The George Washington Law School will be holding a Post-Grant Practice Roundtable Discussion on October 13, 2015 at the George Washington University Law School. The half-day program will explore current issues with U.S. post-grant review from two persp…Continue Reading ...
McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on “Trust Everybody, but Cut the Cards” on October 20, 2015 from 10:00 am to 11:15 am (CT). In this presentation, MBHB attorneys Grantland G. Drutchas and James L. Lovsin will discuss confidentiality agreements and confidentiality provisions and the risks and unintended consequences of such agreements and provisions. Topics to be addressed in the webinar include: • Confidentiality Agreements — negotiation, preparation and risks • Ownership of follow-on IP • Monitoring • Enforcement — options, risks and outcomes • Derivation Actions — procedures, scope and appeals While there…Continue Reading ...
Takeaway: Evidence establishing a specific date of cataloging and shelving before the critical date is desirable, but not required, in a public accessibility determination. In its Final Written Decision, the Board found all challenged claims of the ‘142 patent unpatentable … Continue reading →
appeared first on PTAB Trial Blog.Continue Reading ...
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 ScienceInsiderContinue Reading ...
Takeaway: Where a patent owner has proffered deposition testimony as relevant to secondary indicia of non-obviousness, the Board may determine that such documents are discoverable and relevant. In its Decision, the Board granted Petitioner’s Motion for Additional Discovery with respect … Continue reading →
The post Granting In Part Additional Discovery Regarding Secondary Indicia IPR2015-00841 appeared first on PTAB Trial Blog.Continue Reading ...
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
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
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
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
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.
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
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.
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.
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 caseContinue Reading ...
Author: Christopher B. McKinley Editor: Lauren J. Dreyer In Nordock v. Systems, No. 14-1762 (Fed. Cir. Sept. 29, 2015), the Federal Circuit affirmed that there is no apportionment of “total profits” awards under 35 U.S.C. § 289 in design patent infringement. In this case, Nordock sued Systems for infringing its design patent covering ornamental features […]Continue Reading ...
COPENHAGEN – Google is “really looking for a balanced IP system,” the company’s head of litigation told the Global Patent Congress, while the European Patent Office elaborated on the “Tomato II” case, which for civil society has become the very symbol of an imbalanced IP system. Intellectual Property Watch spoke with senior officials at both Google and the EPO at the conference.Continue Reading ...
By Andrew Williams — Earlier this week, in the Achates Reference Publishing, Inc. v. Apple Inc. case, the Federal Circuit reaffirmed the holding in In re Cuozzo Speed Techs., LLC that it could not review any decision by the Patent Trial and Appeal Boa…Continue Reading ...
Takeaway: The granting of an injunction in a related proceeding, without more, does not demonstrate a nexus between the claimed subject matter and the objective evidence of a secondary consideration of industry praise and acceptance. In its Final Written Decision, … Continue reading →
The post Insufficient Nexus Was Found for Secondary Considerations in Final Written Decision IPR2014-00679 appeared first on PTAB Trial Blog.Continue Reading ...
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.”
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
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.
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 , 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 , 2:64–67,
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.Continue Reading ...
From SPECTRUM PHARMACEUTICALS, INC. v. Sandoz, concerning the
drug Leucovorin, which is used to ameliorate the toxic effects
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.
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.
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.
link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/15-1407.Opinion.9-30-2015.1.PDFContinue Reading ...
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:
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The first claim of US 9.145,667 statesA 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 se…Continue Reading ...
Author: David C. Seastrunk Editor: Jeff T. Watson In Achates Reference Publishing, Inc. v. Apple Inc., Nos. 14-1767, -1788 (Fed. Cir. Sept. 30, 2015), the Federal Circuit held that it lacked jurisdiction to review the PTAB’s decision to institute IPRs of two patents asserted by Achates against Apple in district court. Achates filed suit against […]Continue Reading ...
Takeaway: A declaration submitted to the PTO by or on behalf of a patent owner is not hearsay because the submission evidences the patent owner’s belief that the statements contained within the declaration were true. In its Final Written Decision, … Continue reading →
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The Sixth Annual Latin America Seminar on “The Value of Intellectual Property for Innovation and Health” was recently held at Cayetano Heredia University in Lima, Peru. A varied group of public officials, judges and experts from throughout Latin America gathered to discuss the promotion of innovation, particularly from the perspective of the legal tools offered by patents and other rights available under the intellectual property regime. The process of awareness about the value of innovation and intellectual property can be said to have started in Latin America with the conclusion of the negotiations over the establishment of the World Trade Organization and TRIPs Agreement in 1995, this despite the fact that portions of these arrangements were (and to some extent still are) strongly resisted by many emerging economies. The bilateral trade agreements concluded with the United States after TRIPs, the educational campaign implemented by WIPO, the support provided by the lines of credit made available by the World Bank and the Inter-American Development Bank, as well as lessons learnt from the success of such countries as Israel, South Korea and Singapore, have been key contributory factors.
