Patent Docs

Inovia Releases 2013 Report on Global Patent Trends

May 8, 2013

By Donald Zuhn —

Patent services provider
inovia announced
the release of its 2013 report on global patent and IP trends today. In compiling the report, inovia, which
produces products for PCT national phase entry, European patent validation, and
patent translations, surveyed 125 U.S. companies and universities in January
2013 to identify the trends having the greatest impact on the foreign filing
strategies of U.S. patentees.

The 2013 report notes that
23% of survey respondents are involved in the pharmaceuticals, biotech, or
medical devices industries. Other
sectors or groups represented in the survey include chemicals/materials (13%),
electrical/electronics (10%), mechanical/engineering (10%), IT/software/media
(7%), and university/association/non-profit (18%). The report also indicates that one-third of
survey respondents (33%) had no in-house patent attorneys or agents, 47% had
one to four in-house patent attorneys or agents, and the remainder (20%) had five
or more attorneys or agents. With
respect to the number of in-house patent attorneys or agents, the trend was
towards increasing numbers of in-house practitioners (the 2012 report indicated
that 37% of survey respondents had no in-house patent attorneys or agents, 46%
had one to four in-house patent attorneys or agents, and 17% had five or more
attorneys or agents).

The report states that
among survey respondents, "[t]he theme of 'cautious optimism' from
previous surveys continues." The
report notes, however, that "respondents don't foresee too much growth in
terms of the number of patent families expected to be filed in 2013." Fewer respondents experienced IP budget cuts in
2012 than in 2011, and a greater percentage brought in in-house support or
outsourced annuity payments. Half of
respondents cited final implementation of the Leahy-Smith America Invents Act
as the most important issue/trend of 2013.
Other key trends for 2013 included cost containment, the rising cost to
obtain patent protection, as well as enforcement and patent trolls.

With respect to application
filings, 11% of survey respondents said they filed more patent applications in
2012 than they expected (down from 18% in 2011), 16% said they filed fewer patent
applications (up from 15% in 2011), and 73% said they filed as many patent
applications in 2012 as they expected (up from 67% in 2011). The results of this year's survey, however,
were a significant improvement over those from inovia's first survey (released
in 2010), where 41% of respondents said they filed fewer applications than
expected in 2009.

The 2013 report indicates continued
growth for international patent protection, as 50% of respondents filed more
than half of their patent applications abroad (up from 42% in last year's
report). Respondents, however, are even
more selective with their filings abroad, with 22% of respondents filing
corresponding applications in only 1-3 foreign countries and another 32% filed
internationally in 4-19 countries (the 2012 report indicated that 37% of
respondents filed corresponding applications in 1-3 foreign countries and
another 42% filed internationally in 4-8 countries; this year's survey did not
provide a breakdown of the percentage of respondents filing in 4-8 countries).

With regard to the
countries in which respondents regularly filed, 23% added new countries to
their list (up from 21% in 2011 and 17% in 2010), with 14% adding China and
smaller percentages adding South American countries, India, South Africa, South
Korea, and Japan. Noting that 28% of
respondents added China to their list in 2011, the report stated that the drop
could be an indication that China is now a regular filing destination for many
U.S. applicants. A smaller percentage of
respondents (19%) dropped countries from their lists (up from 17% in 2011),
with the European Patent Office or individual European countries being dropped
by 24% of respondents who pared down their lists, 10% dropping China, Japan,
and Mexico, and 7% dropping Australia, Canada, South Korea, and Russia from
their lists. Respondents who dropped the
European Patent Office or individual European countries believed that the high
cost of pursuing such protection did not justify the value. In ranking foreign jurisdictions, respondents
placed Europe, China, and Japan first, second, and third, respectively, which
was the same ranking respondents provided in last year's report.

Finally, the report noted
that a large majority of respondents (99%) rely on the PCT for foreign
filing. Of these respondents, 75%
selected the EPO as an International Searching Authority (up from 72% in 2011),
50% selected the Korean IP Office (KIPO) (up from 42% in 2011), and 11%
selected the Japan Patent Office (JPO) (down from 12% in 2011).
Rubin v. General Hospital Corp. (Fed. Cir. 2013)

May 7, 2013

By
Donald Zuhn —

On
March 28, the Federal Circuit in Rubin v.
General Hospital Corp. affirmed judgment by the District Court for the
District of Massachusetts dismissing the suit brought by Drs. Berish Rubin and Sylvia Anderson
against The General Hospital Corporation requesting correction of U.S. Patent
Nos. 7,388,093 and 7,407,756, which are assigned to General Hospital. The '093 and '756 patents are directed to genetic
mutations that cause the inherited disease Familial Dysautonomia (FD), also
known as Riley-Day Syndrome, and methods for detecting FD.

Drs.
Rubin and Anderson at the Department of Biological Sciences of Fordham
University, and Drs. Slaugenhaupt and Gusella at Massachusetts General
Hospital, had been independently conducting research to determine the genetic
mutations disclosed in the '093 and '756 patents. Drs. Rubin and Anderson identified two
mutations in the gene encoding IkB kinase complex-associated protein that cause
FD, and on December 20, 2000, submitted a paper describing these mutations to the
American Journal of Human Genetics. When submitting the paper, Dr. Rubin asked
the Editor of the journal to not send the paper to Dr. Gusella and his
colleagues at Mass General for peer-review.
On December 22, 2000, the Editor sent the abstract for the paper to Dr.
Gusella. Dr. Gusella declined to review
the full paper, and on December 28, 2000, Drs. Gusella and Slaugenhaupt
submitted their own paper identifying the same two mutations to the same
journal (as of October 2000, Dr. Gusella had noted that his group had identified
184 candidate mutations, and as of December 12, 2000, further noted that the
responsible mutations had not yet been identified). Both papers were published in the January 22,
2001 issue of the journal.

On
January 6, 2001, Drs. Gusella and Slaugenhaupt filed a provisional application
describing the two mutations and claiming their diagnostic use. On January 17, 2001, Drs. Rubin and Anderson
filed their own provisional application describing the two mutations and
claiming their diagnostic use. The
application filed by Drs. Gusella and Slaugenhaupt eventually resulted in the
issuance of the '093 and '756 patents.
During prosecution of their application, Drs. Rubin and Anderson decided
not to initiate an interference in the U.S. Patent and Trademark Office, despite
the examiner's suggestion that they do so.

