Friday, August 26, 2016

Why do we have suddenly increasing drug prices?

Timothy Holbrook has an interesting post The real reason the EpiPen and other off-patents are so expensive , which raises issues with the role of the FDA in pricing issues for drugs.



Interestingly, though, the patent system is not to blame for many of these price hikes we hear about in the news. Instead, these drugs, such as the EpiPen, are off-patent, suggesting that generic competition should help keep prices lower.

(...)

But even absent consolidation, there is another barrier that appears to be in play: regulations by the FDA, and the huge backlog. Even generic drugs need regulatory approval to be sold, which makes sense: we don’t want fly-by-night companies selling impure or otherwise harmful drugs.

But obtaining approvals does add costs and time to competitors attempting to enter the market. One potential EpiPen competitor, Teva Pharmaceuticals, failed to obtain regulatory approval, delaying their entry into the market Another competitor, Sanofi, recalled its competing epinephrine delivery device because it may be delivering in incorrect dosage. That leaves Mylan alone in the market, with the power to raise prices, which is what it did.



A different issue with the FDA, not mentioned by Holbrook, can be found in recent litigations over
colchicine.
See http://ipbiz.blogspot.bg/2015/05/takeda-v-hikma-tour-of-hatch-waxman.html
http://ipbiz.blogspot.com/2011/05/colchicine-patent-wars.html

Thursday, August 25, 2016

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


Finance.yahoo noted a PTAB ruling on some of Teva's Copaxone patents:


Teva Pharmaceutical Industries Ltd. today [August 24, 2016] confirmed the Patent Trial and Appeal Board (PTAB) decisions from an Inter Partes Review (IPR) to invalidate all claims of the ‘250 and ‘413 patents for 40 mg COPAXONE® (glatiramer acetate injection). Teva plans to appeal to the United States Court of Appeals for the Federal Circuit



link: http://finance.yahoo.com/news/teva-confirms-ptab-decisions-two-214600255.html

The demise of claims in the '250 patent [US Patent 8,232,250 to Ety Klinger, which is a continuation of US 8,399,413] was based on obviousness; from the final written decision in IPR2015-00643:


In sum, upon considering the evidence as a whole, we determine that the combination of Pinchasi and the 1996 SBOA teaches or suggests each limitation of claims 1 and 19, that a person of ordinary skill in the art would have had a reason to combine the references and would have had a reasonable expectation of success in dosing 40 mg GA three times over a seven-day period.


One notes that the use of the SBOA [ Summary Basis of Approval (“SBOA”) for the New Drug Application for 20 mg daily Copaxone ® (NDA #20-622) ] amounted to the use of Teva's information against Teva. [ PTAB noted: the 1996 SBOA was publicly accessible at least by July 17, 2007, more than one year before the earliest possible priority date of the ’250 patent (i.e., August 20, 2008) ] The other key reference was Irit Pinchasi, WO 2007/081975 A2, published July 19, 2007. Pinchasi was mentioned in a 2011 post at Law360 as a former Teva scientist [ http://www.law360.com/articles/257148/ex-teva-scientist-testifies-in-copaxone-patent-battle ].

Of some importance to the outcome was the use of a REVIEWER COMMENT in the SBOA: a reviewer of the 1996 SBOA “recommend[ed] that [Teva] evaluate the necessity of daily [subcutaneous] injections as opposed to more infrequent intermittent administration of the drug.” Id. at 43 (citing Ex. 1007, 252).
And later in the written decision: the 1996 SBOA must still be read in the context of the prior art as a whole, which suggested less frequent dosing of GA was desirable. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986

Of some relevance to a different PTAB matter involving Kyle Bass, in which PTAB dismissed the significance of MRI in evaluating disease-modifying MS treatments, note the text:


In particular, we credit the testimony of Dr. Green, who notes that Pinchasi demonstrates increased efficacy with 40 mg GA when compared to 20 mg GA with no significant difference in side effects. Ex. 1004 ¶¶ 61, 95, 99. Indeed, Pinchasi concludes: The increased efficacy observed with 40 mg/day GA in reducing MRI-measured disease activity and relapse rate indicates that it is well tolerated and can improve the treatment of RRMS patients. The improvement in efficacy, however, is not accompanied by a corresponding increase of adverse reactions which would be expected upon a doubling of the administered dose.



