Monday, January 16, 2017

The Crowley copying considered in context

In the context of a post about Monica Crowley [ Why plagiarism took down Monica Crowley, Trump’s pick for a top national security post ], one commenter stated

I am conservative and I like Monica, but I hate plagiarism. I had a similar experience when I edited a fellow law student’s law review article. I spent a lot of my precious school time improving his article for him, while he resisted the changes in a more than average way. The editor-in-chief called me in and showed me what the footnote checker had discovered – like Monica’s work, the article was full of paragraph-long stolen passages. No wonder he resisted the edits; I was changing presumably excellent published work. This guy was rich and apparently skillful at working his way out of trouble. He was kicked off of the law review but not out of law school. I still have a bitter taste from it.

The main body of the post did mention Biden's plagiarism at Syracuse Law:

If that wasn't bad enough, Biden admitted the next day that while in law school he had
received an F for a course because he had plagiarized five pages from a published article
in a term paper that he submitted.

The post of Aaron Blake did not mention that the length of the paper (for a 1L class) was 15 pages,
and did not mention that a fellow 1L (reviewing the paper) warned Biden about copying from the
published article, which had been provided to the class for the writing exercise. Biden did get an F,
had to retake the course, but remained in law school, and went on to other things. The copying issue
as to Kinnock is less straightforward as to "plagiarism," with the bigger concern that the
copied "life elements" were not true as to Biden.

The post of Aaron Blake did not mention the plagiarism issue with the Ph.D. thesis of Glen Poshard, one-time governor candidate in Illinois. Poshard had to re-write his thesis but did not lose his Ph.D. The less discussed issue was
how the copied material related to Poshard's thesis and how the thesis committee missed the copying and the illogical presentation.

Of Biden, see

Biden and plagiarism

Went to a garden party: does Joe Biden hide in your shoes?

Of "footnote checker" (cite checker),

the Lemley citations about transistor/hearing aid ultimately track back to a non-existent 1947 article in the
New York Times. Cite checkers in law reviews are imperfect.

See the 2004 post:
Inventors of transistor foresaw only a hearing aid application?

CRISPR, intellectual property, and Latour

Further to the IPBiz post
Politics in the academia of intellectual property?
, one notes that Professor Lemley's reference to the lack of understanding by the transistor's inventors of the potential of the transistor appeared in several law reviews. As noted in 2008:

See Mark A. Lemley & R. Anthony Reese, Reducing Digital Copyright Infringement Without Restricting Innovation, 56 STAN. L. REV. 1345, 1387 n.160 (2004) (counting "the inventors of the transistor, who anticipated its use in hearing aids" among "the inventors who did not recognize the potential of their ideas"); Mark A. Lemley, Ex Ante Versus Ex Post Justifications for Intellectual Property, 71 U. CHI. L. REV. 129, 137 n.29 (2004) (same).

A later law review article by Michael Carroll [ 70 Ohio St. L.J. 136 ] relied on this faulty perception:

Our reliance on the allegedly superior information of private innovators is a subject warranting further study. We know from experience that innovators often misjudge the likely market value of their innovations. For example, a number of pioneering inventors undervalued their innovations. See, e.g., Lemley, Ex Ante Versus Ex Post, supra note 31, at 139 (collecting sources).

[Michael Carroll has an A.B. from the University of Chicago, was a journalist in Chicago, and is a Professor of Law at
American University.]

A more recent law review, discussing CRISPR, also cites to Lemley's "Ex Ante" paper [The CRISPR Revolution: What Editing Human DNA Reveals About the Patent System's DNA (64 UCLA L. Rev. Disc. 392)].

**There is another implicit CRISPR/Lemley tie-in, through a reference to CRISPR being somewhat a Latour-esque area (which IPBiz does NOT believe). Note CRISPR: the latest biotech hype at

One Latourian hybrid now fascinating researchers and the public is the gene-editing technique CRISPR-Cas9. What began with an attempt to build a better yogurt now has journalists speculating about Brave New World (1932) scenarios. Scientists, ethicists, entrepreneurs, and officials across the globe want to reap the benefits while guarding against errors and side effects.

Of Latour, wikipedia writes:

In the laboratory, Latour and Woolgar observed that a typical experiment produces only inconclusive data that is attributed to failure of the apparatus or experimental method, and that a large part of scientific training involves learning how to make the subjective decision of what data to keep and what data to throw out. Latour and Woolgar argued that, for untrained observers, the entire process resembles not an unbiased search for truth and accuracy but a mechanism for ignoring data that contradicts scientific orthodoxy.

