Biogen patent on interferon multiple sclerosis drug invalidated

A jury in the federal district court of New Jersey on 23 February 2018 found that U.S. Patent Number 7,588,755 (related to the MS drug Avonex) was invalid, getting Serono's product Rebif off the hook.

From Investors.com


The jury invalidated Biogen's patent, finding that prior knowledge existed of interferons as a treatment for a number of different medical conditions. Biogen had tried to argue that Pfizer and EMD Serono had infringed on two claims of the patent.

"As a result of this finding, there is effectively no patent to infringe and no royalty or settlement obligation payable by Serono to Biogen," [Leerink analyst Geoffrey ] Porges said. "Biogen was seeking multibillion-dollar damages on the basis of a claimed 8.5% royalty on future and prior sales, as well as damages."

(...)

Biogen declined to comment to Investor's Business Daily on the case. The biotech "will have to look hard at the cost of continuing this litigation to appeal, for what is a declining product and a trial with a low probability of legal success," Porges said.

Porges doesn't expect a flood of generic entrants to the class. Interferons are in decline, but still represent a $5.5 billion revenue category. The challenges of manufacturing, developing and commercializing a biosimilar version of interferon are significant.



link: https://www.investors.com/news/technology/biogens-multiple-sclerosis-drug-franchise-takes-another-hit/

Pfizer and EMD Serono have been selling Rebif.

Patent lawyers as magicians?

Many of the "patent law" blogs have been silent on Judge Stark's ruling in favor of Gilead in the hepatitis C dispute. Law.com emphasized the lawyers rather than the substance.

Scott Graham of Law.com on the Stark decision in Idenix/Merck v. Gilead in post Skilled in the Art: Gilead's Houdini Act :


I begin today by asking: Is Fish & Richardson partner Jonathan Singer a distant relative of Harry Houdini? Once again Fish and Singer— this time with help from Irell & Manella and Orrick—have wriggled out of a massive verdict that a jury slapped on client Gilead Sciences Inc.

Fish and Gilead took a $2.5 billion hit in Delaware federal court in December 2016. Jurors found that Gilead willfully infringed a Merck patent on a hepatitis C treatment. But on Friday U.S. District Judge Leonard Stark granted Gilead’s post-trial motion to invalidate Merck’s patent for enablement, saying essentially that the patent wasn’t precise enough to predict breakthrough medicines like Gilead’s sofosbuvir.

Sound familiar? Yes, it does. In 2015 Merck scored a $200 million verdict against Gilead— same medication, different patents—but U.S. District Judge Beth Labson Freeman threw it out based on Merck’s unclean hands. Singer argued both that motion to Freeman and the enablement motion decided Friday.



A key part of the opinion of Judge Stark relies on text from the 2007 post-Supreme Court Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334; 83 U.S.P.Q.2D (BNA) 1673 (CAFC 2007) ; for convenience IPBiz includes the FULL text of the paragraph:


The rule that a jury verdict is reviewed for support by "substantial evidence" does not mean that the reviewing court must ignore the evidence that does not support the verdict. See Reeves, 530 U.S. at 150-51 ("in entertaining a motion for judgment as a matter of law, the court should review all of the evidence in the record"). The Court in Reeves stated that "[i]n the analogous context of summary judgment under Rule 56, we have stated that the court must review the record 'taken as a whole'," citing Matsushita Elec. Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S. Ct. 1348, 89 L. Ed. 2d 538 [page 1682] (1986), and observed that "the standard for granting summary judgment 'mirrors' the standard for judgment as a matter of law, such that 'the inquiry under each is the same'," citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250-251, 106 S. Ct. 2505, 91 L. Ed. 2d 202 (1986). Thus the Court pointed out that "the court must draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence," Reeves, 530 U.S. at 150, but cautioning that "although the court should review the record as a whole, it must disregard all evidence favorable to the moving party that the jury is not required to believe. See 9A Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure § 2529, p. 299 (2d ed. 1995). That is, the court should give credence to the evidence favoring the nonmovant as well as that 'evidence supporting the moving party that is uncontradicted and unimpeached'." Id. (citations omitted).



The portion cited in the opinion by Judge Stark is as follows:


"The rule that a jury verdict is reviewed for support by 'substantial evidence' does not mean that the reviewing court must ignore the evidence that does not support the verdict.... That is, the court should give credence to the evidence favoring the nonmovant as well as that evidence supporting the moving party that is uncontradicted and unimpeached." Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334, 1345 (Fed. Cir. 2007).



Judge Newman, in dissent in Malta v. Schulmerich Carillons, Inc., 952 F.2d 1320; 21 U.S.P.Q.2D (BNA) 1161 (CAFC 1991), laid out the standards for "substantial evidence," drawing in part from cases in the Third Circuit Court of Appeals:


The standard of judicial review of jury verdicts is established. Sometimes described as a "reasonable jury" standard and sometimes as a "substantial evidence" standard, the challenger must show that there was not an evidentiary basis for the verdict. As discussed by the Court:

But where, as here, there is an evidentiary basis for the jury's verdict, the jury is free to discard or disbelieve whatever facts are inconsistent with its conclusion. And the appellate court's function is exhausted when that evidentiary basis becomes apparent, it being immaterial that the court might draw a contrary inference or feel that another conclusion is more reasonable.

Lavender v. Kurn, 327 U.S. 645, 653, 90 L. Ed. 916 , 66 S. Ct. 740 (1946). This standard has its roots in the Constitution and in tradition, for the principles underlying the jury right require that the jury verdict receive judicial deference.

Many illustrations of the requisite standard of appellate review of jury verdicts appear in the precedent of the Third Circuit. 1Link to the text of the note [page 1171] E.g., Chuy v. Philadelphia Eagles Football Club, 595 F.2d 1265, 1273 (3d Cir. 1979) (en banc) ("Our limited function at this point is to ascertain from review of the record whether there is sufficient evidence to sustain the verdict of the jury on this issue"); Dawson v. Chrysler Corp., 630 F.2d 950, 959 (3d Cir. 1980), cert. denied, 450 U.S. 959, 67 L. Ed. 2d 383 , 101 S. Ct. 1418 (1981) (the jury verdict must be sustained unless the record "is critically deficient of that minimum quantum of evidence from which a jury might reasonably [page 1333] afford relief"), quoting Denneny v. Siegel, 407 F.2d 433, 439 (3d Cir. 1969).

Federal Circuit decisions have well illustrated this standard. E.g., Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1571, 1 USPQ2d 1081, 1085 (Fed. Cir. 1986):

To convince this court that a trial judge erred in granting a motion for JNOV, an appellant need only show that there was substantial evidence to support the jury's findings and that those findings can support the jury's legal conclusion.

Also, e.g., DMI, Inc. v. Deere & Co., 802 F.2d 421, 425, 231 USPQ 276, 278 (Fed. Cir. 1986) (to reverse the jury, the findings must not be supported by substantial evidence); Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 619, 225 USPQ 634, 636 (Fed. Cir.), cert. dismissed, 474 U.S. 976 (1985) (determining from the evidence as a whole whether there was substantial evidence in support of the jury verdict); Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893, 221 USPQ 669, 673 (Fed. Cir.), cert. denied, 469 U.S. 857, 83 L. Ed. 2d 120 , 105 S. Ct. 187, 225 U.S.P.Q. (BNA) 792 (1984) ("only when the court is convinced upon the record before the jury that reasonable persons could not have reached a verdict for the non-mover, should it grant the motion for JNOV.")

On judicial review following a duly made motion for judgment n.o.v, the evidence must be viewed and reasonable inferences drawn in the light most favorable to the party with the jury verdict. Continental Ore Co. v. Union Carbide & Carbon Corp., 370 U.S. 690, 696, 8 L. Ed. 2d 777 , 82 S. Ct. 1404 (1962); Danny Kresky Enterprises Corp. v. Magid, 716 F.2d 206, 209 (3d Cir. 1983); Chuy, 595 F.2d at 1273. The reviewing court is not free to reweigh the evidence or substitute its own judgment for that of the jury, Blair v. Manhattan Life Ins. Co., 692 F.2d 296, 300 (3d Cir. 1982), or to pass on the credibility of witnesses. Kinnel v. Mid-Atlantic Mausoleums, Inc., 850 F.2d 958, 961 (3d Cir. 1988).

Those functions are assigned to the fact-finder, in this case the jury. Our function is to determine only whether there is evidence upon which the jury could properly return a verdict, viewing the evidence most favorably to Kinnel the non-movant, and giving Kinnel the benefit of all reasonable inferences.

Id. at 961-62.

The Federal Circuit is in accord. E.g., Orthokinetics, 806 F.2d at 1572-73, 1 USPQ2d at 1085-86 (it is "a misunderstanding of our appellate role" for this court to determine what is supported by the evidence as a whole, rather than whether the evidence the jury could have believed was substantial); Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1546, 220 USPQ 193, 197 (Fed. Cir. 1983) (the appellate court must consider all the evidence in the light most favorable to the non-movant, must not determine the credibility of witnesses, and must not substitute its choice for that of the jury in finding facts, drawing inferences, or deciding between conflicting elements in the evidence). These are functions of the trier of fact, not the reviewing court.



Of review for "substantial evidence," the Court of Appeals for the Federal Circuit had stated in Hoechst Celanese Corp. v. BP Chems. Ltd., 78 F.3d 1575: [jury] determination must be upheld if any set of facts supported by substantial evidence is capable of sustaining the verdict. Orthokinetics, 806 F.2d at 1580, 1 U.S.P.Q.2D (BNA) at 1091.

In Pharmastem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 , the CAFC stated:


Thus, in reviewing the denial of the JMOL motion on the issue of obviousness, we examine the evidence in the light most favorable to the verdict and determine whether a reasonable jury could have found all the facts necessary to support the verdict of nonobviousness, i.e., whether substantial evidence supports the verdict. See Caver v. City of Trenton, 420 F.3d 243, 262 (3d Cir. 2005); Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1546 (Fed. Cir. 1983).



