Saturday, October 03, 2015

The CAFC affirms D. Nev. in Spectrum case on Leucovorin

From SPECTRUM PHARMACEUTICALS, INC. v. Sandoz, concerning the
drug Leucovorin, which is used to ameliorate the toxic effects
of methotrexate.

Spectrum Pharmaceuticals, Inc. (“Spectrum”) appeals
from the decisions of the United States District Court for
the District of Nevada holding claims 1–2 of U.S. Patent
6,500,829 (“the ’829 patent”) invalid as obvious, and
finding claims 5–9 of the ’829 patent not infringed by the
submission of an Abbreviated New Drug Application
(“ANDA”) by Sandoz Inc. (“Sandoz”). Spectrum Pharm.,
Inc. v. Sandoz Inc., No. 2:12-cv-00111, 2015 WL 794674
(D. Nev. Feb. 25, 2015) (“Trial Order”); Spectrum Pharm.,
Inc. v. Sandoz Inc., No. 2:12-cv-00111, 2014 WL 7368845
(D. Nev. Dec. 29, 2014) (“Summary Judgment Order”).
Because the district court did not err in concluding that
claims 1–2 are invalid, and additionally did not clearly err
in finding claims 5–9 not infringed by Sandoz’s ANDA
product, we affirm.

<-- This case involves a molecule with optical activity: Due to an asymmetric C6carbon, leucovorin may exist as a 50/50 mixture of two diastereoisomers, the (6S) and (6R) isomers. The (6S) diastereoisomer is also known as levoleucovorin or l-leucovorin, and is the isomer with the desired biological activity. In the prosecution,
During prosecution of the application that became the ’829 patent, the examiner rejected the application’s claims as anticipated by or obvious over an article disclosing an enzymatic synthesis technique by which 0.91 grams of lleucovorin had been synthesized.

At trial:

Sandoz stipulated to infringement of claims 1 and 2, and the district court subsequently conducted a bench trial only on the validity of those claims. The court found that the prior art disclosed: (i) leucovorin as a mixture of (6R) and (6S) diastereoisomers; (ii) that the therapeutic usefulness of leucovorin derives wholly from the (6S) isomer; and (iii) a rationale for investigating a purified (6S) isomer product for use in 5-FU combination therapy. Trial Order at *6–8, *13–14. The court also found that preparations of purified (6S) isomer by an enzymatic synthesis method and by separation methods had been publicly reported before the ’829 patent’s priority date. Id. at *6–7. In particular, the court analyzed two related prior art references that disclosed a process for separating the diastereoisomers using the solubility differential of the (6S) and (6R) isomer salts, i.e., fractional crystallization. See id. at *11–13 (findings relating to Donna B. Cosulich, Diastereoisomers of Leucovorin, 74 J. Am. Chemical Soc’y 4215–16 (1952) and U.S. Patent 2,688,018 (collectively, “Cosulich” or “the Cosulich references”)).

The arguments in this case are a bit unusual:

Sandoz responds that the district court correctly found that one of skill would have been motivated to make substantially pure (6S) leucovorin starting with the 50/50 mixture to have a more effective pharmaceutical treatment, and would have reasonably expected to succeed in doing so. Sandoz contends that it had no burden to show a motivation to contaminate the prior art pure (6S) isomer compound, because the court’s analysis began with the 50/50 mixture and rejected Spectrum’s arguments on the inoperability of the prior art. Moreover, Sandoz argues, the court found no patentable difference between the claimed substantially pure compound and the prior art pure compound, which presented a prima facie case of obviousness that Spectrum failed to rebut.

Most issues relating to purified diastereoisomers or enantiomers involve the question whether a pure, resolved compound would have been obvious over the corresponding mixture. See, e.g., Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301–03 (Fed. Cir. 2007);


This case is unusual in involving a slightly different question, namely, whether a substantially pure compound would have been obvious when both the 50/50 mixture and the pure compound were known in the art. We agree with the district court that the claimed substantially pure compound would have been obvious over both the 50/50 mixture and the pure (6S) isomer compound in the prior art. First

Spectrum’s position here, that the 92–95% pure material was nonobvious over the known pure material—that position, despite its superficial appeal, is not persuasive.


In the face of that evidence of obviousness, Spectrum did not provide any evidence of unexpected results for the substantially pure compound as compared to the 50/50 mixture or the 100% pure compound.


We owe the district court’s factual findings considerable deference on appeal, and we see no clear error based on the record before us. Based on those findings, we affirm the district court’s conclusion that Sandoz proved by clear and convincing evidence that claims 1 and 2 of the ’829 patent are invalid as obvious.


Friday, October 02, 2015

Coca cola in the cloud?

Within an article on trade secrets in the cloud, one finds the text:

If Coca-Cola were to disclose its secret formula to an outsider, it may no longer be able to protect it as a trade secret in a suit for misappropriation, for example. Generally, unless subject to a confidentiality agreement, the disclosure of a trade secret to a third party can render the information no longer protectable.

The Coca-Cola story reveals an interesting problem. Some have alleged that the Coca Cola formula was disclosed in the
Atlanta Constitution in the February 28, 1979 issue. Now in the presence of an asserted disclosure is the trade secret holder going to say "you got me" or instead, "no, that isn't it"?

As to the cloud issue, JDSupra wrote:

So the question becomes: is a cloud service provider a third party? When a trade secret owner stores a trade secret in the cloud, and effectively “discloses” the information to the cloud service provider, has secrecy been lost? Courts have not had a chance to answer this definitively. The outcome may hinge on the often boilerplate Terms of Use agreements associated with cloud service providers. Unfortunately, such agreements often disclaim any liability on the cloud service provider for loss of confidential information. This may render it difficult for trade secret owners to argue that secrecy was not lost and that reasonable efforts to maintain secrecy were exercised for trade secrets that are or were at any time stored in the cloud.


Plagiarism hinders scientific progress

A post at dw titled Why painstaking detective work beats computer automation in the hunt for plagiarism concerning the copying allegations against German Defense Minister Ursula von der Leyen contains the text:

VroniPlag was set up by Martin Heidingsfelder and is maintained by volunteers, who include, says the website, "the young and the old, men and women, scientists and non-scientists."

Their motivation is simple. Plagiarism, says a detailed comment on the community website, hinders scientific progress.

Clearly, simply copying the work of others does not advance scientific progress. Taking credit for the work of others is an additional problem. But, relevant to arguments of some patent reformers, ignoring the work of others (and re-inventing the wheel) does not advance scientific progress either.

** Of wheel re-invention, recall the IPBiz post Unintentional plagiarism, again with text

In the realm of patent, of course, there is no independent creation defense. If one falls within
the scope of a claim, one infringes, whether or not one knows about the claim.
In theory, that encourages people to know the prior art and not waste time re-inventing the wheel.
And recall the South Park episode relating to "the Simpsons already did it."

As to the classic demonstration, patent law rewards people for writing down their inventions
in timely fashion, so one does not have fuzziness of who invented what when. And, did that
classic experiment prove the unintentional character? Does it comment on the Poshard matter?

Of spats about inventorship, take a good look the CAFC Shukh case of 2 Oct 2015:

Dr. Shukh’s manager also indicated that
Dr. Shukh demonstrated “unsatisfactory” teamwork
skills, explaining that he “is often insistent on getting
appropriate or complete credit for his work” and that he
“repeatedly accused” Seagate workers of “stealing his
work.” J.A. 5223;

**See also the post at ScienceInsider

German defense minister accused of plagiarism

In case you missed it: US Patent 9,145,667--Toilet sanitary shield for male genitalia

The first claim of US 9.145,667 states

A toilet sanitary shield for male genitalia comprising: a shield; a securing device; a ball and socket joint; wherein the ball and socket joint are affixed between the shield and the securing device; wherein the securing device is adapted to be secured to a toilet; wherein the shield is adapted to receive male genitalia thereon so as to protect said male genitalia during usage of said toilet.