One notes an interesting position taken by Teva:


Patent Owner argues that a person of ordinary skill in the art would not have used 40 mg of GA because a later phase III clinical trial (the “FORTE trial”) demonstrated that 40 mg of GA was not more effective than 20 mg of GA, and 40 mg of GA was associated with more frequent adverse events. PO Resp. 17–20. Upon considering the evidence as a whole, we are not persuaded. The FORTE trial found that “the 40 mg dose did not demonstrate increased efficacy in reducing the relapse rate.” Ex. 2001, 1 (emphasis added). At the same time, however, it noted that “the higher [40 mg] dose maintained the favorable safety and tolerability profile of COPAXONE® 20mg.”




PTAB brought up "teaching away" issues:


Because nothing in FORTE criticizes, discredits, or discourages the use of 40 mg of GA, we determine that FORTE does not teach away from the use of 40 mg of GA.
See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (finding “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed”



Obsolete technology arose: In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991) (“[A] reference which disclosed obsolete technology remained in the prior art. This court considered the reference for what it disclosed in relation to the claimed invention.”)

As to predictability: we keep in mind that an obviousness inquiry does not require absolute predictability. In re Longi, 759 F.2d 887, 896 (Fed. Cir. 1985). Indeed, as the Federal Circuit has explained, simply because the formation and properties of a new drug must be verified through testing does not mean that the formulation would have not been obvious, “since the expectation of success need only be reasonable, not absolute.”
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007)





**Back on Jan. 28, 2014, Teva Pharmaceutical Industries Ltd.announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental new drug application (sNDA) for three-times-a-week COPAXONE® 40mg/mL, a new dose of COPAXONE®.

link: http://www.tevapharm.com/news/teva_announces_u_s_fda_approval_of_three_times_a_week_copaxone_glatiramer_acetate_injection_40mg_ml_01_14.aspx

And, one year ago, in August 2015, FiercePharma had written:


What does that mean for Teva? A review of the third patent is likely on the way, and "the odds of invalidation in this case are close to even," Ronny Gal wrote.

That's not great news to Teva, which scrambled to convert 70% of its patient pool over to the successor drug as it awaited word on the fate of original Copaxone. After a lower court dismissed the drug's patents, Teva scored a Supreme Court victory--only to see the case remanded and recently decided again in its rivals' favor.

Now, if Teva does lose its patents, Momenta --which developed the Sandoz knockoff--will "very likely" win FDA approval on a 40 mg generic by January 2017, the point at which copycats can legally enter the market, Gal figures. And the "critical question," as he sees it, is how many of the other four generic filers will get their own green lights and enter the market at the same time.

Whatever happens with Copaxone, though, Teva's in a better spot now than it was when the franchise first encountered IP trouble. Recently, it inked a $40.5 billion pact to buy Allergan's generics business, leaving it less reliant on the MS star. The way Gal sees it, the downside is "limited" for the company; "Teva earnings will trough at $50 in 2017, and the company has a reasonable growth trajectory from there," he wrote.



link: http://www.fiercepharma.com/legal/u-s-patent-office-puts-new-copaxone-s-ip-shield-under-lens

[The US Supreme Court case concerned the 20mg dose.]

Related to US 8,969,302 see IPR2015-00830:
http://fishpostgrant.com/wp-content/uploads/IPR2015-00830.pdf

Harsh penalty dealt to student copying from wikipedia

Ten years ago, in August 2006, in a post titled Plagiarism in academic contexts: a look at the past , IPBiz discussed several academic plagiarism cases, including a certain case at Princeton University, 186 N.J. Super. 548; 453 A.2d 263.

In August 2016, the blog PatentlyO, authored by a 1997 graduate of Princeton, has some discussion of an Illinois case, Drobetsky v. Chicago School of Prof. Psych. The Drabetsky case, involving copying of fragments of wikipedia text into a paper for a class (based on viewing a movie; here, The Curious Case of Benjamin Button) bears some haunting similarities to the earlier case of Alison Routman, who was "expelled" from Semester at Sea for copying wikipedia fragments into a paper about the movie Europa Europa. [For details, see the 2008 IPBiz post UVa expels plagiarizing OhioU student from ship! ]

Apart from the factual similarities [fragmentary copying from wikipedia of facts into a course paper based on viewing of a movie; harsh penalty], there is an interesting attitudinal issue. Several students were caught copying at Semester at Sea (same crime), but only those who did not repent were expelled (different punishment for same crime). As to the Drobetsky matter, from the decision:


Dr. Koonce explained that the reason why plaintiff was dismissed after having been found to have committed plagiarism, instead of being allowed to participate in the academic development plan like the other five or six students, is because of her conduct at the hearing, in which she was argumentative, interrupted questions posed to her by the committee members, and "did not address her behavior or conduct as it
related to the allegation of plagiarism."