Rather
than initiate an interference, Drs. Rubin and Anderson filed suit against Mass
General seeking correction of inventorship of the '093 and '756 patents under
35 U.S.C. § 256. They argued that Dr.
Gusella's receipt of their abstract permitted Dr. Gusella's group to
select and confirm the identity of the FD mutations and file their provisional
patent application, and Drs. Rubin and Anderson asked to be substituted as the inventors of the '093
and '756 patents, or added as joint inventors.
Granting Mas General's motion for summary judgment, the District Court held
that the inventorship could not be changed under § 256 because there was no
"collaboration" between the two teams of scientists, and that Drs.
Rubin and Anderson could not be added as joint inventors because they did not
meet the requirements of § 116 for joint invention. With respect to the correction of
inventorship, the District Court also held that the complete substitution of
inventorship is not a matter for § 256, but rather, is a claim for priority of
invention of the subject matter, and priority should be resolved in an
interference, not under § 256.

On
appeal, the Federal Circuit determined that "the district court correctly
ruled that the independent relationship between these teams of scientists, and
the nature of this communication of information, do not support joint invention
in accordance with §116, or warrant change or substitution of inventorship
under §256." The panel added that:

We agree with the district court that,
whatever actions were taken after the Rubin/Anderson Abstract appeared
uninvited on Dr. Gusella's desk, ultimately the dispute is of priority of
invention; that is, which team was the first to conclusively identify the
operative mutations. The district court
recognized that even if Drs. Gusella and Slaugenhaupt had completed this
identification before they saw the Rubin/Anderson identification, it would
still be necessary to determine priority of invention in order to resolve the
patent rights.

The
panel, therefore, concluded that the District Court acted within its authority
in directing the parties to the USPTO to determine priority of invention, and affirmed
the District Court's judgment of dismissal.

Rubin v. General Hospital
Corp.
(Fed. Cir. 2013)
Nonprecedential
disposition
Panel:
Circuit Judges Newman and Bryson and District Judge Fogel
Opinion
by Circuit Judge Newman
Dawson v. Dawson (Fed. Cir. 2013)

May 6, 2013

By
Donald Zuhn —

On
March 25, the Federal Circuit in Dawson
v. Dawson affirmed a determination by the Board of Patent Appeals and
Interferences that the University of California, San Francisco (UCSF) failed to
establish sole conception by Dr. Chandler Dawson of the claimed inventions in
two patents assigned to InSite Vision Inc.
The case involved an interference between two patents, U.S. Patent Nos.
6,239,113 and 6,569,443, which name Dr. Dawson and Dr. Lyle Bowman as inventors
and which are assigned to InSite, and an application which names Dr. Dawson as
the sole inventor and which is assigned to UCSF. The patents and application ay issue are
directed to a method for topically treating and preventing infections of the
eye.

In
1997, at a meeting of the World Health Organization Alliance for the
Elimination of Trachoma, Dr. Dawson, who was employed by UCSF, gave a
presentation on the topical use of an antibiotic called azithromycin (at right) to control
trachoma (a bacterial infection of the eye).
A report of the meeting ("WHO Report") was subsequently
released, which included a discussion of Dr. Dawson's presentation. A second document ("WHO document"),
which may have been an outline of Dr. Dawson's presentation, provided a similar
discussion of the presentation.

Shortly
after the meeting, Dr. Dawson asked Dr. Kenneth Chern to enlist the assistance
of Dr. Bowman, an employee at InSite (a company involved in the research and
development of ophthalmic products), in creating a suitable ophthalmic medication
with azithromycin that could be applied topically to the eye. Dr. Chern sent 100 mg of azithromycin to Dr.
Bowman for formulating as a topical preparation. Three weeks later, after not hearing back
from Dr. Bowman, Dr. Chern sent azithromycin to Dr. Charles Leiter, a
pharmacist associated with the same foundation as Dr. Chern, to formulate as an
ointment or suspension. Dr. Leiter
prepared an ointment using a mineral oil and petrolatum carrier and containing 0.5%
azithromycin by weight. Upon receipt,
Dr. Chern applied some of the ointment to his own eye to determine whether it
could be well-tolerated, and informed Dr. Dawson of the results of his experiment. Dr. Dawson subsequently left UCSF to work at
InSite, and after joining InSite, was named with Dr. Bowman on a patent
application that led to the issuance of the '113 and '443 patents.

Almost
four years after the '443 patent issued, UCSF filed a patent application naming
Dr. Dawson as an inventor, and copying the specification and claims from both
the '113 and '443 patents in order to provoke an interference. The BPAI declared two interferences between
the InSite patents and UCSF's application, naming UCSF as the junior party (and
therefore UCSFD bore the burden of proving, by a preponderance of the evidence, that
Dr. Dawson alone had conceived of the inventions recited in the counts prior to
InSite's March 31, 1999 filing date).
The count in Interference 105,719, which tracks claim 3 of the '113
patent, recites:

A process for treating an eye, which
comprises:
    topically
applying an aqueous polymeric suspension of an azalide antibiotic, wherein said
suspension comprises water,
    0.01%
to 1.0% of an azalide antibiotic, and
    0.1
to 10% of a polymeric suspending agent which is a water-swellable
water-insoluble cross-linked carboxy-vinyl
polymer which comprises at least 90% acrylic acid monomers and 0.1% to 5%
crosslinking agent.

The
count in Interference 105,729, which tracks claim 1 of the '443 patent, recites:

A process for treating an eye, comprising:
    topically
applying an azalide antibiotic to an eye in an amount effective to treat
infection in a tissue of the eye, wherein said topically applying comprises
supplying a depot of a composition containing said azalide antibiotic on the
eye.

On
the issue of conception, the Board determined that UCSF had failed to prove
sole conception by Dr. Dawson, finding that that Dr. Dawson did not fully
appreciate how his idea was to be implemented in actual practice, and that it
was only after Dr. Bowman became involved that "'something' significant
happened," leading to the March 1999 filing of Dr. Dawson's and Dr.
Bowman's application. UCSF appealed the
Board's decision, contending the Board erred in finding that Dr. Dawson did not
conceive of the claimed inventions by himself prior to his collaboration with
Dr. Bowman.

