the first step being the articulation of the relevant target and the second asking whether the patentee managed to hit that target.  Here, the court defined the target as consisting of one of six possible permutations under the claim construction the patent owner had sought.  Unfortunately, the evidence did not support the conclusion that a person having ordinary skill in the art could make that permutation without undue experimentation.

In the Federal Circuit’s words, Patent No. 5,686,738 “relates to the preparation of monocrystalline GaN films via molecular beam epitaxy.”  Slip Op. at 4. These films are used in creating blue light LEDs.  The plaintiff, Trustees of Boston University (BU), sued defendants for infringing the ‘738 patent.  Following a jury trial, BU obtained a verdict of infringement and no invalidity.  The district judge subsequently denied defendants’ renewed motion for judgment as a matter of law, in which defendants had argued that the asserted claim was not enabled.  Defendants appealed.

Only claim 19 of the ‘738 patent was at issue.  That claim states:

A semiconductor device comprising:

a substrate, said substrate consisting of a material selected from the group consisting of (100) silicon, (111) silicon, (0001) sapphire, (11-20) sapphire, (1-102) sapphire, (111) gallium aresenide, (100) gallium aresenide, magnesium oxide, zinc oxide and silicon carbide;
a non-single crystalline buffer layer, comprising a first material grown on said substrate, the first material consisting essentially of gallium nitride; and
a growth layer grown on the buffer layer, the growth layer comprising gallium nitride and a first dopant material.

Two constructions were key here.  The court construed “grown on” to mean “formed indirectly or directly above” and “a non-single crystalline buffer layer” to mean “a layer of material that is not monocrystalline, namely, [1] polycrystalline, [2] amorphous or [3] a mixture of polycrystalline and amorphous, located between the first substrate and the first growth layer.”  (emphasis added).  It also understood “growth layer” as including within its scope a monocrystalline growth layer.  BU did not challenge any of these constructions on appeal.

In the Federal Circuit’s view, collectively these constructions raised six possible permutations for the relationship between growth layer and buffer layer:

  • (1) monocrystalline growth layer formed indirectly on a polycrystalline buffer layer;
  • (2) monocrystalline growth layer formed indirectly on a buffer layer that is a mixture of polycrystalline and amorphous;
  • (3) monocrystalline growth layer formed indirectly on an amorphous buffer
    layer;
  • (4) monocrystalline growth layer formed directly on a polycrystalline buffer layer; (5) monocrystalline growth layer formed directly on a buffer layer that is a mixture of polycrystalline and amorphous; and
  • (6) monocrystalline growth layer formed directly on an amorphous buffer layer.

Slip Op. at 6. Of these six permutations, defendants focused their enablement argument on #6: whether a person of ordinary skill in the art could practice the invention with a monocrystalline growth layer formed directly on an amorphous buffer layer.

With the court’s attention focused on permutation #6, the enablement analysis was relatively straightforward.  The evidence supporting enablement of #6 was weak: the only technique described in the patent, epitaxy, doesn’t work to grow a growth layer directly on an amorphous structure.  BU tried to argue that the patent didn’t actually teach epitaxy, but the court was unpersuaded: “The ’738 patent’s specification is concise—just over four columns of text—and focuses on epitaxy. Indeed, it is saturated with the word ‘epitaxy’ or variants thereof.”  Id. at 9.  BU also argued that what the patent taught could not be epitaxy “because epitaxy invovles a crystalline layer on top of another crystalline layer,” and an amorphous layer is not “crystalline.”  Id. at 10.  But regardless of whether one called it epitaxy or not, the problem was that  BU couldn’t identify anywhere in the specification that taught how to grow a monocrystalline layer directly on an amorphous layer.  Nor was the expert testimony sufficient as it consisted of conclusory statements.  Testimony that other people had successfully grown a monocrystalline layer on top of an amorphous buffer layer didn’t help either, as “[s]imply observing that it could be done–years after the patent’s effective filing date–bears little on the enablement inquiry.”  Id. at 12.