AND note:

The securing device 102 comprises a suction cup 107 and a socket portion 108 of the ball and socket joint 103. The suction cup 107 is a curved semi-flexible piece of material. The socket portion 108 of the ball and socket joint 103 is attached directly to the convex side 113 of the suction cup 107. When the concave side 112 of the suction cup 107 is adaptively placed against the toilet 114, and the center of the suction cup 107 is pushed to the toilet 114, the air (or water depending on placement) is expelled from the space between the toilet 114 wall and the concave side 112 of the suction cup 107. As the suction cup 107 tries to recover to its original shape, a negative pressure is formed in the space between the toilet 114 wall and the concave side 112 of the suction cup 107. The positive pressure of the air (or water depending on placement) pushes against the convex side 113 of the suction cup 107 holding the securing device 102 in place. Suction cups are well known in the art.

US '667 patent cites to US 7,225,481, the abstract for which contains the lines:

The Big Boys Cave has a Big Boys Rest to position the penis horizontally. This horizontal position avoids the penis from dropping into the toilet thus preventing men from picking up germs on their penis from the waste in the toilet.

CAFC in Shukh: concrete and particularized reputational injury can give rise to Article III standing

SHUKH v. SEAGATE contains a most interesting discussion of
inventor-employer interactions, in the context of a
correction of inventorship case.

From the decision-->

Alexander Shukh appeals from the district court’s
dismissal of some of his claims for failure to state a claim
and its grants of summary judgment on his remaining
claims in favor of the defendants, Seagate Technology,
LLC; Seagate Technology, Inc.; Seagate Technology; and
Seagate Technology PLC (collectively, “Seagate”).
Dr. Shukh also appeals from several of the court’s discovery
orders and other ancillary orders. For the reasons
discussed below, we vacate and remand the court’s grant
of summary judgment on Dr. Shukh’s claim for correction
of inventorship under 35 U.S.C. § 256 and affirm its
remaining holdings.


Dr. Shukh, a native of Belarus, is a leading scientist
in the field of semiconductor physics, with a Ph.D. in
Condensed Matter Physics and a B.S. and an M.S. in
Electronics and Electronic Engineering. In 1997, Seagate
recruited Dr. Shukh to move to the United States and
work for it. Dr. Shukh was employed at Seagate from
September 1997 until his termination in early 2009.
During his employment, Seagate sponsored Dr. Shukh for
an H-1B work visa, a visa extension, and eventually
permanent residency.


He received numerous awards for his achievement and innovation generally and
on specific products, and was named to the Seagate
Technology Inventor’s Hall of Fame. The district court
found that Dr. Shukh had a reputation as “an extremely
successful innovator in the hard disk drives engineering
community.” Shukh v. Seagate Tech., LLC, No. CIV. 10-
404 JRT/JJK, 2013 WL 1197403, at *3 (D. Minn. Mar. 25,
2013) (“Summary Judgment Order”).
When he was hired, Dr. Shukh executed Seagate’s
standard At-Will Employment, Confidential Information,
and Invention Assignment Agreement (“Employment
Agreement”), in which Dr. Shukh agreed to “hereby
assign to [Seagate] all [his] right, title, and interest in and
to any inventions” made while at Seagate. J.A. 600.
Seagate policy prohibited Seagate employees from filing
patent applications themselves for their inventions.
Instead, they were required to submit Employee Invention
Disclosure Forms to Seagate’s Intellectual Property
(“IP”) Department. Inventors were responsible for identifying
co-inventors of their inventions on these forms. The
IP Department would then forward the form to the internal
Patent Review Board, which would determine whether,
for example, to pursue a patent application for the
invention or to protect it as a trade secret.
Dr. Shukh’s time at Seagate was undisputedly tumultuous.
His performance evaluations indicated that he did
not work well with others due to his confrontational style.
Moreover, Dr. Shukh’s conduct interfered with his
productivity. For example, Dr. Shukh applied a “threestrikes”
rule to interactions with his coworkers, under
which he would stop communicating with coworkers who
had engaged three times in behavior he considered dishonest.
Dr. Shukh also frequently accused others of
stealing his work, and his managers criticized him for his
insistence on receiving credit for his work. To avoid
accusations of plagiarism, some Seagate employees refused
to attend presentations by Dr. Shukh.
In 2009, Seagate terminated Dr. Shukh and 178 other
employees. Although he has submitted many job applications
to other potential employers, Dr. Shukh has not yet
secured employment. Dr. Shukh claims that the hiring
manager of Hitachi, a company to which he applied,
contacted a Seagate employee to discuss rumors the
Hitachi manager had heard about Dr. Shukh. Moreover,
a Hitachi engineer told Dr. Shukh during his interview
that he would never find employment at Hitachi with his

This lawsuit stems, in part, from Dr. Shukh’s allegations
that Seagate has not properly credited him for his


In his original complaint, Dr. Shukh asserted thirteen
claims against Seagate, including claims for correction of
inventorship of the disputed patents pursuant to
35 U.S.C. § 256, rescission of his Employment Agreement,
breach of contract, fraud, breach of fiduciary duty, unjust
enrichment, and federal and state retaliation and national
origin discrimination claims.


Seagate moved to dismiss Dr. Shukh’s § 256 claim for
lack of standing. Dr. Shukh alleged three distinct interests
in the patents: an ownership interest, a financial
interest, and a reputational interest. At the motion to
dismiss stage, the district court held that Dr. Shukh had
no ownership or financial interest in the patents because
he automatically assigned all of his inventions to Seagate
in his Employment Agreement. The court left open the
possibility that Dr. Shukh had standing to sue based on
reputational harm caused by his omission from the disputed
patents. The district court also dismissed for
failure to state a claim Dr. Shukh’s claims for rescission of
his Employment Agreement, breach of contract, breach of
fiduciary duty, unjust enrichment, and declaratory judgment.

Two years later, Seagate moved for summary judgment
on Dr. Shukh’s § 256 claim. The court granted
Seagate’s motion, holding that there was no genuine
dispute of material fact as to whether Dr. Shukh suffered
reputational harm from not being named an inventor on
the patents. Summary Judgment Order at *13. It also
granted Seagate’s motion for summary judgment on Dr.
Shukh’s fraud claim. One week later, the district court
granted Seagate’s motion for summary judgment on Dr.
Shukh’s federal and state retaliation and national origin
discrimination claims.

Of importance here -->

Today, we hold that concrete and particularized reputational
injury can give rise to Article III standing. As we
noted in Chou, “being considered an inventor of important
subject matter is a mark of success in one’s field, comparable
to being an author of an important scientific paper.”
254 F.3d at 1359. We reasoned that “[p]ecuniary consequences
may well flow from being designated as an inventor.”
Id. This is particularly true when the claimed
inventor is employed or seeks to be employed in the field
of his or her claimed invention. For example, if the
claimed inventor can show that being named as an inventor
on a patent would affect his employment, the alleged
reputational injury likely has an economic component
sufficient to demonstrate Article III standing.

As to allegations about reputational injury:

first, it harmed his reputation as an
inventor in the field of semiconductor physics, and second,
it contributed to his reputation for poor teamwork due in
part to his accusations that others were stealing his work.
Moreover, Dr. Shukh presented evidence from which a
trier of fact could conclude that these reputational harms
had economic consequences—namely, that Dr. Shukh was
unable to find employment after he was terminated from

Footnote 2 is of relevance to "invention disclosures" and
"performance evaluations":

The district court discounted this evidence because
the manager “clarified in his deposition testimony
that he was concerned with the decrease in the number of
invention disclosures that [Dr.] Shukh made to Seagate,
and not concerned with the decrease in the total number
of patent applications filed with the USTPO that listed
[Dr.] Shukh as an inventor.” Summary Judgment Order
at *12. In doing so, the district court improperly made a
factual finding on summary judgment. Cf. Anderson, 477
U.S. at 249–50. Moreover, this interpretation contradicts
the plain language of the evaluation. The district court
erred when it discounted Dr. Shukh’s performance evaluation
at this stage.