In
a majority opinion written by Judge Bryson and joined by Judge Wallach, the
Federal Circuit began by noting "that the nature of the evidence presented
in this case is unusual," as the Court was "asked to decide whether
and when an invention formed definitely, permanently, and particularly in the
mind of the alleged inventor, but to do so without any testimony from the
supposed inventor himself." Instead
of providing testimony from Dr. Dawson, UCSF contended that the WHO Report and
the WHO document prove Dr. Dawson's conception, and that Dr. Leiter's
preparation of an ointment for Dr. Chern provided further corroboration. The Court, however, disagreed with UCSF's
contention, stating that "[a]t best, . . . the WHO Report and WHO document
announce a general idea, acknowledge many of the difficulties associated with making
that idea operative, and offer some thoughts on how one might proceed
(including by listing a few potential delivery vehicles)." The Court explained (citations omitted) that:

The WHO document is entitled "Potential
Use of Topical Azithromycin in Trachoma Control Programmes," and the WHO
Report describes Dr. Dawson's presentation as a "preliminary report on the
possibility of developing a topical application of azithromycin," while
"recommend[ing] that [Dr.] Dawson continue to work with [others] to
develop a topical application and report back at the next meeting." A "preliminary" statement about a
"possibility" or "potential use," alongside a recommendation
for continued work and a "report back" in the future, falls short of
a "'definite and permanent idea of the complete and operative invention,
as it is hereafter to be applied in practice.'"

Stating
that "[t]he inadequacy of UCSF's showing is equally clear in the context
of the specific interference counts," the Court noted that UCSF's evidence
failed to establish conception of the specific concentrations in the '719
count, and further, that UCSF failed to establish that Dr. Dawson on his own
determined "an amount effective to treat infection in a tissue of the eye"
as recited in the '729 count.

The
Court also noted that the ointment prepared by Dr. Leiter for Dr. Chern did not
establish that Dr. Dawson alone conceived of the subject matter of the counts
because "[t]here is no evidence that Dr. Dawson instructed Dr. Chern to
contact Dr. Leiter or otherwise had any direct connection to the preparation of
the ointment."

On
appeal, UCSF argued that the Board's decision on conception was infected by
several errors in claim construction and admission of evidence. In response to UCSF's argument that the
preamble of the '719 count should not have been read as limiting, and that
treatment can be proactive and can thus occur absent an active infection, the
Court countered that "[t]he proper meaning and scope of the preamble . . .
is irrelevant to our conclusion that UCSF failed to prove sole conception by
Dr. Dawson." In response to UCSF's
argument that the Board erred in considering statements from the specifications
of the '113 and '443 patents on the ground that those statements were inadmissible
hearsay, the Court noted that "UCSF adopted the words in the '113 and '443
patents as its own when it 'copied' those words into the patent application
that provoked these interferences."
In response to USCF's argument that the Board erred by failing to
consider statements made by InSite in an opposition to a European patent
application concerning the topical use of azithromycin (InSite had stated in opposition proceedings that the
WHO document "disclos[es] . . . why topical azithromycin preparations for
eye treatment are highly desirable" and provides "a concrete
disclosure [of] how such preparations can be obtained" and "suggestions
[on] how [they] could be made"), the Court determined that the Board did
not abuse its discretion by following its general rule against giving
controlling weight to documents from foreign patent proceedings. The Court also pointed out that the Board had
properly noted that the instant case involved the issues of conception and
reduction to practice and not lack of novelty or inventive step, the latter of which
were at issue in the opposition.

Writing
in dissent, Judge Reyna stated that:

The record before us demonstrates that Dr. Dawson possessed a definite and
permanent idea of his complete and operative invention when, in the summer of
1997, he delivered a related presentation at a conference of the World Health
Organization ("WHO"). At that
time, Dr. Dawson was employed by UCSF, not InSite. Consequently, I find that Dr. Dawson, through
UCSF, satisfied his burden of demonstrating prior conception.

The
dissent continued by asserting that the WHO Report and WHO document teach each
of the limitations of the '729 count, and establish that he had possession of
each recited feature. In particular, the
WHO references disclose (1) treating an eye, (2) topically applying an azalide
antibiotic (i.e., azithromycin) (3)
an effective dose ("Dr. Dawson suggested that his azithromycin formulation
would use the same dosage known for erythromycin," and the dose "0.5%
by weight[] is used throughout Dr. Dawson's patent as a preferred formulation),
(4) supplying a depot containing the azalide antibiotic ("[b]oth references
contain the same table listing five alternative delivery depots, one of which
is [InSite's] Durasite"). The dissent
concluded that "Dr. Dawson's WHO presentation and the accompanying report
disclose each element of at least the '729 count, and as such, the two WHO
references are sufficient to demonstrate Dr. Dawson's prior conception."

With
respect to Dr. Chern's experiment with Dr. Leiter's ointment, the dissent explained
that:

In the interference proceeding, the Board considered whether Dr. Chern's
experiment showed reduction to practice before the critical date. The Board held that Dr. Chern's experiment
could not be reduction to practice because Chern had not applied the ointment
to an actual infection. The Board based
its determination on its construction of "treating" an eye, which it
construed as "retarding or suppressing infection in a tissue of" an
eye. Because Dr. Chern had not applied
the ointment to treat an actual infection, the Board held that Dr. Chern did
not reduce Dr. Dawson's invention to practice.
The Board erred in two fundamental aspects. First, the term "treating an eye"
in the preamble of the count is not limiting.
Second, "treating an eye" does not require an actual infection.

The
dissent concluded by stating that:

The question is: because Dr. Dawson's WHO presentation demonstrated
conception and Dr. Chern's experiment demonstrated reduction to practice, what
is left to establish inventorship? The
majority opinion leaves open for interpretation whether commercialization is
required for full conception.

But conception does not require
commercialization, nor does commercialization establish initial invention. On the contrary, the record shows that Dr.
Dawson conceived his invention at UCSF. He
turned to Dr. Bowman at InSite only for assistance in commercializing his
invention.

Dawson v. Dawson (Fed. Cir. 2013)
Panel:
Circuit Judges Reyna, Bryson, and Wallach
Opinion
by Circuit Judge Bryson; dissenting opinion by Circuit Judge Reyna
Court Report

May 5, 2013

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Eisai R&D
Management Co., Ltd. v. Rea
1:13-cv-00548;
filed May 2, 2013 in the Eastern District of Virginia

Review and
correction of the patent term adjustment calculation made by the U.S. Patent
and Trademark Office for U.S. Patent No. 8,304,548 ("Method for Producing
1, 2-dihydropyridine-2-one Compound," issued November 6, 2012). View the complaint here.

The Medicines
Company v. Apotex Inc. et al.
3:13-cv-02801;
filed May 1, 2013 in the District of Court of New Jersey

• Plaintiff: The
Medicines Company
• Defendants:
Apotex Inc.; Apotex Corp.

Infringement
of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin
and Process of Making the Same," issued September 1, 2009) and 7,598,343
(same title, issued October 6, 2009) following a Paragraph IV certification as
part of Apotex's filing of an ANDA to manufacture a generic version of The
Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in
patients with unstable angina undergoing percutaneous translurninal coronary
angioplasty). View the complaint here.