In light of how the court understood the focus of the enablement issue, BU’s final argument–that the specification enabled 5 out of the 6 permutations and that was enough–didn’t work.  The court cited the “full scope” language from precedent here, and the “gap-filling” approach didn’t work here since that concept “is merely supplemental; it cannot substitute for a basic enabling disclosure.”   Ultimately, the court concluded that the patent needed to enable all six permutations–a result consistent, the court noted, with the claim constructions that BU itself had sought.  In the end, the court saw this as being in the vein of Liebel-Flarsheim: if you get the claim scope you ask for through construction, you’re also going to need to show enablement of that scope.

For enablement-timing gurus, there’s some interesting language in the section about the post-application successes to ponder.

Fourth Estate Public Benefit Corp. v. Wall-Street.com

In addition to the one patent case (Helsinn), the Supreme Court also has one Copyright case lined-up for its October 2018 term:

Fourth Estate Public Benefit Corp. v. Wall-Street.com, No. 17-571

Section 411(a) of the Copyright Act provides that “no civil action for infringement of the copyright in any United States work shall be instituted until” either (1) “registration of the copyright claim has been made in accordance with this title,” or (2) “the deposit, application, and fee required for registration have been delivered
to the Copyright Office in proper form and registration has been refused.” 17 U.S.C. 411(a).

The question presented is as follows: Whether a copyright owner may commence an infringement suit after delivering the proper deposit, application, and fee to the Copyright Office, but before the Register of Copyrights has acted on the application for registration.

ScotusBlog has the Briefs

Patently-O Bits and Bytes by Juvan Bonni

Recent Headlines in the IP World:

Commentary and Journal Articles:

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Saint Regis Mohawk Tribe, Allergan v. Mylan: No Tribal Immunity for IPR

By Jason Rantanen

Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., AKORN, Inc. (Fed. Cir. 2018) Download Opinion

Panel: Dyk (concurring), Moore (author), Reyna

Last fall, Allergan transferred a set of patents relating to its Restasis product (the “Restasis Patents”) to the Saint Regis Mohawk Tribe (“the Tribe”). The Tribe promptly asserted tribal sovereign immunity in the pending inter partes review proceedings involving the Restasis patents.  In February, the PTAB denied the Tribe’s motion to terminate the IPRs, a decision the Tribe appealed.  Following an expedited briefing schedule, the Federal Circuit has now affirmed the PTAB’s denial of sovereign immunity.

The panel opinion, joined by all three judges, addressed only one of the arguments against sovereign immunity: that under the Supreme Court’s analysis in Fed. Maritime Comm’n v. S.C. State Ports Auth., 535 U.S. 743 (2002), tribal sovereign immunity does not apply.  It’s important to note at the outset that “Generally, immunity does not apply where the federal government acting through an agency engages in an investigative action or pursues an adjudicatory agency action.”   Slip Op. at 5.

The Court in FMC looked to whether the adjudications at issue were “the type of proceedings from which the Framers would have thought the States possessed immunity when they agreed to enter the Union.”  Id. at 5-6. In particular, the Federal Circuit observed that “[i]n doing so, the Court recognized a distinction between adjudicative proceedings brought against a state by a private party and agency-initiated enforcement proceedings.”  Id. at 6.

This question is similar to that of whether an administrative agency can hear a dispute at all, and unsurprisingly the court looked to the Supreme Court’s recent decisions for guidance.  “IPR is neither clearly a judicial proceeding instituted
by a private party nor clearly an enforcement action brought by the federal government,” the court observed, before comparing the views offered by the Court in Oil States v. Greene’s Energy and SAS v. Iancu.  Ultimately, the court concluded, “IPR is more like an agency enforcement action than a civil suit brought by a private party….”  Thus, “we conclude that tribal immunity is not implicated.”  Id. at 8.

