Wednesday, April 23, 2014

Fractured CAFC decision in Braintree v. Novel with two different dissents; case punted back to DNJ

In the case of Braintree v. Novel , the disposition
which states

Because we agree with Novel that the district court
erred in its construction of the claim term “clinically
significant electrolyte shifts,” we reverse the district
court’s claim construction of that term, vacate the district
court’s grant of summary judgment of infringement, and
remand for further factual findings to determine whether
the composition covered by Novel’s ANDA product infringes

under the new claim construction articulated

masks two strong and conflicting dissents.

The issue raised by the dissent of Judge Dyk argues that the defendant
Novel should not have been found an infringer:

In particular, the majority’s decision is contrary to our
decision in Bayer Schering, where we held that because
“the FDA has not approved [the use claimed in the patent]
. . . the defendants cannot be held liable for infringement
of the patent.” 676 F.3d at 1326. There, the
patent claimed the use of a particular drug to achieve
three effects simultaneously, “a contraceptive effect, an
antiandrogenic effect, and an antialdosterone effect.” Id.
at 1319 (quoting U.S. Patent No. 5,569,652). But the
FDA-approved NDA and label indicated the use of the
branded drug only “for oral contraception.” Id. (internal
quotation marks omitted). We held that the accused
ANDAs did not infringe because they did not seek approval
for two of the claimed uses. Id. at 1326. There was
no infringement under § 271(e)(2)(A) because “the defendants’
ANDAs [sought] approval to market the generic
[drug] for contraceptive use, and there is no valid patent
on the use of the drug for that purpose alone.” Id.


Similarly, in Warner-Lambert, 316 F.3d at 1356, we
held that “because an ANDA may not seek approval for an
unapproved or off-label use of a drug . . . it necessarily
follows that 35 U.S.C. 271(e)(2)(A) does not apply to a use
patent claiming only such [an unapproved or off-label]
use.” See also AstraZeneca LP v. Apotex, Inc., 633 F.3d
1042, 1059–60 (Fed. Cir. 2010) (assuming that an ANDA
seeking approval for a twice-daily dose regimen could not
infringe a patent claiming a once-daily dose regimen). In
short, Braintree’s patent claims a composition and a
method, both of which require using a 100-500 mL solution.
Novel’s ANDA seeking FDA approval for a 946 mL
solution cannot infringe the ’149 patent

Furthermore, the dissent does not rely solely on the
Hatch-Waxman issue:

Even if there were no Hatch-Waxman issue,
Braintree’s theory would be unsupportable. Braintree’s
“one bottle” theory rests on a demonstrably incorrect
claim construction. Here, “volume” refers to the total
volume of the recommended dosage and not some portion
of that total volume—whether or not the recommended
dosage is given in one bottle or two bottles.

See the earlier IPBiz post titled Colonoscopies contemplated in Braintree v. Novel; DNJ errs in construing "electrolyte shifts;" "it’s quite a bit of diarrhea that comes out.”

In contrast to Judge Dyk's view, from within Judge Moore's dissent which argues that Novel was an infringer:

Infringement, whether on a large or small scale, is
still infringement.2 See, e.g., Lucent Techs., Inc. v. Gateway,
Inc., 580 F.3d 1301, 1318 (Fed. Cir. 2009). Lucent
makes clear that there is no “rare infringement” exception
to liability, and that even one instance of infringement is
adequate to support a judgment of infringement. Id.
(affirming a finding of direct infringement where a jury
“could have reasonably concluded that . . . more likely
than not one person somewhere in the United States had
performed the claimed method”); see also Broadcom Corp.
v. Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir. 2013) (“It
is well settled that an accused device that sometimes, but
not always, embodies a claim nonetheless infringes.”).
The law responds to rare infringement not by eliminating
liability, but by providing for a correspondingly low award
of damages. See Lucent, 580 F.3d at 1334 (“The damages
award ought to be correlated, in some respect, to the
extent the infringing method is used by consumers.”).

Moore cites Lamb-Weston:

In an effort to avoid this outcome, the majority rewrites
the claim language to allow infringement only if
the drug works in a patient population rather than a
patient.3 But this we cannot do. Chef Am., Inc. v. Lamb-
Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (“[W]e
construe the claim as written . . . .”); Process Control Corp.
v. HydReclaim Corp., 190 F.3d 1350, 1357 (Fed. Cir. 1999)
(“[A] nonsensical result does not require the court to
redraft the claims . . . .”). If the result commanded by the
statute is unsatisfactory, the proper response is for Congress
to amend the statute, making the delayed approval
discretionary rather than mandatory, not for us to redraft
the patent to avoid such a result. For these reasons, I
respectfully dissent. I would affirm the district court’s
summary judgment of infringement.

"Text laundering" fools plagiarism detection software

From How To Fool A Plagiarism Detector

All a hypothetical plagiarist needs to do, to evade such software, is to make sure that no more than, say, any given three or four consecutive words are identical to their source. So they can copy and paste, so long as they, let’s say, change the word order a bit, add or remove some filler words like ‘the’, ‘and’, ‘but’, and replace a few words with synonyms. I call this text laundering.

Tuesday, April 22, 2014

CAFC reverses DNJ on obviousness-type double-pateniting issue in Gilead v. Natco

In Gilead v. Natco, the CAFC addressed an issue
in obviousness-type double-patenting:

This appeal presents a narrow question: Can a patent
that issues after but expires before another patent qualify
as a double patenting reference for that other patent? We
conclude under the circumstances of this case that it can
and, therefore, that the district court erred in excluding
the ’375 patent as a potential double patenting reference
for the ’483 patent.

In terms of law, the CAFC mentioned Application of Robeson, which noted
that 35 U.S.C. § 253’s terminal disclaimer provision provided patent owners a
remedy against a double patenting charge by “permit[
ting] the patentee to cut back the term of a later
issued patent so as to expire at the same time as the
earlier issued patent.” Robeson, 331 F.2d at 614 n.4
(citing commentary of P.J. Federico).

The CAFC also noted: Indeed, as
our predecessor court later explained, a terminal disclaimer
“causes [such] . . . patents to expire together, a
situation . . . which is tantamount for all practical purposes
to having all the claims in one patent.” Application of
Braithwaite, 379 F.2d 594, 601 (CCPA 1967).

