Patent Docs

Court Report

June 13, 2010

By Sherri
Oslick —

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

Allergan Inc. et al. v. Paddock Laboratories Inc.
1:10-cv-00501; filed June 9, 2010 in the District
Court of Delaware

• Plaintiffs: Allergan Inc.; Allergan USA Inc.;
Allergan Sales LLC; Endo Pharmaceuticals Solutions Inc.; Supernus
Pharmaceuticals Inc.
• Defendant: Paddock Laboratories Inc.

Infringement of U.S. Patent No. 7,410,978 ("Once
Daily Dosage Forms of Trospium," issued August 12, 2008) following a
Paragraph IV certification as part of Paddock's filing of an ANDA to
manufacture a generic version of Allergan's Sanctura XR® (trospium, used to
treat overactive bladder). View
the complaint here.

Bayer Schering Pharma AG et al. v. Teva Pharmaceutical
Industries Ltd. et al.
2:10-cv-00872; filed June 7, 2010 in the District
Court of Nevada

• Plaintiffs: Bayer Schering Pharma AG; Bayer
Healthcare Pharmaceuticals Inc.
• Defendants: Teva Pharmaceutical Industries Ltd.;
Teva Pharmaceuticals USA, Inc.; Barr Pharmaceuticals LLC; Barr Laboratories,
Inc.

Infringement of U.S. Patent Nos. RE37,564 ("Composition
for Contraception," issued February 26, 2002), RE37,838 (same title,
issued September 10, 2002), and RE37,253 (same title, issued September 16, 2003)
following a Paragraph IV certification as part of defendants' filing of an ANDA
to manufacture a generic version of Bayer's Yaz® (drospirenone & ethinyl
estradiol, used for oral contraception). View the complaint here.

Abbott Laboratories et al. v. Sun Pharmaceutical Industries
Ltd. et al.
1:10-cv-00488; filed June 4, 2010 in the District
Court of Delaware

• Plaintiffs: Abbott Laboratories; Abbott
Respiratory LLC
• Defendants: Sun Pharmaceutical Industries Ltd.;
Sun Pharma Global FZE

Infringement of U.S. Patent Nos. 6,080,428 ("Nicotinic
Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor,"
issued June 27, 2000) and 6,469,035 ("Methods of Pretreating
Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of
Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by
Nicotinic Acid," issued October 22, 2002) following a Paragraph IV
certification as part of Sun's filing of an ANDA to manufacture a generic
version of Abbott's Niaspan® (niacin extended-release tablets, used to treat
hypercholesterolemia). View the
complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Zydus Pharmaceuticals USA, Inc.
et al.
3:10-cv-02857; filed June 4, 2010 in the District
Court of New Jersey

• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Zydus Pharmaceuticals USA, Inc.;
Cadila Healthcare Ltd.

Infringement of U.S. Patent No. 5,006,528 ("Carbostyril
Derivatives," issued April 9, 1991) following a Paragraph IV certification
as part of Zydus' filing of an ANDA to manufacture a generic version of Otsuka's
Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.

Abbott Laboratories et al. v. Ranbaxy Laboratories Ltd. et al.
2:10-cv-02869; filed June 4, 2010 in the District
Court of New Jersey

• Plaintiffs: Abbott Laboratories; Laboratoires
Fournier S.A.
• Defendants: Ranbaxy Laboratories Ltd.; Ranbaxy
Pharmaceuticals, Inc.; Ranbaxy Inc.

Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate
Pharmaceutical Composition Having High Bioavailability and Method for Preparing
It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006),
and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High
Bioavailabilty," issued May 9, 2006) following a Paragraph IV
certification as part of Ranbaxy's filing of an ANDA to manufacture a generic
version of Abbott's Tricor® (fenofibrate, used in the treatment of increased
triglyceride levels). View the
complaint here.

Elan Pharma International Ltd. et al. v. Ranbaxy Laboratories
Ltd. et al.
2:10-cv-02872; filed June 4, 2010 in the District
Court of New Jersey

• Plaintiffs: Elan Pharma International Ltd.;
Fournier Laboratories Ireland Ltd.
• Defendants: Ranbaxy Laboratories Ltd.; Ranbaxy
Pharmaceuticals, Inc.; Ranbaxy Inc.

Infringement of U.S. Patent Nos. 7,276,249 ("Nanoparticulate
Fibrate Formulations," issued October 2, 2007) and 7,320,802 ("Methods
of Treatment Using Nanoparticulate Fenofibrate Compositions," issued
January 22, 2008), all licensed to Abbott, following a Paragraph IV
certification as part of Ranbaxy's filing of an ANDA to manufacture a generic
version of Abbott's Tricor® (fenofibrate, used in the treatment of increased
triglyceride levels). View the
complaint here.
Conference & CLE Calendar

June 13, 2010

June
15, 2010 – Patent
Reform 2010:
What Shape Will It Finally Take? (Analysis
Group, Georgetown University's Center for Business and Public Policy,
and McKool Smith) – Washington, DC

June
16-18,
2010 – Fundamentals
of Patent Prosecution
2010: A Boot Camp for Claim Drafting & Amendment Writing (Practising
Law
Institute) – New York, NY

June
21-22,
2010 – Follow-on
Biologics (American
Conference
Institute) – New
York, NY

June
20-22,
2010 – IP
Business Congress (Intellectual
Asset
Management (IAM) magazine) – Munich,
Germany

June
23,
2010 – Regulatory
and Intellectual Property Opportunities and
Challenges for Life Science Companies Entering the U.S. Market (American
Bar Association) – 12:00
– 1:30 PM (EST)

June
23-24, 2010 – Maximising
Pharmaceutical Patent Life
Cycles (C5) – London,
England

June
29, 2010 – Navigating
the U.S. Biosimilar Pathway (American
Bar Association) – 1:00
– 2:30 PM (EST)