How is IPR more like an agency enforcement action?  For one thing, the Director chooses whether to institute an IPR.  And while that discretion is limited to an all-or-none decision under SAS, “if the Director decides not to institute, for whatever reason, there is no review.”  Id. at 8.  In addition, “the Board may choose to continue review even if the petitioner chooses not to participate,” reinforcing “the view that IPR is an act by the agency in reconsidering its own grant of a public franchise.”   Id. at 9.  There are also differences between the IPR rules of procedure and the Federal Rules of Civil Procedure; because of these distinctions “the agency procedures in FM much more closely approximated a civil litigation than those in IPR.”  Id. at 10.  Nor does the existence of more “inquisitorial” proceedings in which sovereign immunity would not apply, such as ex parte and inter parte reexamination, mean that sovereign immunity must apply to IPRs.

Judge Dyk joined the panel opinion in full, but wrote separately to describe the history of inter partes review and why those reviews are not adjudications between private parties.  His opinion is a great reference if one wants a thorough description of the history of the proceeding, complete with numerous source citations.

This dispute is clearly not at an end, and I suspect that the Tribe and Allergan will seek en banc review, if not head straight for a cert petition.  Given the expedited briefing schedule, I expect this issue to continue to move quickly.  At the same time, however, keep in mind that in the parallel infringement proceeding in the Eastern District of Texas,  Judge Bryson (sitting by designation) found the Restasis Patents obvious following a bench trial.  Allergan (now joined by the Tribe) appealed that determination.  Oral argument is currently scheduled for September.

Supreme Court Update – July 2018

by Dennis Crouch

Each summer, the Supreme Court takes a recess and patent cases begin to pile-up in the high-court’s docket. Only a handful of intellectual property petitions are granted certiorari each year, but almost all of the petitions raise interesting and important issues of law and policy.

The following is a comprehensive list of Patent cases pending before the Supreme Court.  I have excluded a small handful that have (in my estimation) no shot at certiorari and also fail to raise interesting patent law issues.

Petitions Granted:

  1. Prior Art – On Sale Bar: Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., No. 17-1229. This case questions whether 102(a) prior art under the AIA is limited to publicly available prior art. Particularly, does a pre-filing sale of the invention count as “on sale” prior art where the sale was a private sale that did not publicly disclose the invention? Merits briefing should be complete in October with oral arguments likely held in November 2018.

Petitions for Writ of Certiorari Pending:

  1. Inequitable Conduct: Regeneron Pharmaceuticals, Inc. v. Merus N.V., No. 17-1616. The question presented is “Whether a patent right can be fully extinguished based on misconduct committed by the patentee’s counsel during federal district court litigation to enforce the patent right.”
  2. Validity – Indefiniteness: American Technical Ceramics Corp. v. Presidio Components, Inc., No. 17-1497 (Can a patent’s definiteness be proven based wholly upon post-filing evidence?)
  3. Damages – Enhanced Damages: Bombardier Recreational Products Inc., et al. v. Arctic Cat Inc., No. 17-1645 (Can treble damages for “willful infringement” be based upon a “should have known” standard?)
  4. Validity – Obviousness: Nichia Corporation, et al. v. Everlight Electronics Co., Ltd., et al., No. 17-1707 (Treating obviousness as a question of fact vs law).
  5. Validity – Obviousness: B/E Aerospace, Inc. v. C&D Zodiac, Inc., No. 17-1252 (Process of obviousness analysis — is there first a prima facie obviousness analysis followed by consideration of objective indicia of non-obviousness?)
  6. Procedure – Standing for AIA Trials: Return Mail, Inc. v. United States Postal Service, No. 17-1594 (Whether the government is a “person” who can petition to institute a CBM;  Does a 1498(a) action count as an infringement action?)
  7. Procedure – Standing of AIA Trials: RPX Corporation v. ChanBond LLC, No. 17-1686 (What is required for a petitioner to have standing to appeal an AIA Trial final decision?)
  8. Procedure – Impact of Factual Stipulation: Allergan Sales, LLC v. Sandoz, Inc., et al., No. 18-21 (may the court “ignore a factual stipulation”).
  9. Procedure – Federal Court Patent Jurisdiction: Alexsam, Inc. v. Wildcard Systems, Inc., et al., No. 17-1483 (Does a breach-of-patent-license lawsuit arise under the Federal Patent laws?)
  10. Procedure – Joinder of Co-Owner: Advanced Video Technologies LLC v. HTC Corporation, et al., No. 18-77 (When we have co-owners of a patent, can one co-owner use Fed. R. Civ. Pro. R. 19 to force joinder of the other co-owner in an infringement lawsuit?)
  11. Procedure – Timing of New Trial Motion: Promega Corporation v. Life Technologies Corporation, et al., No. 17-1669.
  12. Inventor Rights: Leitner-Wise v. LWRC International, LLC, et al., No. 18-52.  Leitner-Wise (the inventor) assigned his patent rights as part of a royalty agreement that have not been by the subsequent assignee.  May he now sue the assignee for infringement?
  13. Patent Eligibility: Integrated Technological Systems, Inc. v. First Internet Bank of Indiana, No. 17-1590 (“Does 35 U.S.C. § 282 allow for challenges to a patent’s validity based on patent eligibility under 35 U.S.C. § 101?”)
  14. AIA Trials and Appeals: Stambler v. Mastercard International Inc., No. 17-1140 (Can Congress revoke a patent owner’s right to have the validity of his patent determined by a jury trial before an Article III forum after his patent issues; and (2) whether Federal Circuit Rule 36 contravenes 35 U.S.C. § 144.).
  15. Infringement — Ensnarement as a Defense: Jang v. Boston Scientific Corporation, et al., No. 17-1332 (“Whether the Federal Circuit’s “ensnarement” defense to infringement [under the doctrine of equivalents] violates patent holders’ Seventh Amendment jury-trial rights.”)
  16. Prior Art – Effective Date of Prior Art: Ariosa Diagnostics Inc. v. Illumina Inc, No. 18-****.  (“If a patent discloses but does not claim an invention, does that disclosure qualify as prior art as of the date of the application in which it was first made, such that no one else may patent the same invention based on a later-filed application?”)

 

[UPDATED] The Patent-Antitrust Debate Annotated

Professor Patterson’s antitrust essay has been updated.  I had inadvertently posted a draft version. ☹ – DDC

= = =

Guest Post by Professor Mark R. Patterson (Fordham)

The past few months have seen a remarkable back-and-forth between Makan Delrahim, the Assistant Attorney General for the Antitrust Division of the Department of Justice, and attorneys both objecting to and supporting his views on standard-essential patents (SEPs) and standard-setting organizations (SSOs). For parties who are interested in this controversy but who do not have time to review and compare all the documents, I have annotated them, with Acrobat sticky notes keyed to highlighting of text.

To put my cards on the table, I am largely in agreement with AAG Delrahim’s critics, though I did not sign either of their letters. I agree with Delrahim that it is reasonable to devote scrutiny to the patent “hold-out” problem that is his focus, but doing so does not require dismissing a well-established consensus on the validity and harm of patent “hold-up.” The most compelling evidence for hold-up, it seems to me, is the 100-to-1 ratio of royalty demands to royalty awards that have been seen in some cases. Perhaps that differential is the product of confused courts, but despite the calls of AAG Delrahim and his supporters for evidence or more evidence for hold-up, they themselves provide nothing to show that the courts are confused. Nor do they provide empirical evidence to demonstrate the claimed greater importance of hold-out.

In the (currently) final document from AAG Delrahim in this saga, he states that the DoJ is “not able to comment on any pending investigation or evidence that [they] have reviewed.” As I note on that document, the possible problems he suggests might turn out to be present in the SEP context, perhaps in the process of the 2015 amendment of the IEEE’s patent policy, to which the speeches might obliquely refer. If so, his speeches will merely have been valid warnings to SSOs. Again, though, the speeches seem to go much further than necessary in dismissing other problems.