In this case, the defendant Natco asserted a defense of obviousness-type
double-patenting: Natco asserted that the ’483 patent was
invalid for obviousness-type double patenting in light of
claim 8 of the ’375 patent.

At district court, this defense failed: Relying on two district court cases, the court concluded
that “a later-issued but earlier-expiring patent” cannot
“serve as a double-patenting reference against an earlierissued
but later-expiring patent.” J.A. 7 (citing Abbott
Labs. v. Lupin Ltd., 2011 WL 1897322 (D. Del. May 19,
2011) and Brigham & Women’s Hosp. Inc. v. Teva Pharm.
USA, Inc., 761 F. Supp. 2d 210 (D. Del. 2011))

Of interest in this case, the two patents in this case are NOT part of the same patent family:

Despite their similarities in content, however, the ’375
and ’483 patents are not part of the same family of patents
and were not before the same patent examiner.
Instead, Gilead crafted a separate “chain” of applications,
having a later priority date than the ’375 patent family.
That separate chain resulted in the issuance of the ’483
patent. Because the patents do not claim priority to any
common application, they will expire at different times as
governed by the provisions of the Uruguay Rounds
Agreement Act. The ’375 patent was filed on February
26, 1996, and claims priority to a regular utility patent
application filed on February 27, 1995. It expires twenty
years later on February 27, 2015, and issued on September
14, 1999. The ’483 patent was filed on December 27,
1996, and claims priority to a provisional utility patent
application filed on December 29, 1995.

As to the terminal disclaimer,

After the ’483 patent issued, Gilead filed a terminal
disclaimer in the application that led to the ’375 patent.
Through it, Gilead disclaimed any portion of the ’375
patent term that extended beyond the expiration date of
the ’483 patent—which, absent abandonment, would not
occur since, as explained above, the ’375 patent’s expiration
date is before the ’483 patent’s expiration date. From
the prosecution history records, that appears to be the
first time Gilead informed either the examiner of the ’375
patent or of the ’483 patent about the existence of the
other patent application. No terminal disclaimer was
filed for the ’483 patent.

As to the law in this case:

And that principle is violated when a patent expires
and the public is nevertheless barred from practicing
obvious modifications of the invention claimed in that
patent because the inventor holds another later-expiring
patent with claims for obvious modifications of the invention.
5 Such is the case here. The ’375 patent expires on
February 27, 2015. Thus, come February 28, 2015, the
public should have the right to use the invention claimed
in the patent and all obvious variants of that invention.

In passing, footnote 3 erroneously discusses patents as giving
"rights to make." Patents are rights to exclude.
Footnote 3:

See also, e.g., Dastar Corp. v. Twentieth Century
Fox Film Corp., 539 U.S. 23, 33-34 (2003) (“The rights of a
patentee . . . are part of a carefully crafted bargain . . .
under which, once the patent . . . monopoly has expired,
the public may use the invention . . . at will and without
attribution.” (internal quotation marks and citations
omitted)); Sears, Roebuck & Co. v. Stiffel Co., 376 U.S.
225, 230 (1964) (“[W]hen the patent expires the monopoly
created by it expires, too, and the right to make the article
. . . passes to the public.”); Miller v. Eagle Mfg. Co., 151
U.S. 186, 197-98 (1894) (explaining history of and collecting
cases on double patenting);

CJ Rader dissented. He concluded:

As a final point, I think a number of concerns counsel
for a more restrained approach. Chief among those is the
interplay between today’s decision and the new “firstinventor-
to-file” provision of the Leahy-Smith America
Invents Act, Pub. L. No. 112–29 § 3, 125 Stat. 285–86
(2011) (“the AIA”). Under the AIA’s new “first-inventorto-
file” framework, prospective patentees are under
tremendous pressure to file their applications early. I am
concerned that today’s opinion will have unforeseen
consequences in this new race to the Patent Office.

Colonoscopies contemplated in Braintree v. Novel; DNJ errs in construing "electrolyte shifts;" "it’s quite a bit of diarrhea that comes out.”

The CAFC found that DNJ erred in claim construction in Braintree v. Novel :

Because we agree with Novel that the district court
erred in its construction of the claim term “clinically
significant electrolyte shifts,” we reverse the district
court’s claim construction of that term, vacate the district
court’s grant of summary judgment of infringement, and
remand for further factual findings to determine whether
the composition covered by Novel’s ANDA product infringes
under the new claim construction articulated
herein. Further, we affirm the district court’s findings
that the asserted claims of the ’149 patent are not invalid.

The case is about preparation for colonoscopies:

Braintree is a pharmaceutical company that manufactures
the SUPREP® Bowel Prep Kit (“SUPREP”), which
helps to prepare patients for colonoscopies. The colon
needs to be visually clear in order to successfully perform
a colonoscopy, so prior to the examination patients typically
drink several liters of a solution to induce diarrhea.

The focal point of contention was a composition that does not produce
any clinically significant electrolyte shifts

The background law on claim construction:

Claim construction is a question of law, Markman v.
Westview Instruments, Inc., 52 F.3d 967, 976-79 (Fed. Cir.
1995) (en banc), aff’d, 517 U.S. 370 (1996), that we review
de novo without deference. Cybor Corp. v. FAS Techs.,
Inc., 138 F.3d 1448, 1454-55 (Fed. Cir. 1998) (en banc).

There was a moving target:

in considering the
parties’ summary-judgment motions, the district court
amended its construction and re-defined “clinically significant
electrolyte shifts” to be “alterations in blood chemistry
that are both outside the normal upper or lower limits
of their range and accompanied by or manifested as other
untoward effects.” Infringement Opinion at *7 (emphases
added). The district court explained that it modified its
original construction to make it conjunctive because the
specification refers to “electrolyte shifts leading to serious
health problems for the patient.” Id.

The term was defined in the specification:

On appeal, Novel argues that in requiring both alterations
in blood chemistry and other untoward effects, the
district court ignored the inventor’s clear definition of the
term “clinically significant electrolyte shifts” in the specification.
See ’149 patent col. 2 ll. 47-51 (“The terms ‘clinically
significant’ as used herein are meant to convey
alterations in blood chemistry that are outside the normal
upper or lower limits of their normal range or other
untoward effects.”).