Of relevance to various bean-counting schemes, such as
patent citation analysis:

Finally, the court wrote that
Dr. Shukh’s former co-workers testified that their impression
of Dr. Shukh as an “excellent inventor with good
technical skills” would not change based on the number of
patents he was named on.

The CAFC was critical of the way the district court
handled summary judgment:

In coming to this conclusion, the district court improperly
made findings of fact on summary judgment and
did not make all factual inferences in Dr. Shukh’s favor.
A trier of fact could conclude that Dr. Shukh’s omission
from the disputed patents had a concrete impact on his
reputation in his field. There is significant evidence that
the number of patents an inventor is named on influences
his reputation in the field of the patents. Dr. Shukh’s
professional reputation is based on his work in semiconductor
physics—the same field as the disputed patents.
Moreover, Dr. Shukh is named as an inventor on seventeen
issued patents for work done at Seagate; he argues
here that he should be named as an inventor on an additional
six issued patents and four pending applications.
The disputed patents would therefore form a significant
portion of the patents granted to Dr. Shukh during his
tenure at Seagate.

True, it is undisputed that Dr. Shukh had a reputation
as an excellent inventor, and that this reputation did
not decrease while he was at Seagate. However, this does
not mean that Dr. Shukh’s omission from the patents did
not harm his reputation. The evidence supports the
conclusion that Dr. Shukh’s reputation as an inventor
would have been higher had he been named on the patents.


Dr. Shukh’s
coworkers had years of experience working directly with
Dr. Shukh, unlike potential employers, who likely lack
that first-hand knowledge and are therefore more likely to
rely on their knowledge of Dr. Shukh’s reputation in
evaluating their impression of him. Considering all of the
evidence, we find there is a genuine dispute of material
fact as to whether Dr. Shukh’s reputation as an inventor
was harmed by his omission from the disputed patents

Part of a performance review of Shukh appears in the
decision -->

In his Fiscal Year 2007 Performance
Evaluation, Dr. Shukh’s manager wrote:
[Dr. Shukh’s] insistence on getting appropriate
credit for all design ideas and implementations
stifles open discussion and adoption of his ideas.
Since this issue has become more important to
[Dr. Shukh] as time goes on, and since he believes
he has not been fairly recognized for his past contributions,
it’s an emotional issue. Most unfortunately,
it appears to others that [Dr. Shukh] is
more interested in being right and in getting credit
than in ensuring that Seagate wins.
[Dr. Shukh] will become more effective, and his
contributions will increase significantly, if he can
find ways to let others see that he truly is inter-
ested primarily in Seagate’s success, rather than
in his own advancement or preventing theirs.
J.A. 5222.

Dr. Shukh’s manager also indicated that
Dr. Shukh demonstrated “unsatisfactory” teamwork
skills, explaining that he “is often insistent on getting
appropriate or complete credit for his work” and that he
“repeatedly accused” Seagate workers of “stealing his
work.” J.A. 5223; see also Summary Judgment Order
at *4. Dr. Shukh argues that if he is named an inventor
on the disputed patents, it may rehabilitate his reputation
for seeking credit for his ideas.

<-- Shukh's unemployment arises -->
Finally, Dr. Shukh presented evidence that his alleged
reputational harm had an economic component.
Dr. Shukh has been unemployed since 2009, and he seeks
a job in the field of technology covered by the disputed
patents. A trier of fact could infer that the stronger
Dr. Shukh’s reputation as an inventor, the more likely he
is to be hired. This is particularly true in light of his
difficult personality. Furthermore, there is evidence tying
Dr. Shukh’s negative reputation at Seagate—including,
one presumes, his reputation for seeking credit for his
own inventions—to his unemployment. Summary Judgment
Order at *5 (writing that an engineer at a company
Dr. Shukh interviewed with allegedly told Dr. Shukh that
he would never get a job there because of his reputation
at Seagate). Thus, a trier of fact could conclude that Dr.
Shukh’s employment prospects have been harmed by the
impact of his alleged omission from the disputed patents
on his reputation as an inventor and his reputation for
seeking credit for his own ideas. Moreover, a trier of fact
could infer that Dr. Shukh’s employment prospects would
improve if the inventorship of the disputed patents was
corrected. Dr. Shukh’s inability to obtain employment is
a concrete and particularized financial harm that suffices
to create Article III standing.


Link to case

Thursday, October 01, 2015

PTAB zaps claims on on Novartis' multiple sclerosis blockbuster Gilenya in IPR

In IPR2014-00784 on US Patent 8,324,283, PTAB found claims 1–32 of US '283 unpatentable.
MS drugs are a big deal economically; the current market for MS drugs is worth an estimated $20 billion a year.

This oral drug for treating MS comprises a sphingosine-1
phosphate (S1P) receptor agonist and a sugar alcohol. Ex. 1001, 1:11–14,
1:33–35. “The sugar alcohol may act as a diluent, carrier, filler or bulking
agent, and may suitably be mannitol.”

PTAB noted

We disagree, however, with Patent Owners’ argument that the
inventors’ mere discovery of a new reason to combine fingolimod and
mannitol renders nonobvious an invention that was known in the prior art.
Where the prior art teaches the claimed invention, a claim is not rendered
patentable by virtue of being motivated in the inventors’ minds by a newlydiscovered
advantage of the prior-art combination; allowing such a claim to
stand “would remove from the public that which is in the public domain.” In
re Wiseman, 596 F.2d 1019, 1022 (CCPA 1979); see also Cross Med.
Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed.
Cir. 2005) (“One of ordinary skill in the art need not see the identical
problem addressed in a prior art reference to be motivated to apply its

As explained
above, though, it does not matter that the prior art failed to recognize this
advantage of a fingolimod-mannitol combination. “[T]he motivation in the
prior art to combine the references does not have to be identical to that of the
[patentee] to establish obviousness.” In re Kemps, 97 F.3d 1427, 1430 (Fed.
Cir. 1996)

Of long-felt need:

Next, Patent Owners argue that the invention claimed in claim 19
satisfied the long-felt but previously unmet need “for a solid oral [multiple
sclerosis] treatment.” PO Resp. 55 (citing Ex. 2044 ¶¶ 25–27). The
supporting evidence is a declaration stating that “some patients are resistant,
afraid, or even unwilling to use needles,” which caused some patients to
“drop[] the [multiple sclerosis] treatment”; that “parenteral medications were
universally inconvenient,” making patients less likely to take their
medication; and that “there were a number of side effects commonly
associated with parenteral [multiple sclerosis] treatments” that “discouraged
patients from continuing with their prescribed course[s] of treatment.”
Ex. 2044 ¶¶ 25–27. Although no other evidence is cited in Patent Owners’
briefing,21 additional record evidence shows that patients asked about the
availability of an oral medication as early as 1993, id. ¶ 34, and that the
introduction of the first oral medication in 2010 caused a “‘major shift in the
treatment landscape,’” with “‘many patients . . . switching to oral therapy,’”
id. ¶ 37 (quoting Ex. 2012, 1).
Petitioners argue, Reply 18–19, that there is no evidence that the longfelt
need was for claim 19’s combination of fingolimod and mannitol;
instead, as Patent Owners acknowledge, PO Resp. 55, the need was merely
“for a solid oral [multiple sclerosis] treatment.” According to Petitioners,
any need for a solid oral dosage form of a multiple sclerosis treatment was
satisfied by treatments that were known in the prior art but did not receive
FDA approval until after Patent Owners’ Gilenya product did. Reply 18–19.
Therefore, argue Petitioners, there was no longer any long-felt need by the
time of the invention claimed in the ’283 patent. Id


In 1999, Chiba itself suggested treating multiple
sclerosis using a solid oral form of fingolimod. Ex. 1006, 6:26–49, 8:19–26.
In addition, teriflunomide, marketed in solid tablet form as Aubagio®, was
known in the prior art at least by April 1, 2002, when it was disclosed to be
useful for treating multiple sclerosis when administered in tablets or
capsules. Ex. 1037, at [22], 1:19–30, 2:60–3:2, 5:1–21; Ex. 2045 ¶ 63.22
Similarly, a capsule form of dimethyl fumarate for the treatment of multiple
sclerosis, marketed as Tecfidera™, Ex. 1070, 2, was disclosed in U.S. Patent
No. 6,509,376 B1, issued January 21, 2003. Ex. 1097, at [45], 2:64–67,
4:25–27, 4:31–33.