I make no claim to complete objectivity or thoroughness in my annotations, which are only my immediate responses to various points made in the documents. But I have pointed out what I think are weak points and strong points not only in the comments of Delrahim and his supporters but also in the responses of his critics. Also, some of my points in some of the documents are raised also in others, but I have tried to avoid duplication.

Finally, the annotation approach that I take here might seem more argumentative than necessary. Obviously neither my own writings nor anyone else’s would emerge unscathed from such an approach, but some of the rhetoric in these documents is best addressed in this way. I also think this approach is warranted by the importance of the issues, the dramatic differences in the views expressed, and the unfamiliarity of some with these issues. This controversy deserves even more attention than it has already received.

Mark R. Patterson is a Professor of Law at Fordham University School of Law. 

 

Sci-Fi & Information Law: Essay Competition

The University of Amsterdam’s Institute for Information Law recently announced its essay competition: “Science Fiction and Information Law.”

Authors in both ‘genres’ dedicate a considerable share of their time speculating about how [new] technologies may evolve. Most importantly, science fiction authors, as well as information law scholars, ponder what the implications will be for society, markets and the values that we cherish and seek to protect. . . .

We welcome essays that reflect on our possible data-driven future, where data has been firmly established as an economic asset and new, data-driven smart technologies can change the way we live, work, love, think and vote. How will AI change politics, democracy or the future of the media? What will life be like with robot judges and digital professors? What is the future of transportation in the wake of drones, the autonomous car and perfect matching of transportation needs? Is there a life beyond the ubiquity of social media: Is there bound to be an anti-thesis and if so, what will the synthesis look like? What will happen when social media corporations start fully-fledged co-operation with the police? Or unleash the power of public engagement to solve or prevent crime by themselves? How would crime respond to all this? What could be the true implications of the ‘data economy’ and if we really can pay our bills with our data? How will future information law look like in the age of AI?

The essays will be read and judged — the top five will receive awards, published in the Internet Policy Review, and the authors invited to Amsterdam for a public symposium.

Rules:

  • 8000-15000 words in English.
  • Authors might already be sci-fi authors, but might come from any realm.
  • Essay emailed to Prof. Helberger n.helberger@uva.nl by December 15, 2018.

 

Ariosa Diagnostics v. Illumina: Prior Art Date of a Provisional Patent Application

by Dennis Crouch

The new petition for writ of certiorari in Ariosa raises the questions of what “counts” as prior art — what is disclosed or what is claimed?  The petition asks:

If a patent discloses but does not claim an invention, does that disclosure qualify as prior art as of the date of the application in which it was first made, such that no one else may patent the same invention based on a later-filed application?

[Ariosa Diagnostics Inc. v. Illumina Inc. – cert. petition].  Here, the prior art statute at issue is pre-AIA 102(e), whose equivalent is in the post-AIA 102(a)(2).  The statute seems to squarely answer the question above — a disclosure in an issued US patent will count as prior art as of its filing date regardless of whether the all features of the disclosure were actually claimed in the patent.

102 A person shall be entitled to a patent unless (e) the invention was described in . . . (2) a patent granted on an application for patent by another filed in the United States before before the invention by the applicant for patent.

In the simple case outlined above, the courts all agree that the disclosures found in an issued patent or published application  count as prior art as of the patent’s filing date.  The difficulty comes when we bring priority-claims into play (such as priority to a provisional application).

In this case, the Federal Circuit ruled that a published application can count as prior art as of its provisional filing date — but only as to features actually claimed in the application.  According to the court, features disclosed in the provisional but not claimed in the published application will only be prior art as of their date of public disclosure.