See post on IPBiz on 18 Feb 18:

US District Court of Delaware rules against Merck in case related to hepatitis C drugs Sovaldi and Harvoni

Croatian judge files criminal complaints against members of ethics committee

Science reports on a complicated plagiarism issue in the story
Croatia’s top judge sues national ethics panel after it finds him guilty of plagiarism :



Miroslav Šeparović, president of the Constitutional Court of the Republic of Croatia, announced last week that he has filed criminal complaints against all five members of the Committee on Ethics in Science and Higher Education (CESHE), after it concluded that Šeparović’s 2013 doctoral thesis about children’s rights in EU and Croatian law contained repeated instances of “incomplete and opaque citations” of other people’s work.

St. Regis Mohawk/Allergan lose at PTAB

in DECISION, Denying the Tribe’s Motion to Terminate, 37 C.F.R. §§ 42.5, 42.72 (23 Feb 2018), PTAB stated:



Upon consideration of the record, and for the reasons discussed
below, we determine the Tribe has not established that the doctrine of tribal
sovereign immunity should be applied to these proceedings. Furthermore,
we determine that these proceedings can continue even without the Tribe’s
participation in view of Allergan’s retained ownership interests in the
challenged patents. The Tribe’s Motion is therefore denied.



PTAB found no legal support addressing the tribal immunity issue:



The Tribe and its supporting amici, however, have not pointed to any
federal court or Board precedent suggesting that FMC’s holding with respect
to state sovereign immunity can or should be extended to an assertion of
tribal immunity in similar federal administrative proceedings. Rather, the
Tribe cites certain administrative decisions of other federal agencies to assert
that “[t]he principal [sic] that sovereign immunity shields against
adjudicatory proceedings has been extended to tribes.” Mot. 15–16. We are
not bound by those agency decisions, but even those decisions do not
squarely address the issue.

(...)

In this regard, the Supreme Court has stated that “the immunity
possessed by Indian Tribes is not co-extensive with that of the States.”
Kiowa, 523 U.S. at 756; see also Three Affiliated Tribes of Fort Berthold
Reservation v. Wold Eng'g, 476 U.S. 877, 890 (1986) (“Of course, because
of the peculiar ‘quasi-sovereign’ status of the Indian tribes, the Tribe’s
immunity is not congruent with that which the Federal Government, or the
States, enjoy.”).

(...)

The Tribe also contends that “while the federal government has the
authority to enforce a law of general applicability against a tribe, private
citizens do not have the authority to enforce such laws absent abrogation of
immunity.” Paper 119, 8–9 (citing Fla. Paraplegic Assoc. v. Miccosukee
Tribe of Indians of Fla., 166 F.3d 1126 (11th Cir. 1999) (“Miccosukee”)).
Miccosukee did not involve a federal administrative proceeding, but rather a
private right of action brought in federal district court against a tribal
employer under the Americans with Disabilities Act. 166 F.3d at 1127 (“We
hold that Congress has not abrogated tribal sovereign immunity with respect
to this statute so as to allow a private suit against an Indian tribe.”). To be
clear, there was no federal agency involved in that litigation. As such, we
find the Miccosukee decision to be of minimal relevance to the question of
whether tribal immunity may be invoked in federal administrative
proceedings such as these proceedings.



Of status to continue the proceeding:


It is well settled that “[w]hether a transfer of a particular right or
interest under a patent is an assignment or a license does not depend upon
the name by which it calls itself, but upon the legal effect of its provisions.”
Waterman v. Mackenzie, 138 U.S. 252, 256 (1891). As such, the Federal
Circuit has held that the “party that has been granted all substantial rights
under the patent is considered the owner regardless of how the parties
characterize the transaction that conveyed those rights.” Speedplay, Inc. v.
Bebop, Inc., 211 F.3d 1245, 1250 (Fed. Cir. 2000); see also Alfred E. Mann
Found. for Sci. Research v. Cochlear Corp., 604 F.3d 1354, 1358–59 (Fed.
Cir. 2010) (“Mann”) (“A patent owner may transfer all substantial rights in
the patents-in-suit, in which case the transfer is tantamount to an assignment
of those patents to the exclusive licensee.”).
“To determine whether an exclusive license is tantamount to an
assignment, we ‘must ascertain the intention of the parties [to the license
agreement] and examine the substance of what was granted.’” Mann, 604
F.3d at 1359. However, “[t]he parties’ intent alone is not dispositive” in this
inquiry. Azure Networks, LLC v. CSR PLC, 771 F.3d 1336, 1342 (Fed. Cir.
2014) (vacated on other grounds).



link: http://freepdfhosting.com/6ffa896caa.pdf

Battle about plagiarism on Facebook; Francine Prose speaks for earlier work, now copied.

From the Guardian:


Not different enough, according to a series of barbed Facebook posts by the novelist and critic Francine Prose. That “debt”, she wrote, “is a scene by scene, plot-turn by plot-turn, gesture by gesture, line-of-dialogue by line-of-dialogue copy – the only major difference being that the main characters here are Pakistanis in Connecticut during the Trump era instead of Canadians in post WW-II Geneva.” Prose, a devotee of Gallant’s fiction, went on to lament that her work “is now so unread” that Shepard could “claim to have written what’s essentially her story and publish it in the New Yorker”.

Prose’s post incited a war of words. Among those commenting on her Facebook page were Meg Rosoff, Richard Bausch, and Shepard herself, defending her position – a defence Prose described in reply as “naive”. By the logic of those supporting Shepard, Prose went on, “I can take anything ever written, no matter how complex, reproduce every scene, and simply change the names and ethnicities of the characters and it will be ‘my’ story. Seriously? Then why should we even bother having copyright laws?”




link to Guardian piece: https://www.theguardian.com/books/2018/feb/24/straightjacket-originality-homage-plagiarism

Is the PTAB bound by USPTO guidance?

The discussion at Patent Docs on Ex parte Lukyanov, U.S. Appl. Ser. No. 11/607,828 at
Who's in Charge Here? Or Is the PTAB Bound by USPTO Guidances?

Note text:


It seems curious, and the source of inconsistent policy, for the PTAB to take the position that the Board can choose to ignore USPTO Guidances at its leisure (if not its whim) in view of the stance the Office has taken with regard to the importance of maintaining consistency in its policies in other situations. For example, in convening an expanded panel for deciding whether filing a lawsuit asserting a patent waives sovereign immunity as a grounds to dismiss an inter partes review before the Board

Google loses appeal in AT HOME BONDHOLDERS' case; CAFC observes: Silence is not a genus.

Google lost its appeal of adverse IPR decisions at the CAFC


Google LLC (“Google”) appeals from two final written
decisions of the United States Patent and Trademark
Office Patent Trial and Appeal Board (“the Board”) resulting
from four inter partes review (“IPR”) proceedings
concluding that claims 49–53, 55–59, 61–67, and 69–73 of
U.S. Patent 6,286,045 (“’045 patent”) and claims 1–3, 5–7,
9, 11–20, 22, 24–31, 34–39, 41–47, and 49 of U.S. Patent
6,014,698 (“’698 patent”) are not unpatentable as obvious.
See Google Inc. v. At Home Bondholders’ Liquidating Tr.,
Nos. IPR2015-00657, IPR2015-00660, 2016 WL 5104863,
slip op. at 61 (P.T.A.B. Aug. 10, 2016) (“’045 Decision”);
Google Inc. v. At Home Bondholders’ Liquidating Tr., Nos.
IPR2015-00662, IPR2015-00666, 2016 WL 8969204, at
*24 (P.T.A.B. Aug. 10, 2016) (“’698 Decision”). Because
the Board did not err in its decisions, we affirm.



GARLAND STEPHENS of Weil represented the successful appellee.

Of relevance:


We first address the disclosure of Angles, which is key
to this appeal. Google argues that the Board erred in
determining that Angles did not disclose a non-blockable
request by failing to assess it from the perspective of a
person of ordinary skill in the art. As support for its
position, Google contends that requests for CGI scripts
are non-blockable by default. And because Angles uses a
standard web server, a person of ordinary skill in the art
would have had no reason to consider that Angles referred
to anything other than standard CGI requests, which are
“typically” non-blockable. Appellant’s Br. 31.

(...)

At Home responds that substantial evidence supports
the Board’s finding that Angles does not disclose a nonblockable
request. Specifically, At Home argues that the
Board found persuasive the 1996 textbook, the 1995 W3C
publication, and Dr. Almeroth’s testimony, all of which
confirm that requests to CGI scripts can be blockable, and
are therefore not necessarily non-blockable. Based on this
evidence, At Home contends that the Board correctly
determined that Angles was at best inconclusive, and a
person of ordinary skill in the art would not have automatically
assumed that the mere mention of a CGI request
would also be a disclosure of a non-blockable
request.

We agree with At Home that the Board’s determination
that a person of ordinary skill would not have understood
Angles to disclose a non-blockable request was
supported by substantial evidence. The Board found
persuasive the 1996 textbook and 1995 W3C publication,
which disclosed CGI requests that were blockable. See
’045 Decision, slip op. at 23–25. The Board also credited
Dr. Almeroth’s testimony, which stated that the 1996
textbook and 1995 W3C publication represent how a
person of ordinary skill would have understood CGI
requests. See id. Based on that evidence, the Board
found that a person of ordinary skill would not assume
that Angles disclosed a non-blockable request. See id.
Without more, such as specifics regarding the advertisement
request’s functionality or syntax, the Board found
Angles “inconclusive.” Id. at 21–23.

We see no error in the Board’s analysis of the cited
references or its decision to credit Dr. Almeroth’s testimony.
We therefore conclude that the Board’s finding that
Angles does not disclose the non-blockable limitation was
supported by substantial evidence.



At this point, the opinion has some interesting writing:




At oral argument, Google characterized a “request” as
a genus consisting of two species: blockable requests and
non-blockable requests. See Oral Argument at 3:31–4:17,
Google LLC v. At Home Bondholders’ Liquidating Tr.,
Nos. 16-2727, 16-2729 (Fed. Cir. Jan. 8, 2018),
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20
16-2727.mp3. According to Google, because Angles discloses
a CGI request, which can only be blockable or nonblockable,
Angles must disclose a non-blockable request
by virtue of disclosing a generic CGI request. See id.
That argument, while a good try, ultimately misses the
mark. The genus-species analysis is not applicable here.
Silence is not a genus. The issue here is whether there is
any disclosure of a non-blockable request at all. As discussed
above, the Board properly determined that there
was not. See ’045 Decision, slip op. at 20–30.