Thus, the CAFC was direct:

Under our precedent, the patentee’s lexicography
must govern the claim construction analysis. See Phillips
v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en
banc). Therefore, we disagree with the district court’s
modification of the clear language found in the specification.
We reverse the district court’s claim construction
and construe “clinically significant electrolyte shifts” to be
“alterations in blood chemistry that are outside the normal
upper or lower limits of their normal range or other
untoward effects.”

Anticipation was dealt with quickly:

Anticipation is a question of fact, and a district court’s
findings on this issue are reviewed for clear error. See
Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082
(Fed. Cir. 2008). Below, the district court found that
Novel “did not show proof that met the clear and convincing
standard” that the asserted claims were anticipated
by Hechter. Validity Opinion at *25. The district court
credited Braintree’s expert witness’s opinion that Hechter
does not disclose several limitations of the asserted
claims. Id. at *24. On appeal Novel argues again that
Hechter anticipates the asserted claims of the ’149 patent.
For at least these three reasons, we affirm the district
court’s finding that Hechter does not anticipate the asserted
claims of the ’149 patent.

As to obviousness:

As the district court correctly noted,
Novel did not prove that one of skill in the art would have
been motivated to combine so many references. In other
words, it failed to prove a “plausible rational[e] as to why
the prior art references would have worked together.”
Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343,
1352 (Fed. Cir. 2010). Further, in building its obviousness
case, Novel relies on expert testimony which the
district court found to be less credible. Validity Opinion
at *25. And the prior art, including Hechter, taught that
safe bowel preps should be isotonic, not hypertonic like
the claimed compositions. See, e.g., Hechter col. 2 ll. 60-
64. Therefore, we conclude that the district court did not
err in finding that Novel failed to demonstrate that the
asserted claims of the ’149 patent would have been obvious
at the time of the invention.

Of descriptive words in claims:

Descriptive words like “copious” are
commonly used in patent claims, to “avoid[] a strict numerical
boundary to the specified parameter.” See Pall
Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217
(Fed. Cir. 1995). Further, when asked what copious
would mean to one of skill in the art, Braintree’s expert
witness stated “[w]ell, copious is a lot. . . . I think anyone
who has taken a bowel prep prior to [a] colonoscopy,
knows that it’s quite a bit of diarrhea that comes out.”
J.A. 20161. We agree, and therefore we conclude that one
of skill in the art would understand what a “copious”
amount of diarrhea is in this context.

There was a dissent on the infringement matter:

However, I respectfully dissent from the majority’s
conclusion that Novel’s ANDA meets the volume limitation
of the asserted claims. Under the proper interpretation
of the volume limitation, Novel established noninfringement
as a matter of law. In my view, the majority’s
contrary conclusion is inconsistent with established
authority under the Hatch-Waxman Act.

Of Hatch-Wawman infringement:

In ANDA litigation, because a generic company seeking
FDA approval does not yet “make[], use[], offer[] to
sell, or sell[]” the product and therefore cannot infringe
under 35 U.S.C. § 271(a), pharmaceutical companies must
rely on 35 U.S.C. § 271(e)(2)(A), which creates an “artificial”
act of infringement when the generic company submits
an ANDA seeking approval “‘for a drug claimed in a
patent or the use of which is claimed in a patent.’” Eli
Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675, 676
(1990) (quoting § 271(e)(2)(A)). The infringement occurs
only if the generic company seeks approval for a patented
composition or use that has been approved by the FDA.
Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316,
1319 (Fed. Cir. 2012) (citing Warner-Lambert Co. v.
Apotex Corp., 316 F.3d 1348, 1356 (Fed. Cir. 2003) (“‘[T]he
use’ in § 271(e)(2)(A) refers to the use for which the FDA
has granted an NDA.”)); Glaxo, Inc. v. Novopharm, Ltd.,
110 F.3d 1562, 1567–68 (Fed. Cir. 1997) (composition is
determined by the composition in the ANDA).2
Under the Hatch-Waxman Act, the infringement inquiry
“must focus on what the ANDA applicant will likely
market if its application is approved.” Id. at 1569. Novel’s
ANDA does not cover administration of the drug for
purgation sufficient for “evacuation of a copious amount of
stool from the bowels.” Claim Construction Order at *6.
Rather, Novel’s ANDA states specifically that the drug “is
indicated for cleansing of the colon as a preparation for
colonoscopy in adults.” J.A. 5280.


The majority’s contrary interpretation is inconsistent
with this court’s longstanding precedent. An ANDA
cannot infringe an asserted patent when the FDA approved
dose is not the dose claimed in the patent. As
we held in Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d
1322, 1332 (Fed. Cir. 2003), “a method of use patent
holder may not sue an ANDA applicant for induced infringement
of its patent, if the ANDA applicant is not
seeking FDA approval for the use claimed in the patent
and if the use claimed in the patent is not FDA-approved.”
(emphasis added) (citing Warner-Lambert, 316 F.3d at
1354–55). While the patent here includes both composition
and method of use claims, all claims are limited to
the use of a specified volume of the composition.

Why did the Supreme Court take Teva v. Sandoz?

The U.S. Supreme Court has decided to review the case of Teva v. Sandoz. The legal issue is "what deference" is given to fact-finding by the district court. The science issue concerns measurement of molecular weight. The drug in question is Copaxone.

Teva, which lost at the CAFC as to its patent 5,800,808 (and thus stands to lose months of patent protection), framed the issue to the US Supreme Court as

Whether a district court’s factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires.

See Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

The question, as framed by Teva, gets at the enduring question of the CAFC's de novo review of claim construction of district courts. Under current law, the appellate court gives no deference to the district court on how a patent claim is construed. This approach has been questioned for years. But one wonders if the Teva v. Sandoz case is the right vehicle to resolve the question.

What was the "factual finding" at issue in the case?

The CAFC found "group I" claims, which recited "molecular weights" of 5 to 9 kilodaltons, to be ambiguous because these claims did not specify how to measure the molecular weights. The district court construed the claims to reflect the molecular weight measure Mp (peak average molecular weight). Viewed in this light, the CAFC merely observed the self-evident legal problem: the claim did not say "which measure" of molecular weight was intended. End of story.