Acura
Pharmaceuticals Inc. v. Ranbaxy Inc. et al.
1:13-cv-00750;
filed April 29, 2013 in the District of Court of Delaware

• Plaintiff: Acura
Pharmaceuticals Inc.
• Defendants:
Ranbaxy Inc.; Ranbaxy Laboratories Ltd.

Infringement
of U.S. Patent No. 7,510,726 ("Methods and Compositions for Deterring
Abuse of Opioid Containing Dosage Forms," issued March 31, 2009) following
a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to
manufacture a generic version of Oxecta® (oxycodone hydrochloride, used for the
management of acute and chronic moderate to severe pain where the use of an
opioid analgesic is appropriate, marketed by Pfizer). View the complaint here.

Par
Pharmaceutical, Inc. et al. v. Takeda Pharmaceutical Co., Ltd. et al.
3:13-cv-01927;
filed April 26, 2013 in the Northern District of California

• Plaintiffs:
Par Pharmaceutical, Inc.; Handa Pharmaceuticals, LLC
• Defendants:
Takeda Pharmaceutical Co., Ltd.; Takeda Pharmaceuticals North America, Inc.; Takeda
Pharmaceuticals America, Inc; Takeda Pharmaceuticals U.S.A., Inc.

Declaratory
judgment of non-infringement and invalidity of U.S. Patent Nos. 8,105,626 ("Granules
Containing Acid-Unstable Chemicals in Large Amount," issued January 31,
2012) and 8,173,158 ("Methods of Treating Gastrointestinal Disorders
Independent of the Intake of Food," issued May 8, 2012) in conjunction
with Par and Handa's filing of an ANDA to manufacture a generic version of Takeda's
Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive
esophagitis, maintaining healing of esophagitis, and treating heartburn
associated with symptomatic non-erosive gastroesophageal reflux disease). View the complaint here.
Conference & CLE Calendar

May 5, 2013

May
7-8, 2013 – Paragraph IV Disputes (American Conference
Institute) – New York, NY

May 13-14, 2013 – Generics and Patent Strategies (SMi) – London, UK

May 14, 2013 – Forum on Pharma & Biotech Collaborations (C5 (UK)) – Frankfurt, Germany

May
14-16, 2013 – Fundamentals of Patent Prosecution
2013: A Boot Camp for Claim Drafting & Amendment Writing (Practising
Law Institute) – Chicago, IL

May 15-16, 2013 – Forum on Freedom to Operate (C5 (UK)) – Frankfurt, Germany

May 21-23,
2013 – Pharma Legal Affairs (IBC Life Sciences) – Shanghai, China

May 27, 2013 – A Harmonized Patent World — Are
We Getting There? (Intellectual Property Owners Association) – Brussels, Belgium

May 29, 2013 – AIA and Patent Due Diligence Understanding the AIA Impact and Best Practices for
the Due Diligence Process (Strafford) – 1:00 – 2:30 pm
(ET)

June
5-7, 2013 – Advanced Forum on Biosimilars (American Conference
Institute) – New York, NY

June 12-14, 2013 – Fundamentals of Patent Prosecution
2013: A Boot Camp for Claim Drafting & Amendment Writing (Practising
Law Institute) – New York, NY

June 25-26, 2013 – Maximising
Pharma Patents (C5 (UK)) – London, England

July
10-12, 2013 – Fundamentals of Patent Prosecution
2013: A Boot Camp for Claim Drafting & Amendment Writing (Practising
Law Institute) – San Francisco, CA

***Patent Docs is a media partner of this conference or CLE
A Perspective on the Cost of the Myriad BRCA Gene Test

May 2, 2013

By
Kevin E. Noonan —

One
of the most compelling arguments in the gene patenting debate with the public
has been the cost of the Myriad BRCA gene test: $3,000 per test, a price that
many without insurance coverage cannot afford. The argument rarely is embedded within a comparison with other tests,
and is presented as an absolute indication of Myriad's greed and the putative
pernicious effects of permitting patents on such testing. But an article in the New York Times published last Saturday sheds some light on the
question in a way that might surprise anti-gene patenting partisans.

The
article, "Variations on a Gene, and Tools to Find Them," by Anne Eisenberg,
is concerned with gene testing of patient tumor samples to improve diagnosis
and treatment. It begins by noting the
sea change that cancer genomics has effected on diagnostic criteria: while in
the past, cancers were characterized by tissue type and morphology, in recent
years ("in the age of genetically informed medicine"), the identities
of mutated or disordered genes provides more specific information that can be
used to craft treatment strategies. An
example noted in the article is BRAF V600E (a mutation in the B-raf gene than
changes a valine to an glutamic acid residue at amino acid 600 in the protein's
amino acid sequence) in melanoma. But
the article also recognizes the complexities that this information creates,
quoting Vanderbilt University oncologist Dr. William Pao that "[t]here
are so many genes and so many mutations . . . . The human brain can't memorize
all those permutations."

Dr.
Pao is highlighted in the article for his work in creating an online database, My Cancer Genome, which lists
mutations found to be associated with different cancer types and therapies
(experimental and FDA-approved) that can be used against these specific tumor
types. The article notes that the site "is
maintained by 51 contributors from 20 institutions" and that users
(physicians) are not charged for the service, the site being "supported
almost entirely by [Vanderbilt U]niversity and by philanthropy." This is not the whole story, of course,
because (as stated in the article) "[b]efore doctors go to My Cancer
Genome or a similar site, their patients must have a diagnostic test to find
relevant mutations." The advent of
commercial genome sequencing services has made this testing "available to
neighborhood doctors" after years when such tests were available "mainly
to patients at large university cancer centers, and were often hard to
interpret," according to Dr. Fadi Braiteh, an oncologist at Comprehensive
Cancer Centers of Nevada in Las Vegas.

This
is the point in the article that begins to have specific relevance to the issue
of Myriad's BRCA testing costs. Dr.
Braiteh is quoted in the article as using a test, FoundationOne, from Foundation Medicine in Cambridge,
Mass. The cost: $5,800. Another example cited in the article is Genomic Health, which provides a test
for determining the best chemotherapeutic options for patients with breast
cancer. The cost: $4,290. These costs are justified in the article by
the successes they have enabled: while admitting that the information doesn't
help every patient, doctors are quoted as advocating the use of these tests,
for example, because in one patient the doctors "were able to give a drug []
never used before for this mutation" that was effective in treating the
patient's otherwise therapy-resistant cancer.