Gilenya of Novartis

Novartis’s (NVS) Gilenya reported sales of $825 .0 million in 4Q17, which is a year-over-year (or YoY) drop of 1.0% on a constant currency basis. On April 12, 2017, the United States Court of Appeals for the Federal Circuit ruled against Novartis.

The court declared that Gilenya’s formulation patent protecting the drug until 2026 is invalid. So, Gilenya is protected from generic erosion in the relapsing-remitting multiple sclerosis (or RRMS) indication until 2019.
(...)
Novartis has submitted applications to regulatory bodies in the US and the European Union (or EU) seeking approval for Gilenya in pediatric multiple sclerosis (or MS) indication.

In the first completed Phase 3 trial, PARADIGMS, in thepediatric MS patient population, Gilenya demonstrated an 82.0% drop in the relapse rate compared to interferon β-1a. Additionally, Gilenya scored better on parameters such as MRI lesions, brain shrinkage rate, and safety profile.





link: https://marketrealist.com/2018/02/novartis-focused-expanding-multiple-sclerosis-portfolio-2018

Interesting "improper attribution" case brewing

See the piece by Colleen Flaherty titled ‘Here We Are Again’ relating to a post at IEEE [Did You Know? Computer Matchmaking Started in the 1960s ] relating to lack of attribution of research for the book
Programmed Inequality: How Britain Discarded Women Technologists and Lost Its Edge in Computing (MIT Press) .

Arendi loses appeal in matter of US Patent 6,323,853

The outcome


The Petitioners Google LLC, Motorola Mobility LLC,
and Samsung Electronics Co., Ltd. requested inter partes
review of Claims 1-79 (all the claims) of U.S. Patent No.
6,323,853 (“the ’853 patent”) owned by Arendi S.A.R.L.
(“Arendi”).1 The Patent Trial and Appeal Board (“PTAB”)
instituted review on the ground of obviousness, and after
trial the PTAB held all of the claims unpatentable.2 On
Arendi’s appeal, we affirm the PTAB’s decision, based on
the PTAB’s alternative claim construction.



As to the alternative:


The PTAB alternatively held that even if the prosecution
disclaimer were accepted, the claims are unpatentable
for obviousness in view of Goodhand. PTAB Op. at
*21. The PTAB compared Goodhand with the ’853 pa-
tent’s specification and construed the claims in accordance
with the disclaimer, and found that “Goodhand’s
processing involves essentially the same textual analysis
as disclosed in the ’853 patent, and not user text selection,
as argued by Patent Owner.” PTAB Op. at *21.

(...)

In sum, the PTAB found that Goodhand shows all of
claim 1’s limitations, when giving effect to the prosecution
disclaimer and limiting the scope of the “single entry”
command. This finding is supported by substantial
evidence. On the PTAB’s findings, the alternative conclusion
of unpatentability on the ground of obviousness in
view of Goodhand is sustained.



Separately, on 20 Feb 2018

IAM blog quotes Lemley

From IAM's Patent owners in the US get a big boost after the Federal Circuit hands down a key 101 decision


Just how significant might this shift be? Well, Stanford Law School’s Professor Mark Lemley immediately took to Twitter to label the decision in Berkheimer a “blockbuster”. That’s because the three-judge panel in the case ruled that patent eligibility should not simply be viewed as a legal question. “Whether a claim recites patent eligible subject matter is a question of law which may contain disputes over underlying facts,” Judge Moore wrote in the opinion (she also wrote the majority opinion in Aatrix).

That’s significant because it means that district courts may increasingly be forced to consider patentability at trial and not at an earlier stage in summary judgment. In recent years, so-called Alice motions have handed defendants a particularly effective means of knocking out a patent that has been asserted against them. Critics contend that they have become a means for district court judges to clear their dockets of patent disputes and have become representative of how the US system has swung against IP owners.

If those motions become much harder to bring then, theoretically, more patent disputes could get to the courtroom floor; or defendants might have more incentive to settle and agree to take a licence rather than rely on a lengthy and expensive trial.

According to Lemley, it might also mean that Alice loses some of its edge. “If this approach becomes widespread it will be impossible to resolve patentable subject matter before trial, and Alice will become irrelevant as a practical matter,” he says

DNJ analyzes "puffery" in WILLIAM T. HOEY v. INSMED INCORPORATED

On the subject of "puffery," note a recent decision in the District of New Jersey in the case
WILLIAM T. HOEY v. INSMED INCORPORATED, 2018 U.S. Dist. LEXIS 24907, which included text:


Lead Plaintiff Bucks County Employees Retirement Fund ("Plaintiff") brings this putative class action, on behalf of itself and all other similarly situated individuals and entities, against Insmed Incorporated ("Insmed"), a biopharmaceutical company, as well as Insmed's Chief Executive and Financial Officers, William H. Lewis ("Mr. Lewis") and Andrew T. Drechsler ("Mr. Drechsler"), respectively, alleging violations under various provisions of the applicable federal securities laws.1 Plaintiff's action is based on Defendants' alleged misrepresentations and omissions in connection with Insmed's target drug, Arikayce, and the results of its Phase 2 Trial, which, ultimately, failed to support regulatory approval. In the instant matter, Defendants moves for dismissal of the Amended Complaint, arguing, inter alia, that the challenged representations are not actionable because a duty to disclose was absent, the material statements constitute permissible opinions or corporate puffery, and Plaintiff has failed to adequately plead scienter. For the reasons set forth below, Defendant's Motion to Dismiss is GRANTED.




There is relevance to Bridgewater, New Jersey: Insmed, a publically traded biopharmaceutical company, principally located in Bridgewater, New Jersey, specializes in the development and commercialization of inhaled therapies for patients with serious lung diseases.

Further, as to puffery:


In addition, like forward-looking statements, opinions, and beliefs, a defendant may not be held liable for an alleged misrepresentation that consists of nothing more than vague and nonspecific expressions of corporate optimism. In re Advanta, 180 F.3d at 538. Such statements "constitute no more than 'puffery' and are understood by reasonable investors as such." Id. (quoting Burlington, 114 F.3d at 1428 n. 14). Thus, if a false or misleading statement is "too vague to ascertain anything on which a reasonable investor might rely," it is inactionable as corporate [*25] puffery. In re Aetna, 617 F.3d at 284.

(...)

As articulated by the Third Circuit, material representations contrasted with statements of subjective analysis or extrapolations, such as opinions, motives and intentions, or general statements of optimism, "constitute no more than 'puffery' and are understood by reasonable investors as such." In re Aetna, 617 F.3d at 283 (internal quotations and citation omitted). In the same vein, "[a] representation is immaterial if the statement at issue is too vague to be actionable," and, in turn, cannot form the basis of a claim for securities fraud. Id. (internal quotations and citations omitted).

(...)

Likewise, Plaintiff fails to state a claim under the second subset of statements, wherein Insmed merely described the EMA as, inter alia, "collaborative and supportive," as well as "enthusiastic" about the results of the trial. Based on Plaintiff's pleadings, it appears that "support" and "enthusiasm" were expressed by the EMA during the applicable time period. In fact, Insmed, following discussions with the EMA, was confident in submitting an MAA based solely on the Phase 2 Trial, which was not initially intended to support regulatory approval. That decision, which was made after Insmed's discussions with the EMA, is suggestive of Insmed's positive interactions with that agency. These representations, therefore, cannot serve as a basis for Plaintiff's securities claims. Gillis, 197 F. Supp. 3d at 589 (holding that the challenged statements [*52] were statements of opinion, because they did not "address[] existing objective facts," but rather "express[ed] [the defendants'] views, either as to the FDA's actions and communications, or as to [its drug's] prospects."); Kleinman, 706 F.3d at 153 ("We have also held that words like 'encouraging' are the type of 'expressions of puffery and corporate optimism' that do not generally 'give rise to securities violations.'") (quoting Rombach v. Chang, 355 F.3d 164, 174 (2d Cir. 2004))).

Lastly, the third group of statements, with respect to Arikayce's approvability, are both forward looking and inactionable as corporate puffery. For instance, the statement, given by Mr. Lewis during Insmed's first investor conference in March of 2015, reads, in pertinent part: "I think one of the nice things about this company two and a half years ago when I had the privilege to talk to the board and to look at the opportunity was, I saw an approvable drug, bottom line." Pl.'s Opp'n, at 14; AC ¶ 50. This statement suffers from the same flaw in Plaintiff's previous arguments; in demonstrating falsity, Plaintiff references concerns which were raised after the fact. And, more to the point, a reasonable investor would not rely on this statement. Indeed, it clearly embodies the opinion [*53] of Mr. Lewis, and amounts to nothing more than a "gut feeling" stemming from a vaguely described interaction with Insmed's corporate board, at a time before conducting a Phase 2 Trial. Statements of this kind are a paradigm of corporate puffery, and, therefore, they cannot serve as the basis for § 10(b) liability. Vallabhaneni v. Endocyte, Inc., No. 14-1048, 2016 U.S. Dist. LEXIS 673, at *47 (S.D. Ind. Jan. 4, 2016) ("Courts frequently consider loosely optimistic statements that are so vague, so lacking in specificity, or so clearly constituting the opinions of the speaker that no reasonable investor could find them important to the 'total mix of information available' to be immaterial as a matter of law." (internal citation omitted)); Lopez v. CTPartners Exec. Search, Inc., 173 F. Supp. 3d 12, 28 (S.D.N.Y. 2016) (holding that statements which are "so broad and nebulous as to not provide any specific or concrete guarantee" are not relied on by reasonable investors); Medimmune, 873 F. Supp. at 964 ("Mere expressions of hope or expectation regarding future approval, not worded as guarantees, are not actionable.")

Patent pool for CRISPR technology?

See The competition law issues of the CRISPR patent pool

IPBiz previously discussed patent pool issues as to embryonic stem cells as well as motivations in the aviation patent pool of the early 20th century.