That is, without going into any "facts," one observes that the claim itself does not specify "which" measure of molecular weight is to be be used. This ambiguity was specifically identified by the Examiner during prosecution of the '539 and '847 patents. One might have thought the Examiner would have required insertion into the respective claims of the specific molecular weight measure. However, the Examiner apparently accepted arguments without requiring an amendment to achieve clarity. For the '539 patent, Teva said it was peak average, but for the '847 patent it was weight average. The contradictory resolution is a self-evident problem.

The matter of "facts" in the case enters in with the testimony of Teva's expert, Dr. Grant. The gist of his argument seems to be that because only Mp can be read directly from a size exclusion curve, Mp must have been intended for the "group I" claims. One wonders "why" the ability to read a parameter directly from a graph is proof of "which parameter" was intended in a claim.

As to legal matter of "clear error," the clear-error standard “requires
us appellate judges to distinguish between the situation in
which we think that if we had been the trier of fact we would
have decided the case differently and the situation in
which we are firmly convinced that we would have done so.”); Carr v. Allis
on Gas Turbine Div., Gen. Motors Corp., 32 F.3d 1007,
1008 (7th Cir. 1994)

Arguably, the crediting of the reasoning of Dr. Grant by the district court could be deemed clear error, and the debate rendered moot. [same outcome under either standard]

One also wonders why the Supreme Court took this case to begin to address the "de novo" review issue. When the standard for obviousness under 35 USC 103 was reviewed in KSR v. Teleflex, a very simple fact pattern existed. In the Teva case, one has some esoteric "molecular weight" issues, and some seemingly contradictory facts, which renders this case murky.

From a chemistry point of view, one of ordinary skill in the art knows that there are different measures of molecular weight, which give different results, and without guidance as to "which to use", one would not know the scope of the claim.

See earlier IPBiz post Teva prevails in Copaxone case, but was the case correctly decided?


Monday, April 21, 2014

Glenmark loses appeal at CAFC

The CAFC affirmed DNJ in Sanofi-Aventis v. Glenmark

We conclude that jurisdiction is proper,
and affirm the district court’s judgment and related rulings.

Glenmark's unsuccessful argument

Glenmark argues that the verdict cannot stand, as
a matter of law, on the premise that if a combination of classes of compo-
nents is already known, all selections within such classes
are obvious to try, as a matter of law. (...)

Glenmark argued at trial, and repeats on this appeal,
that the Tarka® product simply substituted one known
ACE inhibitor for another. The Plaintiffs responded that
there were hundreds if not thousands of potential combi-
nations of ACE inhibitors and calcium antagonists in
1986, and that none of the available information pointed
directly at the combinations claimed.

The CAFC noted:

This court has elaborated that the identified path
must “present a finite (and small in the context of the art)
number of options easily traversed to show obviousness.”
Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
520 F. 3d 1358, 1364 (Fed. Cir. 2008). As illustrated in
In re O’Farrell, 85 3 F.2d 894, 903 (Fed. Cir. 1988), it would not
be “obvious to try” when “the prior art gave either no
indication of which parameters were critical or no direc-
tion as to which of many possible choices is likely to be

Sunday, April 20, 2014

"The Good Wife". On April 20

Michael J. Fox gets to say I may be a scum bag, but I'm your scum bag.

The NSA tap on Alicia (a three jump) is made known to Alicia and then Peter. Peter deals with it.
Initially, Peter calls a US Senator who denies the tap, but Peter proceeds to discuss confidential information on the phone and quickly realizes the Senator is lying. Then, the instigator of the tap is pranked by calls from suspicios Arab sounding people, and comes under suspicion.

The NSA contractor who disclosed the issue vanishes.

Use of plagiarism-detection software on rise in Japan following Obokata/STAP flap

Within the post Riken affair boosts orders for anti-plagiarism software , one learns there has been increased interest in Japan for plagiarism detection software following the Obokata/STAP cell incident.

As to the "copying without attribution" matter, the article observed:

Riken, in its final investigation earlier this month, said Obokata had not engaged in willful misconduct concerning the passage, noting the quote was the only one of 41 where Obokata did not give attribution, and that the method in question is a common procedure used in many laboratories.

An article by Dennis Normile [RIKEN Panel Finds Misconduct in Reprogrammed Stem Cell Papers ] gives a more complete discussion of the problem with Obokata's actions

For example, part of a description of a method for karyotyping—examining the number and structure of chromosomes in a cell—was not only copied from a paper published by a separate group, but was also not consistent with the procedure actually followed by Obokata’s team. But the committee says Obokata had faithfully cited many other publications and couldn't recall where the text came from, so the committee found it impossible to call this misconduct.

Thus, although the copied method text was well-known, the real issue was that the copied method text was not descriptive of the method actually used. The greater "bad act" was the misrepresentation, not the copying without attribution.

"The reason universities patent basic research tools is to provide the incentive to develop it"

Within the post Broad Institute Gets Patent on Revolutionary Gene-Editing Method, Susan Young Rojahn gets into some patent issues associated with Feng Zhang's CRISPR patent which issued on Tuesday, April 15, 2014 [US Patent 8,697,359].

* The invention is described in the text:

The patent, issued just six months after its application was filed, covers a modified version of the CRISPR-Cas9 system found naturally in bacteria, which microbes use to defend themselves against viruses. The patent also covers methods for designing and using CRISPR’s molecular components.

* There is mention of a pending patent application to Jennifer Doudna, who along with Zhang, is a co-founder of Editas.
The "background" section of Doudna's published US 20140068797 mentions:

[0004] About 60% of bacteria and 90% of archaea possess CRISPR (clustered regularly interspaced short palindromic repeats)/CRISPR-associated (Cas) system systems to confer resistance to foreign DNA elements. Type II CRISPR system from Streptococcus pyogenes involves only a single gene encoding the Cas9 protein and two RNAs--a mature CRISPR RNA (crRNA) and a partially complementary trans-acting RNA (tracrRNA)--which are necessary and sufficient for RNA-guided silencing of foreign DNAs.