June
30, 2009 – Markman
Hearings and Claim Construction
in Patent Litigation 2010 (Practising
Law
Institute) – New
York, NY (with groupcasts in Atlanta, GA;
Mechanicsburg, PA; Philadelphia, PA; and
Pittsburgh, PA)

July
7, 2010 – Prior
Art &
Obviousness 2010: Current Trends
in Sections 102 & 103 (Practising
Law
Institute) – New
York, NY

July
7-9, 2010 – Fundamentals
of Patent Prosecution
2010: A Boot Camp for Claim Drafting & Amendment Writing (Practising
Law
Institute) – San Francisco, CA

July
19-20,
2010 – Hatch-Waxman
Boot Camp*** (American
Conference
Institute) – Boston,
MA

July
29-31, 2010 – Intensive
Patent Law
Training Workshop (Chisum
Patent Academy) – Seattle,
WA

August
18-19, 2010 – The
Life Sciences
Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions***
(American
Conference
Institute) – New
York, NY

September
15, 2010 – Prior
Art &
Obviousness 2010: Current Trends
in Sections 102 & 103 (Practising
Law
Institute) – San
Francisco, CA

***Patent Docs is a media partner of this conference or CLE
Re-examination Ordered on “Expired” Harvard Oncomouse Patent

June 11, 2010

    By Kevin E. Noonan —

On Monday, the U.S.
Patent and Trademark Office granted an ex parte reexamination request for U.S. Patent No. 5,925,803, the
latest-filed and last-granted member of the Harvard Oncomouse patent
family. Remarkable about the
petition is that the third party requester (TPR), Ellen Gonzales of Gonzales
Patent Services, contends that the '803 patent has expired by operation of a
terminal disclaimer filed in an earlier-filed application, but maintains that despite
the putative expiration, the Office retains jurisdiction to consider the
re-examination request.

There are three claims
in the '803 patent, all directed to methods for testing a compound suspected to
be a carcinogen:

1. A method of
testing a material suspected of being a carcinogen, comprising exposing a
transgenic mouse to said material and detecting neoplasms as an indication of
carcinogenicity, wherein the germ cells and somatic cells of said mouse contain
an activated oncogene sequence introduced into said mouse, or an ancestor of
said mouse, at an embryonic stage.

2. A method of
testing a material suspected of conferring protection against the development
of neoplasms, said method comprising
    (1) providing a first
and a second transgenic mouse, the germ cells and somatic cells of which
contain an activated oncogene sequence introduced into said mice, or an
ancestor of said mice, at an embryonic stage,
    (2) treating said first
mouse with said material, and
    (3) detecting, as an
indication of said protection, a reduced incidence of development of neoplasms
in said first mouse, compared to the incidence in said second mouse, which is
not so treated.

3. The method
of claim 1, further comprising exposing said first and second mice to a
carcinogen prior to, after, or simultaneously with treating said first mouse
with said material.

The TPR asserted six
substantial new questions (SNQ) of patentability against these claims:

• SNQ1: Claim 1 of the '803 Subject Patent is obvious in
view of Claims 1, 11, and 12 of [grandparent U.S. Patent No. 4,736,866] in view
of Ward et al. or Schach et al. under the doctrine of judicially-created
obviousness-type double patenting.

• SNQ2: Claims 1-3 of the '803 Subject Patent are unpatentable
in view of the Claims 1-12 of the '866 Grandparent Patent under the doctrine of
judicially-created obviousness-type double patenting.

• SNQ3: Claims 2-3 of the '803 Subject Patent are
obvious in view of the claims of the '866 Grandparent Patent in view of the
Proctor Patent, under the doctrine of judicially-created obviousness-type double
patenting.

• SNQ4: Claims 1-3 of the '803 Subject Patent are
obvious under 35 U.S.C. 103(a) in view of Schwab et al.

• SNQ5: Claims 2-3 of the '803 Subject Patent are
obvious under 35 U.S.C. 103(a) over Jaenisch et al. in view of the Proctor
patent.

• SNQ6: Claim 1 of the '803 Subject Patent is obvious
under 35 U.S.C. 103(a) over Jaenisch et al. in view of the either Ward et al.
or Schach et al.

TPR contends that the
following describes the priority chain and the relationship between the
grandparent '866 patent, parent U.S. Patent No. 5,087,571, and the '803
patent. The '866 patent, according
to the TPR, contained claims 1-12 directed to the Harvard oncomouse; claims
13-19 directed to methods for testing a compound suspected of being a
carcinogen; and claims 20-22 directed to plasmid constructs; claim 1 is representative:

1. A transgenic
non-human mammal all of whose germ cells and somatic cells contain a
recombinant activated oncogene sequence introduced into said mammal, or an
ancestor of said mammal, at an embryonic stage.

The TPR contends in her
request that the applicant cancelled the claims to the testing methods and let
claims to the Harvard Oncomouse proceed to grant as the '866 patent.

The application that
gave rise to the parent '571 patent, the TPR contends, was improperly
designated as a "divisional application," despite the fact that no
restriction requirement was raised against any of the claims of the '866 patent
and that the patentee voluntarily cancelled the testing method claims in the '866
patent as part of their patenting strategy. This application was filed initially with original claims
13-24 that had been cancelled during prosecution of the '866 patent. Prosecution of the '571 patent resulted
in two granted claims:

1. A method of
providing a cell culture comprising
    (1) providing a
transgenic non-human mammal, all of whose germ cells and somatic cells contain
a recombinant activated oncogene sequence introduced into said mammal, or an
ancestor of said mammal, at an embryonic stage; and
    (2) culturing one or
more of said somatic cells.

2. A cell
derived from a somatic cell obtained from a transgenic non-human mammal, all of
whose germ cells and somatic cells contain a recombinant activated oncogene
sequence introduced into said mammal, or an ancestor of said mammal, at an
embryonic stage which cell contains said recombinant activated oncogene
sequence.