Latour and Woolgar produced a highly heterodox and controversial picture of the sciences. Drawing on the work of Gaston Bachelard, they advance the notion that the objects of scientific study are socially constructed within the laboratory—that they cannot be attributed with an existence outside of the instruments that measure them and the minds that interpret them. They view scientific activity as a system of beliefs, oral traditions and culturally specific practices— in short, science is reconstructed not as a procedure or as a set of principles but as a culture

The transistor/hearing aid saga would be an extreme example of Latour-esque activity, because the underlying "data" (a non-existent article in the New York Times and citations to it) are not present, and the actual Bell Labs public demonstration involved three different tangible applications of the transistor, none of which involved a hearing aid.

**BUT note a later reference to Lemley's understanding of inventors' understanding of patent value in Masur, 2 J. of Legal Analysis 687:

These conceptions of large quantities of uncertainly valued patents credit inventors with little ability to discern the worth of innovation in their own commercial fields, contrary to evidence that patent applicants have "a fairly good sense ex ante as to which of their patents will be the most valuable (Burk & Lemley 2009, 52)."

[ Burk, Dan L., & Mark A. Lemley. 2009. The Patent Crisis and How the Courts Can
Solve It. Chicago: The University of Chicago Press. One notes that, if it were true that the transistor inventors thought only of hearing aids, as Lemley stated in 2004, then the 2009 text is problematic.]

Separately, Masur gives a rather incomplete "history" of the patent grant rate saga, among other things omitting reference to the paper of Clark, who gave a figure of about 75% years before the Lemley paper.

A number of separate studies have attempted to determine the proportion of
patents approved by the PTO, with varying results. One early study found that
the PTO grants approximately 97 percent of the patents it examines (Quillen &
Webster 2001), a figure that was later revised downward to 85 percent (Quillen,
Webster, & Eichmann 2002); another study found a grant rate of approximately 75
percent (Lemley & Sampat 2008). n16 Irrespective of the precise figure, there
is ample evidence to indicate that patent examiners are performing poorly when
it comes to weeding out invalid patent applications (Merges 1999; Schaafsma

Politics in the academia of intellectual property?

A post at PatentlyO on an article by Jonathan Barnett titled Has the Academy Led Patent Law Astray? produced some comments about Mark Lemley:

I doubt that few within the patent academy are willing to ideologically challenge someone like Lemley as his ability to alter career prospects is probably quite real.


Also, I couldn’t agree more regarding Lemley and his influence over academia. He has also gotten a lot of these professors their jobs. Lemley is unethical and should be taken down based on his unethical conduct.


Of the 40+ names that signed the proposed patent “deform” bill some years back, more than 1/3 had ties to large serial infringers, with of course, “Professor” Lemley being the biggest paid for name on the list. He and his minions are fond of putting their names on these faux academic studies without revealing their representation of their large infringing clients (Google for example).

As to the impact of Professor Lemley, one notes that the word "Lemley" appears 203 times in the last six months on the LEXIS law review database. For example, an article titled "Are universities special? ( 49 Akron L. Rev. 671 ) has as footnote 4: See Mark A. Lemley, Are Universities Patent Trolls?, 18 Fordham Intell. Prop. Media & Ent. L.J. 611, 612-13 (2008) ("Universities are non-practicing entities. They share some characteristics with trolls ... but they are not.")
And an article titled "THE CIRCULAR LOGIC OF ACTAVIS " has: n129. See Lemley & Shapiro, supra note 126, at 75 ("When a patent holder asserts its patent against an alleged infringer, the patent holder is rolling the dice.").
The word "patentlyO" appears 52 times and the word "ipwatchdog" 53 times. The word "crispr" appears 13 times.

More than five years ago, there was some discussion about Lemley's theory on the "myth of the solo inventor," which got into both Edison's light bulb and Lemley's assertion that the inventors of the transistor thought it would be useful only in the context of hearing aids. The support for the latter was a non-existent article supposedly in the New York Times. There was an article in the New York Times, the day after the public release by Bell Labs of information on the transistor, which article was mainly about the radio show "Our Miss Brooks." Thus, more in keeping with history, it was the New York Times, not the inventors of the transistor, who did not recognize the potential of the transistor. Lemley was wrong to refer to a non-existent article and wrong not to appreciate the actual significance of the Times article.