[In passing, one recalls Joe Biden was caught copying 5 pages of a 15 page paper as a 1L at Syracuse Law, and flunked (and repeated) the course, but was not expelled, and went onto to bigger things. The plagiarizing Princeton undergrad (who applied to law school) sustained only a delayed graduation.]

As to standards of review, the Drobetsky court cited to an earlier decision involving the University of Chicago:


Plaintiff bears the "heavy" burden of establishing arbitrary, capricious, or bad-faith
conduct, and to meet the burden she must show that her dismissal was " 'without any discernible
rational basis.' " Id. (quoting Holert v. University of Chicago, 751 F. Supp. 1294, 1301 (N.D. Ill.
1990)). A dismissal is without a discernible rational basis when " 'it is such a substantial
departure from accepted academic norms as to demonstrate that the person or committee
responsible did not actually exercise professional judgment.' " Raethz, 346 Ill. App. 3d at 732
(quoting Regents of the University of Michigan v. Ewing, 474 U.S. 214, 225 (1985)). When, in
dismissing a student, the private college or university substantially complied with its own
standards and procedures for student discipline, no breach of contract action will lie if the
dismissal had a rational basis. See Holert, 751 F. Supp. at 1301.



As to legal matters, the reviewing court in Drobetsky sustained the outcome (Drobetsky loses), but not for the reasons articulated by the trial court:


In conclusion, we find that the trial court's finding that plaintiff met her heavy burden of
proving that defendant acted arbitrarily, capriciously, or in bad-faith by dismissing her without
any discernible rational basis was against the manifest weight of the evidence.

The trial court found that plaintiff's failure to appeal her dismissal to the dean of
academic affairs, as provided for under the academic catalog, necessitated judgment in favor of
defendant on plaintiff's breach of contract action, notwithstanding its earlier findings that
defendant had acted arbitrarily and capriciously when conducting the hearing and in dismissing
her.

(...)

We may affirm the trial court's judgment after a bench trial on any basis in the record,
regardless of whether the trial court relied on that basis or whether the trial court's reasoning was
correct. Northwestern Memorial Hospital v. Sharif, 2014 IL App (1st) 133008, ¶ 25. We affirm
the trial court's judgment in favor of defendant on plaintiff's breach of contract action, not on the
grounds stated by the court (which were based solely on plaintiff's failure to appeal her dismissal
to the dean of academic affairs and on the lack of proof of damages) but rather on plaintiff's
failure to meet her heavy burden of proving that defendant acted in an arbitrary, capricious, or
bad-faith manner by dismissing her without any discernible rational basis.



Thus, it might seem that a school's dismissing a student who copied fragments from wikipedia, and argued about the significance thereof, is not arbitrary, capricious, or in bad-faith.


An interesting line from the reviewing court:


On appeal to this court, the parties struggle to explain the basis of the trial court's
decision.


Also, as to the definition of plagiarism, from the school:


"Plagiarism is intentionally or unintentionally representing words, ideas, or data
from any source as one's own original work. The use or reproduction of another's work
without appropriate attribution in the form of complete, accurate, and properly formatted
citations constitutes plagiarism. Examples of plagiarism, include but are not limited to,
copying the work of another verbatim without using quotation marks, revising the work
of another by making only minor word changes without explanation, attribution, and
citation, paraphrasing the work of another without the appropriate citation. Students are
expected to produce original work in all papers, coursework, dissertation, and other
academic projects *** and to follow appropriate rules governing attribution that apply to
the work product. (...) Further, a single example of failing to
use quotation marks appropriately may be considered plagiarism."



[One recalls in the case of Glenn Poshard at Southern Illinois University, much was made of the defense of "unintentional" plagiarism, which might not have been effective at Chicago School of Prof. Psych. See the IPBiz post
Poshard: unintentional plagiarism?
BUT self-plagiarism might get a pass at Chicago School of Prof. Psych. See IPBiz post
Self-plagiarism and the "repurposing" of research
]

Background on Princeton case PRINCETON PLAGIARISM PENALTY UPHELD

Tuesday, August 23, 2016

Garlock prevails at the CAFC in Smith case, 2015-1758. WD Missouri reversed.


Garlock won a reversal of a decision by the Western District of Missouri:


This appeal arises from a jury verdict finding Garlock
Equipment Company (“Garlock”) liable for infringement
of the asserted claims of U.S. Patent No. 8,240,431 (the
“’431 Patent”), and awarding damages for lost profits and
reasonable royalties. Garlock moved for judgment as a
matter of law on both findings. The district court denied
Garlock’s motions and proceeded to issue an injunction
prohibiting infringing activities involving the accused
products. Garlock now appeals the district court’s denial
of its motions for judgment as a matter of law and the
district court’s injunction order. For the reasons set forth
below, we reverse the district court’s denial of judgment as
a matter of law regarding infringement. Because the
accused devices do not infringe the asserted claims of the
’431 patent, we vacate the jury award of damages and the
district court’s injunction order.