The patent challenger argues that this interpretation is wrong — and particularly that the effect of the priority claim should be governed by 35 U.S.C. §§ 119(e)(1) and 120, which provide for applications properly claiming priority back to an earlier filing “shall have the same effect, as to such invention, as though filed on” the earlier date.  On the other side – the statutory hook for the Federal Circuit’s limitation here is the fact that the statute gives priority for “the invention” — i.e., the claimed invention — but not for the disclosure as a whole. In addition Sections 119 and 120 develop the rules for patents claiming priority — not for prior art.

In the petition, the patent challenger offers the following question:

Question presented: Do unclaimed disclosures in a published patent application and an earlier application it relies on for priority enter the public domain and thus become prior art as of the earlier application’s filing date, or, as the Federal Circuit held, does the prior art date of the disclosures depend on whether the published application also claims subject matter from the earlier application?

There are several important prior cases on-point:

  • Alexander Milburn Co. v. Davis-Bournonville Co., 270 U.S. 390 (1926) (judicially establishing the precursor to 102(e)).
  • Hazeltine Research, Inc. v. Brenner, 382 U.S. 252 (1965)
  • In re Wertheim, 646 F.2d 527 (C.C.P.A. 1981)
  • Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir. 2015)

The petition cites my Patently-O commentary on the situation in which I argue that a disclosure’s prior art status should not depend upon what is claimed.

A leading commentator has observed that “[a]nyone who works with prior art knows that this setup is an oddball way to address the situation. A patent’s disclosure for prior art purposes should not depend upon what was claimed or not but instead should focus on what was disclosed.” Dennis Crouch, Federal Circuit Backtracks (A bit) on Prior Art Status of Provisional Applications and Gives us a Disturbing Result; see also id. (“The result here is silly—and somewhat disturbing—that under the first-to-invent rule the second inventor gets a patent.”).

Although it is unclear, I don’t believe that the AIA will be seen to have changed the statute in a way that changes the rule here.  Thus, the outcome of this case will likely bind post-AIA cases as well.

Upping the Trade War with China

Earlier in 2018, the Office of the US Trade Representative (USTR) imposed a 25% added-value tariff on a set of particular Chinese-made products expected to valued at about $34 billion per year.  A prior notice indicated a plan to increase the 25% tariff to $50 billion worth of goods (an additional $16 billion on Chinese goods ).  Doing the math here – the US is planning here to collect $12.5 billion in tax revenue from the Chinese goods entering into the US. Although a tariff already applied to most Chinese imports, the rate is usually less than 5%.

As expected, in response to the US tariffs, China imposed increased duties on US goods.

The USTR has now proposed upping the bet — this time “in the form of an additional 10 percent ad valorem duty on products of China with an annual trade value of approximately $200 billion.” [FR Notice].   Easy math: the new 10% tax should raise an additional $20 billion in general revenue for the U.S. Government.

China cannot match this added tariff in direct parallel fashion – Since the U.S. only exports about $130 billion to China per year.  However, China could instead collect the $20 billion with a higher duty; impose quotas; or apply some other non-tariff countermeasure (such as by adjusting IP rights owned by US entities).

In addition to each country’s unilateral measures, both countries (as well as our other global trading partners) have taken their cases to the World Trade Organization (WTO) asking for enforcement of the rules of The General Agreement on Tariffs and Trade (GATT) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Trade Secret Litigation in Federal Court

LexMachina has released a new report on Trade Secret litigation in Federal Court.

The basics: Federal Trade Secret litigation is up about 30% following enactment of the Defend Trade Secrets Act (DTSA) in 2016.  (1134 cases filed in 2017). The DTSA created a federal cause of action for trade secret litigation and resulting original jurisdiction in federal court for the federal claims. Prior to the DTSA, state-law trade secret claims found their way into federal court either via supplemental jurisdiction (typically linked to an a federal IP claim) or via diversity jurisdiction (parties from different states).

The vast majority of trade secret actions include additional causes of action — most often breach of contract or other commercial law claim.