There
are a few things that need to be considered from this information about these tests,
not only that they are even more costly than the Myriad BRCA gene test. First, these tests are given to individuals already diagnosed with cancer, and are
used to direct treatment decisions. Thus, there is little to no need to provide genetic counseling to the
patients, or to convince insurers of the benefits of the testing — these
patients are already recognized as being sick, and any treatment that is
effective will almost assuredly reduce the costs the insurers will need (or be
required) to pay. Also, the testing is
being performed in 2013, 16 years after the BRCA gene patents were granted and
Myriad began to develop genetic testing for the BRCA genes. This type of genetic testing is now both
widespread and accepted both by doctors and insurers (to some extent at least),
public and private. It must be
remembered that in 1997 genetic testing was in its infancy, and companies like
Myriad were under the burden to convince payors that the tests did the one
thing that all insurers, public or private, require of such tests: save them
money in the long run, by identifying patients with a high probability of
becoming ill and costing the insurers much more for treatment than the costs of
prophylaxis. Moreover, Myriad and like companies
needed to convince doctors that the testing was worthwhile, and to establish a
network of genetic counselors who could explain to healthy women that they were
at much greater risk of developing breast or ovarian cancer than normal, under
circumstances that resulted in empowerment from the information and not abject
fear. And in 1997, genetic sequencing technology
was not as developed as it is now, and the mechanisms and techniques needed to
minimize or eliminate the occurrence of false positives or negatives had not
been conclusively established.

The
question of whether $3,000 a test is what is required to provide an appropriate
return on investment to Myriad's investors is beyond our scope, and the extent
to which what Myriad, Foundation Medicine or Genome Health charge for its tests
is an indictment of the U.S. healthcare system cannot be definitively determined
here. But it is clear that Myriad's
costs are in line with what other genetic diagnostic test providers charge for
their tests, and that the efforts to demonize Myriad for these costs is at best
uninformed. It remains to be seen
whether the touted "$100 BRCA test" will be provided by those who
perform this testing when Myriad's patents expire in the next few years
(whether or not the ACLU prevails in its attempt to have the Supreme Court ban
gene patenting). The information in Ms.
Eisenberg's article indicates that such an outcome is unlikely.
Allergan, Inc. v. Sandoz Inc. (Fed. Cir. 2013)

May 1, 2013

By
Andrew Williams —

Can
a method of treatment claim be inherent in the prior art if neither the
formulation nor the method of using the formulation twice a day were in the
prior art? Earlier today, the Federal
Circuit determined in Allergen
v. Sandoz that a claimed method for treating glaucoma (which
differed from the three-times-a-day dosage regimens required of the individual
components) was not inherently obvious, and thereby prevented a group of generic challengers from being
able to market their own versions of Combigan^® before the expiration
of the patent containing the claimed method. However,
Judge Dyk, dissenting-in-part, found no difference between the instant case and Federal Circuit
precedent — although the precedent relied upon was all directed to inherent
anticipation. Nevertheless, the majority
and dissent agreed that the claims directed to the formulation itself were
obvious in view of the prior art, and therefore reversed the lower court's
finding of validity of all the claims.

This
case involved Allergan's formulation for a combination eye-drop product marketed
as Combigan^®, a product which combines a well-known alpha₂-agonist
Alphagan^® (0.2% brimonidine) and a well-known beta-blocker Timoptic^®
(0.5% timolol). Allergan had found that
by co-formulating these drugs, patient compliance increased because the drugs
could now be administered at the same time, and because (unexpectedly) the
number of daily administrations could be dropped from 3 to 2. The inventors obtained four patents on this
formulation and methods of its use, all stemming from an application filed on
April 19, 2002, which Allergan listed in
the Orange Book. For the purposes of the
appeal, the parties treated almost all of the asserted claims as one group, referring
to claim 1 of U.S. Patent No. 7,323,463 ("the '463 patent") as the
representative claim, which read:

1. A composition comprising about 0.2% timolol by weight and about 0.5%
brimonidine by weight as the sole active agents, in a single composition.

The
only other asserted claim was claim 4 of U.S. Patent No. 7,030,149 ("the '149
patent"), which read:

4. A method of reducing the number of daily topical ophthalmic doses of
brimondine administered topically to an eye of a person in need thereof for the
treatment of glaucoma or ocular hypertension from 3 to 2 times a day without
loss of efficacy, wherein the concentration of brimonidine is 0.2% by weight,
said method comprising administering said 0.2% brimonidine by weight and 0.5%
timolol by weight in a single composition.

Sandoz
Inc., Alcon Laboratories, Inc., Alcon Research Ltd., Alcon, Inc., and Falcon
Pharmaceuticals, Ltd. (collectively, "Sandoz"), and the other
defendants Apotex Inc. and Apotex Corp., and Watson Laboratories, Inc., each
filed Abbreviated New Drug Applications with the FDA seeking to market generic
versions of Combigan^®. In
turn, Allergan sued them under 35 U.S.C. § 271(e)(2)(A). After a claim construction determination, the
lower court granted summary judgment of non-infringement as to claims 1-3 of
the '149 patent, and the parties stipulated to infringement of the remaining
claims. After a bench trial, the District Court found all of the claims nonobvious over the prior art. The defendants appealed.

The
Formulation Claims – Claim 1 of the '463 Patent as Representative

The
lower court had rejected an invalidity allegation that Claim 1 of the '463
patent was obvious primarily in view of U.S. Patent No. 5,502,052 ("DeSantis"). This reference taught the use of a
combination of alpha₂-agonists and beta-blockers for treating
glaucoma, but did not teach that brimonidine could be one of those alpha₂-agonists. Nevertheless, DeSantis incorporated by
reference a publication by Timmermans, which disclosed brimonidine and its
tartrate salt. Also, even if not
mentioned by name, the ranges of the components of claimed formulations fell
within the ranges as taught by DeSantis — 0.02 to 2.0% alpha₂-agonist
and 0.01 to 3.0% beta-blocker. Also in
the art was a reference that taught the topical administration of 0.2%
brimonidine with 0.5% timolol in combination, although spaced five minutes
apart, and the fact that it was common to dose the serial application of these
two drugs twice a day. Moreover, there
were only three known pharmaceutically acceptable alpha₂-agonists at
the time for the treatment of glaucoma — clonidine, apraclonidine, and
brimonidine. The Federal Circuit did not
necessarily disagree with any of the factual findings of the lower court
related to obviousness, but instead reversed because it believed that the facts
instead supported a finding of obviousness.