The CAFC noted:


A patent claim is literally infringed only if the accused
device embodies each limitation of the asserted claim.
Research Plastics, Inc. v. Fed. Packaging Corp., 421 F.3d
1290, 1297 (Fed. Cir. 2005) (citation omitted). The absence
of a single limitation in the asserted claim thus
defeats literal infringement. Id.

(...)

In support of its infringement allegations, Smith
submitted Mr. Kernell as an expert to explain how the
Multi-Man performs each limitation of claim 5 of the ’431
patent. On cross examination, Garlock focused on demonstrating
that the Multi-Man does not satisfy the claim
limitation “wherein the force causes the arm to shift to
the lowered position.” In particular, Garlock asked Mr.
Kernell to explain how the Multi-Man arm “pivots.” The
following exchange is exemplary of the dialogue between
Garlock’s counsel and Mr. Kernell on this point:
A: That pulley rotates and pivots to drive that
arm down into the surface, and that is the pivotal
movement of that arm.
Q: So it’s your opinion that this arm pivots?
A: Yes. The entire assembly, that pivoting of that
arm around that pulley that is my opinion.
Q: I’m not asking about the entire assembly.
We’re talking about the arm. This item says the
arm pivots. This arm does not pivot, does it?
A: No. That’s not correct. That is not my opinion.
If you look at the claim language, you’re taking
something out of context. In the claim language it
says the arrestor assembly has this pivoting motion
with the arm, and it is the pivoting around
that pulley that causes the arrestor assembly to
shift or pivot between the raised position and the
lowered position.
Q: Sir, back to our infringement definition. Each
and every element of the patent claim must be included
in the product; and as to Claim 5, the Multi-Man
does not – Multi-Man’s arm does not pivot,
and therefore, it does not infringe, correct?

A: No. That’s not correct.
J.A. 2104-05. Notably, Mr. Kernell did not answer the
question of whether the Multi-Man’s arrestor arm itself
pivoted. Mr. Kernell instead testified that there was
some pivoting motion involved in the arrestor assembly as
a whole, and that this motion was sufficient to satisfy the
claim limitation requiring that the arm itself pivot. See
id.




Footnote 1 of the CAFC decision references a footnote:



In a single footnote in its brief, Smith contends
that “[w]hile Plaintiffs disagree with this construction, as
the prevailing parties below, they lack standing to appeal
the district court’s claim construction order.” Appellee Br.
at 7 n.3 (citing Novartis Pharmaceuticals Corp. v. Abbott
Labs., 375 F.3d 1328, 1339 (Fed. Cir. 2004)). Smith then
stated in an isolated sentence that “if this Court is inclined
to reverse the district court’s entry of judgment, it
also should reverse the district court’s claim construction
order and hold that the phrase ‘shift to,’ as used in claim
5, must be given its common and ordinary meaning in any
retrial of this matter.” Id. Smith’s comment is appealing
on its face; the plain meaning of the term “shift” does
seem different from the term “pivot.” We nonetheless do
not have occasion to address whether the district court’s
claim construction was proper because Smith has failed to
present any argument on appeal beyond their single
conclusory statement that we “should reverse the district
court’s claim construction.” See SmithKline Beecham
Corp. v. Apotex Corp., 439 F.3d 1312, 1320 (Fed. Cir.
2006) (holding that when “a party includes no developed
argumentation on a point . . . we treat the argument as
waived”).



The CAFC invoked Johns Hopkins:


Our prior decision in Johns Hopkins controls the present
dispute. In Johns Hopkins, we considered infringement
of a claim to a method for mechanically fragmenting
blood clots to prevent occlusion of blood vessels.

(...)

Accordingly, we dismissed as
improper the prevailing party’s cross-appeal concerning
the claim construction, precisely because that party
prevailed before the district court. Thus, while Smith
could not have filed a cross appeal in this case concerning
the claim construction, Smith could have asserted “alternative
grounds in the record for affirming the judgment.”
Because Smith did not raise any such alternate grounds
on appeal, we cannot address the correctness of the district
court’s claim construction.

(...)