Significantly,
applicants filed a terminal disclaimer over the claims of the '866 patent in
order to overcome an obviousness-type double patenting rejection raised against
these claims. The following
language in the terminal disclaimer is important for the arguments successfully
raised in the request (with emphasis
added):

Your
petitioner, President and Fellows of Harvard College, hereby disclaims any
portion of an patent granted on the above-identified application or on any application which is entitled to
the benefit of the filing date of this application under 35 U.S.C. 120 not
extending the term of any patent granted on that application beyond the term of
issued U.S. Patent No. 4,736,866 issued April 12, 1988.

The TPR contended that
this language was not required in a terminal disclaimer and the patentees were
bound by it (i.e., that it cannot be
rescinded by certificate of correction, reissue, or reexamination, even if it
was filed in error). As in the '866
patent, patentees cancelled the testing method claims in the application that
granted as the '571 patent.

The application that
granted as the '803 patent was the first member of the priority chain having a
restriction requirement, which was filed with claims 1-13 and 15-24 of the
grandparent application. This
restriction requirement identified three groups: claims 1-12 and 15-17,
directed to a transgenic animal and methods for producing such an animal;
claims 13, 18 and 19, drawn to suspected carcinogen testing methods; and claims
20-24 being drawn to plasmids; applicants elected to prosecute the testing method claims. During prosecution the applicants
overcame an obviousness rejection based on the '866 patent and the Ward and Schah
references on the grounds that 35 U.S.C. § 121 "prohibits the USPTO from
rejecting a later divisional application 'where (as here) the divisional
application is filed as the result of a restriction requirement in the original
case.'" The TPR contended
that this statement is inaccurate, insofar as there was no restriction
requirement issued during prosecution of either the grandparent '866 patent or
the '571 patent.

The TPR argued in the
request that the '803 patent expired by operation of the terminal disclaimer
filed in the '571 patent on July 12, 2005, the expiration date of the '866
patent. Reexamination is
still proper, she contended, because a reexamination "may be declared for
an expired patent at any time during the enforceability
of the patent" (emphasis in
original), which will run until July 12, 2011 (i.e., six years after the
patents expiration date; M.P.E.P. § 2211). Moreover, a question arising as a result of obviousness-type double
patenting is appropriate for raising a substantial new question of patentability
in a reexamination (M.P.E.P. § 2217). Finally, the TPR argued that public policy concerns supported the Office
granting her request for reexamination:

TPR
respectfully requests that a Reexamination nonetheless be declared to serve the
public notice function of Reexaminations (i.e., to make it clear on the record
that the '803 Subject Patent is only avoiding the double-patenting rejections because
of the terminal disclaimer in the '571 Parent Patent, which likewise
informs the public that the patent expired on July 12, 2005). In such a case,
even if a Reexamination is not declared, to serve the public notice function,
TPR respectfully requests that the Patent Office indicate in writing that the
terminal disclaimer in the '571 Parent Patent application insulates the '803
Subject Patent from obviousness type double patenting rejections, and further,
affirmatively state that the '803 Subject Patent therefore expired on July 12,
2005. This public notice function is particularly important in this case as the
Patentee is publicly advertising that the '803 Subject Patent does not expire
until July of 2016, which is 11 years past the actual expiration date.

The Office agreed. As set forth under Reexamination
Control No. 90/010,955, the Office granted the reexamination based on all six
substantial new questions of patentability. Although the paper granting the request cited revisions to
the reexamination statute (35 U.S.C. § 301 et
seq.) enacted by Congress in 2002 in response to the Federal Circuit's
decision in the In re Portola Packaging
case, which permit a reexamination request to be granted on art considered by
the Office during ex parte
prosecution provided that a substantial new question of patentability is
raised, the paper also notes that all of the art cited by the TPR (except for
the Ward reference) had not been
considered by the examiner during prosecution of the '803 patent. Moreover, the Office did not separately
address the standing issue raised by the TPR, apparently agreeing that a
reexamination is properly granted on an expired patent during the period where
the patent right can be enforced.

The reexamination will
be considered by Primary Examiners Brenda Brumback, Padmashri Ponnaluri, and SPE
Deborah Jones.
Biotech/Pharma Docket

June 10, 2010

By James DeGiulio —

Endo Settles with Impax and
Sandoz in Opana Patent Suits

Endo Pharmaceuticals Inc. has settled patent
infringement suits against Sandoz Inc. and Impax Laboratories Inc. over generic
versions of painkiller Opana ER. The
agreement allows Impax to begin selling a version of the drug on January 1, 2013, and
allows Sandoz to enter the market on September 15, 2012.

In January 2008, Endo brought suit against Impax
and Sandoz after their ANDA filings, alleging infringement of two of Endo's patents (U.S. Patent Nos. 5,662,933
and 5,958,456), which cover Opana. Endo further alleged that Impax abused the
regulatory system for resolving patent disputes over ANDAs, arguing that Impax
violated FDA rules by continuing to send Paragraph IV notices even though the
agency rescinded its initial acceptance of Impax's ANDA.

The
settlements were announced shortly after a bench trial in the District of New
Jersey in front of Judge Katharine S. Hayden. Additional
details on the licensing agreements with Impax and Sandoz were not disclosed.

Sanofi, Abbott Unable to Block
Glenmark's Launch of Generic Tarka

Sanofi and Abbott have failed to
block Glenmark's launch of a generic version of Tarka after the U.S. District
Court for the District of New Jersey
denied their motion for preliminary injunction and a temporary restraining order.

In
October 2007, Glenmark notified Abbott and Sanofi that it had filed an ANDA with
the FDA to make a generic drug containing trandolapril and verapamil
hydrochloride, the active ingredients in Tarka. Sanofi and Abbott responded by
filing the current lawsuit in December 2007, alleging Glenmark was planning to
infringe the 5,721,244 patent which covers Tarka (see "Court Report," December 16, 2007). On May 14, Abbott and Sanofi asked the
court to preliminarily enjoin and temporarily restrain Glenmark from selling
generic versions of Tarka, arguing that denying this action would cause the
plaintiffs irreparable harm due mostly to market loss.