Motivation
to Combine

The
lower court relied heavily on the fact that there would be no motivation to
develop fixed combination products, even though such formulations might improve
patient compliance, because the FDA does not consider patient compliance as a
factor when approving new formulations. The Federal Circuit noted that FDA approval might be a factor in an
obviousness determination, for example when determining whether there was
motivation to develop a drug or whether there was skepticism regarding
efficacy. However, it also noted that motivation
to combine may be found in many different places, not just in the rationale used
by the FDA as a basis for its approvals. In view of the overwhelming amount of prior art related to the claimed
formulation, the Federal Circuit thought there was sufficient support to find a
motivation to combine, notwithstanding the FDA's approval process. Somewhat lacking in the analysis, however, was
how the FDA's position regarding patient compliance does factor into the
obviousness determination.

Reasonable
Expectation of Success

The
lower court found that the unpredictability in the chemical arts weighed in
favor of a finding of nonobviouness. As
a factor, the District Court considered Allergan's challenges formulating Combigan^®. The Federal Circuit did not agree, because
some degree of unpredictability is fine, provided there is a reasonable
probability of success. In this case,
DeSanits provided that reasonable probability. Moreover, Allergan's formulation
difficulties stemmed from the fact that it was attempting to use a proprietary
preservative. There is no record of
continued difficulties once its scientists switched to a commonly used
preservative. The fact that the claims were not drawn to the precise
formulation Combigan^® was important, because there is no requirement
that there be a reasonable expectation of success in formulating Combigan^®.

Teaching
Away

The
lower court had found factors that taught away from the claimed formulation,
including the potential side effects, differing dosing regimens, and disparate
half-lives of brimonidine and timolol. However, as the Federal Circuit explained, the District Court did not
consider the impact that these factors would have on the clear motivation to
combine (probably because it did not find a motivation to combine). Interestingly, the Federal Circuit pointed
out that the lower court did not find that the prior art as a whole taught away from the claimed invention. The Court, therefore, accepted the factual
findings from below, but concluded that they did not render the invention
nonobvious.

Secondary
Factors

Finally,
the Federal Circuit accepted all the lower court's factual findings with regard
to secondary considerations of nonobviousness, but still found that they did
not weigh heavily enough to overcome obviousness of the claims. With regard to long-felt need, the District Court's findings were apparently entirely conclusory. With regard to unexpected results, the lower
court had found that the claimed formulations were able to overcome previous
difficulties in treating patients with twice-per-day dosage regimens. The Federal Circuit thought this was somewhat
irrelevant. The Court did agree that
these results were unexpected. However, while
such results might be meaningful to method of treatment claims, they were not
as relevant to the formulation claims.

The
Method-of-Treatment Claim – Claim 4 of the '149 Patent

As
shown above, the treatment claim has a couple of relevant limitations,
including the above-referenced formulation of brimonidine and timolol, and the
use of this formulation twice a day with the same efficacy as brimonidine administration three times a day. The problem with administering brimonidine only twice a day was that efficacy would drop eight to nine
hours after administration, in a phenomenon referred to as "afternoon
trough." The majority found that
the defendants did not establish by clear and convincing evidence that the
claimed method would have been obvious. Importantly, the defendants apparently did not argue that the "efficacy
limitation" is inherent to all fixed combination products containing brimonidine
and timolol, or that a dose reduction would inherently flow from the obvious
formulation included in the claims. And,
the defendants' citation to the success in using timolol with other non-alpha₂-agonist
ophthalmic drugs with reduced doses was found to be irrelevant, because there
was no reason why the use of these unrelated drugs would make the claimed
method obvious.

Judge
Dyk, in dissent, disagreed — he would have also reversed the finding of
nonobviousness of this claim. He relied
heavily on his belief that the method claim only contained one step — applying
a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day. It was not explained, however, why he
considered two administrations to be a single step. Nevertheless, Judge Dyk believed that the twice-a-day
dosing of a formulation that was not in the prior art would have nonetheless
been obvious to one skilled in the art, and that the alleged avoiding-"loss
of efficacy" limitation was just the result of the claimed method. As support for this proposition, Judge Dyk
cited to three Federal Circuit cases: Abbott
Labs. v. Baxter Pharm. Prods., 471 F.3d 1363 (Fed. Cir. 2006); In re Cruciferous Sprout Litig., 301
F.3d 1343 (Fed. Cir. 2002), and Bristol-Myers
Squibb Co. v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir. 2001). However, each of these cases relates to
inherent anticipation, not inherent obviousness. It is not self-evident that the reasoning
behind allowing the inherent result flowing from the use of a prior art
composition or method to anticipate a claim would apply with equal force to a
composition or method that was only obvious in view of the prior art. In other words, citation of these cases,
without more, is like comparing apples with oranges.

Moreover,
Judge Dyk does not appear to consider the fact that there were two limitations
that were not taught in the prior art — the formulation and its method of
use. It should not be sufficient to
conclude that, just because a formulation was obvious, any method of using it
must also be. Granted, this case would
have been completely different if the claimed formulation was taught in the
prior art, and the only potentially obvious limitation was its use twice a
day. In such a case, it is possible that
its use might have been obvious, and the "efficacy" result that
flowed from it could therefore have been inherent. This is, perhaps, why the majority agreed in
footnote 1 that "the inherency doctrine may apply to an otherwise obvious
claim" in some situations. Nevertheless, this was not the case and, without more, the majority's
position was more grounded in the facts of the case, and in the Court's
precedent.

Allergan,
Inc. v. Sandoz Inc. (Fed. Cir. 2013)
Panel:
Circuit Judges Dyk, Prost, and O'Malley
Opinion
for the court by Circuit Judge Prost; opinion concurring-in-part and
dissenting-in-part by Circuit Judge Dyk
Biotech Venture Funding Down 33% in First Quarter

April 30, 2013

By Donald Zuhn —

Earlier this month, the
National Venture Capital Association (NVCA), a trade association representing
the U.S. venture capital industry, released the results of its MoneyTree Report
on venture funding for the first quarter of 2013. The report, which is prepared by NVCA and
PriceWaterhouseCoopers LLP using data from Thomson Reuters, indicates that venture
capitalists invested $5.9 billion in 863 deals in the first quarter, which
constituted a 12% decrease in dollars and a 15% decrease in deals as compared
with the fourth quarter of 2012, when $6.7 billion was invested in 1,013 deals
(see chart below; data from MoneyTree
Reports).

Investment in the life sciences
sector (which combines the biotechnology and medical device industries)
experienced an even bigger decline, with funding dropping by 28% and the number
of deals decreasing by 23%. Although the
biotechnology industry ranked second in terms of dollars invested, with $875
million going into 96 deals, biotechnology funding dropped 33% in terms of
dollars and 30% in terms of deals from the fourth quarter of 2012. The software industry ranked first among all
industries with $2.3 billion being invested in 329 deals in the first quarter, which
marked the fourth straight quarter in which that industry topped $2 billion in
funding. Overall, eleven of the
seventeen sectors tracked by the NVCA saw decreases in dollars invested in the
first quarter.

