Patent Docs

Business of Biosimilars Conference

July 9, 2010

The Institute for
International Research (IIR) will be holding its 2nd Annual Business of
Biosimilars conference from September 20-22, 2010 in Boston, MA. The conference will allow attendees to:

• Navigate
worldwide regulatory and legislative issues;
• Build strategic
partnerships with emerging markets;
• Adopt effective
IP and patent protection strategies for biosimilars;
• Evaluate
scientific implications of biosimilars to ensure safety, quality, and efficacy;
• Manage risk and
make investment decisions to ensure ROI;
• Obtain branding
strategies to differentiate a product on the market;
• Negotiate pricing
and reimbursement strategies with government and payers;
• Profit from
practical lessons in Canada and Europe's regulatory policies and market
experience; and
• Discuss evolving
consumer and physician perspectives on biosimilars.

In particular,
IIR's faculty will offer presentations on the following topics:

Full Day Symposium
— September 20:

• Understand
comparability criteria for biosimilar development;
• Minimize unwanted
immunogenicity issues for biosimilars to avoid adverse clinical consequences;
• Implement best
practices in immunogenicity testing for clinical safety and product
comparability; and
• Assembling the
Biologics License Application (BLA) for your biologic, biosimilar and
biobetter.

Day One of
Conference — September 21:

• Industry
landscape overview — Adapt to a changing marketplace;
• Government
perspective on current and pending legislation and the Administration's impact
on the biopharmaceutical industry;
• FDA perspective
on regulation in the U.S. and compliance abroad: Bioequivalence, safety and efficacy considerations;
• Lessons learned
from European regulatory policies and market experience;
• Canada's
regulatory perspective on biosimilars;
• Stakeholders
debate biosimilar regulations in the U.S. versus the global market;
• Competitive
economic landscape — Develop techniques to optimize your business model;
• Strategic
alliances in an era of globalization — How to find the right partner strategic
alliances in an era of globalization — How to find the right partner; and
• Worldwide
experience with biosimilar development.

IP Protection and
Patent Litigation Strategies for Biosimilars — Dinner Workshop — September
21:

• Prepare your
patent portfolio — to be presented by Patent
Docs author Donald Zuhn;
• Develop offensive
and defensive strategies to prepare your company for patent disputes; and
• Assess the impact
of past and current cases on the biopharmaceutical industry.

Day Two of
Conference — September 22:

• Wall street
address: Making biosimilar
investment decisions;
• Meet payer needs
— Formulary placement and pricing and reimbursement strategies;
• Evolving
physician and consumer perspectives on biosimilars;
• Develop a
strategy to ensure a successful biosimilar product launch;
• Industry insights
of the EPO market; and
• The future of
biosimilars and the biopharmaceutical industry.

A complete brochure
for this conference, including an agenda, list of speakers, descriptions of the
scheduled presentations, and registration information can be downloaded here.

The registration
fee for this conference is $2,195 (conference only), $2,595 (conference and
dinner workshop), $2,895 (conference and symposium), or $3,095 (conference,
dinner workshop, and symposium).
Those registering before July 30, 2010 will receive a $400 discount, and
those registering before August 27, 2010 will receive a $300 discount. Those interested in registering for the
conference can do so here, by
calling 1-888-670-8200, or by sending an e-mail to register@iirusa.com.
Biotech/Pharma Docket

July 8, 2010

By
James DeGiulio —

Sanofi,
Abbott Successfully Request Sanctions against Glenmark in Tarka Dispute

Sanofi
and Abbott were successful in their request for sanctions against Glenmark in
their patent suit over Tarka, after it was found that Glenmark destroyed evidence
relevant to the impending litigation.

The
dispute began in October 2007, when Glenmark notified Abbott and Sanofi that it
had filed an ANDA for 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 infringement of U.S. Patent No. 5,721,244 patent
which covers Tarka (see "Court
Report," December 16, 2007). Recently, Abbott and Sanofi asked the District Court to preliminarily enjoin and temporarily restrain Glenmark from selling
generic versions of Tarka, but the Court ruled against the injunction (see "Biotech/Pharma Docket,"
June 10, 2010).

In
a July 1 order, Judge Dennis Cavanaugh of the U.S. District Court for the
District of New Jersey found that Glenmark had destroyed evidence relevant to
the reasonably foreseeable litigation associated with filing an ANDA. Prior to implementing any litigation
holds, Glenmark practiced systematic document destruction. The plaintiffs argued that a litigation
hold arises as soon as a company decides to create a generic of a drug with an
unexpired patent. Glenmark claimed
its duty to impose a litigation hold did not arise until its ANDA filing. Judge
Cavanaugh refused to find that a litigation hold arises as early as a company's
decision to create a generic drug, but also found that the litigation hold
arises before the ANDA filing, depending on the facts in the case.

Judge
Cavanaugh also rejected Glenmark's claim that certain documents were privileged
under the work-product doctrine, and issued sanctions on Glenmark for its destruction. The amount of the sanctions was not disclosed in the order.

Judge
Cavanaugh's sanction order can be found here.