The 2011 post in "written description" on "myth" had some commentary by Oullette:

Thanks for citing your article about Lemley's claim that "[t]he transistor was originally conceived primarily as useful in hearing aids" (to make it easier for others reading these comments, here is a link to your article on Hein, and the relevant page is 86). I haven't carefully checked your sources (just as I don't carefully check the sources of articles I blog about, since this is a blog, not a law review), but it looks like you are right that this is as much a myth as the other myths Lemley debunks!

Lemley: Myth of the Sole Inventor

**As to Edison, apart from the fact that Edison's basic light bulb patent does not mention bamboo at all, the key discovery was as to "high resistance" (which was not part of the work of prior investigators). See the discussion in the IPBiz post

Shaver on Edison's light bulb: "Scientifically speaking, his team’s discoveries were neither the first, nor the most important."

**In passing, from Jason Rantanen, The Doctrinal Structure of Patent Law's Enablement Requirement , 69 Vand. L. Rev. 1679 (2016) :

See Jason Rantanen, Patent Law's Disclosure Requirement, 45 LOY. U. CHI. L.J. 369, 370 n.1 (2013). But see J. Jonas Anderson, Secret Inventions, 26 BERKELEY TECH. L.J. 917 (2011) (analyzing the situations in which the disclosure function operates and suggesting changes to encourage the use of secrecy by inventors where appropriate); Mark A. Lemley, The Myth of the Sole Inventor, 110 MICH. L. REV. 709, 745 (2012) ("Disclosure theory cannot, however, support the modern patent system."). For a discussion of why enablement might matter even irrespective of whether disclosure theory actually supports the patent system, see Lisa Larrimore Oullette, Do Patents Disclose Useful Information?, 25 HARV. J.L. & TECH. 545 (2012).

**In passing, note post at Huffington by Michelle Lee Patent Quality is Here to Stay

Sunday, January 15, 2017

CBS Sunday Morning on 15 January 2017, the Sunday before the inauguration

The cover story was done by Martha Teichner, giving an analysis of the Obama presidency. Michelle Miller on Jackie Evancho, who will be singing at the inauguration. Lee Cowan on Viola Davis, who noted praise doesn't always last (or bring employment). Chip Reed on Ruth Westheimer. Rita Braver on inaugural gowns. Faith Salie on Eric Fanning, the outgoing Army Secretary.

The first mentioned news item was the ice storm in the midwest, from Oklahoma to Illinois. Trump on Lewis. Jennifer Holliday, of Broadway musicals "Dreamgirls" and "Your Arms Too Short to Box with God," backs out of performing at the inauguration. Ringling Brothers circus going out of business after 146 years. SpaceX launch.

A streaming fact: 6 million signed petition for Martin Luther King holiday.

Martha Teichner's cover story prominently featured known plagiarist Doris Kearns Goodwin. Goodwin noted that, although
unpopular on leaving office, Truman and Johnson were treated well by history and suggested history would be kind to Obama. The power of the symobolism of Obama was noted.

Of the design of inaugural gowns, contemplate also text from Roger Martin : A design thinker can draw on both the traditional forms of analytical thinking -- inductive and deductive logic (...) If you can go to designers and create private-label versions of sweaters and shirts and the like, you can get customers to buy something without comparison. They don’t have any comparison reference, but it’s a great design and is much lower priced than a similar thing at Nordstrom.
IPBiz notes: but recall how the Martha Stewart/KMart deal worked out.
[link: ]

Bill Plant, now retiring, did a piece on White House photographer Pete Souza.

A short piece on St. Paul's Chapel of Trinity Church, Manhattan.

The moment of nature continues to be more generically described, this time in the New Jersey Pine Barrens.
Whistling swans (also known as tundra swans) are found in the area of Whitesbog Village. Whistling swans don't actually whistle, and simply over-winter in the Pine Barrens.

Sunday Morning moment of nature did the Pine Barrens about one year ago on 21 Feb. 2016:

Saturday, January 14, 2017

Evaluating the value of patents; a lesson from baseball?

From time to time, the use of forward patent citation numbers to evaluate the value of
a patent arises, and IPBiz points out the errors of this approach.

In baseball, the value of players involved in a trade is frequently debated. 2017 marks the
five year anniversary of the Pineda (pitcher)/Montero (catcher) trade, and someone posted, noting
that it takes fives years to evaluate a trade. See Five Years Later

The trade in baseball involving the most players happened in late 1954, with key
components involving pitchers (Turley, Larsen) and a catcher (Triandos).
In spite of Turley's 1958 season and Larsen's 1956 perfect game, some have
argued that Baltimore, with Triandos, got the better of the deal.