Judge Dennis M. Cavanaugh of the District
Court for the District of New Jersey denied the preliminary injunction due to
public interest and Glenmark's likelihood of success on invalidating the '544
patent due to obviousness. Glenmark presented strong prior art, including ten references
and a 1992 patent held by the plaintiffs. Judge Cavanaugh noted the commercial success of Tarka,
but found the prospective harm to Glenmark would be too great to grant the
preliminary injunction.

Judge Cavanaugh's opinion can be
read here.

James
DeGiulio has a doctorate in molecular biology and genetics from
Northwestern University and is a third-year law
student at the Northwestern University School of Law. Dr. DeGiulio
was a member of MBHB's 2009 class of summer associates, and he can be
contacted at degiulio@mbhb.com.
CAFC Sets Date for Oral Argument En Banc in Inequitable Conduct Appeal

June 9, 2010

By
Donald Zuhn —

Last
week, the Court of Appeals for the Federal Circuit issued an order
setting a date for oral argument en banc
in Therasense, Inc. v. Becton, Dickinson & Co. The order indicates that oral argument will take place on
November 9, 2010 at 10:00 am in courtroom 201.

In
April, the Federal Circuit granted a petition for rehearing en banc submitted by
Plaintiffs-Appellants Abbott Diabetes Care, Inc. (formerly Therasense, Inc.)
and Abbott Laboratories (see "Federal
Circuit Grants En Banc Review in Therasense v. Becton Dickinson"). Last month, the Court extended the
deadline by which Plaintiffs-Appellants need to file their brief to July 26 (see "Therasense, Inc. v. Becton,
Dickinson & Co. — Briefing Schedule Update"). According to the Court's original
order, Defendants-Appellees must file their response 30 days from the date of
service of Plaintiffs-Appellees' brief.
Pursuant to Rule 29(e) of the Federal Rules of Appellate Procedure, amicus curiae briefs must be filed no
later than 7 days after the principal brief of the party being supported is
filed, or no later than 7 days after the Plaintiffs-Appellants' principal brief
is filed when an amicus curiae does
not support either party.

For
additional information regarding this topic, please see:

• "Therasense,
Inc. v. Becton,
Dickinson & Co. — Briefing Schedule Update," May 16, 2010
•
"Therasense,
Inc. v. Becton, Dickinson & Co. Briefing," May 13,
2010
• "Federal
Circuit
Grants En Banc Review in Therasense v. Becton Dickinson," April 28, 2010
AMP v. USPTO: What Everyone Else Is Saying – Part II

June 8, 2010

By Donald Zuhn —

In March, the District Court for the Southern
District of New York found
the claims of
several of Myriad Genetics patents (directed to the BRCA1 and BRCA2 genes) invalid, ruling in favor of the plaintiffs in Association of
Molecular Pathology v. U.S. Patent and Trademark Office (see "Round One Goes to the ACLU"). Following the decision, we discussed
the parties' reaction to the outcome (see "AMP v. USPTO: What the Parties
Are Saying About the Decision"),
and then examined what others were saying or reporting about the decision (see
"AMP v. USPTO: What Everyone Else Is Saying"). With the deadline for appealing the lower court's decision less than two weeks away (defendants have until June 18 — or 60 days
after judgment was entered on April 19 — to file a notice of appeal), we take a second look at what others have been saying about the decision over the past two months.

• In "IP Position Critical to Biotech Investment:
Looming Battle over Gene Patenting Could Jeopardize Medical Advances,"
Genetic Engineering & Biotechnology News contends that:

Whether patents are for genes encoding therapeutic proteins such as
insulin and growth hormones, antibodies such as Herceptin® and Rituxan®, or
mutated genes that are indicative of breast or ovarian cancer, precluding
patents on this subject matter will halt the forward progress that has been
made in the biotech industry over the past 30 years since [Diamond v.]
Chakrabarty was decided.

The article suggests that "[i]n essence, the
lawsuit challenges the entire field of gene patenting when it seems that the
true question is whether our healthcare system provides access to specific
genetic tests (or therapeutics)."
If plaintiffs ultimately prevail, the article asks whether the
plaintiffs "next go after Genentech because it has patents and a market
for Herceptin for Her2 positive breast cancer; Pfizer and AstraZeneca, for
their patents on statins; Biogen-Idec for Rituxan for the treatment of certain
types of B-cell non-Hodgkin lymphoma; or Bristol-Myers Squibb, which sells
Erbitux?" With respect to the
impact the case might have on investment, Robert More of Frazier Healthcare
Ventures observes that he has "seen quite a few technologies over the
years that would be of potential great benefit to patients, but the
intellectual property was simply not there to support protecting the product
from fast followers in the market place," adding that "because of the
enormous sums of money required to discover, develop, test, and approve
anything in the healthcare sector, quite aside from the time it takes, IP is
critical." Mr. More also
suggests that "20 years or less of exclusivity . . . is a small price for
us to pay for innovation."

• In "How Gene Patents Harm Innovation,"
Forbes.com declares that the decision marks "the first battle in which the
future of medicine confronted the past — and the future won." The article argues that:

Far from hurting biotech innovation, eliminating pure gene patents will
greatly speed innovation in the biotech sector. Instead of tying up basic genetic information with patents,
the biotech industry will have to become more like computer industry. It will compete on the quality of its
machines and software algorithms, not by making scientific discoveries and
locking up the information for decades with a patent. Numerous high-tech gene
companies will be able to flourish thanks to superior technology.

• In "Who owns your genes?" a
San Francisco Chronicle editorial predicts that the case will eventually reach
the Supreme Court and advises that "[t]he high court should strike it
down," arguing that "[g]enes are the common property of humanity, not
the private fiefdoms of individual companies."