The present case does not involve a simple “battle of
the experts,” wherein the fact finder must weigh the
merits of the competing expert testimony. Here, the
record does not evidence a disagreement between the
experts as to whether the arrestor arm is pivoting. In
light of the absence in the record of any evidence that
could support the jury’s verdict of infringement, we must
reverse the district court’s denial of Garlock’s motion for
judgment as a matter of law on the issue of whether the
Multi-Man infringes claim 5. See The Shaw Group v.
Marcum, 516 F.3d 1061, 1065 (Fed. Cir. 2008) (holding
that judgment as a matter of law is appropriate where
there is a “complete absence of probative facts and only
speculation supports the verdict”).


The bottom line:

CONCLUSION
As discussed above, the district court erred in denying
Garlock’s motion for judgment as a matter of law that the
Multi-Man and Twin-Man products do not infringe the
asserted claims of the ’431 patent. Accordingly, we reverse
the judgment of the district court concerning infringement
of the asserted claims. Because the accused
devices do not infringe, we vacate the jury award of
damages and the district court’s injunction order.
REVERSED-IN-PART AND VACATED-IN-PART

Monday, August 22, 2016

The President of Mexico, Enrique Peña Nieto, accused of plagiarism while in law school

As reported by the New York Times, and others, Carmen Aristegui has written a report suggesting that
the current Mexican president, Enrique Peña Nieto, plagiarized work while a law school student.

The Times article observed:


The journalist, Carmen Aristegui, has reported on several articles that have contributed to the president’s declining public approval ratings, including the disclosure in 2014 of his wife’s questionable real estate dealings with major government contractors.

Ms. Aristegui lost her job in 2015 after her reporting on the Mexico City mansion built for the president’s wife, Angélica Rivera, by a firm that had received hundreds of millions of dollars in government contracts. Since then, Ms. Aristegui has been publishing her work on her own website.



The Times article did not disclose "how much" of Nieto's work was copied, but other sources have done so. For example, the Huffington Post noted:


Of the 682 paragraphs that made up the 200-page thesis, titled ‘Mexican Presidentialism and Alvaro Obregon,’ 197, or 28.9 percent, were found to be plagiarized, the report said



The Aristegui report is in Spanish. It notes in part:


Aristegui Noticias tuvo acceso a un amplio análisis de la tesis de Peña Nieto elaborado por un grupo de especialistas y académicos, quienes descubrieron que una buena parte de la tesis se realizó con materiales plagiados.
Este medio corroboró directamente en los libros y fuentes originales de cada uno de los párrafos analizados en el estudio y concluyó que el hoy presidente de México plagió al menos 197 párrafos de los 682 que integran el texto.
Es decir, por lo menos el 28.8 por ciento del contenido de su tesis de abogado fue robado de las obras de otros autores.





Of copying of work by an ex-President


El plagio más escandaloso es el que Enrique Peña Nieto cometió con una obra escrita por un antecesor suyo: Miguel de la Madrid Hurtado. A lo largo de su tesis nunca hizo referencia al expresidente y ni siquiera lo citó en la bibliografía.





Of the person who reviewed the work of Nieto:


El asesor de tesis del joven Peña Nieto fue el doctor en Derecho Eduardo Alfonso Guerrero Martínez, actual magistrado del Poder Judicial de la Ciudad de México. En su currículum, se afirma que el funcionario ha dirigido más de 193 tesis y ha sido jurado en más de 367 exámenes profesionales.




Of other "victims" of Nieto:


En la revisión hecha al texto se evidenció que Peña Nieto también copió de manera textual párrafos completos de libros de Linda Hall, académica de la Universidad de Nuevo México; de los historiadores Enrique Krauze, Alberto Morales Jiménez, Víctor López Villafañe, José María Calderón y Emilio Rabasa; y también de los doctores en derecho Diego Valadés, José de Jesús Orozco Henríquez, Felipe Tena Ramírez y del fallecido jurista Jorge Carpizo.



The name of Benito Juarez appears:


En el apartado 2.1 de la tesis, titulado “Benito Juárez: Dictadura Presidencial”, Enrique Peña Nieto plagió de manera casi textual seis párrafos del libro “Génesis del presidencialismo mexicano”, del historiador José María Calderón, publicado por Ediciones El Caballito en 1973.



There is a matter of copying the citations of others:


Además, en 18 ocasiones el joven Peña Nieto copió letra por letra las citas que el jurista Jorge Carpizo o el historiador José María Calderón, entre otros autores, entrecomillaron y citaron en sus libros para ilustrar sus argumentos, pero eliminó la referencia a dichos autores, por lo que aparece como si él los hubiera consultado de forma directa.



In passing, recall Joe Biden had a plagiarism issue at Syracuse Law School, copying 5 pages of a 15 page paper, without citation.