On November 17, 1954, Paul Richards of the Orioles and George Weiss of the Yankees engineered the largest two team swap of personnel in major league history. The deal was announced in the media in two stages - first, on November 18 it was announced that the Orioles had sent the "Second Coming of Bob Feller" Bullet Bob Turley (American League leader in K's and BB's), Don Larsen (AL leader in losses with 21) and Billy Hunter (the 0's starting shortstop) to the New York Yankees for pitchers Harry Byrd and Jim McDonald; outfielder Gene Woodling; shortstop Willie Miranda; and minor league catchers Gus Triandos and Hal Smith (the American Association's batting champ with a .350 average). Because of waiver and draft regulations the rest of the trade was not officially announced until December 2, 1954. Baltimore sent pitcher Mike Blyzka, catcher Darrell Johnson, first baseman Dick Kryhoski, and outfielders Ted del Guercio and Tim Fridley to the Yankees to complete their end of the deal. The Yankees in turn sent to the Orioles pitcher Bill Miller, second baseman Don Leppert, and third baseman Kal Segrist. Originally, it was reported, that the trade was to have also included Oriole pitcher Lou Kretlow, but the 0's withdrew his name and George Weiss agreed to a nine for eight swap instead of nine for nine.


If longevity and consistency are the chief attributes a baseball player can offer, then the Orioles with Gus Triandos had the edge over the Yankees with Turley and Larsen

Day in and day out, Baltimore got more impact from Triandos. Applying the
five year rule, both Larsen and Turley were of less value to the Yankees than Triandos
to the Orioles by December 1959. Larsen, with a sore arm, was traded to Kansas City in December
1959, as part of the Roger Maris deal, though Larsen would have some revenge in the 1962 World Series,
on the sixth anniversary of his perfect game. This was on October 8, 1962, and, as a bit of trivia, as between Don Larsen and Whitey Ford, it is Larsen who last won a World Series game. (Ford was the starter on October 8, but not the losing pitcher; Ford did lose on October 15, 1962). Triandos was an all-star in 1957, 1958, and 1959, and managed 17 home runs in 1961. Also, Gene Woodling ended up in Cleveland, and hit .321 in 1957 with 19 home runs, and even batted .300 for Baltimore in 1959 with 14 home runs, and was an all-star.

Value in baseball can be measured by tangible values, such as games won or batting average. Patent citations are at best an inferred proxy for value, and the time that
they occur might be relevant to assessing (asserted) impact. Especially, for patents, citations both "too soon" and "too late" are not likely to be correlated with economic value. Moreover, popularity and
trendiness, at the end of the day, do not prove economic value.

As to "too late" in baseball, one notes that at the end of the 1964 season, Triandos played 73 games and batted .250; in 1965, the last year of his 13 year career, 54 games and .175. Bob Turley's last year with the Yankees was 1962, and in baseball 1963. Don Larsen lasted in the majors until 1967; his last winning season was with the Giants in 1962 (5-4).

In the realm of patents, US 4,237,224 (Cohen/Boyer, issued December 2, 1980) is listed in the USPTO database as "referenced by" 304 patents, most recently by US 9,399,667, on July 26, 2016. The 100th most recent citing patent is US 6,042,837, issued in 2000.

**Separately, as to CRISPR patents

--> note the two comments at the labiotech post:

--> CRISPR: The Latest Biotech Hype

UPDATE after Steelers beat Chiefs on 15 Jan 2017:

**Separately, contemplating the value of advice from intellectual property academics who are neither IP practitioners nor entrepreneurs proposing to establish economic value of patents, one considers the words of Pittsburgh Steeler guard Ramon Foster on football prognostication:

”I think we proved that wrong this weekend. Those odds are for people that bet on the game. We play the game.

Thursday, January 12, 2017

CAFC affirms SD Ind in Lilly v. Teva in pemetrexed case Teva loses;

The overview of the action:

Eli Lilly & Co. (“Eli Lilly”) is the owner of U.S. Patent
No. 7,772,209 (“’209 patent”). It filed this consolidated
Hatch-Waxman suit against Teva Parenteral Medicines,
Inc.; APP Pharmaceuticals LLC; Pliva Hrvatska D.O.O.;
Teva Pharmaceuticals USA, Inc.; and Barr Laboratories,
Inc. (collectively, “Defendants”) to prevent Defendants
from launching a generic version of a chemotherapy drug
with accompanying product literature that would allegedly
infringe methods of treatment claimed by the ’209
patent. The United States District Court for the Southern
District of Indiana held two bench trials, one on infringement
and one on invalidity. The district court found that
no single actor performs all steps of the asserted claims
because the actions of both physicians and patients are
required. Nonetheless, under Akamai Technologies, Inc.
v. Limelight Networks, Inc. (Akamai V), 797 F.3d 1020,
1022 (Fed. Cir. 2015) (en banc) (per curiam), cert. denied,
136 S. Ct. 1661 (2016), the court found direct infringement
attributable to physicians and held Defendants
liable for inducing that infringement. The court also
determined that the asserted claims were not invalid for,
inter alia, indefiniteness, obviousness, or obviousnesstype
double patenting.