Industry praise must be linked to the patented invention. Power-One,
Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1352 (Fed. Cir. 2010). Again, if
objective indicia of nonobviousness are “due to an element in the prior art,
no nexus exists.” Tokai Corp., 632 F.3d at 1369. Here, the evidence shows
that what was praised about Gilenya was not the specific formulation recited
in claim 19, but rather the general fact that Gilenya was a solid oral multiple
sclerosis medication. As discussed above, however, a solid oral multiple
sclerosis formulation was known in the prior art, so there is no nexus
between the claimed invention and the industry praise.

Tysabri (natalizumab ) is mentioned

In either case, Dr. Blackburn excluded
from his analysis any data regarding sales of Tysabri, id. ¶ 20 n.24,24
multiple sclerosis drug that generates more than $1 billion in annual sales,
Ex. 1041 ¶ 38; Ex. 1057, 5–6; Ex. 1058, 37. Dr. Blackburn’s evidence of
Gilenya’s market share is biased towards more significant sales of Gilenya
by this exclusion and, thus, is unreliable as evidence that Gilenya’s sales are
significant in relation to the relevant market as a whole.

As to amendment:

Because we find each of claims 1–32 unpatentable, we next address
Patent Owners’ motion to amend, in which claims 33–64 are proposed.
Motions to amend are permitted by 35 U.S.C. § 316(d) and 37 C.F.R.
§ 42.121. In moving to amend their claims, as the moving the party, Patent
Owners have the burden to show entitlement to the relief requested. 37
C.F.R. § 42.20(c). “The burden is not on the petitioner to show [the]
unpatentability [of the proposed claims], but on the patent owner to show
patentable distinction over the prior art of record and also [the] prior art
known to the patent owner.” Idle Free Sys., Inc. v. Bergstrom, Inc., Case
IPR2012-00027, slip op. at 7 (PTAB June 11, 2013) (Paper 26)
(representative). The “prior art of record” includes “any material in the
prosecution history of the patent,” “any material art of record in the current
proceeding, including art asserted in grounds on which the Board did not
institute review,” and “any material art of record in any other proceeding
before the Office involving the patent.” MasterImage 3D, Inc. v. RealD
Inc., Case IPR2015-00040, slip op. at 2 (PTAB July 15, 2015) (Paper 42)

***Gilyena is for relapsing remitting MS ["RRMS"]. Forbes noted a possible
game changer as to primary progressive MS, with new results on ocrelizumab [by Roche / Biogen], which
is a humanized anti-CD20 monoclonal antibody, which targets mature B lymphocytes:

On Monday [28 Sept 2015], the company disclosed that its experimental multiple sclerosis treatment ocrelizumab has become the first therapy to hit the main endpoint in a large Phase III study for primary progressive MS. This form of the disease accounts for between 10% and 15% of all MS patients, but is devoid of effective therapies.

As such, ocrelizumab is looking like an increasingly significant future sales growth driver for Roche, capable of generating multi-billion dollar sales on a global basis. In June, the company announced that two Phase III studies in the more common form of relapsing remitting MS had hit their primary and key secondary endpoints. Full data from each of the late-stage trials will be presented at next month’s annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

CD-20 immune cells are thought to be a key contributor to myelin and axonal damage in MS.

Forbes noted that ocrelizumab might compete against Tysabri in the RRMS market :

In the larger RRMS market, there is a growing consensus that ocrelizumab will gain an initial foothold in second-line patients and compete primarily with Biogen’s Tysabri. Roche’s drug offers comparable efficacy, but what appears to be a notably superior safety profile. Furthermore, while Tysabri is dosed once a month, ocrelizumab is administered twice a year.

Another monoclonal antibody for MS is alemtuzumab (Lemtrada) which binds to CD52, a protein present on the surface of mature lymphocytes,

See the story from 14 Nov. 2014 Sanofi’s Lemtrada Wins U.S. Approval to Treat MS which includes the text:

There are about 10 treatments for relapsing-remitting MS, in a market estimated at $16 billion, including Avonex made by Biogen Idec Inc. and Copaxone from Teva Pharmaceutical Industries Ltd. Multiple sclerosis, a neurological disease that can cause severe disability, affects as many as 350,000 people in the U.S. and is twice as likely to occur in women, according to the National Institute of Neurological Disorders and Stroke.
Patients receive five infusions of Lemtrada in the first year, followed by three more a year later. Data presented at a meeting in September showed that 70 percent of those involved in the key clinical trials of the drug didn’t require any additional treatment after the first two years. The drug will cost $158,000 over the two years, compared with about $135,000 for Merck KGaA’s Rebif, Sibold said.

“We could see that this would become the most cost-effective, least-expensive, highest-value product over time,” he said.

Chaffetz on drug price increases before the patent cliff

As to Congressman Chaffetz, Investors Business Daily noted:

a group of congressional Democrats sent a letter to Rep. Jason Chaffetz, chair of the House Committee on Oversight and Government Reform, requesting a subpoena to make Valeant turn over documents related to last February's triple-digit price increases on two heart drugs, Nitropress and Isuprel.

Link to Investor's Business Daily article, Valeant Defended After Politics-Induced Sell-Off:

IBD was somewhat cool on the idea of Chaffetz favorably responding to Democrats, but IPBiz notes Chaffetz is a different type of chairman.

From realclearpolitics :

When Chaffetz campaigned to run the committee in the new Congress – Issa was forced to leave because of Republican term limits on chairmanships – the Utah lawmaker ran partially on a platform of taking the committee in a new, less fiery direction, promising improved relationships with Democrats. And in the first six months, the reviews of Chaffetz’s nascent tenure are positive across the board, and across the aisle.

And Chaffetz gets along well with Elijah Cummings.

FORTUNE asks three questions about the Microsoft/Google patent agreement

1. How much has Microsoft really changed?

Fortune brings up the past use by Microsoft of third party mercenaries amounting to proxy attacks by privateers and trolls.

2. Will Google still play nice with its big patent pile?

Is Google now like mature companies (such as IBM) hich, once their most innovative days are over, turn to milking their patent portfolio for licensing revenue.

3. Will the Google-Microsoft deal help resurrect patent reform?

[Probably not]


Separately, see post on fosspatents:

CAFC in Achates v. Apple: PTAB determinations as to petitions are final and nonappealable

The key point:

Achates contends that the Board’s decisions
were outside of the Board’s statutory authority because
the underlying petitions for IPR were time-barred under
35 U.S.C. § 315(b). As part of its appeal, Achates also
challenges the Board’s denial of Achates’ motion for
discovery. See Apple Inc. v. Achates Reference Publ’g, Inc.,
2013 WL 6514049 (P.T.A.B. Apr. 3, 2013) (“Discovery
Decision”). Because the Board’s determinations to institute
IPRs in this case are final and nonappealable under
35 U.S.C. § 314(d), this court lacks jurisdiction and dismisses
the appeals.

The CAFC discussed the relevant law:

Both IPR and CBMR proceed in two stages. In the
first stage, the Director determines whether to institute
IPR or CBMR. By regulation, “[t]he Board institutes the
trial on behalf of the Director.” 37 C.F.R. § 42.4; see also
37 C.F.R. §§ 42.100(a) (explaining that IPR proceedings
are subject to these trial procedures); 42.300(a) (same for
CBMR). In the second phase, the Board conducts the IPR
or CBMR proceedings on the merits and issues a final
written decision.
Based on the petitions and any responses, the Board
decides whether there are sufficient grounds to institute
the proceedings—in IPR petitions there must be a “reasonable
likelihood” that the petition will prevail, 35
U.S.C. § 314(a), and in CBMR petitions it must be “more
likely than not,” 35 U.S.C. § 324(a). An IPR proceeding
“may not be instituted if the petition requesting the
proceeding is filed more than 1 year after the date on
which the petitioner, real party in interest, or privy of the
petitioner is served with a complaint alleging infringement
of the patent.” § 315(b). No analogous time-bar
exists for CBMR proceedings. IPR proceedings are not
limited to specific types of patents. On the other hand,
CBMR proceedings are only permitted “for a patent that
is a covered business method patent.” AIA § 18(a)(1)(E).
Importantly, identically worded statutory provisions
make explicit that “[t]he determination by the Director
whether to institute [IPR or CBMR] under th[ese] section[s]
shall be final and nonappealable.” See § 314(d)
and § 324(e), respectively.