NVCA head of research John
Taylor indicated that the decreased investment in the first quarter was not
unexpected. He noted that "[t]he
venture industry has been raising less capital than it has been investing now
for several years," adding that "we are seeing less money going into
traditionally capital-intensive sectors such as clean tech and life sciences,
especially in first-time deals."
Tracy Lefteroff, the global managing partner of the venture capital
practice at PricewaterhouseCoopers, noted that "[t]he bright spot in the
first quarter was Software," pointing out that "[t]hese
capital-efficient companies that have shorter time frames to a liquidity event
— whether that is M&A or IPO — continue to be attractive to an
ever-shrinking pool of VC funds."

For additional information regarding this and other related topics, please see:

• "Annual Venture Funding Drops for First Time in Three Years," February 4, 2013
• "Biotech Venture Funding Up 64% in Third Quarter," October 29, 2012
• "Venture Funding in Life Sciences Sector Drops 9% in Second Quarter," July 22, 2012
• "Biotech Venture Funding Drops 43% in First Quarter," May 3, 2012
• "Venture Funding Increased 22% in 2011," February 2, 2012
• "Life Sciences Venture Funding Drops in Third Quarter," October 27, 2011
• "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
• "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
• "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011 
• "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010 
• "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010 
• "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010 
• "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
• "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009 
• "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009 
• "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009
Coelacanth Genome Sequence Determined

April 29, 2013

By Kevin E. Noonan —

The
coelacanth, an aquatic animal described as a "living fossil" when discovered in 1938, was thought to have gone
extinct during late Cretaceous period, ~70 million years ago. Only about 300 specimens of the African
coelacanth, Latimeria chalumnae, are known to exist and a second species, Latimeria menadoensis, was discovered
in 1997. These animals are morphologically
primitive, resembling fossils dating ~300 million years ago, which has
suggested that these are "slowly evolving" species (although this is
more a descriptive than an informed characterization). There have been sporadic reports of
coelacanth gene sequencing over the past decade, but last week Nature
published the first report on whole genome sequencing (Ameniya et al., "The
African coelacanth genome provides insighted into tetrapod evolution," Nature
496: 311-16, April 18, 2013).

The article reports that the coelacanth genome
comprises 2.68 gigabases, on 48 chromosomes, with 19,033 protein-coding genes
comprising 21,817 transcripts, 2,894 "short" non-coding RNAs, and 1,214 "long"
non-coding RNAs. 336 of protein-encoding
genes were found to have undergone gene duplication. The authors examined transcripts from 251
genes from coelacanth and compared these genes with Protopterus annectens
(the African lungfish) expressed in brain, gonad, and kidney and with 15
terrestrial vertebrate lineages (dog, human, mouse, elephant, armadillo, Tammar
wallaby, opossum, platypus, chicken, turkey, zebra finch, lizard, Western
clawed frog, Chinese brown frog) and five modern fish species (tilapia,
pufferfish, zebra fish, spotted catshark, little skate, and elephant shark). The results of these analysis, comprising
100,583 concatenated amino acid positions, was consistent with the lungfish
being the earliest relative of modern tetrapods (four-limbed animals),
answering a previously unresolved uncertainty as to the role of the coelacanth
in vertebrate evolution.

Turning to the question of the status of the
coelacanth as a "living fossil," the authors confirmed earlier
conclusions (based on Hox genes and protocadherins) that this species
evolves slowly, the authors assessed the data from the 251 genes used in their
phylogenetic analyses. This was done as
follows:

Pair-wise
distances between taxa were calculated from the branch lengths of the tree
using the two-cluster test proposed previously to test for equality of average
substitution rates. Then, for each of the following species and species clusters
(coelacanth, lungfish, chicken and mammals), we ascertained their respective
mean distance to an outgroup consisting of three cartilaginous fishes (elephant
shark, little skate and spotted catshark). Finally, we tested whether there was
any significant difference in the distance to the outgroup of cartilaginous
fish for every pair of species and species clusters, using a Z
statistic.

The coelacanth genes showed 0.89 substitutions per
site, compared with 1.05 substitutions/site in the lungfish, 1.09 substitutions/site
in chicken, and 1.21 substitutions/site in mammals.

The authors also ascertained the "abundance"
of transposable elements in the coelacanth genome, because these elements are
believed to provide "templates for exaptation," i.e., to facilitate
formation of novel protein exons and regulatory elements, as well as providing
targets for genomic rearrangement. Transposable element content was "high" (~25%, which the
authors consider an underestimate) and also showed a "wide variety of
transposable-element superfamilies," with 14 such families being "currently
active." The authors acknowledge
that these results "contrast[] with the slow protein evolution observed."

"[E]xtensive conservation of synteny" was
observed in a comparison of chromosomal breakpoints in coelacanth and tetrapod
genomes, and "indicate that large-scale rearrangements have occurred at a
generally low rate in the coelacanth lineage." Interchromosomal rearrangements indicated
that "karyotypic evolution in the coelacanth lineage has occurred at a
relatively slow rate, similar to that of non-mammalian tetrapods" (31 in
coelacanth, 20 in salamander and 21 in Xenopus species). Comparison of the two coelacanth species, L.
chalumnae (Africa) and L. menadoensis (Indonesia), showed divergence
rates similar to those found between humans and chimpanzees, and the authors
estimated that these species diverged "slightly more than" 6-8 million
years ago, based on the slower substitution rates found in coelacanth species.

The authors then looked at estimates of how
vertebrates adapted to the terrestrial environment. They identified 50 genes found in coelacanth
but not terrestrial tetrapods, presumably because these genes were not needed
when the animal left water for land. These genes included "components of fibroblast growth factor (FGF)
signalling, TGF-β and bone morphogenic protein (BMP) signalling, and WNT
signalling pathways, as well as many transcription factor genes," and
specifically that 4 genes (And1, And2, Fgf24 and Asip2)
not present in tetrapod genomes were indeed present in the coelacanth genome. These genes also included 13 genes involved
in fin development, 8 genes in otolith and ear development, 7 genes for kidney
development, 13 genes for eye development, and 23 genes for brain
development. In contrast, there were
only slight differences in homeobox genes. There were also changes in gene regulation, wherein 6% of "conserved
non-coding elements (CNEs)" ("promoters, enhancers, repressors and
insulators") had originated after divergence of the coelacanth from the
ancestral lineage. Further analysis
showed that tetrapod-specific CNEs were most closely (genetically) linked to
genes involved in smell perception (consistent with the recognized expansion of
olfactory receptor genes in the evolution of tetrapods from teleost fishes) and
"morphogenesis (radial pattern formation, hind limb morphogenesis, kidney
morphogenesis) and cell differentiation (endothelial cell fate commitment,
epithelial cell fate commitment)" and immunoglobulin VDJ
recombination.