• In "End of Gene Patents Will Help Patients,
Force Companies to Change,"
WIRED opines that "[w]hen you went to sleep last Sunday night [March
28th], 20 percent of your genome belonged to a researcher or company[, and o]ne
day later, following federal district court judge Robert Sweet’s ruling, it
belonged to you." Discussing
the plaintiffs' case, the article states that:

Beyond the absurdity of gene patents — imagine patenting gold, the
human arm, or gravity — [plaintiffs] said that patents had hurt patients,
stifled business and stunted research.
Myriad’s monopoly prevented women from getting second opinions on their
breast-cancer gene tests. More
broadly, existing gene patents dissuaded researchers from studying sections of
the genome that were already claimed, and high licensing fees discouraged
would-be entrepreneurs.

In the article, 23andMe CEO Linda Avey states that
"[m]y hope is that this ruling stands and companies will need to actually
innovate and create new advances based on genetic findings, not depend[] on
sole access to them." If the
decision stands, she predicts that "[r]ather than relying on obscure
patent language and legal strategies, companies will need to develop products
that are competitively positioned."

• In "The absurdity of patenting genes,"
The Guardian offers a few reasons "why gene patents like [Myriad's] are
stupid." While acknowledging
that "[p]atents are a sensible idea, because people are more likely to
invest in innovation if they believe it will give them a competitive advantage
over other people, and because patents allow people to share their discoveries
safely, instead of monetising their advantage by keeping a discovery
secret," the article states that "patents also act as a barrier to
innovation, and gene patents bring these disadvantages [sic] into stark
relief." On the
"chilling effect" gene patents alledgedly have on clinical activity and research,
the article states that:

Almost all basic science research on the BRCA1 breast cancer gene over
the past 12 years has infringed Myriad's patent, and although the company has
tended not to go after basic science researchers, they have never promised that
they won't in the future, so this academic research on a major risk factor for
a major killer — the most common cancer in women worldwide — continues only
with Myriad's indulgence, making it risky work.

• In "Gene Patenting: Biotech Can Blame Itself
for this PR Nightmare,"
BNET refers to the "60 Minutes" report on the case back in April (see
"'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene
Patenting Story"),
and asks:

[W]hy didn’t Myriad explain how much money they’ve
spent developing life-saving diagnostics?
Why didn’t they produce patient spokespersons who’ve been saved from
cancer and think $3,200 is a pretty reasonable price to pay for it?

• In "Myriad elicits a genetics tempest," The Salt Lake Tribune quotes
Myriad executive vice president and in-house legal counsel Richard Marsh as
stating that:

In my mind I just cannot fathom the time, effort and cost it took us to
try to get the testing to where it is today. Most of the plaintiffs in this case are academic centers,
and I just cannot see an academic center spending hundreds of millions of
dollars employing a thousand people all to try to promote the science.

• Finally, in "Elements of humanity should not be
patented,"
a St. Petersburg Times editorial states that "for years companies have
been turning our genes into products, patenting them and keeping people from
accessing their own genetic information," and opines that "[t]hese
patents on nature should never have been granted." The article notes that "[t]he
[District Court's] ruling has thrown the biotech industry into a tizzy,"
but declares that "the judge's reasoning is airtight." On the issue of innovation, the piece
states that:

Biotech firms argue that they need the patents to spur investment in
study. But this is a red
herring. There are all sorts of
ancillary parts of genetic research that are subject to patent and hugely
profitable. Instead, the ruling
will be a boon to genetic science and public health. Competition in the field
of genetic testing will bring costs down, giving access to more people to know
what disease proclivities they carry.

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

• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60
Minutes' and 'Newshour' Take Different Apporaches to Covering Gene
Patenting Story," April 5, 2010
• "AMP
v. USPTO: What the Parties Are Saying About the Decision,"
April 1, 2010
• "Caught
in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims,"
March 30, 2010
• "Round
One
Goes to the ACLU," March 29, 2010
•
"Debating
Gene Patents – Round Four," February 10, 2010
• "Newsweek
= Newspeak on Gene Patenting," February 8, 2010
• "Everybody
Knows — The Boston Globe Weighs in on Gene Patenting,"
February 1, 2010
• "The
USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
•
"Top
Stories of 2009: #4 to #1," January 4, 2010
•
"Gene
Patenting: Australian Potpourri," December 28, 2009
•
"Science
Progress Article Examines Impact of Gene Patents on Research,"
December 21, 2009
•
"Gene
Patenting Debate Continues – Round Three," December 17, 2009
•
"BRCA
Patent Suit to Continue in Southern District of New York,"
November 2, 2009
•
"Empirical
Research Fails to Support Gene Patenting Ban," October 22,
2009
•
"The
Tragedy of a Bad Idea," August 25, 2009
•
"Gene
Patenting Debate Continues – Round Two," August 4, 2009
•
"The
Unwanted Consequences of Banning Gene Patenting," June 16, 2009
•
"Falsehoods,
Distortions and Outright Lies in the Gene Patenting Debate,"
June 15, 2009
•
"Gene
Patenting Debate Continues," June 9, 2009
•
"Association
for Molecular Pathology v. U.S. Patent and Trademark Office,"
May 17, 2009
•
"Court
Report: Special Edition," May 13, 2009
News from Abroad: Australian Senate to Release Gene Patenting Findings Next Week

June 8, 2010

By Damian Slizys —

Following the discussion in Patent Docs of the Australian Senate's gene patent inquiry last December (see "Gene Patenting: Australian Potpourri"), we now expect the findings of the Senate enquiry to be set down on 17 June 2010, following two extensions of time. The inquiry was allegedly initiated, in part, because of the attempts to enforce the Myriad Genetics patents in Australia which relate to the use of BRCA1/BRCA2 genes in breast cancer screening and as isolated products per se. In light of the recent decision in Association for Molecular Pathology v. U.S. Patent and Trademark Office (09cv4515, U.S. District Court for the District of New York), the report will be of major interest. This is particularly the case as many of the proposals put forward to the Senate committee will increase the burden on patentees significantly and/or exclude more than naturally-occurring genes from patentability. For instance, one proposal requires that a patentee must publicly disclose sufficient information to enable the replication of the invention to the same standard as its closest commercial competitor before the payment of each renewal fee. We will provide a report on the enquiry's finding once it has been handed down.