If a proceeding is instituted, the Board considers the
merits and “issue[s] a final written decision with respect
to the patentability of any patent claim challenged by the
petitioner and any new claim added” during the proceedings.
35 U.S.C. §§ 318(a) (IPR), 328(a) (CBMR).
“[P]art[ies] dissatisfied with the final written decision of
the Patent Trial and Appeal Board under section[s]
[318(a) or 328(a)] may appeal the decision pursuant to
sections 141 through 144.” Id. §§ 319 (IPR), 329 (CBMR).
Sections 141 through 144 of title 35 generally explain that
Board decisions are appealable to this court. Of particular
relevance, 35 U.S.C. § 141(c) states, with emphasis

A party to an inter partes review or a post-grant
review who is dissatisfied with the final written
decision of the Patent Trial and Appeal Board under
section 318(a) or 328(a) (as the case may be)
may appeal the Board’s decision only to the United
States Court of Appeals for the Federal Circuit.

The Cuozzo case was mentioned:

This court also has considered whether the Director’s
institution decision is subject to review after a final
written decision by the Board. In In re Cuozzo Speed
Techs., LLC, 793 F.3d 1268 (Fed. Cir. 2015), the Director
instituted an IPR of certain claims relying in part on
references not cited in the petition. On appeal, Cuozzo
argued that the IPR was improperly instituted because
the petition-as-filed did not provide “a reasonable likelihood
that the petition would prevail” as required
by § 314(a). Id. at 1273. Cuozzo argued that the reviewability
prohibition of § 314(d) applied only to interlocutory
appeals, and that the initiation decision becomes available
for review once the Board issues a final written decision.
The court disagreed with Cuozzo and declined to
review the initiation decision, remarking that § 314(d) “is
not directed to precluding review only before a final
decision” and cannot be directed only to precluding interlocutory
appeals because §§ 319 and 141(c) already serve
that role. Id. The court then recognized that “the IPR
statute [does not] expressly limit the Board’s authority at
the final decision stage to the grounds alleged in the IPR
petition” and that “the failure to cite those references in
the petition provides no ground for setting aside the final
decision.” Id. at 1273 and 1274.

As to CBM review

The court first recognized the distinction between the
final merits decision and the initiation decision: “institution
and invalidation are two distinct actions.” Id. at
1319. “[I]t is the merits of the final written decision that
are on appeal; we are not here called upon to review the
determination by the [Board] whether to institute a CBM
review, and indeed [35 U.S.C. § 324(e)] expressly instructs
that we may not.” Id. at 1315. The court went on to
point out that although the issue of whether a patent is a
CBM was first determined by the Director at the initiation
stage, the same issue was necessarily implicated in
the final merits determination and was appropriate for
review because of the fundamental limitation of the
Board’s “ultimate invalidation authority” in a CBMR to
those patents that meet the CBM definition:
[O]ne of the limits on § 18 invalidation authority
is that the patent at issue be a CBM patent. . . . If
a particular patent is not a CBM patent, there is
no proper pleading that could be filed to bring it
within the [Board’s] § 18 authority.
Id. at 1320. Compare Cuozzo, 793 F.3d at 1274 (“The fact
that the petition was defective is irrelevant because a
proper petition could have been drafted.”)

Cuozzo-like arguments appear:

Just as the pleading in Cuozzo could have been sufficient by
the inclusion of the missing prior art reference, see 793
F.3d at 1274 (“The fact that the petition was defective is
irrelevant because a proper petition could have been
drafted.”), the timeliness issue here could have been
avoided if Apple’s petition had been filed a year earlier or
if a petition identical to Apple’s were filed by another
party. This is in contrast to the issue in Versata II, where
“no proper pleading [] could be filed to bring it within the
[Board’s] § 18 authority.” 793 F.3d at 1320.

The words "too crabbed" appear:

Finally, Achates also contends that § 314(d) does not
limit this court’s review of the timeliness of Apple’s petition
under § 315, because § 314(d) says “[t]he determination
by the Director whether to institute an inter partes
review under this section shall be final and nonappealable”
(emphasis added). Achates’ reading is too crabbed
and is contradicted by this court’s precedent. The words
“under this section” in § 314 modify the word “institute”
and proscribe review of the institution determination for
whatever reason.

Pro se appellant loses at CAFC in In re Steed

The issue in In re Steed:

The principal issue on appeal is whether Steed antedated
the Evans reference in accordance with the requirements
and law implemented by Rule 131, for Steed
bears the burden to establish “facts . . . in character and
weight, as to establish reduction to practice prior to the
effective date of the reference, or conception of the invention
prior to the effective date of the reference coupled
with due diligence from prior to said date to a subsequent
reduction to practice or to the filing of the application.”
37 C.F.R. § 1.131(b). Steed argues that the Declaration
and exhibits meet the requirements of either actual
reduction to practice or conception plus diligence.

There was no waiver:

The Board held that “assertions that the claimed invention
was actually reduced to practice in December of
1997, and at the latest by August of 2000 are not set forth
in the Appeal Brief or the Reply Brief, and are thus
considered waived.” Bd. Op. at 6. We discern no such
waiver. To the contrary, the appeal briefs included well
over a hundred pages of exhibits and arguments, all
directed to actual reduction to practice. Although the
Board concluded that the evidence did not establish an
actual reduction to practice, the issue was not omitted
from the appeal briefs.
Steed’s briefs before the Board are clear that Steed
was attempting to establish conception, diligence, and
actual reduction to practice. The flaw in Steed’s proofs
was in the content of the documentary evidence, not in
any purported waiver. It is beyond debate that Steed was
attempting to swear back of Evans, and that this was the
focus of the evidence and argument presented to the
Examiner and the additional documents and affidavits
presented to the Board.

The problem

We agree that the exhibits are not self-explanatory,
and the Examiner had adequately warned the applicant,
stating in the Final Office Action that “most of the notes
included for the [year] 2000 are all notes to call people
without actually including what phone calls were being
made about and what was being accomplished with
reference to the invention” and “there are 57 months of
time unaccounted for in applicant’s attempt to show due
diligence,” among other things. Office Action, Paper No.
34 at 5–6 (March 3, 2011). In an earlier Office Action, the
Examiner stated that “Appendix A . . . does not include
any specifics of the actual invention” and “there are
significant gaps of time between each of the Appendices
A-D that amount to entire years of diligence being omitted.”
Office Action, Paper No. 17 at 3–4 (Dec. 9, 2009).


We agree with the PTO argument, on this appeal,
[T]he Board cannot be faulted for not reviewing
evidence that was not presented to it or to the Examiner.
To the extent Appellants have better
proof of an earlier actual reduction to practice or
conception date, the proper remedy is to file a continuation
application and present the evidence to
the Examiner in the first instance.
PTO Br. 24. We conclude that substantial evidence
supports the Board’s findings, and the ruling that Steed
did not establish an actual reduction to practice before the
Evans effective date of December 23, 2002. That ruling is

As to conception:

An inventor can antedate a Section 103 reference by
showing that the invention was conceived before the
effective date of the reference, with diligence to actual or
constructive reduction to practice. 37 C.F.R. § 131(b).
Conception is “the formation, in the mind of the inventor,
of a definite and permanent idea of the complete
and operative invention, as it is thereafter to be applied in
practice.” Mergenthaler v. Scudder, 11 App. D.C. 264, 276
(D.C. Cir. 1897); see Coleman v. Dines, 754 F.2d 353, 359
(Fed. Cir. 1985). The Board found that the evidence that
Steed provided did not establish conception before the
Evans effective date, and that Steed did not adequately
explain the exhibits and how they showed conception of
the claimed subject matter, or when such conception
occurred. The Board recognized that the Table “identifies
that a piece of evidence corresponds to a certain date” but
criticized the absence of evidence to “explain what fact
that piece of evidence is meant to support as having
occurred on that date.” Bd. Op. at 15.