**Update. Within the post Plagiarism? Hey, You Try To Write 200 Pages On Álvaro Obregón, Buddy! , one finds the text



It’s a law thesis — there was sure to be some boilerplate in there. I mean, how much can one say about Obregón’s betrayal of his own roots in putting down the Yaqui rebellion of 1926-27? Am I right?



Given that Nieto's paper is about "presidentialism," and that Obregon was president between 1920 and 1924, one suspects Obregon's Yaqui matter, with Obregon's military period against the Yaqui's being between October 1926 to April 1927 is not relevant to Nieto's thesis; the answer is "no, not right."

The President of Mexico, Enrique Peña Nieto, accused of plagiarism while in law school

As reported by the New York Times, and others, Carmen Aristegui has written a report suggesting that
the current Mexican president, Enrique Peña Nieto, plagiarized work while a law school student.

The Times article observed:


The journalist, Carmen Aristegui, has reported on several articles that have contributed to the president’s declining public approval ratings, including the disclosure in 2014 of his wife’s questionable real estate dealings with major government contractors.

Ms. Aristegui lost her job in 2015 after her reporting on the Mexico City mansion built for the president’s wife, Angélica Rivera, by a firm that had received hundreds of millions of dollars in government contracts. Since then, Ms. Aristegui has been publishing her work on her own website.



The Times article did not disclose "how much" of Nieto's work was copied, but other sources have done so. For example, the Huffington Post noted:


Of the 682 paragraphs that made up the 200-page thesis, titled ‘Mexican Presidentialism and Alvaro Obregon,’ 197, or 28.9 percent, were found to be plagiarized, the report said



The Aristegui report is in Spanish. It notes in part:


Aristegui Noticias tuvo acceso a un amplio análisis de la tesis de Peña Nieto elaborado por un grupo de especialistas y académicos, quienes descubrieron que una buena parte de la tesis se realizó con materiales plagiados.
Este medio corroboró directamente en los libros y fuentes originales de cada uno de los párrafos analizados en el estudio y concluyó que el hoy presidente de México plagió al menos 197 párrafos de los 682 que integran el texto.
Es decir, por lo menos el 28.8 por ciento del contenido de su tesis de abogado fue robado de las obras de otros autores.





Of copying of work by an ex-President


El plagio más escandaloso es el que Enrique Peña Nieto cometió con una obra escrita por un antecesor suyo: Miguel de la Madrid Hurtado. A lo largo de su tesis nunca hizo referencia al expresidente y ni siquiera lo citó en la bibliografía.





Of the person who reviewed the work of Nieto:


El asesor de tesis del joven Peña Nieto fue el doctor en Derecho Eduardo Alfonso Guerrero Martínez, actual magistrado del Poder Judicial de la Ciudad de México. En su currículum, se afirma que el funcionario ha dirigido más de 193 tesis y ha sido jurado en más de 367 exámenes profesionales.




Of other "victims" of Nieto:


En la revisión hecha al texto se evidenció que Peña Nieto también copió de manera textual párrafos completos de libros de Linda Hall, académica de la Universidad de Nuevo México; de los historiadores Enrique Krauze, Alberto Morales Jiménez, Víctor López Villafañe, José María Calderón y Emilio Rabasa; y también de los doctores en derecho Diego Valadés, José de Jesús Orozco Henríquez, Felipe Tena Ramírez y del fallecido jurista Jorge Carpizo.



The name of Benito Juarez appears:


En el apartado 2.1 de la tesis, titulado “Benito Juárez: Dictadura Presidencial”, Enrique Peña Nieto plagió de manera casi textual seis párrafos del libro “Génesis del presidencialismo mexicano”, del historiador José María Calderón, publicado por Ediciones El Caballito en 1973.



There is a matter of copying the citations of others:


Además, en 18 ocasiones el joven Peña Nieto copió letra por letra las citas que el jurista Jorge Carpizo o el historiador José María Calderón, entre otros autores, entrecomillaron y citaron en sus libros para ilustrar sus argumentos, pero eliminó la referencia a dichos autores, por lo que aparece como si él los hubiera consultado de forma directa.



In passing, recall Joe Biden had a plagiarism issue at Syracuse Law School, copying 5 pages of a 15 page paper, without citation.

**Update. Within the post Plagiarism? Hey, You Try To Write 200 Pages On Álvaro Obregón, Buddy! , one finds the text






Thursday, August 18, 2016

TenSec prevails at CAFC in appeal against Adobe


From the decision


TecSec, Inc. (“TecSec”) challenges certain claim
construction rulings and appeals from a grant of summary
judgment of non-infringement by Adobe Systems, Inc.
(“Adobe”) of TecSec’s U.S. Patents Numbers 5,369,702
(“’702 patent”), 5,680,452 (“’452 patent”), 5,717,755 (“’755
patent”), and 5,898,781 (“’781 patent”), collectively the
Distributed Cryptographic Object Method patents
(“DCOM patents”). TecSec, Inc. v. Int’l Business Machines
Corp., No. 1:10-cv-115 (E.D. Va. May 7, 2015) (“TecSec
V”). Adobe contests TecSec’s arguments and asserts a
number of alternative grounds for affirmance. TecSec
also requests that the case be reassigned to a different
district judge on remand.