For example, Patent Thickets and the Wright Brothers

Also: http://ipbiz.blogspot.de/2006/07/warfthomson-patents-on-stem-cells-and.html

US District Court of Delaware rules against Merck in case related to hepatitis C drugs Sovaldi and Harvoni

On 16 February 2018, U.S. District Judge Leonard Stark of D. Delaware overturned a $2.54 billion jury verdict against Gilead and instead ruled that Merck’s patent, asserted against hepatitis C drugs Sovaldi and Harvoni, was invalid.

Of past events, see Merck wins $2.54 billion in hepatitis C drug trial against Gilead from 16 Dec 2016:


Merck on Thursday was awarded $2.54 billion in royalties by a federal jury in a patent lawsuit against Gilead Sciences over Gilead's blockbuster hepatitis C drugs Sovaldi and Harvoni.

(...)

Harvoni's list price is $1,125 per pill and $94,500 for a 12-week regimen. Foster City, California-based Gilead, one of the world's largest biotechnology companies, made nearly $20 billion on the two drugs in 2015.


See also a piece by MICHAEL HILTZIK in the October 26, 2017 Los Angeles Times:


To begin with, the evidence that Gilead itself uses its profits to "innovate" is thin at best. In 2016, the company reported profit of $13.5 billion. It spent $11 billion to repurchase its own shares, and about $2.5 billion on stock dividends. So the buybacks and dividends together came to $13.5 billion, in effect consuming 100% of the company's profit.

All that spending benefits shareholders -- the repurchases prop up the value of their shares and enhance their gains when they sell, and dividends are, of course, a direct payout. Innovation? Gilead spent $5 billion on research and development, according to its annual report.

In 2015, a similar phenomenon reigned. Gilead recorded $18.1 billion in profit, and spent $10 billion of it on buybacks and $1.87 billion on dividends. R&D cost $3 billion. Since 2011, the Gilead board has authorized stock repurchases totaling $37 billion, of which $9 billion was still unspent as of the end of 2016. Gilead declined to comment for this column.

Gilead doesn't do much research and development itself. Instead, it has acquired firms that have done the heavy lifting and market their successes. It acquired its blockbuster hepatitis C drug, Sovaldi, by paying $11 billion for the drug's developer, Pharmasset, in 2011.

(...)
Gilead rationalized the price by noting that the near-term cure of hepatitis C meant even greater savings over time from a reduction in liver disease; but that was cold comfort to public budget makers and private insurers. They were faced with the prospect of laying out millions of dollars in a single year for benefits that would appear over decades, often reaped by other insurers or programs.

The near-term consequences included rules that limited approvals for the new drug to the sickest patients -- ironically, those who probably would benefit from Sovaldi the least. Because of the price, potentially millions of hepatitis sufferers went without a cure, if temporarily, until the company and insurers were able to work out discounts.

Evidence produced in 2015 by the Senate Finance Committee showed that Gilead executives didn't spend much time on the consequences for patients deprived of the cure by budgetary pressures. Instead, they calculated how high they could set the price of Sovaldi without shrinking its potential market so much that total profits would fall. The executives concluded that Gilead could make a profit by charging $55,000 per 12-week treatment. But the company decided to charge $84,000, which would deliver higher profits, albeit from fewer patients. A follow-on drug known as Harvoni, which incorporates Sovaldi, was introduced in 2016 at a price close to $100,000 for a full treatment.

Gilead at first refused to offer anything but minimal discounts to big insurers and Medicaid programs, even though they acknowledged that thousands of patients might have to go without the treatments. The company didn't seem concerned about a public backlash over its pricing, figuring that complaints from patient advocates wouldn't lead to problems with regulators or legislators. "Let's not fold to advocacy pressure ... whatever the headlines," one top executive counseled his colleagues.

It's certainly true that drug development doesn't come cheap. But there's reason to believe it doesn't cost nearly what the industry claims, and no reason to believe that the enormous profits reaped on some drugs get funneled back into research and development. When drug companies have a potential blockbuster in hand, they'll charge whatever the market will bear to maximize profits. And funding "innovation" isn't always the goal.




BUT, Business Monitor Online discussed the cost of a drug being successful:


Since 2015, Gilead's revenue has been decreasing, following the decline of its highly successful hepatitis C virus (HCV) portfolio. The medication's high cure rates reduced the patient pool, and pricing pressures rose due to greater levels of competition. Indeed, the firm's total revenue has decreased from USD30.4bn in 2016 to USD26.1bn revenue in 2017.



Text of relevance in the 2018 D. Del. opinion:


Two limitations are of particular significance in resolving Gilead's enablement challenge.

First, the claim includes structural limitations (hereinafter, the "Structural Limitations"). The term "β-D-2'-methyl-ribofuranosyl nucleoside" encompasses any β-D-nucleoside that includes "a five member sugar ring with a methyl group in the 2' up position and non-hydrogen substituents at the 2' down and 3' down positions." (D.I. 237 at 12; D.I. 516 at 22)

Second, at Idenix's urging, the Court construed the claims to contain a functional limitation, through claim l's preamble ("A method for the treatment of a hepatitis C virus infection") and its "effective amount" term. (See D.I. 446 at 8-13) Specifically, the Court concluded that claim 1's preamble is limiting and that the term "effective amount" means "an amount [of the . . . ribofuranosyl nucleoside . . .] that is effective to treat HCV" (hereinafter, the "Functional Limitations") (D.I. 447).

Combining these two limitations, the claims cover all those nucleosides, but only all those nucleosides, that meet the Structural Limitations — including a methyl group at the 2'-up position [*29] — and the Functional Limitations of exhibiting effective anti-HCV activity. (See, e.g., D.I. 446 at 8-13; Secrist Tr. at 1576-77; Meier Tr. at 1865-66) Thus, as further explained below, the claims as construed combine Structural Limitations that are satisfied by an enormous number of compounds with Functional Limitations that are satisfied by an unknown, but far smaller, number of undisclosed compounds.

Also pertinent to the Court's analysis is what is not in its claim construction. Targeting the NS5B polymerase — which Idenix contends is the key to a compound demonstrating effectiveness in the treatment of HCV (see, e.g., D.I. 554 at 8) (identifying "a defined target (NS5B)") — is not an explicit claim limitation. The patent claims are not limited to compounds that are effective in treating HCV due to their acting on the NS5B polymerase. Nor does the patent specification even teach that to identify effective compounds a person of ordinary skill in the art ("POSA") must or even should be looking for compounds that target the NS5B polymerase. Instead, the patent explains that effective compounds can act through "inhibiting HCV polymerase, by inhibiting other enzymes needed in the replication [*30] cycle, or by other pathways."



Of note:



The Court now turns from the undisputed facts to those facts that are disputed but which, in the Court's view, present disputes on which a reasonable jury, taking the trial record in the light most favorable to Idenix and drawing all reasonable inferences in favor of Idenix, could only have found in favor of Gilead. "The rule that a jury verdict is reviewed for support by 'substantial evidence' does not mean that the reviewing court must ignore the evidence that does not support the verdict.... That is, the court should give credence to the evidence favoring the nonmovant as well as that evidence supporting the moving party that is uncontradicted and unimpeached." Integra Lifesciences I, Ltd. v. Merck KGaA, 496 F.3d 1334, 1345 (Fed. Cir. 2007).

The Court concludes that while each of the following topics were disputed, they are not genuinely in dispute, in that a reasonable factfinder could only have found for Gilead on these disputes. Nor does the Court find that there are any other material factual disputes regarding enablement that are in genuine dispute. Instead, Gilead has shown that "the record is critically deficient of the minimum quantity of evidence to sustain the verdict." Accumed LLC v. Advanced Surgical Servs., Inc., 561 F.3d 199, 211 (3d Cir. 2009) (internal quotation marks omitted).

(...)

For the reasons stated above, a reasonable jury, even taking all the evidence in the light most favorable to Idenix and drawing all reasonable inferences in favor of Idenix, could only have concluded that Idenix's '597 patent is invalid due to lack of enablement. The only reasonable finding, based on the trial record, is that Gilead met its burden to prove nonenablement by clear and convincing evidence. The trial revealed that there are no genuinely disputed material facts with respect to enablement. Accordingly, Gilead is entitled to judgment as a matter of law that the asserted claims of the '597 patent are invalid due to lack of enablement.


Footnote 13:



Neither Gilead nor its experts have endorsed the position that inventions in this area of art — or even inventions in this area of art having structural limitations that are literally satisfied by billions of compounds — are automatically non-enabled or inherently suspect. As is made clear throughout the remainder of this Opinion, the required enablement analysis must take into account numerous factors, facts, and circumstances, leading to an ultimate conclusion as a matter of law. A wide disparity between the number of compounds satisfying the Refined Structural Limitations and those also satisfying the Functional Limitations, combined with only a little bit of guidance given in the patent for how to navigate from the larger to the smaller category, are big factors (though not the sole considerations) in rendering the '597 patent invalid for lack of enablement. See generally Wands, 858 F.2d at 737 ("Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations."); but see also generally In re Fisher, 427 F.2d 833, 839, 57 C.C.P.A. 1099 (C.C.P.A. 1970) ("In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.").


Relevant:
7,608,597
Methods and compositions for treating hepatitis C virus

CBS Sunday Morning on February 18, 2018 does puffery

The February 18 show continued the slide into puff over substance.

The Almanac feature celebrated the birthday of Vanna White, born as Vanna Marie Rosich on February 18, 1957. Not mentioned in the clip was White's foray into intellectual property. From the case:

In running a particular advertisement without Vanna White's permission, defendants Samsung Electronics America, Inc. (Samsung) and David Deutsch Associates, Inc. (Deutsch) attempted to capitalize on White's fame to enhance their fortune. White sued, alleging infringement of various intellectual property rights, but the district court granted summary judgment in favor of the defendants. We affirm in part, reverse in part, and remand.

California state law and the Midler case arose: White first argues that the district court erred in rejecting her claim under section 3344. Section 3344(a) provides, in pertinent part, that "[a]ny person who knowingly uses another's name, voice, signature, photograph, or likeness, in any manner, ... for purposes of advertising or selling, ... without such person's prior consent ... shall be liable for any damages sustained by the person or persons injured as a result thereof."