In addition, on 8 June 2010, plaintiff law firm Maurice Blackburn, initiated proceedings in the Australian Federal Court directed to invalidating the Myriad Genetics patents in Australia. Although we have yet to review the pleadings, public statements by Maurice Blackburn indicate that the main legal argument against the patents was one of discovery over invention, but there were also big ethical and philosophical questions about whether the body could be privatised. ''It's a healthcare rights issue and an issue of freedom of research into the fundamental building blocks of our being,'' the lawyers stated. The progress of this case will clearly be of marked interest, particularly as the legal arguments proposed do not sit easily within the established grounds of invalidity under Australian law.

Dr. Slizys is a Partner at FB Rice & Co in Melbourne, Australia.
Purdue Pharma Products L.P. v. Par Pharmaceutical, Inc. (Fed. Cir. 2010)

June 7, 2010

Further Adventures in Obviousness and Inequitable Conduct

By Kevin E. Noonan —

In Purdue
Pharma Products L.P. v. Par Pharmaceutical, Inc., the Federal Circuit
exercised its prerogative to illustrate its fractured jurisprudence on two
issues, obviousness and inequitable conduct, in a (fortunately)
nonprecedential decision. Contrary to its Congressional mandate to bring
jurisprudential consistency to U.S. patent law, on these matters at least the
outcome is highly dependent on the constitution of the panel rather than a
consistent application of the law. In view of the fact-intensive nature of the issues involved it is
perhaps inevitable, but that does little to help the patent community understand
what behavior does (and does not) fit within the statutory standard.

This case arose after Par filed an ANDA for Purdue
Pharma's Ultran ER® product, a sustained release formulation of the opiate
analgesic tramadol, with a Paragraph IV certification that Purdue Pharma's
Orange Book-listed, U.S. Patent Nos. 6,254,887 and 7,074,430 were invalid
and/or unenforceable. The District
Court held that Par's generic tramadol formulation infringed claims 3, 13, 27, and 29 of the '887 patent and claims 5, 7, and 11 of the '430 patent. However, the Court also found that
these claims were invalid for obviousness over the disclosure of U.S. Patent
No. 5,580,578 ("the Oshlack patent") but that the patents were not
unenforceable for inequitable conduct.

The Federal Circuit affirmed, in an opinion by
Judge Lourie joined by Judges Linn and Dyk. The panel's grounds for affirming the obviousness
determination was that the Oshlack patent disclosed tramadol as one of 14
opiate drugs that could be formulated in an extended-release formulation, dosing
to encompass a bioavailability profile of from 10 to 33 hours, and a "controlled
release coating" comprising water-insoluble polymethacrylate and
polyvinylpyrrolidone. Purdue's
patents disclosed alternative, water-insoluble coatings. The Court held that the Oshlack patent selected
tramadol as one of 14 opiate drugs (out of the "myriad other possible
active ingredients" that could have been used to prepare an
extended-release formulation), and that this disclosure rendered Purdue's
claimed formulations obvious "regardless of whether or not the patent
lists tramadol as a preferred embodiment." (The Court helpfully cited another case, Perricone v. Medicis Pharm. Corp., that "reject[ed]
the notion that one of [14 listed] ingredients cannot anticipate because it
appears without special emphasis in a longer list," relying it seems on
the maxim that "anticipation is the epitome of obviousness," In re Kalm, 378 F.2d 959, 962 (CCPA
1967).) The Court also found
that the Oshlack reference expressly taught "once-daily" tramadol
formulations albeit without necessarily enabling production thereof (citing Symbol Technologies Inc. v. Opticon, Inc.,
935 F.2d 1569, 1578 (Fed. Cir. 1991)). The panel held that Purdue had waived arguments relating to the
non-obviousness of formulations having bioavailability profiles disclosed and
claimed in the '887 and '430 patents, as well as (and perhaps more importantly)
the argument that the Oshlack patent was not prior art under 35 U.S.C. § 102(e),
because these arguments were not raised before the District Court. A review of Patent Office records indicates that the Oshlack
patent was assigned to Purdue in December 1997, suggesting that Purdue's
argument was that this patent was not available as prior art under § 102(e)
pursuant to the provisions of 35 U.S.C. § 103(c). This argument, properly made, should have been enough to
overcome Par's obviousness defense. Finally, the Court continued its recent pattern of disregarding the "secondary
considerations" of non-obviousness under the Supreme Court's Graham v. John Deere precedent, agreeing
with the District Court that evidence of copying was irrelevant in an ANDA
context (an argument of apparently first enunciation), and that Purdue had not
provided sufficient context (or perhaps sufficient "nexus") for its commercial success evidence to rebut
the District Court's legal conclusion of obviousness.

Turning to inequitable conduct, the panel agreed
with the District Court that Purdue had withheld material information from the Office in the form of experimental data, and indeed had submitted a "misleading"
affidavit during prosecution: the declaration contained "more favorable"
experimental data than the data that Purdue withheld. Par reasonably contended that this constituted inequitable
conduct, since Purdue could provide "no credible explanation" for these
actions. In finding no inequitable
conduct, the District Court found insufficient evidence of deceptive
intent. For example, the Court characterized
the declaration as being "an overly
aggressive attempt to put a positive spin on the data." Par also contended that the District Court erred in relying on "evidence" of good faith, which included
that the declarant failed to recall why the less-favorable data was not submitted
to the Office, "that the formulators did not recognize the data's import
to patentability when the evidence showed that they did," and that
patentees had later submitted "similar" (presumptively negative) data
to the Office.