For the reasons below, we affirm

The Akamai issues

The parties agree for purposes of this appeal that no
single actor performs all steps of the asserted claims;
rather, the steps are divided between physicians and
patients. Though physicians administer vitamin B12 and
pemetrexed, patients self-administer folic acid with
guidance from physicians. Eli Lilly’s theory of infringement
therefore requires establishing liability for divided
infringement—an area of law that this court was actively
reconsidering during the pendency of this case.

In June 2013, Defendants conditionally conceded induced
infringement under then-current law set forth in
Akamai Technologies, Inc. v. Limelight Networks, Inc.
(Akamai II), 692 F.3d 1301 (Fed. Cir. 2012) (en banc) (per
curiam), rev’d, 134 S. Ct. 2111 (2014).1 At the time, the
Akamai II decision was the subject of a petition to the
Supreme Court for a writ of certiorari. The parties’
stipulation included a provision reserving Defendants’
right to litigate infringement if the Supreme Court reversed
or vacated Akamai II.

Of Akamai V:

Here, the district court decided that “the factual circumstances
[we]re sufficiently analogous to those in
Akamai [V] to support a finding of direct infringement by
physicians.” Eli Lilly & Co. v. Teva Parenteral Meds., Inc.
(Eli Lilly III), 126 F. Supp. 3d 1037, 1041 (S.D. Ind. 2015).
The court observed initially that taking folic acid in the
manner recited by the asserted claims is a “critical” and
“necessary” step to “reduc[e] . . . potentially lifethreatening
toxicities caused by pemetrexed,” i.e., to
“receive the benefit of the patented method.” Id. at 1042.
Regarding the first Akamai V prong, the court found,
based on the product labeling, that “taking folic acid in
the manner specified is a condition of the patient’s participation
in pemetrexed treatment.” Id. Regarding the
second prong, the court found that physicians would
“prescrib[e] an exact dose of folic acid and direct[] that it
be ingested daily.” Id. at 1043. The court therefore held
that, under Akamai V, the performance of all steps of the
asserted claims would be attributable to physicians.

Meeting the two prongs of Akamai is not sufficient to
prove induced infringement:

Although we conclude that the two-prong Akamai V
test is met here, this does not end our inquiry. “The mere
existence of direct infringement by physicians, while
necessary to find liability for induced infringement, is not
sufficient for inducement.” Takeda Pharm. USA, Inc. v.
West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir.
2015). To show inducement, Eli Lilly carries the burden
of further proving “specific intent and action to induce
infringement.” Takeda, 785 F.3d at 631. Mere
“knowledge of the acts alleged to constitute infringement”
is not sufficient. DSU Med., 471 F.3d at 1305.


We make two observations at the outset. First, to be
clear, the intent for inducement must be with respect to
the actions of the underlying direct infringer, here physicians.
Second, we have not required evidence regarding
the general prevalence of the induced activity. When the
alleged inducement relies on a drug label’s instructions,
“[t]he question is not just whether [those] instructions
describ[e] the infringing mode, . . . but whether the instructions
teach an infringing use such that we are willing
to infer from those instructions an affirmative intent to
infringe the patent.” Takeda, 785 F.3d at 631 (internal
quotation marks omitted). “The label must encourage,
recommend, or promote infringement.” Id. For purposes
of inducement, “it is irrelevant that some users may
ignore the warnings in the proposed label.” AstraZeneca
LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010).