[0005] In recent years, engineered nuclease enzymes designed to target specific DNA sequences have attracted considerable attention as powerful tools for the genetic manipulation of cells and whole organisms, allowing targeted gene deletion, replacement and repair, as well as the insertion of exogenous sequences (transgenes) into the genome. Two major technologies for engineering site-specific DNA nucleases have emerged, both of which are based on the construction of chimeric endonuclease enzymes in which a sequence non-specific DNA endonuclease domain is fused to an engineered DNA binding domain. However, targeting each new genomic locus requires the design of a novel nuclease enzyme, making these approaches both time consuming and costly. In addition, both technologies suffer from limited precision, which can lead to unpredictable off-target effects.

[0006] The systematic interrogation of genomes and genetic reprogramming of cells involves targeting sets of genes for expression or repression. Currently the most common approach for targeting arbitrary genes for regulation is to use RNA interference (RNAi). This approach has limitations. For example, RNAi can exhibit significant off-target effects and toxicity.

[0007] There is need in the field for a technology that allows precise targeting of nuclease activity (or other protein activities) to distinct locations within a target DNA in a manner that does not require the design of a new protein for each new target sequence. In addition, there is a need in the art for methods of controlling gene expression with minimal off-target effects.

* Rojahn's article talks of the need for patents by universities:

The reason universities patent basic research tools is to provide the incentive to develop it, says Nelsen. Transforming such a technology into a medical treatment is an immensely expensive process, she says. “If you didn’t patent, that wouldn’t get done,” says Lita Nelsen [director of the MIT Technology Licensing Office ].

MIT does not go after academic scientists who produce lab-made versions of the molecular components for the gene-silencing technology, she says. If the Broad technology licensing office follows that example, then the new patents should not affect academics wanting to use the tool for basic research, says Nelsen. That would be good news, because CRISPR is thought to be a huge boon for biological science. For now, however, the Broad is keeping a tight lid on their plans for the patent.

Saturday, April 19, 2014

Forbes: back to the past on "low quality patent" argument?

The text in The Patent Drain on Economic Growth

Over the years, however, the system has broken down in a number of ways. An overworked Patent and Trademark Office issued too many patents of questionable quality and in markets (software is the prime example) where the very idea of patentability is questionable. An explosion of low quality patents ignited an explosion of litigation, and today the legitimacy of IP itself is under assault.

evokes the long discredited analysis of Quillen and Webster. See 4 Chi.-Kent J. Intell. Prop. 108 (2004-2005).
But see 23 Fed. Cir. B.J. 179 (2013) , which cites in note 4:

See Cecil D. Quillen, Jr. & Ogden H. Webster, Continuing Patent Applications and Performance of the U.S. Patent and Trademark Office, 11 Fed. Cir. B.J. 1 (2001) [hereinafter Quillen I]; Cecil D. Quillen, Jr. et al., Continuing Patent Applications and Performance of the U.S. Patent and Trademark Office--Extended, 12 Fed. Cir. B.J. 35 (2002) [hereinafter Quillen II]; Cecil D. Quillen, Jr. & Ogden H. Webster, Continuing Patent Applications and Performance of the U.S. Patent and Trademark Office--Updated, 15 Fed. Cir. B.J. 635 (2006) [hereinafter Quillen III]; Cecil D. Quillen, Jr. & Ogden H. Webster, Continuing Patent Applications and Performance of the U.S. Patent and Trademark Office--One More Time, 18 Fed. Cir. B.J. 379 (2009) [hereinafter Quillen IV]. See Quillen IV, at 380-83 and accompanying notes, for an overview of these previous Articles.

but does not cite any criticism of these articles.

See also 4 Chi.-Kent J. Intell. Prop. 186 for the discussion of the infamous "footnote 22" in Mark A. Lemley and Kimberley L. Moore, Ending Abuse of Patent Continuations, 84 B. U. L. Rev. 63 (2004).

Loss for Teva in Copaxone patent war

On Good Friday, April 18, 2014, Chief Justice Roberts, denied Teva a request for a stay in the Copaxone case, noting that he was not convinced Teva had shown the "likelihood of irreparable harm" if the application was denied, because if Teva wins the Supreme Court case it can seek damages from the generic companies for past infringement on its patents.

In this case, Teva, a known generic manufacturer, is in the role of proprietary drug maker, fighting the generic arm of a proprietary company [Novartis AG's Sandoz Inc ]. Major role reversals! [Copaxone is the world’s best-selling multiple sclerosis drug; from a compositional point of view, Copaxone is a polymer of the amino acids glutamate, alanine, lysine, and tyrosine mixed in defined molar ratios but in no set order or structure. See footnote 606 of 60 Food Drug L.J. 143 (2005) ]

And Teva, well-known for attacking deficiencies in the patents of proprietaries, is in the position of defending against attacks for indefiniteness associated with definitions of molecular weight.

IPBiz covered the earlier CAFC case in the post Teva prevails in Copaxone case, but was the case correctly decided? Yes, Teva won on some of the claims, but sadly lost on the more important ones. Of those, IPBiz noted

As to the group I claims, Teva had a problem because of arguments made in file histories. For one application, Teva argued molecular weight was Mp (peak average) but for another Mw (weight average). As the CAFC observed, Teva's two definitions cannot be reconciled. There was also an inconsistency within a figure as between the graph itself and the legend for the figure.

[The CAFC stated the peak average molecular weight Mp is the molecular weight of the most abundant molecule in the sample, so that it is not an "average" molecular weight." The CAFC also noted that Mn is the total mass of all molecules divided by the number of molecules, but did not give a definition for Mw. For completeness, Mw is the sum of the (square of molecular weight X number with that molecular weight) divided by sum of (molecular weight X number with that molecular weight).)

Link for Roberts decision Supreme Court denies Teva stay in Copaxone patent fight

Also, note Sam Hananel wrote in the Boston Globe:

The rival companies had argued that granting a stay would effectively extend Teva’s monopoly for years to come. That’s because Teva is trying to switch existing Copaxone patients to a new formulation of the drug that has patent protection until 2030.

Teva released the following text:

in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808 (the “’808 patent”), [Roberts] denied the Company’s application to stay the Federal Circuit's decision due to the potential for the Company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate injection) 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for COPAXONE®.

Teva previously prevailed in the District Court, which upheld the validity of nine COPAXONE® patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE® patents that expire in May 2014, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition.