The Federal Circuit affirmed the District Court's finding of no inequitable conduct based on several
factors that are consistent with the deference that the "abuse of
discretion" standard is intended to produce, as well as others that are
less reasonably related to the conclusion. These include witness credibility, but also include that the
declaration was "prepared" to overcome a rejection on inherent
anticipation before the European Patent Office (but if it wasn't submitted to
the USPTO it could not have been used to support an inequitable conduct
defense). The panel also seemed to
sanction as a factor related to deceptive intent the later submission of "more
pertinent experimental results," which the Court noted had been "generated
for a foreign litigation." Also impliedly sanctioned was the "credible excuse" proffered
by Purdue, that "[t]he omitted data did not reproduce conditions from the
prior art and revealed dissolution rates outside those claimed in the asserted
patents." The panel stated
that "[e]ven assuming that the applicants withheld material data and submitted
a materially misleading declaration, as the district court found" in
affirming the District Court's decision, a statement that seems to stretch to
the breaking point the principle that intent to deceive cannot be inferred from
materiality alone. And the fact
that Purdue later disclosed "similar" experimental data seems equally
inadequate to overcome the behavior the District Court found, and the panel
agreed, was exhibited by Purdue in not only withholding material information but
filing a misleading affidavit (compare, for
example, different panel holdings in Aventis Pharma S.A. v. Amphastar Pharma, Inc. and Ferring
B.V. v. Barr Laboratories, Inc.). In making this determination, the panel seems to distinguish an earlier
panel's decision in Cargill, Inc. v. Canbra Foods, Ltd., 476 F.3d 1359 (Fed.
Cir. 2007) on the grounds that in Cargill, the patentees consistently submitted
misleading information to the Office. And the panel found that "the reasonableness of inferring that any
omission or misleading statement in the preparation of the declaration was made
with the specific intent of deceiving the PTO" was diminished because the
declaration was prepared for an EPO proceeding (ignoring the fact that the
issue was the intent in submitting the declaration to the USPTO during
prosecution of the '887 and '430 patents). For this panel, at least, the District Court's decision of
no inequitable conduct was affirmed "[b]ecause intent to deceive is not
the single most reasonable inference that can be drawn from the evidence."

Perhaps the en banc
court's decision in Therasense v. Becton,
Dickenson & Co. will bring some consistency to the Court's inequitable
conduct jurisprudence.

Purdue Pharma Products L.P.
v. Par Pharmaceutical, Inc. (Fed. Cir. 2010)
Nonprecedential
disposition
Panel:
Circuit Judges Lourie, Linn, and Dyk
Opinion
by Circuit Judge Lourie
Venter Denies Synthetic Cell Discovery Is Artificial Life, Vatican Agrees

June 6, 2010

By
James DeGiulio —

Last
week, we reported that a research team led by Dr. Craig Venter had developed a "synthetic
cell" controlled by purely synthetic DNA (see "Dr. Craig Venter Creates
First Cell Controlled Entirely by Synthetic DNA") Dr. Venter and co-author Dr. Daniel Gibson
have written an op-ed piece that was recently published in The Wall Street Journal, entitled "How
We Created the First Synthetic Cell," which describes their scientific advance and addresses some of the ethical
issues involved. Perhaps fearing a
bioethical backlash, the two researchers vehemently deny that they have created
life, instead suggesting that they "transformed existing life into new
life." Drs. Venter and Gibson describe their research process as using
digitized information to synthesize a modified version of the "naturally
occurring" Mycoplasma mycoides
genome.

As
a historical example, Drs. Venter and Gibson reference the 1967 discovery by Nobel
prize winner Dr. Arthur Kornberg (at left), who successfully copied the phiX174 virus
DNA. The authors note that
President Lyndon Johnson, at that time, hailed Dr. Kornberg's work as "a very
spectacular breakthrough," yet accurately predicted "[i]f you think
about some of these decisions the present president is making — it is going to be
a kindergarten class compared to the decisions some future president is going
to have to make." Indeed,
President Obama, in a letter last week to the chair of his new bioethics
commission, wrote: "This development raises the prospect of important
benefits, such as the ability to accelerate vaccine development. At the same
time, it raises genuine concerns, and so we must consider carefully the
implications of this research." Drs. Venter and Gibson close the piece by welcoming and encouraging such
review and dialogue.

The
Vatican, after evaluating the methodology of Dr. Venter's creation of the "synthetic
cell," has reached the same conclusion put forth by the researchers: that the discovery is not "creating life" and thus does not move
beyond the church's bioethical boundaries. Furthermore, perhaps surprising to some, the Vatican has
publicly praised the discovery. The Vatican newspaper L'Osservatore
Romano published an article calling it an "interesting result"
and was optimistic that the development could help cure disease. Importantly, rather than considering
the development as creating life, the article considered that the researchers
instead had merely "replaced one of its motors," and that "the
DNA, even though it is an excellent engine, is not life."

Though
the Vatican's response may appear surprising, the church actually does not
officially oppose genetic engineering, so long as the science avoids embryonic
stem cells, cloning, or anything else that dabbles in the re-creation of human
life. Nonetheless, the Vatican
recognizes that the Venter discovery has taken a substantial step closer to
creating life. Despite the praise in the article, the Venter research team was
encouraged to "join courage with caution," when moving forward into
such delicate territory.

Patent Docs will report on the
scientific community's response to Dr. Venter's "synthetic cell"
discovery in a later post.

James
DeGiulio has a doctorate in molecular biology and genetics from
Northwestern University and is a third-year law
student at the Northwestern University School of Law. Dr. DeGiulio
was a member of MBHB's 2009 class of summer associates, and he can be
contacted at degiulio@mbhb.com.
Court Report

June 6, 2010

By Sherri
Oslick —

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

Shire LLC et al. v. Anchen
Pharmaceuticals Inc. et al.
1:10-cv-00484; filed
June 2, 2010 in the District Court of Delaware

• Plaintiffs: Shire LLC; Supernus Pharmaceuticals
Inc.; Amy F.T. Arnsten PhD; Pasko Rakic MD; Robert D. Hunt MD
• Defendants: Anchen Pharmaceuticals Inc.; Anchen
Inc.