Wednesday, January 11, 2017

Cloud Farm loses at CAFC

Cloud Farm Associates LP (“Cloud Farm”) sued
Volkswagen Group of America (“Volkswagen”) and ZF
Sachs AG (“ZF”) (collectively, “defendants”) in the United
States District Court for the District of Delaware alleging
infringement. Specifically, Cloud Farm alleged that
Volkswagen had infringed four patents directed towards
vehicular tilt control apparatuses, and that ZF had infringed
three of those patents. Following two rounds of
claim construction, the parties stipulated that, if the
district court’s constructions were not reversed or modified
on appeal, Cloud Farm could not prove infringement
of any asserted claims. Joint Stipulation 4-5, ECF 349-1.
Cloud Farm and Volkswagen further stipulated that
under the district court’s constructions, two asserted
claims are invalid as indefinite under 35 U.S.C. § 112. Id.
at 5–6. The district court adopted the joint stipulation
and entered a final judgment of non-infringement and
invalidity. Final Judgment 1-2, ECF 350. Cloud Farm
appeals the district court’s construction of several claim
terms. Because we agree with the district court’s construction
of those terms, we affirm.

Tuesday, January 10, 2017

In Phigenix v. Immunogen, the CAFC discusses the "injury in fact" requirement for standing in appeals from USPTO decisions

Overview of the case:

Appellant Phigenix, Inc. (“Phigenix”) sought inter
partes review of U.S. Patent No. 8,337,856 (“the ’856
patent”), alleging that claims 1–8 (“the Asserted Claims”)
of the subject patent are unpatentable as obvious over
various prior art references. In its final written decision,
the U.S. Patent and Trademark Office’s (“USPTO”) Patent
Trial and Appeal Board (“PTAB”) found the Asserted
Claims nonobvious. See generally Phigenix, Inc. v. ImmunoGen,
Inc., No. IPR2014-00676, 2015 WL 6550500
(P.T.A.B. Oct. 27, 2015).

Phigenix appeals. We possess subject matter jurisdiction
pursuant to 28 U.S.C. § 1295(a)(4)(A) (2012). Because
Phigenix has not offered sufficient proof
establishing that it has suffered an injury in fact, it lacks
standing to bring suit in federal court. We dismiss.

Briefing on a standing issue was requested:

Before the parties fully briefed the subject appeal,
ImmunoGen filed a motion to dismiss, asserting that
Phigenix lacked standing to appeal the PTAB’s Final
Written Decision. See generally ImmunoGen’s MTD.
Phigenix opposed. See generally Phigenix’s Resp. to MTD.
A single judge of this court denied the Motion, “deem[ing]
it the better course for the parties to address the standing
issue in their briefs.” Phigenix, Inc. v. ImmunoGen, Inc.,
No. 2016-1544 (Fed. Cir. Apr. 20, 2016) (order denying
ImmunoGen’s MTD).

It was foreseeable that the WARF/stem cell case would be

“[A]lthough Article III standing is not necessarily a
requirement to appear before an administrative agency,”
Consumer Watchdog v. Wis. Alumni Research Found., 753
F.3d 1258, 1261 (Fed. Cir. 2014) (citation omitted), an
appellant must nevertheless supply the requisite proof of
an injury in fact when it seeks review of an agency’s final
action in a federal court
,2 see Massachusetts, 549 U.S. at
517 (explaining that, when a party appeals from a final
agency action, it must demonstrate that it suffers an
injury “that is either actual or imminent” (quoting Lujan,
504 U.S. at 560–61)).

Footnote 2 states:

An appellant’s obligation to establish an injury in
fact remains firm even though it need not “‘meet[] all the
normal standards for redressability and immediacy’”
when, as here, a statute provides the appellant with a
right to appeal. Massachusetts, 549 U.S. at 517–18 (quoting
Lujan, 504 U.S. at 572 n.7).

In the Phigenix case the CAFC noted past omissions:

In the nearly thirty-five years since the court’s inception,
we have not established the legal standard for
demonstrating standing in an appeal from a final agency
action. This standard must identify the burden of production;
3 the evidence an appellant must produce to meet
that burden; and when an appellant must produce that
evidence. We discuss each item in turn.

Footnote 3 states: “Burden of production” means “[a] party’s duty to
introduce enough evidence on an issue to have the issue
decided by the fact-finder, rather than decided against the
party in a peremptory ruling such as a summary judgment
or a directed verdict.” BurdBurden of Production, Black’s
Law Dictionary (10th ed. 2014).