Any purported generic version of COPAXONE® would be required to obtain the approval of the Food and Drug Administration prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.

The Company is confident COPAXONE® will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.


Teva recruited a predecessor of Sanofi-Aventis to help sell its multiple sclerosis drug Copaxone. Sanofi-Aventis, Annual Report (Form 20-F), at 61 (Mar. 7, 2008); Teva Pharmaceutical Industries Ltd., Annual Report (Form 20-F), at 20 (Mar. 31, 2001).

Virginia Supreme Court gives expansive definition to "proprietary" in FOIA case involving documents of Michael Mann

IPBiz examined the "trade secret" exemption to FOIA requests in the post Wyoming Supreme Court adopts FOIA definition of "trade secret" in "public records" dispute In the case American Tradition Institute v. University of Virginia , the Virginia Supreme Court adopted an expansive definition to the meaning of "proprietary" which gives broad scope to exemptions from Virginia's "Freedom of Information" law.

The case involved a FOIA request for records at the University of Virginia
related to climate researcher Michael Mann.
Later in time, Mann himself intervened:

In September 2011, Professor Mann filed a motion to
intervene, arguing that the University could not sufficiently
protect his interests in privacy, academic freedom, and free
speech. The trial court granted his motion on November 1,

By 2013, the legal issue centered on the meaning of "proprietary":

The parties primarily disputed
documents that may have been "proprietary." The significance
of the dispute is highlighted by the use of the term in Code §
2.2-3705.4(4) which addresses certain public records that are
exempt from disclosure. To be exempt, the public record must

Data, records or information of a
proprietary nature produced or collected
by or for faculty or staff of public
institutions of higher education, other
than the institutions' financial or
administrative records, in the conduct of
or as a result of study or research on
medical, scientific, technical or
scholarly issues, whether sponsored by the
institution alone or in conjunction with a
governmental body or a private concern,
where such data, records or information
has not been publicly released, published,
copyrighted or patented.
Code § 2.2-3705.4(4).

The "intellectual property" issue:

UVA argued that the definition of "proprietary" applied
in Green v. Lewis, 221 Va. 547, 555, 272 S.E.2d 181, 186
(1980), should be applied in the VFOIA context. In
Green we stated:

"A proprietary right is a right customarily associated
with ownership, title, and possession. It is an interest or a
right of one who exercises dominion over a thing or property,
of one who manages and controls." Id. In contrast, ATI
argued that the General Assembly intended to equate
"proprietary" with "competitive advantage."

At trial, the court adopted the meaning in Green.

As to the analysis:

ATI’s first assignment of error focuses exclusively on
the trial court's construction of the statutory term
"information of a proprietary nature." VFOIA contains no
definition of "proprietary" upon which we may rely.
6 See Code § 2.2-3701. Therefore, we must use accepted rules of
statutory construction to interpret the provisions of Code §

The Supreme Court rejected ATI's argument:

We reject ATI's narrow construction of financial
competitive advantage as a definition of "proprietary" because
it is not consistent with the General Assembly's intent to
protect public universities and colleges from being placed at
a competitive disadvantage in relation to private universities
and colleges. In the context of the higher education research
exclusion, competitive disadvantage implicates not only
financial injury, but also harm to university-wide research
efforts, damage to faculty recruitment and retention,
undermining of faculty expectations of privacy and
confidentiality, and impairment of free thought and

The Supreme Court credited testimony of John Simon, which

If U.S. scientists at public institutions
lose the ability to protect their
communications with faculty at other
institutions, their ability to collaborate
will be gravely harmed. (...)
For faculty at
public institutions such as the University
of Virginia, compelled disclosure of their
unpublished thoughts, data, and personal
scholarly communications would mean a
fundamental disruption of the norms and
expectations which have enabled research
to flourish at the great public
institutions for over a century . . . .
Scientists at private institutions such as
Duke, where I previously worked, that are
not subject to state freedom of
information statutes, will not feel that
it is possible to continue collaborations
with scientists at public institutions if
doing [s]o means that every email or other
written communication discussing data,
preliminary results, drafts of papers,
review of grant proposals, or other
related activities is subject to public
release under a state FOIA in
contravention of scholarly norms and
expectations of privacy and
confidentiality. . . .

One notes that, although the Supreme Court rejected
ATI's argument about "competitive advantage," the text
of Simon the Court credited related to [financial] "competitive advantage,"
rather than to the Green definition of "proprietary."

The decision does not say "who paid for"
Mann's research. The relevant Virginia statute includes the
text -- whether sponsored by the
institution alone or in conjunction with a
governmental body or a private concern --

There is a problem with the Green definition of "proprietary"
as to federally-funded research [Green: A proprietary right is a right customarily associated
with ownership, title, and possession. ]
In federally-funded work, the federal recipient does not own
the results of the work. As Gerald Barnett has pointed out in the context
of Bayh-Dole

Bayh-Dole assures the government of its interest in subject inventions, but does not dictate university interests. There is no vesting of title to inventions, as some have claimed. University administrators may request assignment of a subject invention,

Gerald Barnett in a post
Reef or Trench? University research and open access to results gets
into some issues with federally-funded research.
Discussing OMB Circular A-110 (2 CFR 215) , Barnett writes

Under a grant, the investigators typically have an obligation to submit reports, including a final report, and there may be requirements for delivery of data as well. However, there typically is not a requirement to publish results.

Of the Virginia statute text --where such data, records or information
has not been publicly released, published,
copyrighted or patented. --, one wonders the status of information
not publicly released but obligated for disclosure to a governmental body?
Does a member of the public have a right to see information that should
be disclosed to the government funding body, even if such information is
not otherwise published?

Separately, the text of Simon argues that a limited definition of "proprietary"
would place the public school (University of Virginia) at a disadvantage relative
to a private school (e.g., Duke). But taxpayers pay for what goes on at the public school.
There is a difference.

Wednesday, April 16, 2014

Intellectual Ventures handed defeat in ED Va in Capitol One case

Reuters notes that the two Intellectual Ventures [IV] patents in the case comprised claims to abstract ideas that were not
directed to patentable subject matter.