[Report here – Registration Required]

Actual Use vs Inherent Disclosure: Endo v. Custopharm

Endo Pharms. Sols., Inc. v. Custopharm Inc., — F.3d —, 2018 U.S. App. LEXIS 19265 (Fed. Cir. 2018).

by Dennis Crouch

Endo’s injectable testosterone Aveed is listed in the Orange Book as being covered by Bayer’s U.S. Patent Nos. 7,718,640 and 8,338,395.  Endo and Bayer sued Custopharm after it submitted an Abbreviated New Drug Application (ANDA) to produce a generic version. (Under 35 U.S.C. 271(e), submission of the ANDA is an act of infringement).

On appeal, the Federal Circuit has sided with the patentee — affirming the district court judgment of validity.

The claimed invention here requires the use of testosterone undecanoate (TU) at a concentration of 250 mg/ml in a vehicle containing a mixture of about 40% castor oil and 60% benzyl benzoate. (Claim 1 of the ‘640 patent). Three key prior art references are all research articles that report using the same concentration of TU and also the castor oil.  The prior-art articles do not, however, actually report that benzyl benzoate was used — it turns out though that the researchers (including one overlapping listed inventor here) used the same 40/60 split of castor oil and benzyl benzoate.  The asserted claim 2 adds a limitation that 750 mg TU is injected — the articles describe the use of 1000 mg.

A primary question on appeal was whether the prior art articles inherently taught the benzyl benzoate concentration. “Custopharm contends that the Articles inherently describe the vehicle formulation (40% castor oil and 60% benzyl benzoate).”

The inherency doctrine has been quite limited by the Federal Circuit — Under the law, a prior art reference inherently discloses a claim limitation only when “the
limitation at issue necessarily must be present, or [is] the natural result of the combination of elements explicitly disclosed by the prior art.” Par Pharmaceutical, Inc. v. TWI Pharmaceutical, Inc., 773 F.3d 1186 (Fed. Cir. 2014).

In this case, we know that 60% benzyl benzoate concentration was actually present in the prior art experiments, but that knowledge was not expressly part of the prior art. Thus, the court focused on whether the existence of benzyl benzoate was necessary based upon the prior art itself. From that frame of reference, the elements were not inherently disclosed by the prior art.

The district court reasonably found that this was not enough “to establish [with clear and convincing evidence] that the Articles barred the possibility of an alternative vehicle being used in the prior art compositions” to meet the rigorous standard of inherency.

Prior Publications Compared with Prior Uses or Sales: I believe that this case could have come out differently if the challengers had been able to rely upon the uses in the experiments as prior sales or public uses. In those circumstances, the question would focus on what was actually in the injection rather than what was publicly known or disclosed about the injection. My conjecture here appears to be based upon alternative facts since the articles in-question stem from research studies and so were likely sufficiently protected by secrecy and experimental use limitations.

The other question here is what to do about the fact that Bayer (or its predecessor) was involved with the prior art articles.  Here, Doris Hübler is the first named inventor on the patents at issue and also one of the authors of the prior art article and that Bayer provided the TU ampules used for the testing.  I believe that the answer here is that Bayer only runs into trouble here if (1)the experiments count as commercialization under cases such as Metallizing Engineering or (2) Bayer somehow abandoned the invention. Neither of these appear appear to fit here.

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USPTO: Claim Construction in AIA Trials

Claim construction continues to hold focus as the centerpiece of contested patent cases — both in court and in administrative AIA trials (primarily, Inter Partes Review proceedings) before the Patent Trial and Appeal Board (PTAB).  One element of current practice is that the USPTO applies a different standard for construing claims than do courts or the USITC in infringement litigation. (Compare Broadest Reasonable Interpretation with Phillips / Ordinary Meaning standards).

One of PTO Director Iancu’s early initiatives has been to unify the standards.  That process began with a notice of proposed rulemaking with finalized rules coming later this fall.