White argues that the Samsung advertisement used her "likeness" in contravention of section 3344. In Midler v. Ford Motor Co., 849 F.2d 460 (9th Cir.1988), this court rejected Bette Midler's section 3344 claim concerning a Ford television commercial in which a Midler "sound-alike" sang a song which Midler had made famous. White's loss on summary judgment was affirmed by CA9. White obtained reversal of adverse SJ decisions on right of publicity and Lanham Act claims.

Mo Rocca did a piece supposedly picking the worst president. On the internet this piece begins:


A question on this Presidents' Day weekend: Which of our former Chief Executives was the worst ever? Presidential historians have been making a list ... and our Mo Rocca may have the winner:

No survey of forgotten presidents (such as James Buchanan, Chester A. Arthur or Millard Fillmore) would be complete without our 17th president, Andrew Johnson.



On the broadcast, Warren Harding, rather than Arthur, was the second "candidate" mentioned. It appears that CBS transcripts are not really reproductions of what is broadcast.
Furthermore, whether there is an agreement that Johnson was the worst president remains to be seen.

Adding further puff to the broadcast was the Tracy Smith piece Jimmy Buffett and "Margaritaville" come to Broadway

The cover story, Infidelity: Why the oldest taboo continues to be broken by Tony Dokoupil [of Katy Tur and George Washington University, where the marketing major earned a 3.87 GPA and was named to GW's Dean's Honor List ] included favorable discussion of Ashley Madison.


The broadcast included an opinion piece by Stoneman Douglas high school senior David Hogg; for some reason, it was followed by a piece by Faith Salie, as if Hogg's thoughts needed re-enforcement. [One notes that Hogg appeared on "Face the Nation" and thereon asserted President Trump controlled the Senate and House. There was discussion of a march on March 24.]

The "moment of nature," on Everglades National Park, included a reference to Marjory Stoneman Douglas. As to "who" pushed for creation of the park, consider text from wikipedia:


The [Tropical Everglades National Park ] commission was also tasked with proposing a method to raise the money to purchase the land.[74] The search coincided with the arrival of the Great Depression in the United States, and money for land purchase was scarce.[75] The U.S. House of Representatives authorized the creation of the new national park on May 30, 1934, but it passed only with a rider that ensured no money would be allotted to the project for at least five years.[74] Coe's passion and U.S. Senator Spessard Holland's politicking helped to fully establish the park, after Holland was able to negotiate 1,300,000 acres (5,300 km2) of the park, leaving out Big Cypress, Key Largo, the Turner River area, and a 22,000-acre (89 km2) tract of land called "The Hole in the Donut" that was too highly valued for agriculture. Miami Herald editor John Pennekamp was instrumental in pushing the Florida Legislature to raise $2 million to purchase the private land inside the park boundaries.[76] It was dedicated by President Harry Truman on December 6, 1947, one month after Marjorie Stoneman Douglas' book; "The Everglades: River of Grass" was released.[77]



One notes the existence of Garald G. "Jerry" Parker, Sr. (1905–2000) who was a B.S. level hydrologist and is known as the "Father of Florida groundwater hydrology."

Snap-on wins claim construction argument at CAFC but still loses appeal

Snap-on challenged patents via IPR, lost, appealed, and then lost at the CAFC:



Snap-on Incorporated (Snap-on) appeals from the final
written decisions of the Patent Trial and Appeal
Board (Board) in the above-captioned inter partes review
proceedings (IPRs) that found certain claims of three of
Appellees’ patents to be nonobvious over prior art combinations
argued by Snap-on.



Of interest, Snap-on won on claim construction but lost
via the "substantial evidence" standard:


Snap-on also argues that the Board erred in “entirely
read[ing] out” the term “average” in its construction.
Snap-on Open. Br. 33. We agree. As a general matter, we
construe a claim term to take on its plain and ordinary
meaning to one of skill in the art when read in the context
of the specification and prosecution history. Wasica Fin.
GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1282 (Fed.
Cir. 2017). Appellees’ own cited expert testimony states:
One of ordinary skill in the art in relation to the
patents in suit would have understood that the
term “average discharge current greater than or
equal to approximately 20 amps” as used in the
patents in suit referred primarily to the capability
of providing an average discharge current of approximately
20 amps, and that it included the operational
range of currents for battery packs for
hand held power tools.

J.A. 12336–37 (emphasis added). Thus, Appellees’ own
expert included the word “average” in his stated interpretation
of the 20-Amp Limitation.

Appellees nevertheless argue that omission of the
word “average” from the Board’s construction is supported
by evidence in the record showing that batteries were
commonly tested using “[c]onstant current discharge
tests” that held current constant while measuring voltage.
Resp. Br. 42 (citing J.A. 3898–99). While this may be
true, there is no indication in the specification4 that this
sort of testing should limit the plain and ordinary meaning
of “average,” which would include situations when
current rises above and dips below the 20-amp target so
long as the average discharge current over the entire
rated capacity is 20 amps or greater.
The specification references the 20-Amp Limitation in
only one place:
In some constructions, the battery pack 30 can
power various power tools (including a driver drill
300 and circular saw 305) having high discharge
current rates. For example, the battery pack 30
can supply an average discharge current that is
equal to or greater than approximately 20 A, and
can have an ampere-hour capacity of approximately
3.0 A-h.
J.A. 267, ’290 patent col. 10 ll. 20–26. Snap-on argues,
and Appellees do not dispute, that a battery pack discharges
current in bursts when used with a circular saw,
such that the current would swing above and below 20
amps. The fact that the phrase “average discharge current”
is only used in the portion of the specification describing
an “example” of embodiments that undisputedly
discharge current at levels that swing above and below 20
amps shows that the word “average” should take on its
ordinary meaning, especially given the Board’s obligation
to use the broadest reasonable construction in IPRs.
Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142
(2016).
For the foregoing reasons, we hold that the correct
claim construction of the 20-Amp Limitation is: “the
battery cells, when configured together in a battery pack,
are capable of producing, on average, reasonably close to
20 amps of discharge current or greater over the course of
delivering their entire rated capacity.” Although the
Board erred in omitting the word “average” from its
construction, the Board’s fact findings regarding obviousness
are still supported by substantial evidence and the
Board’s legal determinations of obviousness are correct
under the proper claim construction.5 The harmless error
rule applies to appeals from the Board. See, e.g., In re
Watts, 354 F.3d 1362, 1369 (Fed. Cir. 2004). Re

Dealing with choices in disease treatment

Back in law school, I wrote a column for the University of Chicago Phoenix on the "Let's Make a Deal" problem of accepting Monty Hall's offer to switch doors. The correct answer is to switch doors, and you will win 2/3 of the time.

In the October 1998 issue of Intellectual Property Today, I reviewed the matter:


BACKGROUND

Of my columns for my law school newspaper, the most discussed was the presentation of the "Let's Make a Deal" problem. On seeing it, most people get it wrong, although on discussion, most people get it right. Some never do. On August 6, I was explaining it to a former colleague of mine as we rode the PATH to the World Trade Center. He got it wrong. More interestingly, a stranger who was listening to us, who claimed to be a Ph.D. in statistics from Harvard, intervened to argue for the wrong position. At that point, I thought it worthwhile to resurrect the material.

LET'S MAKE A DEAL

The set-up of the problem arises from a game show, begun in the 1960's and hosted by Monty Hall, entitled "Let's Make a Deal." There were three doors, behind only one of which was a valuable prize. After some preliminaries, a contestant would choose one door from among the three. The selected door remained closed. At this point, Monty would sometimes open one of the two unchosen doors, behind which was no prize. Monty would then offer the contestant the opportunity to switch choice from the initially-chosen door to the remaining unopened door. The question is simply: should the contestant switch?
Most people see the situation as one of equal probability. There are two unopened doors, and behind one of them is the prize. In fact, by switching choice, one wins two times out of three. The key point is that there are three states of the system, not two.
To work through the situation, let's assume the contestant picks door number 1. One-third of the time, the prize will be behind door number 1, and the contestant will win if does not change and he will lose if he changes. Two thirds of the time, the prize will not be behind door number 1 (one third of the time behind door number 2; one third of the time behind door number 3). The contestant will lose if he does not change and he will win if changes. One could stop here.
However, the difficulty arises when one confronts the opening of the door without a prize. There are two doors left, and one prize, ergo a seeming probability of one-half. But, because Monty cannot open the initially-selected door of the contestant, he cannot change the probability as to that door. It will remain at one third. Some people do not find this correct.
Instead of the "three door" problem, visualize a lottery with one million tickets, only one of which is a winner. You buy one ticket and put it in your pocket. Monty, who knows which ticket is a winner, tears up 999,998 losing tickets and offers to trade you his ticket for yours. There are only two tickets left and one is a winner. Do you think the probability is 50/50?
There are many messages from this problem. I'll consider two.

KNOWLEDGE IS GOOD

If you understand the problem, you will switch doors and you will win 2/3 of the time. The elimination of the one door gave added knowledge. The probabilities were not 50/50.
Did you ever wonder why appellate panels have more than one member? Assuming a district judge and an appellate judge have the same probability of "getting it right", and that the probability is greater than 50%, a panel will give the right answer more frequently than the single judge.
To take a simple case, let us assume that a given judge has a probability of getting the right answer (2/3) of the time, and that this probability is independent of the analysis of the other judges. Consider a three judge panel which requires at least a 2-1 vote for a decision. The joint probability of getting it right is 20/27 (=74.1%), which comprises the 3-0 vote (8/27=(2/3)<3>) and three 2-1 votes (each of joint probability 4/27). This is 11.1% higher than the probability the single judge will get it right ((74.1-66.7)/66.7).




An interesting twist on this involves the choice to employ a drug.

Imagine that you have a certain disease that is not life threatening but greatly diminishes quality of life. There is a treatment that will be effective in removing symptoms 2/3 of the time, but ineffective 1/3 of the time. Good idea to try it.

HOWEVER, there is an additional factor. In the 1/3 of the time the treatment does not work, you develop an additional problem.

If the problem were death, likely this would be a bad idea. But suppose the problem is the development of another disease (similar to the first), so that 1/3 of the time you don't solve the initial problem AND you develop a new problem, making your situation "twice" as bad as when you started. What do you do?