Chaffetz, the Secret Service, and data security

Various news reports discuss the unauthorized access (and likely disclosure) by Secret Service employees of an unsuccessful employment application to the Secret Service by Republican congressman Jason Chaffetz of Utah, who recently has been investigating bad acts by the Secret Service.

There are at least two aspects of the disclosure.

@1. The implication that Chaffetz is somehow "inferior" because his application was turned down.
@2. The implication that the investigations by Chaffetz of the Secret Service are payback for being turned down, and thus are not objectively based.

Both aspects are captured in the Washington Post text:

One official told The Post that the material included a parody poster that pictured Chaffetz leading a hearing on the Secret Service from his congressional dais, with the headline “Got BQA from the Service in 2003.” Within the Secret Service, “BQA” is an acronym meaning that a “better qualified applicant” was available.


NPR noted:

Chaffetz told the AP that Homeland Security Secretary Jeh Johnson personally apologized to him. Chaffetz called the experience "intimidating," saying: "It's what it was supposed to be."

link: Secret Service Violated Privacy Protocol, Wanted To Embarrass Congressman

As to disclosure of unsuccessful job applications, such disclosure can occur in unexpected ways.
This author learned in 2001 of a disclosure which had happened in 1987, because of an employment action taken by someone else.

See the earlier IPBiz post

Startup Act 2.0: are you turning up your nose at $150K/year jobs?

Apart from recounting the story of the Dickakian matter [ In the Matter of Exxon Chemical Company (on behalf of Dickakian), 87-INA-615 ], the post mentioned issues with a data breach at LinkedIn:

"In this job market, I'm just happy the Russians who hacked LinkedIn have my resume," one guy tweeted.

"Okay, maybe it's just me, but if my LinkedIn was hacked... who cares? More people will see my resume?" someone else said.

In passing, as to Chaffetz, it appears that a number of people have underestimated Chaffetz in the past. It might be that the Secret Service is the one who got it wrong in 2003.

Monday, September 28, 2015

Copying issue with the movie "The Martian"?

See the post at CinemaBlend including the text:

Gorgadze said that Raskhodnikov wrote the script back in 2008 and shopped it around to a number of studios. The lawyer also said that Raskhodnikov is positive that his script made its way to Fox’s main headquarters, and the plot line and "some details" from the script were used for The Martian. The suit is currently slated to be considered in October, and Gorgadze brought up Russia’s Culture Minister, Vladimir Medinsky, saying he has a legal right to suspend the October 8 release of the film until this situation is resolved.


CAFC addresses patent issues related to Vermont's Consumer Protection Act

The background:

On May 8, 2013, Plaintiff-Appellee State of Vermont
(“Vermont” or “the State”) filed a state court action
against Defendant-Appellant MPHJ Technology Investments
LLC (“MPHJ”) alleging violations of the Vermont
Consumer Protection Act, 9 V.S.A. §§ 2451 et seq.
(“VCPA”). The complaint alleged that letters mailed to
Vermont businesses informing them that they may be
infringing certain patents were deceptive and otherwise
violative of the VCPA. MPHJ removed the case twice to
the United States District Court for the District of Vermont,
once under the State’s original complaint (“original
complaint”) and once under the State’s amended complaint
(“amended complaint”). The district court remanded
the case to state court both times. Before this court is
MPHJ’s appeal of the district court’s second remand
order. Because removal under § 1442(a)(2) is not authorized
in the circumstances at issue here, and MPHJ does
not appeal the district court’s other removal rulings in the
second remand order, we affirm.

The issue in the first removal:

MPHJ timely filed a motion to remove the case to the
United States District Court for the District of Vermont
on June 7, 2013 (“the first removal”). MPHJ claimed that
the court had diversity jurisdiction and that the court had
federal question jurisdiction because the validity, infringement,
and enforcement of its patents were at issue.
The State thereafter moved to remand, arguing that its
complaint sounded solely in the VCPA, a state law.
MPHJ then filed a motion to dismiss the case for lack of
personal jurisdiction and a motion for sanctions under
Federal Rules of Civil Procedure (“FRCP”) 11. The district
court held a hearing on these pending motions on
February 25, 2014, and expressed concern that the State’s
second request for an injunction could prevent MPHJ
from sending legitimate assertions regarding patent
infringement to Vermont businesses.

As to jurisdiction, the CAFC noted:

The parties dispute our jurisdiction over this appeal.
The State asserts that we have none and asks that we
dismiss the appeal. MPHJ argues that we do have jurisdiction
over this appeal and correctly points out that, even
if we disagreed with that contention, the appropriate
remedy would be a transfer to the Second Circuit, not
dismissal. 28 U.S.C. § 1295 defines the scope of this
court’s jurisdiction. Specifically, it provides that this
court has jurisdiction “in any civil action arising under, or
in any civil action in which a party has asserted a compulsory
counterclaim arising under, any Act of Congress
relating to patents.” 28 U.S.C. § 1295(a)(1). Because we
find jurisdiction on the basis of at least one of MPHJ’s
counterclaims, counterclaim 5, we have jurisdiction over
this appeal. We, therefore, do not need to assess whether
this court could exercise jurisdiction on the basis of
MPHJ’s other counterclaims or Vermont’s claim.

An article in Law360 is discussed:

Finally, although MPHJ relies on a Law 360 article
featuring an interview with Vermont Attorney General
William Sorrell, which it originally included as an exhibit
to its notice of removal, that article supports the State’s
position. In that interview, which was published two
months after the State filed its conditional motion to
amend, Sorrell was asked whether the lawsuit against
MPHJ was filed under the VCPA:
Q: So the case against MPHJ was filed under the
then existing consumer protection law?
A: Yes.

In the end, MPHJ loses

In these circumstances, we see no reason to
disturb the district court’s finding that the State is not
seeking an injunction that requires MPHJ’s compliance
with the BFAPIA. Given this conclusion, if the State
prevails on the merits in state court, it may not seek an
injunction requiring MPHJ to comply with the BFAPIA
based on the amended complaint. Because MPHJ relies
on the BFAPIA as its basis for removal under
§ 1442(a)(2), the necessary consequence of our decision is
that we find no grounds for removal to federal court.

Given these conclusions, we decline to decide whether
§ 1442(a)(2) applies to intellectual property rights or
whether the phrase “derived from” a federal officer means
the property right at issue must have been obtained by
the removing defendant itself from such an officer, rather
than by a predecessor in interest to that defendant.
Because MPHJ has not appealed the district court’s
ruling pursuant to 28 U.S.C. § 1454, we have no occasion
to address the timeliness or propriety of MPHJ’s attempted
removal under that statute or how that newly enacted
provision should be interpreted in light of the other
amendments to jurisdictional statutes adopted in the AIA.

For the foregoing reasons, we hold that there is no basis
for removal to federal court under § 1442(a)(2). We,
therefore, affirm.

Docket: 2015-1310

Joule's US Patent 8,986,964

Further to the March 2015 post on IPBiz [Bold predictions for biofuel production by Joule Unlimited published in BiofuelsDigest on 23 March 2015 ], note that Joule's US Patent 8,986,964 cites as a reference:

Statement of Opposition in re European Patent No. 2285948, filed Oct. 8, 2014, on behalf of Algenol Biofuels Switzerland GmbH before the European Patent Office, twenty-nine pages. cited by applicant .