Because the district court erred in its construction
of “selecting a label,” because we find no merit in Adobe’s
alternate grounds for affirmance, and because we find
nothing to warrant reassignment on remand, we vacate
the district court’s summary judgment of noninfringement
and remand for further proceedings consistent
with this opinion.




Background of the issue


In its written opinion, the district court addressed
both the claim construction issues raised by Adobe and
Adobe’s motion for summary judgment of noninfringement.
In addressing claim construction, the court
began by construing “selecting a label for the object.” The
court noted that while the parties did not propose a
construction for that limitation and declined the opportunity
to brief the issue, they clearly disputed whether
selecting a label includes creating a label or selecting the
components that go into a label. For that reason, the
court stated that that it had a duty to resolve that dispute,
citing O2 Micro International, Ltd. v. Beyond Innovation
Technology Co., 521 F.3d 1351, 1362 (Fed. Cir.
2008). TecSec V at 19. The court then concluded that
“before an object can be selected, it must first be created.”
Id. at 20. Moreover, it construed the limitation as meaning
“choosing a pre-existing label” and not merely selecting
“the components used in its creation.” Id. at 23.



An issue which the CAFC did NOT address:


TecSec first contends that the district court committed
serious procedural error when it granted summary
judgment on the basis of its sua sponte construction of
selecting a label, without providing proper notice. Because
we vacate the district court’s summary judgment on
the merits, we need not and do not address TecSec’s
assertion of procedural error, but instead turn directly to
the issues raised.



A problem with the district court analysis:



The problem with this reasoning is that first, the “selecting
an object” and “selecting a label” limitations are
separate and different limitations. Moreover, while the
doctrine of claim differentiation requires that the limitations
in a parent claim be construed to be different in
scope from those in dependent claims, it does not necessarily
mean that they are mutually exclusive. The only
requirement is that the limitation in the parent be at
least broad enough to encompass the limitation in the
dependent claim. Tr. of Columbia Univ. in City of New
York v. Symantec Corp., 811 F.3d 1359, 1370 (Fed. Cir.
2016) (“Thus, in a situation where dependent claims have
no meaningful difference other than an added limitation,
the independent claim is not restricted by the added
limitation in the dependent claim. In such situations,
construing the independent claim to exclude material
covered by the dependent claim would be inconsistent.”);
Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d
1335, 1348 (Fed. Cir. 2012) (holding that an independent
claim including the limitation “magnetic member” includes
ferromagnetic material in addition to a magnet, in
light of dependent claim limiting “magnetic member” to a
magnet); Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d
1354, 1360 (Fed. Cir. 2010) (concluding that “[u]nder the
doctrine of claim differentiation, those dependent claims
[reciting the use of particular wavelengths] give rise to a
presumption that the broader independent claims [reciting
that laser radiation be ‘absorbed substantially completely’]
are not confined to that range”).

Here, the district court’s reliance on the doctrine of
claim differentiation is flawed.

(...)

Moreover, it is beyond cavil that the plain and ordinary meaning
of the term “selecting” can naturally refer to a choice
of a not-yet extant object. Parties regularly select any
number of things that do not exist when the selection is
made and are only later made to order.


The district court also relied on the portion of the
specification that “requires a user to actively choose a preexisting
label.” TecSec V at 21. This too was error. First,
as the district court acknowledged, it is improper to
import limitations from the specification into the claims.
Second, the specification does not in any way indicate or
suggest that one cannot select a label that does not yet
exist, such as a label identifying the location of a terminal
that is not yet connected. Nothing in the intrinsic record
precludes such a possibility, or limits the meaning of
“selecting a label” to the selection of pre-existing labels.



link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1686.Opinion.8-16-2016.1.PDF

**Separately on 18 August 2016:

Wednesday, August 17, 2016

CAFC affirms PTAB in Ericsson Inc. v. Intellectual Ventures I LLC, IPR2014-00527; IV's claims gone in US 7,496,674


In 2015-1947, the CAFC affirmed the PTAB under Rule 36 [ AFFIRMED. See Fed. Cir. R. 36. ], meaning that patentee-appellant Intellectual Ventures lost.