***
See also

"Let's Make a Deal" problem

Appellant Kenneth Hodges prevails at CAFC

The appellant Hodges got some traction at the CAFC:


Appellant Kenneth Andrew Hodges appeals from examination
of U.S. Patent Application No. 12/906,222
(“’222 application”), in which the Patent Trial and Appeal
Board (“Board”) affirmed the examiner’s rejection of all
claims as anticipated and/or obvious. See Ex Parte Kenneth
Andrew Hodges, No. 2014-009710, 2016 WL 6441834
(P.T.A.B. Oct. 28, 2016). For the following reasons, we
reverse the Board’s anticipation determinations, vacate
its obviousness determinations, and remand for further
proceedings



There was an "inherent" argument in the Examiner's
anticipation rejection:


Thus, as the Board noted, the propriety of the examiner’s
rejection turns on whether Rasmussen’s unlabeled
valve containing the inlet seat is “define[d]” by Rasmussen’s
valve body—i.e., whether it “can properly be consid-
ered to be a part of Rasmussen’s drain valve body.”
Hodges, 2016 WL 6441834, at *2. The Board found that it
could. In particular, the Board found that Rasmussen’s
unlabeled valve is “connected to, and therefore allow[s] or
prevent[s] flow into, inlet port 17A,” and that the seat of
the unlabeled valve would therefore “be ‘an internal part’
of and contained within the ‘outer casing’ of drain valve
10.” Id. That finding is unsupported by substantial
evidence.

(...)

The Board neither supported its assertion of
similarity, however, nor explained how the positioning of
the unlabeled valve in Rasmussen’s Figure 7 would enable
a skilled artisan to “practice the invention without
undue experimentation.” Spansion, 629 F.3d at 1356
(internal quotation marks omitted). And, even if Rasmussen’s
unlabeled valve is ostensibly “similar to” the ’222
application’s second member 16 in some respects, it is
different in the only respect that is relevant to the claims
at issue—i.e., it is not an internal part of or contained
within the valve body. We therefore conclude that substantial
evidence does not support the Board’s anticipation
findings.


Of note:


The Patent Office shoulders the burden during initial
examination of establishing that the examined claims are
anticipated. See 35 U.S.C. § 102 (“A person shall be
entitled to a patent unless[] . . . .”); cf. In re Oetiker, 977
F.2d 1443, 1445 (Fed. Cir. 1992) (“If examination at the
initial stage does not produce a prima facie case of unpatentability,
then without more the applicant is entitled
to grant of the patent.”). Because the Board failed to meet
that burden here, and because the only permissible finding
that can be drawn from Rasmussen is that it does not
disclose the claim limitation at issue, we reverse the
Board’s anticipation determination with respect to Rasmussen
as to appealed claims 1–3 and 5–8.



Footnote 7:


The dissent asserts that we may reverse the
Board’s patentability determinations in only two circumstances—i.e.,
when the Board (1) “committed legal error
and no further factual findings are required,” or (2) “made
erroneous factual findings and only one permissible
factual finding exists.” Dissent at 2–3 (internal quotation
marks omitted). Whether or not the dissent is correct
that these are the only two circumstances in which reversal
is permitted, its conclusion that this case does not fit
within the second circumstance is incorrect. As described
above, the Board’s finding that the inlet seat within
Rasmussen’s unlabeled valve is contained in Rasmussen’s
housing is plainly contrary to the only permissible factual
finding that can be drawn from Rasmussen itself. This
case therefore fits squarely within the second circumstance
identified by the dissent.



Also


We therefore reverse the Board’s anticipation determination
based on Frantz as to appealed claims 1–2 and
21. See Smith, 871 F.3d at 1382–84 (reversing the
Board’s anticipation finding predicated on an unreasonably
broad claim construction); In re Skvorecz, 580 F.3d
1262, 1267–68 (Fed. Cir. 2009) (reversing the Board’s
rejection of reissue claims predicated on an incorrect
construction, and noting that “[a]nticipation cannot be
found, as a matter of law, if any claimed element or
limitation is not present in the reference”).



Of obviousness:



The Board concluded in a single paragraph that the
claims would have been obvious over Rasmussen in view
of Frantz because the unlabeled valve depicted in Rasmussen’s
Figure 7 could be made part of Rasmussen’s
drain valve body such that the seat of the unlabeled valve
would be “‘an internal part’ of and contained within the
‘outer casing’ of drain valve 10.” Hodges, 2016 WL
6441834, at *5. But the Board did not explain how Rasmussen’s
drain valve assembly could be so modified. In
another paragraph, the Board agreed with the examiner
that it also “would have been obvious to a skilled artisan
to include Rasmussen’s sensor in Frantz’s valve body for
the purposes of generating a control signal that purges a
high condensate level from Frantz’ [sic] [main] chamber.”
Id. (internal quotation marks omitted). But the Board did
not explain how such a sensor would be downstream of
the inlet seat and generate a signal reflective of a pressure
downstream of said inlet seat, as required by the
claims. Instead, the Board merely determined that the
claims would have been obvious over Frantz in view of
Rasmussen “[f]or the same reasons as presented above.”
Id. The Board made no findings, moreover, regarding the
obviousness factors laid out in Graham v. John Deere Co.
of Kan. City, 383 U.S. 1 (1966).
Our review of the Board’s decision “is rooted not just
in the law of obviousness but in basic principles of administrative
law.” Personal Web Techs., LLC v. Apple, Inc.,
848 F.3d 987, 992 (Fed. Cir. 2017). The Board must
therefore “explicate its factual conclusions, enabling us to
verify readily whether those conclusions are indeed supported
by ‘substantial evidence’ contained within the
record.” Gartside, 203 F.3d at 1314; see also Power Integrations,
Inc. v. Lee, 797 F.3d 1318, 1326–27 (Fed. Cir.
2015) (holding that the Board’s reasoning must be set out
“in sufficient detail to permit meaningful appellate review”).
The Board did not do so here. Unlike the Board’s
anticipation determinations, which contravene the only
permissible findings that can be drawn from the prior art
under the proper constructions of the relevant claim
terms, the Board’s obviousness determinations involve
“potentially lawful but insufficiently or inappropriately
explained” factual findings, In re Van Os, 844 F.3d 1359,
1362 (Fed. Cir. 2017)

When faced with similarly deficient factual findings,
“we have consistently vacated and remanded for further
proceedings.” Id. (collecting cases); Icon Health & Fitness,
Inc. v. Strava, Inc., 849 F.3d 1034, 1046 (Fed. Cir. 2017)
(“Although the [Board] made a factual finding, this finding
did not have an adequate basis in the record, and the
[Board] did not adequately explain its reasoning. Thus,
we vacate and remand for additional [Board] findings and
explanation.”); Personal Web Techs., 848 F.3d at 994
(vacating and remanding “for the Board to reconsider the
merits of the obviousness challenge, within proper procedural
constraints”); see also Fla. Power & Light Co. v.
Lorion, 470 U.S. 729, 744 (1985) (explaining that, when
an agency’s fact-findings and explanation are deficient,
“the proper course, except in rare circumstances, is to
remand to the agency for additional investigation or
explanation”).
We therefore vacate the Board’s obviousness rejections
with respect to appealed claims 1–3, 5–8, and 21,
and remand for further factual findings and explanation
on this score.

"But nothing can ever truly be deleted on the Internet"

A post titled Boston police sent Black History Month tribute to Red Auerbach and people were not happy contains the text


But nothing can ever truly be deleted on the Internet.



IPBiz is not so sure. Vai Sikahema's polemic "Rutgers is Wrong" seems to be gone. LBE's paper at SSI-11 [Intersection of Science and Law] is gone [ Not Found
The requested URL /~ssi11/SSI-11Papers/P3.pdf was not found on this server. ]

The initial link to the famous 1997 "I am Alan Hale" letter [ The requested URL /~somos/hale.html was not found on this server. ] is gone, although one can still find the letter:

http://www.spectacle.org/597/hale.html

http://user.it.uu.se/~kostis/FunStuff/hale.html

although one wonders how many people pay attention to it in 2018.

Remyelination and MS

From Stem Cells and Cloning: Advances and Applications » Volume 11

A review on stem cell therapy for multiple sclerosis: special focus on human embryonic stem cells

Published 12 February 2018 Volume 2018:11 Pages 1—11

From within the abstract:

**
Recent research has shown that cellular therapies hold a potential for CNS repair and may be able to provide protection from inflammatory damage caused after injury. Human embryonic stem cell (hESC) transplantation is one of the promising cell therapies; hESCs play an important role in remyelination and help in preventing demylenation of the axons. In this study, an overview of the current knowledge about the unique properties of hESC and their comparison with other cell therapies has been presented for the treatment of patients with MS.
**

Note US published application 20180010098

Elsewhere, Gold Nanocrystals May Remyelinate Lesions in Multiple Sclerosis

Recall IPBiz post:
Gold nanoparticles and Curley paper

US 20120190386 and "survey eggs"

From published US patent application 20120190386 :



[0003] At present, when performing a boundary survey for a particular property, survey instruments are utilized to locate the corners of a property owner's lot. The surveyors often mark these corners by driving wooden stakes in the ground.

[0004] When the work is done that necessitated the boundary survey, the wooden stakes are (often) removed.

[0005] Unfortunately for the property owner, if additional work needs to be done, say a few years later, the owner must incur the cost of performing another boundary survey all over again (with potentially varying results).

SUMMARY OF THE INVENTION

[0006] The present Invention is conceived as a response to the above-described disadvantages of the conventional art. The present Invention relates to wireless, location-establishing devices (hereafter "Survey Eggs"), that are wireless Global Positioning Satellite (GPS) devices that enable surveyors to permanently locate the boundary points of property lines. Survey Eggs address problems such as having a property owner's boundary surveyed over and over, for thousands of dollars each time the owner, say, renovates their property.

Plagiarizing principal and Shakespeare?