Note also


- Ref Country Code: DE

- Ref Legal Event Code: R026

- Ref Document Number: 602009021285

- Country of Ref Document: DE

- Effective date: 20141008

Sunday, September 27, 2015

Another German politician charged with plagiarizing Ph.D. thesis

Of the case of alleged plagiarism by German Defence Minister Ursula van der Leyen:

The Berlin-based law professor Gerhard Dannemann, who investigated her thesis and published his findings on the internet platform Vroniplag Wiki, said several passages of her thesis were clearly from sources that were not attributed.

"In think the flaws are more severe than in the case of Mrs Schavan," Dannemann told Sueddeutsche Zeitung newspaper in an interview to be published on Monday. "We're not talking about a borderline case here."

Schavan resigned as education minister in 2013 after being stripped of her doctorate for plagiarism, embarrassing Merkel and the conservatives in the run-up to the elections that year.


**The Telegraph noted:

Ms von der Leyen is alleged to have copied text in her obstetrics doctorate verbatim from other sources without proper attribution on 27 of the 62 pages of her 1990 dissertation, according to Berlin-based law professor Gerhard Dannemann, who examined the thesis and published his findings on VroniPlag.

The defence minister, a member of Mrs Merkel's centre-right CDU party and a mother of seven, qualified as a doctor in 1987 and was awarded a doctorate in medicine in 1991, working as a gynaecologist and in public health before entering politics, according to her website.


Statistics on the use of 101 at PTAB from IPWatchdog

In a post titled PTAB Wonderland: Statistics show Alice PTAB interpretation not favorable to patent applicants , IPWatchdog concludes

Overall, the above statistics provide a depressing prognosis for those who are hoping that the PTAB will overturn an examiner’s § 101 rejection (even when the examiner did not apply Alice) based on the PTAB’s current application of Alice. Moreover, while we identified no PTAB decisions that have been issued based on the examiner applying Alice during prosecution, the PTAB’s current trends strongly suggest that successfully appealing such a rejection in the future will be challenging. As a result, filing an appeal to the PTAB is no sure escape from Alice’s not-so-wonderful wonderland.

The word "wonderland" appears only in the title and in the conclusion. One suspects the use of "wonderland" is not favorable to PTAB.

Saturday, September 26, 2015

More on CRISPR: Zhang on a class 2 CRISPR effector

The Boston Globe mentions newly published work by Feng Zhang of MIT:

In a study published on Friday, scientists led by Feng Zhang of the Massachusetts Institute of Technology report that they discovered enzymes that cut more precisely than those now in use in CRISPR, a technique with an uncanny ability to make a beeline for a targeted stretch of DNA, snip it out, and replace it.

The abstract of Zhang's paper in Cell includes the text:

The microbial adaptive immune system CRISPR mediates defense against foreign genetic elements through two classes of RNA-guided nuclease effectors. Class 1 effectors utilize multi-protein complexes, whereas class 2 effectors rely on single-component effector proteins such as the well-characterized Cas9. Here, we report characterization of Cpf1, a putative class 2 CRISPR effector. We demonstrate that Cpf1 mediates robust DNA interference with features distinct from Cas9. Cpf1 is a single RNA-guided endonuclease lacking tracrRNA, and it utilizes a T-rich protospacer-adjacent motif. Moreover, Cpf1 cleaves DNA via a staggered DNA double-stranded break.

Boston Globe story on a new development in the CRISPR saga:

EFF discusses dispute over meaning of the word "integer"

Within the post Our Broken Patent System at Work: Patent Owner Insists the “Integers” Do Not Include the Number One , EFF notes

In patent litigation, patent owners and alleged infringers often disagree about the meaning of words in patent claims and ask the court to resolve the differences (a process known as “claim construction”). In Core Wireless’ case against LG, the majority of the disputes seem like usual ones in terms of patent litigation.

Except for the dispute about “integer.”

You may have learned what an “integer” was in high school. It’s a common concept many teenagers learn about when they take algebra. In Ontario, Canada, for example (where Conversant is based), teachers discuss integers in the 9th and 10th grades. As defined in the Ontario Curriculum, an integer is: “Any one of the numbers . . . , –4, –3, –2, –1, 0, +1, +2, +3, +4, . . . ”


To be clear: the law allows patent applicants to redefine words if they want. But the law also says they have to be clear that they are doing that (and in any event, they shouldn't be able to do it years after the patent issues, in the middle of litigation). In Core Wireless’ patent, there is no indication that it used the word “integer” to mean anything other than what we all learn in high school. (Importantly, the word “integer” doesn’t appear in the patent anywhere other than in the claims.)

It appears that Core Wireless is attempting to redefine a word—a word the patent applicant freely chose—because presumably otherwise its lawsuit will fail. The Supreme Court has long disapproved of this kind of game playing. Back in 1886, it wrote:

Some persons seem to suppose that a claim in a patent is like a nose of wax which may be turned and twisted in any direction, by merely referring to the specification, so as to make it include something more than, or something different from, what its words express.

EFF correctly notes the source of the nose of wax line as the Supreme Court, which is more specifically White v. Dunbar, 119 U.S. 47 (1886).

Earlier, the 717MadisonPlace blog had written:

Judge Plager was the author of the “nose of wax” line from Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553 (Fed. Cir. 1995) in which he stated:

Claim drafting is itself an art, an art on which the entire patent system today depends. The language through which claims are expressed is not a nose of wax to be pushed and shoved into a form that pleases and that produces a particular result a court may desire. The public generally, and in particular, the patentees’ competitors, are entitled to clear and specific notice of what the inventor claims as his invention. That is not an easy assignment for those who draft claims, but the law requires it, and our duty demands that we enforce the requirement. There is no room in patent claim interpretation for the equivalent of the cy pres doctrine; that would leave the claiming process too indefinite to serve the purposes which lie at the heart of the patent system.


***As to the future, the Recorder notes that there are no patent cases currently docketed by the Supreme Court:

So far the high court has not put a single patent case—or trademark or copyright, for that matter—on its 2015-16 docket. Some patent law experts believe the court is taking a break from patent law after a period of exceptional activity, including a record six decisions in 2013-14.

"I don't think we'll see six" this term, said Emory University School of Law professor Timothy Holbrook. "I wouldn't be surprised if we saw none."

"It may be that other things are crowding out patent law for awhile," said Fenwick & West patent litigation chief Michael Sacksteder.


Thursday, September 24, 2015

CAFC tackles preliminary injunction issues in M-I LLC V. FPUSA, LLC

The outcome

FPUSA, LLC, appeals from an order of the district
court granting M-I LLC’s motion for a preliminary injunction.
The district court enjoined FPUSA from promoting,
selling, or renting a system for recovering drilling fluid
that infringes claims 1 and/or 16 of M-I’s patent. Because
the district court did not abuse its discretion in granting
an injunction with respect to claim 16, we affirm the
preliminary injunction as to claim 16, vacate as to claim
1, and remand with instructions to reform the injunction
consistent with this opinion.

As to claim 16:

The district court did not abuse its discretion in granting
a preliminary injunction as to claim 16. The district
court did not err in finding that M-I is likely to prove
infringement of a valid claim. The court’s construction of
the “first” and “second” modifiers was proper in light of
the claim language and the specification. And based on
FPUSA’s representation that the Vac-Screen system only
applies a vacuum to one screen, the one closest to the
shaker outlet, the district court’s finding that the VacScreen
system meets the “first screen” limitation was not
clearly erroneous. Nor was the district court’s determination
that the Vac-Screen likely meets the “degassing
chamber” limitation, based on the disclosures in the ’959
patent and Technology Evaluation Report.
The district court also did not err in finding that
FPUSA had not raised a substantial question of invalidity.
There is a statutory presumption that issued patents
are valid. 35 U.S.C. § 282. The district court did not err
in determining that the claims of the ’288 patent are
supported by the written description in the parent application,
which was filed in 2006.