Infringement of U.S.
Patent Nos. 5,854,290 ("Use of Guanfacine in the Treatment of Behavioral
Disorders," issued December 19, 1998), 6,287,599 ("Sustained Release
Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles,"
issued September 11, 2001), and 6,811,794 (same title, issued November 2, 2004)
based on Anchen's filing of an ANDA to manufacture a generic version of Shire's
Intuniv (guanfacine, used to treat attention-deficit hyperactivity disorder). View the complaint here.

Teva Pharmaceuticals USA, Inc. et
al. v. Bayer Schering Pharma AG et al.
1:10-cv-04340; filed
June 1, 2010 in the Southern District of New York

• Plaintiffs: Teva Pharmaceuticals USA, Inc.; Barr
Laboratories, Inc.
• Defendants: Bayer Schering Pharma AG; Bayer
Healthcare Pharmaceuticals Inc.

Declaratory judgment of
non-infringement and invalidity of U.S. Patent Nos. RE37,564 ("Composition
for Contraception," issued February 26, 2002), RE37,838 (same title,
issued September 10, 2002), and RE37,253 (same title, issued September 16,
2003) based on Teva's filing of an ANDA to manufacture a generic version of
Bayer's Yaz® (drospirenone & ethinyl estradiol, used for oral
contraception). View the complaint here.

Bayer Schering Pharma AG et al. v.
Teva Pharmaceutical Industries Ltd. et al.
1:10-cv-00474; filed
June 1, 2010 in the District Court of Delaware

• Plaintiffs: Bayer Schering Pharma AG; Bayer
HealthCare Pharmaceuticals Inc.
• Defendants: Teva Pharmaceutical Industries Ltd.;
Teva Pharmaceuticals USA Inc.; Barr Pharmaceuticals LLC; Barr Laboratories
Inc.

Infringement of U.S.
Patent Nos. RE37,564 ("Composition for Contraception," issued
February 26, 2002), RE37,838 (same title, issued September 10, 2002) and RE37,253 (same title, issued September 16, 2003) following a Paragraph IV
certification as part of Teva's filing of an ANDA to manufacture a generic
version of Bayer's Yaz® (drospirenone & ethinyl estradiol, used for oral
contraception). View the complaint here.

Medicines Co. v. APP
Pharmaceuticals LLC et al.
1:10-cv-00476; filed
June 1, 2010 in the District Court of Delaware

• Plaintiff: Medicines Co.
• Defendants: APP Pharmaceuticals LLC; APP
Pharmaceuticals Inc.

Infringement of U.S.
Patent No. 7,598,343 ("Pharmaceutical Formulations of Bivalirudin and
Process of Making the Same," issued October 6, 2009) following a Paragraph
IV certification as part of APP'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.

Biogen Idec MA Inc. v. EMD Serono,
Inc. et al.
2:10-cv-02760; filed May
28, 2010 in the District Court of New Jersey

• Plaintiff: Biogen Idec MA Inc.
• Defendants: EMD Serono, Inc.; Pfizer Inc.; Bayer
Healthcare Pharmaceuticals Inc.; Novartis Pharmaceuticals Corp.

Infringement of U.S.
Patent No. 7,588,755 ("DNA Sequences, Recombinant DNA Molecules and
Process for Producing Human Fibroblast Interferon-like Polypeptides,"
issued September 15, 2009) based on defendants' manufacture and sale of IFN-β
products (Rebif®, Betaseron®, Extavia®). View the complaint here.

Novo Nordisk Inc. et al. v. Paddock
Laboratories, Inc.
0:10-cv-02199; filed May
28, 2010 in the District Court of Minnesota

• Plaintiffs: Novo Nordisk Inc.; Novo Nordisk A/S
• Defendant: Paddock Laboratories, Inc.

Infringement of U.S.
Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004)
following a Paragraph IV certification as part of Paddock's filing of an ANDA
to manufacture a generic version of Novo Nordisk's Prandin® (repaglinide, used
to treat non-insulin dependent diabetes mellitus in combination with
metformin). View the complaint here.

Bayer Healthcare Pharmaceuticals
Inc. v. Biogen Idec Inc.
2:10-cv-02734; filed May
27, 2010 in the District Court of New Jersey

Declaratory judgment of
invalidity and non-infringement of U.S. Patent No. 7,588,755 ("DNA
Sequences, Recombinant DNA Molecules and Process for Producing Human Fibroblast
Interferon-like Polypeptides," issued September 15, 2009) based on Bayer's
manufacture and sale of its Betaseron® product. View
the complaint here.

Magnachem International
Laboratories, Inc. v. Kappos
1:10-cv-00892; filed May
26, 2010 in the District Court of the District of Columbia

Review and correction of
the patent term adjustment calculation made by the U.S. Patent and Trademark
Office for U.S. Patent No. 7,323,495 ("Synthetic Lactone Formulations and
Method of Use," issued January 29, 2008). View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Actavis
Inc. et al.
2:10-cv-02795; filed May
24, 2010 in the District Court of New Jersey

• Plaintiffs: Sanofi-Aventis U.S. LLC; Aventisub II
INC.; Carderm Capital L.P.
• Defendants: Actavis Inc.; Actavis Mid Atlantic LLC

Infringement of U.S.
Patent Nos. 6,399,632 ("Method of Providing an Antihistaminic Effect in a
Hepatically Impaired Patient," issued June 4, 2002), 6,187,791 (same
title, issued February 13, 2001), and 6,037,353 (same title, issued March 14,
2000), following a Paragraph IV certification as part of Actavis' filing of an
ANDA to manufacture a generic version of Aventis' Allegra® Oral Suspension
(fexofenadine hydrochloride oral suspension, used to treat allergies). View the complaint here.

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