Of the PTAB case:


Patent Owner had filed a Motion to Exclude information including the above-mentioned Stadler reference as well as excerpts from the cross-examination of Patent Owner’s expert, Dr. Newman. In this connection, Patent Owner had “objected to Stadler on the grounds of hearsay and lack of authenticity.” The Board disagreed with Patent Owner, accepting that the publication information on the IEEE copyright line in Stadler constituted sufficient “evidence of its date of publication and public accessibility.” The Board denied Patent Owner’s attempt to exclude excerpts of the cross-examination deposition testimony of Dr. Newman as being outside of the scope of direct examination because “[i]n the testimonial excerpts under consideration, Dr. Newman repeatedly admitted a lack of familiarity with the subject matter of the ’674 patent . . . (‘I really haven’t spent very much time looking at this . . . .’)[,]” which led the Board to conclude that “[t]his testimony goes to Dr. Newman’s credibility and, therefore, does not exceed the proper scope of cross-examination.”



from http://ptabtrialblog.com/publication-date-on-an-ieee-publication-found-to-meet-exception-to-hearsay-rule-in-final-written-decision-ipr2014-00527/

Separately, as to the obviousness issues in the case, see

http://www.jonesday.com/obviousness-in-iinteri-partes-review-proceedings-02-05-2016/

Tuesday, August 16, 2016

Apotex loses appeal at CAFC; Senju Pharm. Co. v. Lupin Ltd., 780 F.3d 1337, 1346 (Fed. Cir. 2015) explained



Apotex tried IPR to invalidate a Wyeth patent.


In March 2013, Apotex filed a petition to institute inter
partes review of the ’828 patent [of Wyeth]. The Board instituted
review based on one ground: that claims 1–23 would have
been obvious over the combination of Chinese Patent
Publication No. 1390550A (“CN ’550”); V. Naggar et al.,
Effect of Solubilizers on the Stability of Tetracycline, 29
PHARMAZIE 126 (1974) (“Naggar”); and E. Pawelczyk et
al., Kinetics of Drug Decomposition: Part 74: Kinetics of
Degradation of Minocycline in Aqueous Solution, 34 POL.
J. PHARMACOL. PHARM. 409 (1982) (“Pawelczyk”).


From the decision:


Apotex Inc. appeals from the U.S. Patent and Trademark
Office Patent Trial and Appeal Board (“the Board”)
final written decision in an inter partes review concluding
that claims 1–23 of U.S. Patent 7,879,828 (“the ’828
patent”) are not unpatentable as obvious. See Apotex Inc.
v. Wyeth LLC, No. 2014-00115, 2015 WL 1848261, at *14
(P.T.A.B. Apr. 20, 2015). For the reasons that follow, we
affirm.



Note that there was an "incorrect translation" issue:


In its decision to institute, the Board relied on an
incorrect translation of CN ’550. See Apotex, 2015 WL
1848261, at *3–4. Apotex submitted a corrected translation
in response to Wyeth’s objections, and the Board
relied on that corrected translation in its final written
decision. See id. at *4. Discrepancies between the two
translations are not relevant to this appeal. See Appellant’s
Br. 11 n.4.



Apotex had two arguments:



Apotex challenges the Board’s conclusion regarding
obviousness in two respects. First, it contends that the
Board imported an epimeric stability limitation into the
claims, and thereby wrongly relied on the failure of CN
’550 to teach the epimeric stability of its composition.
Second, Apotex argues that the Board failed to consider
any motivation to combine the prior art of record beyond
the problem the patentee was trying to solve, in contravention
of KSR International Co. v. Teleflex Inc., 550 U.S.
398 (2007), and cases from this court. We address and
reject each challenge in turn.


As to the first, the CAFC observed:


To the extent the Board considered epimeric stability
during its obviousness analysis generally, it did so in the
context of assessing whether a skilled artisan would have
been motivated to combine references. That is not the
same as importing a limitation into the claims.



Of the second, as to the Senju case:


We further find Apotex’s invocation of Senju unpersuasive.
As an initial matter, Senju does not stand for the
general proposition that a skilled artisan would always be
motivated to try later generation compounds in an old
composition. Rather, the conclusion of obviousness in
Senju turned on the very specific factual findings made by
the district court about the teachings of the prior art and
the similarities across the quinolone family of compounds.
See, e.g., Senju, 780 F.3d at 1343 (“The ’470 patent also
teaches that each of the disclosed quinolones have ‘similar
substituents,’ and that pharmaceutical formulations of
gatifloxacin follow ‘the routes well known’ with respect to
‘oral[] and parenteral[]’ administration.” (internal citation
omitted)).