**As to the concept of "self-evident standing"

Self-evident standing typically arises
when an appellant “is ‘an object of the action (or forgone
action) at issue.’”5 Id. at 900 (quoting Lujan, 504 U.S. at
561–62). “When the [appellant]’s standing is not selfevident,
however, the [appellant] must supplement the
record to the extent necessary to explain and substantiate
its entitlement to judicial review.” Id. In so doing, an
appellant may submit “arguments and any affidavits or
other evidence” to demonstrate its standing. Id. Taken
together, an appellant “must either identify . . . record
evidence sufficient to support its standing to seek review
or, if there is none because standing was not an issue
before the agency, submit additional evidence to the court
of appeals,” such as “by affidavit or other evidence.” Id. at
899 (internal quotation marks and citation omitted).


an appellant must identify the relevant evidence
demonstrating its standing “at the first appropriate” time,
whether in response to a motion to dismiss or in the
opening brief, Sierra Club, 292 F.3d at 900; see id at 901.
Imposing on an appellant the dual obligations of producing
the evidence and producing the evidence early in the
litigation comports with the reality that such evidence is
“necessarily peculiar to” the appellant and “ordinarily
within its possession.” Id. at 901. Thus, if there is no
record evidence to support standing, the appellant must
produce such evidence at the appellate level at the earliest
possible opportunity.

Phigenix argued:

Phigenix does not contend that it faces risk of
infringing the ’856 patent, that it is an actual or prospective
licensee of the patent, or that it otherwise plans to
take any action that would implicate the patent. See
generally Phigenix’s Resp. to MTD; Appellant’s Br.; Appellant’s
Reply. Instead, Phigenix asserts that it has suffered
an actual economic injury because the ’856 patent
increases competition between itself and ImmunoGen, see
Phigenix’s Resp. to MTD at 6, and “‘[i]ncreased competition
represents a cognizable Article III injury,’” id. (quoting
Liquid Carbonic Indus. Corp. v. FERC, 29 F.3d 697,
701 (D.C. Cir. 1994)).

CAFC noted:

A “conclusion[] of law” in a declaration “cannot be
utilized [i]n a summary-judgment motion.” 10B Charles
Alan Wright & Arthur R. Miller, Fed. Prac. & Proc. § 2738
(4th ed. 2016) (internal quotation marks and footnotes
omitted); accord F.R.C. Int’l, Inc. v. United States, 278
F.3d 641, 643 (6th Cir. 2002); Schubert v. Nissan Motor
Corp. in U.S.A., 148 F.3d 25, 30–31 (1st Cir. 1998); Orthopedic
& Sports Injury Clinic v. Wang Labs., Inc., 922
F.2d 220, 224 (5th Cir. 1991); Barfield v. Orange Cty., 911
F.2d 644, 650 (11th Cir. 1990); Toro Co. v. Krouse, Kern &
Co., 827 F.2d 155, 162 n.3 (7th Cir. 1987).


See Lujan v. Nat’l Wildlife Fed’n, 497
U.S. 871, 888 (1990) (explaining that “[t]he object” of Rule
56 “is not to replace conclusory allegations of the complaint
or answer with conclusory allegations of an affidavit”).

One should note footnote 6:

Several aspects of the Declarations submitted by
Phigenix also fail to lay the requisite foundation to be
“admissible in evidence,” as Rule 56(c)(4) requires. See
10B Charles Alan Wright & Arthur R. Miller, Fed. Prac.
& Proc. § 2738 (4th ed. 2016) (explaining that “the rules of
evidence and their exceptions determine what allegations
the affidavit may contain” (footnote omitted)); see also
Fed. R. Evid. 901(a) (“To satisfy the requirement of authenticating
or identifying an item of evidence, the proponent
must produce evidence sufficient to support a finding
that the item is what the proponent claims it is.”). For
example, Dr. Carlton D. Donald testified that “Phigenix
and Genentech had multiple discussions
through . . . telephone conversations concerning the
Phigenix technology and its patent portfolio,” Donald
Decl. at ¶ 8; however, Dr. Donald does not establish that
(1) a particular number was dialed; (2) the number dialed
was “assigned at the time” to Genentech; or (3) “the call
related to business reasonably transacted over the telephone,”
Fed. R. Evid. 901(b)(6).

Also note:

In relevant part, § 141(c) provides that “[a]
party to an inter partes review . . . who is dissatisfied
with the final written decision of the [PTAB] . . . may
appeal the [PTAB]’s decision” to this court. Phigenix
cannot base its injury in fact upon a violation of § 141(c)
because it has been permitted to file its appeal, and the
exercise of its right to appeal does not necessarily establish
that it possesses Article III standing. See Raines v.
Byrd, 521 U.S. 811, 820 n.3 (1997) (“Congress cannot
erase Article III’s standing requirements by statutorily
granting the right to sue to [an appellant] who could not
otherwise have standing.” (citation omitted)). As the
Supreme Court has observed, statutorily “broadening the
categories of injury that may be alleged in support of
standing is a different matter from abandoning the requirement
that the party seeking review must himself
have suffered an injury.” Sierra Club v. Morton, 405 U.S.
727, 738 (1972); accord Massachusetts, 549 U.S. at 516–17
(discussing the need for injury in fact to pursue appeal
from a final agency action); Lujan, 504 U.S. at 578 (same).