The bottom line for a penalty for plagiarizing a graduation speech: a fine and compulsory attendance at a creative writing course:


The state this month ordered former principal Mark Stenner to pay a $750 fine and take a college-level course on creative writing after he admitted lifting large parts of someone else’s graduation speech.



link: http://www.sun-sentinel.com/news/education/fl-palm-principal-plagiarism-reprimand-20180208-story.html

Elsewhere, some allegations about Shakespeare; see Shakespeare stole from George North? How lucky for George North


On Thursday, literary clickbait broke in the New York Times that Shakespeare, a good poet, had been caught red-handed in some plagiaristic adventuring. (In London, this was gossip hot enough to hit the tabloids.) Using software designed to nab kids who crib from SparkNotes, Dennis McCarthy, a self-taught Shakespearean, found that the language and ideas from an obscure 1576 manuscript pervade some of Shakespeare's most famous plays, including the "Now is the winter of our discontent" soliloquy, from "Richard III."

CBS Sunday Morning on 11 Feb 2018 does crash dummy inventor Sam Alderson

In its almanac feature on February 11, Sunday Morning profiled Samuel W. Alderson, who died February 11, 2005 at age 90.

Alderson's father owned a sheet metal shop, which vocation would play a role in Alderson's development. Alderson studied for a Ph.D. under Oppenheimer and Lawrence at UC/Berkeley, but did not obtain his degree. After a stint at IBM involving a prosthetic arm, Alderson founded his own company in 1952, to create dummies to test the safety of airplane ejection seats. By 1968, he had created the VIP, a dummy for automobile accidents. Alderson later created medical phantoms, designed to measure radiation exposure.

Of patents, see for example, US 2580987 titled " Electrically operated artificial arm for above-the-elbow amputees " and US 3010223 titled "Human equivalent dummy," filed September 2, 1959. [See also "Timeline of United States inventions (1946–91) " at ipfs.]

On September 13, 1899: Henry Bliss becomes the first pedestrian known to be killed by an automobile in North America. Less than ten years later, on September 17, 1908, Thomas Selfridge was the first aircraft fatality. [The world's first road traffic death involving a motor vehicle is alleged to have occurred on August 31, 1869. Irish scientist Mary Ward died when she fell out of her cousins' steam car and was run over by it. ]

**

The cover story on February 11 was The growing acceptance of autism in the workplace


Moment of Nature: Culebra (Puerto Rico)

**Separately, over at NBC:

The network responded on Saturday by having anchor Carolyn Manno read a statement:

“During our coverage of the Parade of Nations on Friday we said it was notable that Japanese Prime Minister Shinzo Abe made the trip to Korea for the Olympics, “representing Japan, a country which occupied Korea from 1910 to 1945 but every Korean will tell you that Japan is a cultural, technological and economic example that has been so important to their own transformation.” We understand the Korean people were insulted by these comments and we apologize.”


**Separately, Major Garrett did a good job on "Face the Nation" on 11 Feb 2018

See Transcript: OMB Director Mick Mulvaney on "Face the Nation," Feb. 11, 2018

Jurisdiction at CAFC via Walker Process denied in XITRONIX CORP. v. KLA-TENCOR CORP.

The CAFC noted:


There is nothing unique to patent law about allegations
of false statements. Indeed, in responding to the
court’s order to show cause, the parties both cited portions
of the complaint that focus on fraud and misrepresentation,
not patent law. See, e.g., Xitronix Supp. Br. (Sept.
26, 2017) at 4–5 (“KLA-Tencor affirmatively (and repeatedly)
misrepresented the patentability of the claims it
sought, including making false representations about
what was taught by the relevant prior art.”); KLA Supp.
Br. (Sept. 26, 2017) at 8–9 (“KLA’s prosecution and procurement
of the [’]260 patent was undertaken in bad faith
in order to monopolize the . . . market.”). We acknowledge
that a determination of the alleged misrepresentations to
the PTO will almost certainly require some application of
patent law.



AND


The underlying patent issue in this case, while important
to the parties and necessary for resolution of the
claims, does not present a substantial issue of patent law.
See id. at 263–64. There is no dispute over the validity of
the claims—patent law is only relevant to determine if
KLA intentionally made misrepresentations. Patent
claims will not be invalidated or revived based on the
result of this case. Because Federal Circuit law applies to
substantive questions involving our exclusive jurisdiction,
the fact that at least some Walker Process claims may be
appealed to the regional circuits will not undermine our
uniform body of patent law. See Golan v. Pingel Enter.,
Inc., 310 F.3d 1360, 1368 (Fed. Cir. 2002) (“Federal Circuit
law applies to causes of action within the exclusive
jurisdiction of the Federal Circuit.”); Mars Inc. v. Kabushiki-Kaisha
Nippon Conlux, 24 F.3d 1368, 1371 (Fed.
Cir. 1994) (Deference to regional circuit law “is inappropriate
when an issue involves substantive questions
coming exclusively within our jurisdiction, the disposition
of which would have a direct bearing on the outcome.”
(internal citations and quotation marks omitted)).



AND


Both Nobelpharma and Cipro were decided before the
Supreme Court decided Gunn. To the extent our prior
precedent could be interpreted contrary to Gunn, the
Supreme Court rendered that interpretation invalid.
While the parties argue Gunn is inapplicable because it
concerns district court jurisdiction over state claims, the
indistinguishable statutory language of §§ 1295 and 1338
requires our careful consideration of Gunn in interpreting
our jurisdictional statute. “[W]e have no more authority
to read § 1295(a)(1) as granting the Federal Circuit jurisdiction
over an appeal where the well-pleaded complaint
does not depend on patent law, than to read § 1338(a) as
granting a district court jurisdiction over such a complaint.”
Christianson, 486 U.S. at 814 (citing Pratt v.
Paris Gas Light & Coke Co., 168 U.S. 255, 259 (1897)); see
also id. at 808–09 (noting “linguistic consistency” with the
statute for a district court’s federal question jurisdiction
demands a similar application for the Federal Circuit’s
“arising under” jurisdiction).

Mixed outcome at CAFC in Polaris Indistries v. Arctic Cat

The outcome of Polaris v. Arctic:


For the foregoing reasons, we affirm the Board’s determination
in the 1427 Decision that claims 1–16, 20–33,
and 35 of the ’405 patent are unpatentable as obvious.
We vacate the Board’s obviousness determination as to
claims 17–19, 34, and 36–38 and remand for further
proceedings. We affirm the Board’s determination in the
1428 Decision that Arctic Cat failed to meet its burden of
demonstrating that the claims of the ’405 patent are
unpatentable.



Of an assertion of "conclusory"


Relying on these principles, we considered how the
Board should treat undisputed evidence from a patentee
that its product is the invention disclosed in the challenged
claims in PPC Broadband, writing:
When the patentee has presented undisputed evidence
that its product is the invention disclosed in
the challenged claims, it is error for the Board to
find to the contrary without further explanation.
There was no such explanation here. The Board
in its opinions did not explain why the SignalTight
connectors fail to embody the claimed features,
or what claimed features in particular are
missing from the SignalTight connectors.
(...)
Here, the Board “decline[d] to accord . . . substantive
weight” to the patentee’s undisputed evidence that its
product is the invention disclosed in certain claims because
it characterized the patentee’s evidence as “conclusory.”
1427 Decision, 2016 WL 498434, at *16. On these
facts, we conclude that the Board erred in failing to credit
Polaris’s undisputed evidence that its RZR vehicles embody
and are coextensive with claims 34 and 36–38 of the
’405 patent.

Merck loses to Amneal at CAFC in mometasone furoate monohydrate [Nasonex] case

This case, arising on appeal of a decision by Judge Robinson in D. Delaware, is strongly related to a case arising in D. New Jersey, and also appealed to the CAFC [2012 U.S. Dist. LEXIS 83414; Merck Sharp & Dohme Corp. v. Apotex Inc., 517 F. App’x 939 (Fed. Cir. 2013). ]

There is a lot to discuss.

For starters, there was an appeal of a discovery ruling.

This included the text


Following two discovery hearings on the issue, the
district court became aware of Amneal’s discovery violation
and acknowledged that ideally Amneal should have
produced samples of the Day 4 and A Batches. The
district court determined, however, that it did not have
enough information at the time to determine whether the
Day 4 and A Batch samples were materially different
from the Day 1 Batch samples. The district court concluded
that it was “not persuaded sitting right here that
mixing [] makes a substantive difference, and if it doesn’t,
then it doesn’t matter that Amneal didn’t give [Merck] a
sample of both [the Day 4 and A Batches] . . . [and] only
gave [Merck the Day 1 Batch].” J.A. 128 at 27:7–12. The
district court did not compel Amneal to produce the
additional samples. Nor did the court postpone trial.
Instead, the district court gave Merck the opportunity to
prove at trial that the Day 4 and A Batch samples were
substantively different than the Day 1 Batch samples and
warned Amneal that it was at risk of incurring costs if
Merck prevailed on the issue.

(...)

We start our analysis with the district court’s discovery
ruling. We review the district court’s denial of additional
discovery under regional circuit law. Digeo, Inc. v.
Audible, Inc., 505 F.3d 1362, 1370 (Fed. Cir. 2007). The
Third Circuit will not disturb a denial of additional discovery
absent an abuse of discretion and “a showing of
actual and substantial prejudice.” Anderson v. Wachovia
Mortg. Corp., 621 F.3d 261, 281 (3d Cir. 2010).

The district court’s standing discovery order required
Amneal to “immediately make available to Merck samples
of any further representative commercial batches sent to
the FDA.” J.A. 82 (emphasis added). Amneal, however,
did not produce samples of its Day 4 Batch that it submitted
to the FDA, in violation of the discovery order.




The earlier case in D.N.J. has some interesting text about
Dr. Matzger, who testified in the Amneal case:



Dr. Threlfall found Dr. Matzger's testimony troubling in four ways. Dr. Threlfall stated:

I think he went wrong at four levels: I don't think he applied proper scientific judgment to his testing; I think that the design of his experiments was wrong; the actual performance of experiments leads a lot to be desired; and I think that he analyzed the data incorrectly.
(T. 909, 15-19).
Dr. Threlfall opined that Dr. Matzger had "the mindset of an advocate rather than of a scientist. And in particular, Dr. Matzger [*13] went on the hunt for traces of material, without really applying scientific judgment, . . . ." (T. 910, 10-14). Although Dr. Matzger found that conversion begins to occur as soon as the Apotex ANDA Product is manufactured, Dr. Threlfall's calculation was far different. According to Dr. Threlfall, the "Apotex formulation would be stable against conversion to the monohydrate for around 800 years." (T. 922, 21-24).