The USPTO has posted comments submitted on the proposed change — with over 350 submissions.  Although the bulk of submissions favor the change, a substantial number also argue that the BRI standard is an important aspect of IPR effectiveness — with the beneficial result of lowering consumer costs and improving access to medicines. It will take some time to review these comments.

I was involved in two of the submissions:

  • Professors of Law: Supporting change as promoting uniformity and clarity. Although I provided some input on this document, the primary drafter was Prof. Vishnubhakat (Tex.A&M).
  • Prof. Crouch:  I also submitted my own memo highlighting the issue of estoppel and deference to claim construction by other tribunals.  The proposed rule do not address directly these issues, and I suggest that the USPTO should establish its rules and practices associated with PTAB Trial Proceeding claim construction in a way that best ensures that later tribunals will honor those constructions.

Other Law Prof Submissions:

  • Profs. Sarnoff and Ghosh: “We generally support the idea of a unitary post-grant interpretive standard in the PTO and the courts. However, we . . . encourage you to seek legislation to require the courts to adopt BRI for infringement litigation.” (Same from Prof. Dreyfuss).

Jazz Pharms: Federal Register; Public Notice; and Printed Publications

Jazz Pharms., Inc. v. Amneal Pharms., Inc., — F.3d —, 2018 U.S. App. LEXIS 19268 (Fed. Cir. 2018)

The patented invention at issue in Jazz Pharms is not a drug or drug treatment, but rather to a “drug distribution system for tracking prescriptions” for drugs with a risk of abuse[1]  The PTAB found claims from all six patents to be invalid as obvious.

The core issue on appeal was whether a pre-filing disclosure by Jazz counted as a prior art “printed publication.”

Printed Publication: As the language suggests, a “printed publication” must be both “printed” and also a “publication.”  These requirements though have been broadly construed.  “Printed” publications go well beyond physical hard-copies to allow for various media – including video and online forms.  To be a “publication,” the reference needs to be made sufficiently available to the public – publication.  In the leading case of In re Hall,[2] the Federal Circuit explained that accessibility to the relevant public is key – we ask “whether interested members of the relevant public could obtain the information if they wanted to.”  Although the court has developed a number of guide posts, the question of sufficient availability is seen as a factual inquiry handled on a case-by-case basis.

The prior art here was developed as part of an FDA drug safety review for one of Jazz’s drug products that was known as a potential date-rape drug.  In May 2001, the FDA announced in the Federal Register an upcoming public meeting – noting that the focus of the meeting would be on risk management for the drug.  The notice included a hyperlink to the pin-cite that eventually included meeting information, including background material, minutes, transcripts, and slides.

With these facts, Jazz Pharms appears an easy case – the materials were freely available online and relevant members of the public were directed to the material via the official public source.

A few caveats here:

  • The materials were not proven to be searchable or indexed at the time. In response, the court explained that these are not required elements of publication if sufficiently disseminated via other mechanisms.
  • Jazz argued that folks of skill would not have seen the notice in the Federal Register and therefore not have been pointed to the underlying documents. In response, the Federal Circuit explained that a Federal Register notice might not always be sufficient to place the relevant public on notice of a publication, but that it was sufficient in this case since it was indexed and directed toward members of the public interested in systems to protect the public from potentially dangerous drugs.  The court also endorsed the PTAB’s “sensible observation that the purpose of the Federal Register is to provide notice of government action such as the advisory committee meeting here.”

Note here that with publication, the touch stone is “accessibility” rather than “actual access.”  The court has repeatedly explained that “[i]f accessibility is proved, there is no requirement to show that particular members of the public actually received the information.”  Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560 (Fed. Cir. 1988).

= = = =

[1] U.S. Patents 7,668,730, 7,765,106, 7,765,107, 7,895,059, 8,589,182, 8,457,988.

[2] In re Hall, 781 F.2d 897 (Fed. Cir. 1986).

Practice before the PTAB: Recent Informative Decisions

The USPTO has recently designated five PTAB decisions as “informative.” (I have also included the recent Western Digital decision as well).