A particular set of genes compared in the study are
genes for digits, "[a] major innovation in tetrapod evolution," and
specifically Hox genes for regulating limb development in ray-finned
fish, coelacanths and tetrapods (mouse). Three of the six "cis-regulatory elements" showed
sequence conservation limited to tetrapods, with one element being shared by
tetrapods and coelacanth but not the ray-finned fish; this latter element could
function in transgenic mouse assays to "drive reporter gene expression in
a limb-specific pattern." Another
particular set of genes compared between tetrapod and coelacanth lineages were
genes for the urea cycle, because "[e]xcretion of nitrogen is a major
physiological challenge for terrestrial vertebrates." Urea cycle genes involved in producing urea
for nitrogenous waste disposal (such as carbamoyl phosphate synthase I) showed
strong evidence of selection whereas genes (such as mitochondrial arginase)
involved in arginine metabolism but not excretion did not show such selection. The authors conclude that this is evidence of adaptive evolution in the
transition from water to land. Hox
gene studies also indicated changes from the coelacanth and tetrapod lineages
implicated in placental and other reproductive structures not found in animals
living in an aquatic environment. Finally,
the coelacanth genome lacks genes for immunoglobuins of the M class but did
possess two IgW genes previously found only in lungfish and certain
cartilaginous fish.

In addition to establishing that lungfish not the
coelacanth was the common ancestor to all terrestrial vertebrate, the authors also
established that the coelacanth also showed a slow rate of evolutionary change,
which they speculate might be due to "a static habitat and lack of
predation" and promising that "[f]urther study of these changes
between tetrapods and the coelacanth may provide important insights into how a
complex organism like a vertebrate can markedly change its way of life."

The
authors were affiliated with the following institutions: The Broad Institute at
MIT; Benaroya Research Institute and University of Washington; University of Konstanz, Germany; Universite
de Montreal; University of Oregon; Institute of Molecular and Cell Biology,
Singapore; Universidade Federal do Para, Brazil; Harvard University; University
of Utah; Ecole Normale Superieure de Lyon; University of Kentucky; Rhodes
University, South Africa; Wellcome Trust Sanger Institute; University of
Trieste; University of Liege; Victoria University, Australia; University of
Tuscia; University of Hamburg; Polytechnic University of Marche, Italy;
University of South Florida; University of Western Cape, South Africa; Woods
Hole Oceanographic Institution; Oxford University; Universitat Leipzig; Keio
University, Japan; The Graduate University
for Advanced Studies, Japan; European Molecular Biology Laboratory; University
of Wuerzburg, Germany; University of Illinois at Chicago; National Institute of
Genetics, Japan; and Uppsala University.

Image of Latimeria chalumnae (above) by Alberto Fernandez Fernandez, from the Wikipedia Commons under the Creative Commons Attribution 3.0 Unported license.
Court Report

April 28, 2013

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Mayo Foundation for Medical
Education and Research v. ARUP Laboratories, Inc.
0:13-cv-00933; filed April 22,
2013 in the District Court of Minnesota

Infringement of U.S. Patent
Nos. 7,700,365 ("Vitamin D Deficiencies," issued April 20, 2010),
7,901,944 (same title, issued March 8, 2011), and 8,349,613 ("Mass
Spectroscopy Techniques for Detecting Vitamin D Compounds in a Sample,"
issued January 8, 2013) based on ARUP's diagnostic testing referred to as "25-Hydroxyvitamin
D2 and D3 by Tandem Mass Spectrometry." View the complaint here.

Bioniche Life Sciences, Inc.
v. Rea
1:13-cv-00491; filed April 22,
2013 in the Eastern District of Virginia

Review and correction of the
patent term adjustment calculation made by the U.S. Patent and Trademark Office
for U.S. Patent No. 8,293,745 ("Use of Imatinib to Treat Liver Disorders
and Viral Infections," issued October 23, 2012). View the complaint here.

Precision Biosciences Inc. et
al. v. Lonza Group Ltd. et al.
1:13-cv-00708; filed April 19,
2013 in the District Court of Delaware

• Plaintiffs: Precision
Biosciences Inc.; Duke University
• Defendants: Lonza Group
Ltd.; Lonza Sales Ltd.; Lonza Biologics plc; Lonza Inc.; Lonza Walkersville
Inc.; Lonza Biologics Inc.

Infringement of U.S. Patent
No. 8,377,674 ("Method for Producing Genetically-Modified Cells with
Rationally-Designed Meganucleases with Altered Sequence Specificity,"
issued February 19, 2013) based on Lonza's manufacture, use, and sale of
certain products, including the GS Xceed^TM Gene Expression System
and CHOK1SV GS knock-out host cell. View
the complaint here.

Pfizer Inc. et al. v. Inventia
Healthcare Private Ltd.
1:13-cv-02986; filed April 19,
2013 in the Northern District of Illinois

• Plaintiffs: Pfizer Inc.;
Pharmacia & Upjohn Co. LLC; Pfizer Health AB
• Defendant: Inventia
Healthcare Private Ltd.

Infringement of U.S. Patent
Nos. 6,630,162 ("Pharmaceutical Formulation and Its Use," issued
October 7, 2003) and 6,770,295 ("Therapeutic Formulation for Administering
Tolterodine with Controlled Release," issued August 3, 2004) following a
Paragraph IV certification as part of Inventia's filing of an ANDA to
manufacture a generic version of Pfizer's Detrol LA® (extended release
tolterodine tartrate, used to treat overactive bladder). View the complaint here.

Helsinn Healthcare SA et al.
v. Aurobindo Pharma Ltd. et al.
1:13-cv-00688; filed April 16,
2013 in the District Court of Delaware

• Plaintiffs: Helsinn
Healthcare SA; Roche Palo Alto LLC
• Defendants: Aurobindo Pharma
Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos.
7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron,"
issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), and
7,960,424 (same title, issued June 14, 2011) following a Paragraph IV
certification as part of Aurobindo's filing of an ANDA to manufacture a generic
version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution,
used to prevent chemotherapy induced nausea and vomiting). View the complaint here.

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