Footnote 7 is also of interest:

To the extent Phigenix alleges that Spokeo overruled
the Supreme Court’s prior decisions on standing,
that argument ignores governing law. See Hohn v. United
States, 524 U.S. 236, 252–53 (1998) (“Our decisions remain
binding precedent until we see fit to reconsider
them, regardless of whether subsequent cases have raised
doubts about their continuing vitality.” (citation omitted)).

The WARF/stem cell case is referenced before the "conclusion":

In Consumer Watchdog, we explained that a similar estoppel
provision “do[es] not constitute an injury in fact” when, as
here, the appellant “is not engaged in any activity that
would give rise to a possible infringement suit.” 753 F.3d
at 1262 (citation omitted). We see no reason to reach a
different conclusion on the facts before us.

Phigeniz loses:

Because Phigenix has not substantiated its alleged injury
in fact, it lacks standing to appeal the PTAB’s Final
Written Decision affirming the patentability of the Asserted
Claims of the ’856 patent. We have considered
Phigenix’s remaining arguments to the contrary and find
them unpersuasive. Accordingly, Phigenix’s appeal is

The outcome of this case is relevant to potential appeals
of IPRs of Kyle Bass in the pharma area.

Monday, January 09, 2017

How is Teva's MS drug Copaxone doing

Pantagraph talks about possible investor concerns over Teva/Copaxone:

For example, concerns over Copaxone are largely overstated. Teva Pharmaceutical was able to reformulate Copaxone into an extended-release medication that only needs to be taken three times a week. The patent loss on Copaxone, and what generic drugmakers will be producing, is a less desirable, more frequent once-daily injection. With Teva able to keep its Copaxone brand-name intact and offer multiple sclerosis patients and physicians the same therapy with even more convenience, it's unlikely to lose much in the way of revenue. In other words, Copaxone should remain a $4 billion drug, annually.

link to Pantagraph:

Patents covering "three per week" dosing were not at issue in the Supreme Court case of Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015).

But see also
Teva loses on 40mg Copaxone (for MS) at PTAB

Separately, from on 9 January 2017:

Impax Laboratories, Inc. IPXL announced that it has filed an Abbreviated New Drug application (ANDA) with the FDA for a generic version of Sanofi's Aubagio (teriflunomide) tablets, 14 mg. Aubagio has been approved for the treatment of relapsing forms of multiple sclerosis (MS).


Sanofi has filed a patent infringement lawsuit against Impax in the U.S. District Court for the District of Delaware.


The ANDA of Impax contained a paragraph IV certification.

The - Monica Crowley- copying matter

A post at CNN begins:

Conservative author and television personality Monica Crowley, whom Donald Trump has tapped for a top national security communications role, plagiarized large sections of her 2012 book, a CNN KFile review has found.

The review of Crowley’s June 2012 book, "What The (Bleep) Just Happened," found upwards of 50 examples of plagiarism from numerous sources, including the copying with minor changes of news articles, other columnists, think tanks, and Wikipedia. The New York Times bestseller, published by the HarperCollins imprint Broadside Books, contains no notes or bibliography.

Crowley did not return a request for comment. A spokesperson for HarperCollins told CNN on Sunday: "We have no comment at this time. We are looking into the matter

A lot of the examples given at CNN pertain to the copying of factual information
from an earlier source, without citing the earlier source.

For example, Crowley wrote:

Reuters reported Soros’s
connection to Adbusters, the magazine that is
reported to have come up with the Occupy Wall
Street idea after the
Arab Spring" protests brought down
governments in Egypt, Libya, and Tunisia.
Adbusters is funded by the Tides Center, which
collects and disseminates a huge number
of donations to a slew of Leftist groups.

Aaron Klein had written in 2011:

Yesterday, in an article entitled, Who’s behind
the Wall St. protests?"
Reuters reported on the billionaire’s
connection to Adbusters, the magazine that is
reported to have come up with the Occupy Wall
Street idea after
Arab Spring protests toppled
governments in Egypt, Libya and Tunisia.
Adbusters is funded by the Tides Center, which
acts like a massive clearinghouse
of donations to a slew of liberal groups.

Link to CNN:

As noted many times before, plagiarism, which is copying without
attribution, is distinct from copyright infringement, which among
other things, requires copying of copyrightable text.