Dr. Threlfall was very critical of the shaking or vortexing procedure of Dr. Matzger. Dr. Matzger indicates that the shaking was "gentle." Dr. Threlfall disagreed, he honed in on vortexing.

A. Vortexing is an even more energetic process. I mean it's like creating a mini tornado within the tube. And you can imagine that sort of — smashes all things to pieces, it grinds the nuclei together, it causes them to break and nascent surfaces to form, and nascent surfaces are much more susceptible to change than the intact one would be, because they lost their coatings basically for a moment, and therefore they can change when they wouldn't have otherwise been subjected to change.
(T. 925, 18 through T. 926, 1). Likewise, Threlfall was critical of the washing. He opined that Dr. Matzger [*14] "washed out some of the essential components," (T. 926, 8-10), and that the removal of Avicel by shaking and washing was deleting its "protective coating." (T. 926, 20). Threlfall likened the removal of Avicel to an explorer sent to the Arctic, and then his clothes are "pinched, and you leave him in his underwear." (T. 926, 19-23). Evidently, Threlfall believes that when Dr. Matzger washed and shaked the Apotex product, he was undermining the stability of the compound. (T. 926, 23-24).
In commenting on Dr. Matzger's procedures, Threlfall stated "I would describe this as making scrambled eggs and then claiming you still had the eggs with the shells in the carton." (T. 927, 17-19).


Also of interest are the following statements in the DNJ opinion:


XRPD is the standard method for looking at solid materials and polymorphs. (T. 228, 17-23). 7 XRPD looks at arrangement and characteristic spacings of molecules by measuring the intensity of refracted X-rays at different angles. (T. 230, 10-20). According to Dr. Matzger, XRPD is relatively sensitive and excellent at being able to differentiate between different forms of the same compounds. (T. 228, 17-23). Dr. Cockcroft found that Dr. Matzger did not find peaks due to the lack of intensity; and at best, he found "bumps." (T. 781, 13).

(...)

Dr. Cockcroft, 8 an expert for Apotex, noted that x-ray diffraction is covered by a very simple equation "developed by Nobel prize winner William Brack in 1913." The Brack formula relates "to the two-theta values in a diffraction powder" in terms of intensity. (T. 780, 13-21). Based on this formula, the XRPD testing device (diffractometer) was created, and it depicts material on a graph based on the intensity of its peaks. In Dr. Matzger's testing, he used an automatic diffractometer on which he set the scan through the two-theta angles. Once he filled a cell with the prepared sample, the diffractometer then automatically records any peaks based on the intensity on [*19] a graph. (T. 262, 21-25). A peak is produced by a clear signal or intensity. That is, the diffractometer "measures an intensity at each angle . . . so [there] is an intensity versus two-theta peak." (T. 261, 3-6). Often the prepared sample may have some different materials commingled in it during XRPD testing, and the peak may be surrounded by noise (non-peak sound). The signal to noise factor was critical in this case for several reasons.

(...)

According to Dr. Cockcroft, the history of the three peaks standard is derived from the work of Mr. Hanawalt. Evidently, in the 1940's, Hanawalt was researching numerous minerals which required him to perform XRPD tests on many minerals. Since there were so many samples, Hanawalt devised a database of XRPD patterns so he could identify each one. In developing a card system to identify each sample, he listed the three most intense peaks of the material on a separate card. This format became known as the Hanawalt Search Index. (T. 788, 4-12). Due to this practice, most scientists still use three peaks to identify a pattern. (T. 788, 4-12).

Lastly, the use of the Brack Formula recognizes [*22] that if a peak occurs at a specific level (say 7.8 degrees) and another peak occurs at a factor of 2 (say 15.6), the second peak is a duplication of the first; and hence it is not considered a unique peak (T. 780, 19-25). Hence, duplication must be considered in analyzing XRPD results.

All four samples were subject to XRPD analysis and recorded on a graph (PTX-451). In each of the samples, Dr. Matzger found "evidence of conversion" with peaks at 7.8 and 11.6 as recorded on figure 2 of the patent. (T. 272, 19-25). 9 On sample 012245, Dr. Matzger found that XRPD showed three peaks "consistent with conversion," namely 7.8, 15.6 and 11.6. (T. 277, 13-19). With regard to the 15.6 peak, it is a factor of 2 of the 7.8 peak. Dr. Matzger noted it "illustrates . . . the problems you can have with overlap because there is a shoulder here that is associated with the 15.6 degree peak as opposed to a "distinct peak as it did in the previous pattern." (T. 278, 11-18) (PTX-480). Despite the fact that it is a shoulder and not a peak, he opined that "its all consistent with conversion." (T. 278, 20). In sample 012245, Dr. Matzger fails to consider the limitation within Brack's formula (see above). Dr. [*23] Cockcroft had indicated that a peak at 7.8 and a peak at 15.6 were duplicative based on the application of the Brack formula. Hence, in sample 012245, there are not three peaks as Dr. Matzger finds, but only two in accordance with the Brack formula. Dr. Matzger never refuted the Brack formula, as such, the limitations within the Brack formula are credible.



For accuracy, the Nobel Prize in Physics 1915 was awarded jointly to Sir William Henry Bragg and William Lawrence Bragg "for their services in the analysis of crystal structure by means of X-rays" The experiment is x-ray diffraction, not refraction.

The Hanawalt method relates to identifying an unknown sample via powder x-ray diffraction. In the 1930's, Hanawalt decided to use the d-values of the three strongest strongest lines in the
diffraction pattern of the unknown (d1, d2, d3) along with their respective respective intensities intensities (I1,I2, I3) to search the powder diffraction diffraction file (PDF) database. There is no database search involved in the Nasonex matter.

Elbit loses appeal at CAFC

The outcome



Appellant Elbit Systems of America, LLC (“Elbit”)
sought inter partes review of various claims of Appellee
Thales Visionix, Inc.’s (“Thales”) U.S. Patent No.
6,474,159 (“the ’159 patent”). The U.S. Patent and
Trademark Office’s Patent Trial and Appeal Board
(“PTAB”) issued a final written decision, see Elbit Sys. of
Am., LLC v. Thales Visionix, Inc., No. IPR2015-01095
(P.T.A.B. Oct. 14, 2016) (J.A. 1–25), finding that, inter
alia, Elbit failed to demonstrate by a preponderance of the
evidence that claims 3–5, 13, 24–28, 31, and 34 (“the
Asserted Claims”) of the ’159 patent would have been
obvious over U.S. Patent No. 4,722,601 (“McFarlane”) in
combination with two other prior art references, see
J.A. 2, 4−5.

Elbit appeals. We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(4)(A) (2012). We affirm.


The CAFC noted:


Substantial evidence supports the PTAB’s conclusion
of nonobviousness. It is undisputed that the method of
calculating the “relative angular rate signal” taught in the
’159 patent “is not explicitly disclosed” in the prior art
because the prior art and the Asserted Claims employ
different steps to calculate the orientation or position of a
moving object relative to a moving reference frame.




Of experts:


Elbit’s expert attempts to undermine this testimony
by arguing that the two- and three-step methods are
“mathematically equivalent” and that “there is no practical
difference” between them. J.A. 2034. However, the
PTAB determined that Elbit’s expert’s testimony was
“unsupported” and entitled to “little weight” because he
did not address or account for the recited relative angular
rate signal limitation “anywhere in his opinion.” J.A. 17–
18. “The PTAB [i]s entitled to weigh the credibility of the
witnesses,” Trs. of Columbia Univ. v. Illumina, Inc., 620
F. App’x 916, 922 (Fed. Cir. 2015); see Inwood Labs., Inc.
v. Ives Labs., Inc., 456 U.S. 844, 856 (1982) (“Determining
the weight and credibility of the evidence is the special
province of the trier of fact.”), and, thus, we decline to
disturb these credibility determinations here



Of waiver:


Elbit conceded that it failed to argue that substantial
evidence does not support the PTAB’s decision to credit
Thales’s explanation of the nonobviousness of the twostep
method, see Oral Arg. at 27:30–32 (acknowledging
that they “did not make . . . a legal argument” that the
PTAB’s decision is unsupported by substantial evidence),
which constitutes waiver, see Nan Ya Plastics Corp. v.
United States, 810 F.3d 1333, 1347 (Fed. Cir. 2016) (holding
that failure to present arguments under the operative
legal framework “typically warrants a finding of waiver”)



Calculus appears in footnote 5:


Pursuant to this principle, “as a matter of calculus,
the sum of integrals is equal to the integral of sums.”
J.A. 2144. According to Elbit, this principle dictates that
the same result will be reached whether data is “first
integrated, then subtracted” or “first subtracted, then
integrated,” such that “the order in which these steps are
performed does not matter.” Appellant’s Br. 3. As applied
to the ’159 patent, Elbit contends that the sum of
integrals principle renders the ’159 patent “no more than
a predictable variation of the prior art” and, thus, unpatentable.
Id. at 5 (citation omitted).





AND



“[w]e will not find
legal error based upon an isolated statement stripped
from its context.” Waymo LLC v. Uber Techs., Inc., 870
F.3d 1350, 1361 (Fed. Cir. 2017) (internal quotation
marks and citation omitted). As for whether a PHOSITA
“would understand that the sum of integrals principle
applies to all equations, including navigation equations,”
Appellant’s Br. 37 (capitalization omitted); see id. at 37–
41, Elbit fails to present any evidence supporting this
contention beyond attorney argument, see id. at 37–41,
and “[a]ttorney argument is not evidence” and cannot
rebut other admitted evidence, Icon Health & Fitness, Inc.
v. Strava, Inc., 849 F.3d 1034, 1043 (Fed. Cir. 2017). In
contrast, Thales’s expert testified that a PHOSITA could
have determined that it would be “mathematically inappropriate
or invalid” to apply the principle to the navigation
equations disclosed in the ’159 patent. J.A. 2143. In
sum, substantial evidence supports the PTAB’s determination
that the Asserted Claims would not have been
obvious to a PHOSITA.