Nathan Myhrvold. IV head, made news elsewhere. Various sources are reporting on published US application 20140078164, titled UNAUTHORIZED VIEWER DETECTION SYSTEM AND METHOD
which has as inventors Chan; Alistair K.; (Bainbridge Island, WA) ; Duncan; William D.; (Kirkland, WA) ; Gates; William; (Redmond, WA) ; Gerrity; Daniel A.; (Seattle, WA) ; Holman; Paul; (Seattle, WA) ; Hyde; Roderick A.; (Redmond, WA) ; Jung; Edward K.Y.; (Las Vegas, NV) ; Kare; Jordin T.; (Seattle, WA) ; Levien; Royce A.; (Lexington, MA) ; Lord; Richard T.; (Tacoma, WA) ; Lord; Robert W.; (Seattle, WA) ; Malamud; Mark A.; (Seattle, WA) ; Myhrvold; Nathan P.; (Bellevue, WA) ; Rosema; Keith D.; (Olympia, WA) ; Tegreene; Clarence T.; (Mercer Island, WA) ; Wood, JR.; Lowell L.; (Bellevue, WA) .

Although the assignee is "ELWHA LLC ", one notes IV patent attorney Tegreene is one of the inventors.

The first claim:

1. A system for detecting and responding to an intruding camera, comprising: an electronic media display device having a screen configured to display content; a sensor; and a processing circuit configured to: obtain information from the sensor; analyze the information to determine a presence of a camera; and edit any displayed content in response to the presence of the camera.

MIT Technology Review on CRISPR patent, US 8,697,359 inventor Feng Zhang

In a post titled The Harvard-MIT genomic science institute trumpets its claims to an important genome editing technology , the MIT Tech Review talked glowingly about US Patent 8,697,359.

Application 14/054,414 was filed October 15, 2013 and the patent issued April 15, 2014, six months later. The applicants used the accelerated examination procedure (filing an "examination support document" [ESD], as distinct from using the prioritized ["track 1"] procedure.)

The first claim states

A method of altering expression of at least one gene product comprising introducing into a eukaryotic cell containing and expressing a DNA molecule having a target sequence and encoding the gene product an engineered, non-naturally occurring Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)--CRISPR associated (Cas) (CRISPR-Cas) system comprising one or more vectors comprising: a) a first regulatory element operable in a eukaryotic cell operably linked to at least one nucleotide sequence encoding a CRISPR-Cas system guide RNA that hybridizes with the target sequence, and b) a second regulatory element operable in a eukaryotic cell operably linked to a nucleotide sequence encoding a Type-II Cas9 protein, wherein components (a) and (b) are located on same or different vectors of the system, whereby the guide RNA targets the target sequence and the Cas9 protein cleaves the DNA molecule, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together.

Claim 8 is to a system

An engineered, non-naturally occurring CRISPR-Cas system comprising one or more vectors comprising: a) a first regulatory element operable in a eukaryotic cell operably linked to at least one nucleotide sequence encoding a CRISPR-Cas system guide RNA that hybridizes with a target sequence of a DNA molecule in a eukaryotic cell that contains the DNA molecule, wherein the DNA molecule encodes and the eukaryotic cell expresses at least one gene product, and b) a second regulatory element operable in a eukaryotic cell operably linked to a nucleotide sequence encoding a Type-II Cas9 protein, wherein components (a) and (b) are located on same or different vectors of the system, whereby the guide RNA targets and hybridizes with the target sequence and the Cas9 protein cleaves the DNA molecule, whereby expression of the at least one gene product is altered; and, wherein the Cas9 protein and the guide RNA do not naturally occur together.

The first paragraph of the summary of invention states:

There exists a pressing need for alternative and robust systems and techniques for sequence targeting with a wide array of applications. This invention addresses this need and provides related advantages. The CRISPR/Cas or the CRISPR-Cas system (both terms are used interchangeably throughout this application) does not require the generation of customized proteins to target specific sequences but rather a single Cas enzyme can be programmed by a short RNA molecule to recognize a specific DNA target, in other words the Cas enzyme can be recruited to a specific DNA target using said short RNA molecule. Adding the CRISPR-Cas system to the repertoire of genome sequencing techniques and analysis methods may significantly simplify the methodology and accelerate the ability to catalog and map genetic factors associated with a diverse range of biological functions and diseases. To utilize the CRISPR-Cas system effectively for genome editing without deleterious effects, it is critical to understand aspects of engineering and optimization of these genome engineering tools, which are aspects of the claimed invention.

A news report from the Independent included the text:

"Crispr is absolutely huge. It's incredibly powerful and it has many applications, from agriculture to potential gene therapy in humans," Craig Mello of the University, of Massachusetts Medical School, who shared the 2006 Nobel prize in medicine, told The Independent in November. "It's a tremendous breakthrough with huge implications for molecular biology and molecular genetics. It's a real game-changer."

IPBiz notes the MIT Tech Review is not always spot-on in recognizing good technology; from an earlier IPBiz post:

IPBiz notes the following commentary by the same MIT Technology Review on the fraudulent work of Jan Hendrik Schon:

Hendrik Schön is reinventing the transistor at the place it was born. He and his Bell Labs coworkers have produced single-molecule transistors whose electrical performance is comparable to that of today’s best silicon devices but which are hundreds of times smaller. Making such molecular transistors, which could lead to ultrafast, ultrasmall computers, has been a goal of researchers for years; Schön’s clever design established Bell Labs as a leader in the race. But Schön is not interested in simply reinventing the transistor. He wants to change the very materials that form microelectronics,replacing inorganic semiconductors with organic molecules. Schön has made an organic high-temperature superconductor, renewing hopes that superconductors could have widespread electronic applications. He also helped devise the first electrically driven organic laser, which could mean cheaper optoelectronic devices. The soft-spoken Schön recalls being “very surprised” by how well his molecular transistors worked. But it won’t be a surprise if Schön helps transform microelectronics.

Of course, it would be a surprise if the fraudulent work of Schon transformed anything. And where is Bell Labs now?


Goose confusingly similar to turkey?

See A Small Irish Whiskey Brand Takes on Bacardi Over Trademark

Do you remember the "Wild Geese" from 17th century Ireland?

--Advanced biofuels are the fuel of the future, and always will be --?