Further, the district court did not err in determining
that irreparable harm would likely result based on the
evidence in the record. FPUSA admitted in its briefing
before the district court that enjoining FPUSA would
“leav[e] M-I as the sole source of a substitute technology,”
J.A. 480, which means that absent an injunction, M-I
would likely suffer an irreparable loss of market share.
See Robert Bosch LLC v. Pylon Mfg. Corp., 659 F.3d 1142,
1151 (Fed. Cir. 2011) (“[The existence of a two-player
market] creates an inference that an infringing sale
amounts to a lost sale for the patentee.”). M-I only started
marketing its product in 2015, while FPUSA has been
on the market since 2010. And while FPUSA faulted
M-I’s reliance on a third-party report as evidence of
FPUSA’s inability to satisfy a judgment, FPUSA did not
offer any evidence of its profitability. Finally, the district
court did not err in finding that the balance of equities is
neutral, and that the public interest weighs in favor of an


Defendants do not make out well in Shire v. Amneal, et al. in Vyvanse® case

The outcome:

Because defendants have failed to raise a genuine issue of material
fact that the asserted claims are obvious, we affirm the
district court’s judgment of nonobviousness.

Because the district court did not abuse its discretion in denying
defendants’ motion to amend their invalidity contentions
to include an on-sale bar claim, we affirm that ruling.

Because in the circumstances of this case Johnson Matthey
cannot be liable for induced infringement prior to the
grant of FDA approval of the application filed by the
ANDA defendants, we reverse the district court’s judgment
that Johnson Matthey has induced infringement of
the asserted compound claims and remand the case for
further proceedings consistent with this opinion.

Some of the history

Shire is the assignee of the patents-in-suit and markets
LDX dimesylate capsules. These capsules are approved
by the Food and Drug Administration (“FDA”) and
distributed under the brand name Vyvanse®. The FDA’s
Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the “Orange Book”) lists
all the patents-in-suit for Vyvanse®.
The ANDA defendants filed Abbreviated New Drug
Applications (“ANDAs”) for their generic versions of
Vyvanse® seeking approval prior to the expiration of the
patents-in-suit. The ANDAs included certifications
pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2012) (commonly
referred to as “Paragraph IV certifications”) stating
that the claims of the patents-in-suit are invalid and/or
not infringed. Pursuant to § 355(j)(2)(B), the ANDA
defendants notified Shire of the Paragraph IV certifications.
In response, Shire sued the ANDA defendants for
infringing the asserted claims, along with certain other
claims not at issue in this appeal, under 35 U.S.C.
§ 271(e) (2012). In each suit, Shire also sued Johnson
Matthey. Johnson Matthey supplied LDX dimesylate to
the ANDA defendants and correspondingly filed a drug
master file with the FDA, see 21 C.F.R. § 314.420, but did
not itself file an ANDA. The district court consolidated all
the lawsuits

As to the obviousness defense:

The district court concluded that (1) the prior art did
not disclose LDX or make it obvious; (2) even if it did, the
prior art did not disclose that LDX was known as an
active drug substance; (3) even if it did, the prior art
provided no motivation to pick LDX as a starting compound;
and (4) even if it did, the prior art provided no
motivation to make mesylate salts of LDX. Op. at *15–17.
Shire did not introduce and the district court did not
analyze any secondary considerations.
Defendants maintain that there is a genuine issue of
material fact whether Australian Patent Application No.
54,168/65 (“AU ’168”), actually discloses LDX. Specifically,
they claim that page 7 of AU ’168 identifies 18 amino
acids by name, including lysine, and states a preference
for L-amino acids and d-amphetamine. Upon reading this
passage, defendants argue, a person of skill in the art
would immediately envisage LDX. Defendants also claim
that Formula IV and Example 24 of AU ’168 disclose
LDX. Defendants also contend that there is a genuine
issue of material fact whether the prior art as a whole
rendered the mesylate salts of LDX obvious. There is also
a genuine issue of material fact, defendants argue,
whether mesylate salts of LDX were obvious and whether
there was a reasonable expectation of success that the
mesylate salt of LDX would serve its intended purpose.
In addition to AU ’168, defendants rely on several other
pieces of prior art, including U.S. Patent No. 3,843,796
(“Miller”), to bolster their obviousness argument.
Shire denies that AU ’168 discloses LDX. Shire
claims that the record fails to show that a person of skill
in the art would: “(i) start with d-amphetamine, (ii) chemically
modify d-amphetamine, (iii) make a prodrug of damphetamine,
(iv) synthesize [LDX] while ignoring other
conjugates of d-amphetamine, (v) make a salt of [LDX]
instead of using the freebase form, and finally (vi) specifically
choose a mesylate salt rather than any other salt.”
Resp. Br. at 19.

The matter of deference to the USPTO for consideration of
a reference of record arises:

On this record, there is no genuine issue of material
fact that the prior art did not disclose or make obvious the
mesylate salt of LDX. Defendants’ primary reference is
AU ’168. AU ’168 is listed on the face of the patents-insuit
and therefore the examiner is presumed to have
considered it.
Defendants therefore “ha[ve] the added
burden of overcoming the deference that is due to a qualified
government agency presumed to have properly done
its job, which includes one or more examiners who are
assumed to have some expertise in interpreting the
references and to be familiar from their work with the
level of skill in the art and whose duty it is to issue only
valid patents.” PowerOasis, Inc. v. T-Mobile USA, Inc.,
522 F.3d 1299, 1304 (Fed. Cir. 2008) (citations omitted).

Here, a generic disclosure is not enough to render
the species obvious:

AU ’168 discloses combining amphetamine, in any of
its stereochemical forms, with numerous amino acids, in
various stereochemistries and with many potential protecting
groups. Nothing in AU ’168 specifically suggests
combining d-amphetamine with L-lysine. Page 7 of AU
’168, relied on heavily by defendants, lists 18 amino acids
“and the like,” and states they can belong to the D- or Lseries.
Even this list, therefore, does not limit itself to 18
amino acids. AU ’168 expressly suggests posttranslational
modifications of the amino acids, see id. at 8,
thus further increasing the potential amino acid groups to
be utilized. While page 7 states that “[a]cids of the Lseries
are preferred,” AU ’168 actually describes numerous
D-series amino acids. Read in context of the whole
reference, a person of skill in the art would, therefore, not
focus exclusively on amino acids with the L stereochemistry.


There is no genuine issue of material fact that AU ’168 does not
disclose L-lysine as part of a limited class of compounds
for ‘A’. AU ’168 suggests that ‘A’ can be selected from one
of three lists, and as defendants’ expert candidly admitted,
Formula IV “does not indicate any preference” among
the different options. Thus, Formula IV discloses all the
compounds from all three lists, the first of which lists 17
amino acids (including lysine), the second of which teaches
over a hundred possible combinations of amino acids
and protecting groups and the third of which does not
even provide a definite list of compounds. This too is not
a definite and limited class. Further, as described above,
AU ’168 does not meaningfully describe a preference for
the L stereochemistry of its amino acids.

As to induced infringement:

Shire counters by asserting that Johnson Matthey is
properly in the suit and can be liable for induced infringement.
According to Shire, this court’s decision in
Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc.,
501 F.3d 1263 (Fed. Cir. 2007), held that a party can be
liable “under section 271(e)(2) for its future infringement
under section 271(b) as the ANDA-filers’ API supplier.”
Resp. Br. at 52. Shire contends that on the facts before us
“Forest cannot be distinguished.” Id. at 55 (capitalization
altered). Finally, Shire argues that under the reasoning
of Forest Labs., Johnson Matthey can be enjoined.
Johnson Matthey is correct that it cannot be liable for
the API it sold the ANDA defendants up to this point.
Johnson Matthey, as an API supplier, has thus far done
nothing more than provide material for use by the ANDA
defendants in obtaining FDA approval. As the district
court found, these sales, and the ANDA defendants’ use of
the API for filing the ANDA, were “reasonably related to
the submission of an ANDA.” Op. at *12. As such, Johnson
Matthey’s activities are protected by the safe harbor
of § 271(e)(1), and the district court erred by entering
judgment that Johnson Matthey has induced infringement
of the compound claims at issue.