It is encouraging to note that a number of Latin American governments are giving explicit recognition to the crucial importance of innovation for increasing competitiveness and promoting growth at the national level. Therefore, although the proportion of investments directed to promoting innovation is still relatively low, the trajectory is positive and at an increasingly higher rate. Thus, it is currently estimated that investment in innovation in the region as a whole is 0.68% of the growth domestic product (GDP) (versus between 2% to 4% in more developed innovative economies). Only Brazil has reached a level of investment of more than 1% of GDP (albeit before its current economic crisis). In particular, the pharmaceutical sector continues being a major actor in private R&D investment. For example, in Chile, R&D in pharma and biotech is at the top of private investment in innovation (14.38%), followed by software (9.86%).
Still, Latin America continues to wrestle with the problem of how to attract private investment for R&D activities in the region. It is officially estimated that two-thirds of investments in innovation are made by the public sector, while informal estimates suggest that private investment is only about 20% of the total R&D. Regarding how innovation is promoted, each country in the region continues to set its own policies. For example, Peru has approved new tax incentives for R&D investments, effective as of January 1, 2016. Argentina also developed a scheme of providing tax benefits to promote biotech projects, but the law was not implemented. In Chile, research by the public agency CORFO has revealed that R&D-subsidized projects tend to cease as soon as the subsidies come to an end. In Ecuador, an innovative government scheme to hire retired senior experienced researchers to train and help design projects is facing strong headwinds in the face of plummeting international oil prices.
At the intra-country level, there is little coordination among the relevant national agencies in designing and implementing innovation promotion policies, and often such agencies work at cross purposes. There is even less collaboration among countries in the region; mistakes made in one country may be simply repeated in another. An independent Observer monitoring the processes of innovation in the region may be helpful. Such a proposal was made during the Seminar to the Peruvian representative of the Pacific Alliance Free Trade Agreement, comprising Colombia, Chile, Mexico and Peru. Indeed, the Pacific Alliance may be a good opportunity for more extensive collaborations, but to bring it to fruition both the academic and private sectors will need to be more actively engaged. At the enterprise level, only a few firms with activities across Latin America are involved in innovation. On the whole, private companies in the region still must still work on how to develop an innovation culture. Designing realistic long-term innovation strategies is necessary as is better training of staff to support such efforts. As mentioned, finance for innovation projects continues being scarce and while there are many startups in the region, few can be described as engaged in technology. Still, the forecast is that more Latin American companies will be investing in R&D in the future.
As for IP, the biggest challenges are fragmentation at both the intra-national and transnational levels within the region as well inconsistent treatment of IP rights. For instance, regarding incremental inventions, such as new uses, there are substantial differences in the way that Mexico and Brazil deal with them, on the one hand, as compared with Argentina on the other, which provides thin patent protection for pharmaceutical and biotech inventions. Moreover, studies point to the fact that IP rights and the advantages that they offer for innovation and development are still poorly appreciated by public and private researchers in the region.
At the most basic level, empirical data indicate that better IP effective protection means more foreign direct investment, which is essential for the region, even more so when growth is slowing. In this vein, the myth that patents work against access to medicines is strongly entrenched. In addition, confusion reigns between the process of patent grant and health-marketing authorization. The result is that there are far too few patents being issued. It is estimated that Latin America registers annually a total of 1,400 national patents. In contrast, a country such as South Korea, with less than 10% of the total Latin American population, registers more than 20 times the number of patents. Against this backdrop, the promotional and educational efforts made by the various national IP agencies should be expanded.
A particularly interesting panel at the Seminar dealt with compulsory licenses. The panel discussed the regime currently applied in Ecuador, where 33 applications for compulsory licenses of pharmaceutical products have been filed, out of which eight have been withdrawn by the applicants, five refer to patents that have ready already expired, ten have already been granted by the Patent Office, while the rest are in the grant process. In contrast, in other Latin American countries, such as Peru and Colombia, applications for compulsory licenses have been far less successful due to the failure by the applicants to provide sufficient supporting the request. Moreover, the regulatory regime for the compulsory licenses in place in Ecuador (Instruction 10-04 issued by IEPI, the I.P. Agency) is not consistent with international and national legislation, with the result that the granting of compulsory licenses under this provision has the perverse effect of de facto abrogating rights in pharmaceutical patents. In doing so, the end result is to send a negative message to foreign investors as to their property rights in Ecuador.
As for the protection of test data, the regulations in force in those Latin American countries that do accept test data protection for the registration of pharmaceuticals by the health authorities restrict such protection to new molecules. Here again, there is a contradiction between government efforts to promote innovation while, at the same time, not providing data protection for incremental innovations, which may well make more sense for developing countries than the invention of an entirely new molecule. In this regard, it is noted that Argentina and Brazil do not grant any type of test data protection for pharmaceuticals.
Overall, the principal take-away from this year’s seminar is that there is much work to do in the region to meet the challenge of attracting more private R&DS investments for innovation.
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KAMPALA, UGANDA – The pharmaceutical industry in the East African Community is approaching a higher level of production quality and manufacturing practices. To benefit the industry and increase access to medicines, stakeholders are working towards a un…Continue Reading ...
Takeaway: The Board may exercise its discretion to deny institution of covered business method patent review where the petitioner cites different prior art references from another proceeding in which it is also a party, but the different prior art references … Continue reading →Continue Reading ...
Takeaway: At the institution phase of a proceeding, the Board may accept the presence of a copyright notice, together with the listing of the reference in an IDS, as some evidence of public accessibility as of a particular date. In … Continue reading →Continue Reading ...