Within a New York Times post titled Dual Turning Point for Biofuels
, one has the text

There is an old joke in the energy business that advanced biofuels are the fuel of the future, and always will be

This is indeed an old line. In 2004, IPBiz, in a post Oil shale: history repeating? , had the text:

As has been said, synfuel is the fuel of the future and always will be.

See also Henry Ford and ethanol

The NYT article was less than clear on what the "dual turning point" was.

One issue was market saturation:

But even as Abengoa and other companies prepare to produce significant amounts of cellulosic ethanol, using corn stalks and wheat straw as opposed to corn itself, the appetite for such fuels seems to be diminishing.

The market is saturated with ethanol from corn.

Also mentioned was the changed circumstances from fracking, etc.:

Other things have changed, too, since 2007. A boom in shale drilling has produced a sudden gush of domestic oil. Increasingly efficient cars and a sluggish economy have cut demand for fuel.


A major obstacle for the biofuel industry is the “blend wall,” the current 10 percent limit on ethanol at most gasoline stations. Some car companies warn that above that level, fuel could damage engines in older vehicles. The Energy Department has disputed such concerns, and the E.P.A. has approved use of 15 percent ethanol blends for cars manufactured after 2001. But gasoline stations have been slow at installing the necessary equipment. And only a modest number of vehicles can use E-85, a blend that is 85 percent ethanol.

But biofuel producers and lobbyists say the country needs more of their product. “Cellulosic biofuel has the promise to deliver tens of billions of gallons of ethanol to the United States, but there needs to be a market for that,” Brian Foody, president and chief executive of the Canadian biofuel company Iogen, told reporters in a recent conference call by industry executives discussing the impact of the E.P.A. proposal. “We believe it’s critical for E.P.A. to create a segment or space in the market for E-85 to grow and to set numbers that will provide incentives.”

Tuesday, April 15, 2014

Are cyanobacteria deemed microorganisms under TSCA?

from within -- Finding Promise in Pond Scum: Algal Biofuels, Regulation, and the Potential for Environmental Problems --, 42 Tex. Envtl. L.J. 59 (2011) :

EPA has extended TSCA oversight to commercial and research activities involving microorganisms by defining "chemical substance" broadly to include microorganisms. n116 However, TSCA pre-manufacture reporting requirements only apply to a "new microorganism," which is further limited to an "intergeneric microorganism." n117 In other words, the requirements apply only to "a microorganism that is formed by the deliberate combination of genetic material originally isolated from organisms of different taxonomic genera." n118 Under TSCA, the term "microorganism" encompasses red and green algae (i.e., microalgae and macroalgae, although notably not cyanobacteria). n119 Under this formulation, microorganisms that are not intergeneric - including naturally occurring and classically mutated or selected microbes, as well as genetically modified microbes whose genetic material originates in a single genus - are not considered to be new and are exempt from TSCA's reporting requirements. n120 To clarify: only those micro-and macroalgal species that have been purposefully cross- [*72] bred or genetically modified to include genes from more than one genera fall under TSCA.


Kudzu is known as "the plant that ate the South" because it has so rapidly taken over the southern U.S. n175 Estimated losses and control efforts due to invasive plants cost roughly $ 34 billion annually. n176 NISC has expressed concern that "a number of potentially harmful non-native algal species are being considered for use in the production of biodiesel, renewable biodiesel, and jet fuel (e.g. the toxic freshwater cyanobacteria, Anabaena circinalis)." n177 The theory is that, because these algae strains are bred to self-replicate and have no natural adversary in the area, once released into the environment they would be very hardy and could outcompete and displace native species, eventually overpopulating and reducing biodiversity. n178 Indeed, the very traits that maximize biofuel crop yield and foster the ability for biofuels to be cultivated in marginal environments, including perennial growth patterns and tolerance to salinity, increase the risk of invasiveness. n179

Some footnotes

n119. Id.; see Microbial Products of Biotechnology, 62 Fed. Reg. at 17,926.

n120. See Microbial Products of Biotechnology: Summary of Regulations under the Toxic Substances Control Act, Envtl. Prot. Agency, (last visited Sept. 26, 2011).

n121. 40 C.F.R. §§725.3, 725.234 (2010).

n122. Premanufacture Notification, 48 Fed. Reg. 21,722, 21,722-24 (May 13, 1983); see Rodgers, supra note 113, at § 6:5(B)(1) (demonstrating that, historically, EPA takes no action on about 85% of premanufacture notices and grants post-notice exemptions from regulation to about 88% of applicants, allowing commercial production to proceed in both cases).

n123. Plant Protection Act, 7 U.S.C.§§7701-7758 (2010).

n124. 7 C.F.R. § 340.2 (2010).

n125. Regulations Affecting the Use of Genetically Modified Algae for Biofuel Production, D. Glass Assoc., Inc., (June 09, 2010, 7:55 PM), production-2.

Eli Lilly: place Canada on US Trade Priority Watch list for countries that provide insufficient patent protection or enforcement

Trolls as owners of large numbers of patents?

In an article about patent trolls, the Pittsburgh Post-Gazette states that patent law suits by non-practising universities are NOT trollish in nature:

Not all suits brought to fight patent infringements are trollish in nature, Mr. Singer said, pointing to two recent lawsuits in favor of Carnegie Mellon University and the University of Pittsburgh, respectively.

A jury found that Marvell Technology Group willfully infringed on computer chip technology patented by a CMU professor and student. And Varian Medical Systems last week settled patent litigation with Pitt over technology used during radiation therapy.

Thus, "not practicing" the claims of the patent does not make the patent assertor a "patent troll," in this view.

Elsewhere in the article

The definition of a patent troll varies, but for the most part they are companies that file or purchase large numbers of patents — sometimes from bankrupt companies — and then file lawsuits or demand fees against infringing companies.

IBM files large numbers of patent applications. And one recalls IBM Hits Twitter With Patent Infringement Claims Ahead of IPO And, as the New York Times noted in 2006 of two lawsuits by IBM against

I.B.M. filed its suits in two federal courts in the Eastern District of Texas, in Tyler and Lufkin. The Eastern District courts there are known for handling patent suits quickly and for often awarding large settlements to plaintiffs, said Gregory P. Silberman, a patent lawyer at the firm of Kaye Scholer.