Seven
Actions Related to Enzo's Patents for Detecting DNA Stayed Pending Supreme
Court Review

Seven
suits over Enzo Biochem Inc.'s patents claiming methods of detecting nucleic
acids were stayed while Applera Corp. petitions the U.S. Supreme Court to
decide the validity of the patents. The asserted patents involve the technology
of labeling, hybridizing and detecting nucleotides for use in assaying diseases
in a sample of blood.

The
stayed suits, which were brought in the Southern District of New York between
2002 and 2004, include five infringement actions brought by Enzo, as well as
two brought by Affymetrix and Roche seeking declaratory judgments of
noninfringement and invalidity of the patents-in-suit, which are U.S. Patent Nos.
4,711,955, 5,328,824, 5,449,767, 5,476,928, 5,241,060, 5,175,269, 4,707,440,
and 4,994,373. The seven cases were initially stayed in March 2009, when Enzo
appealed a District of Connecticut decision invaliding four of the patents to
the Federal Circuit. The Federal Circuit overturned the findings of
indefiniteness and anticipation on the '824 and '767 patents, and denied en
banc review (see Patent Docs report). On June 9, Applera
filed a motion to stay the suit while it petitioned the Supreme Court to
challenge the Federal Circuit's decision upholding the '824 and '767 patents.

On
June 30, Judge Richard J. Sullivan ruled that the seven suits can remain stayed
pending Applera's resolution of its pending petition for writ of certiorari
to the Supreme Court. Judge
Sullivan additionally ordered the other parties in the case — PerkinElmer Inc.,
Roche Diagnostics GmbH, Amersham PC, Molecular Probes Inc., Affymetrix Inc. and
Orchid Biosciences Inc. — to submit a follow-up joint status letter by July 28, notifying the District Court of any developments from the Supreme Court.

Judge
Sullivan's order can be found here.

Apotex's
Second Request for Reexamination of Plavix Patent Denied by USPTO

Bristol-Myers
Squibb Co. and Sanofi-Aventis SA bolstered their case against Apotex Inc. for
infringement of their patent covering Plavix, after the U.S. Patent and
Trademark Office denied Apotex's second request for reexamination of U.S. Patent No. 4,847,265.

Sanofi
sued Apotex in 2002, shortly after the generics maker filed an ANDA to market a
generic version of clopidogrel bisulfate, the active ingredient in Plavix. Apotex asserted that the '265 patent
was invalid due to obviousness, but both the District Court and the Federal
Circuit ruled against Apotex, upholding the patent claims. The Federal Circuit denied Apotex's
request for rehearing, and the U.S. Supreme Court denied its petition in
November 2009. Apotex sought to
stay the District Court infringement action in April, pending the results of
the reexamination by the USPTO, but this motion was denied. The infringement action is currently in the damages stage.

Apotex
first asked the USPTO for reexamination of the patent claims of the '265 patent
last year, seeking a finding of invalidity. The USPTO agreed to conduct the
first reexamination, but the agency upheld the claims in March. On April 5, Apotex filed a request for
a second reexamination. However,
on June 23, the USPTO decided that Apotex had raised no substantial new
question of patentability with respect to the '256 patent claims, and denied the
request for reexamination. The '265 patent is due to expire in November 2011.

James
DeGiulio has a doctorate in molecular biology and genetics from
Northwestern University and is a graduate of Northwestern University
School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be
contacted at degiulio@mbhb.com.
News from Abroad: European Gene Patent Scope Limited by Landmark EU Court Ruling

July 8, 2010

By Devanand Crease —

The much anticipated ruling in Monsanto Technology v Cefetra (Case C-428/08) has now issued and confirms the earlier indications that within the European Union (EU) patent protection for gene sequences only extends to material in which the patented gene is actually performing its function. In Monsanto's case (European Patent No. 0 546 090), claims to an isolated herbicide resistance gene sequence were not held to extend to cover soya meal derived from transgenic plants and containing trace amounts of the patented gene, because the residual genetic material was not actually performing its intended function in the soya meal.

The Court of Justice of the EU handed down its ruling following a referral from a Dutch Court. Determination of whether soya meal from Argentina, where Monsanto did not have patent protection, infringed Monsanto's European gene patents when imported into Europe revolved around interpretation of Article 9 of Directive 98/44/EC (the "Biotech Directive").

Article 9 of the Biotech Directive states:

The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material . . . in which the product is incorporated and in which the genetic information is contained and performs its function.

The European Court took the view that because it is a requirement to disclose the function of a DNA sequence for it to be patentable, it follows that the patented DNA must be able to perform its function in the material in which it is incorporated in order to benefit from that patent protection.

The judgment applies to all patented gene claims within the European Union and, thus, applies to patents granted in the UK, Germany, and France amongst others. The judgment also has retroactive effect even to patents filed before implementation of the Biotech Directive into national laws.

Dr. Crease is a Partner at Keltie in London, UK.
House Slips Pay-For-Delay Provision into Appropriations Bill

July 7, 2010

By
Donald Zuhn —

Ordinarily,
the passage of a supplemental appropriations bill would likely go
unnoticed by those in the pharmaceutical industry. Last week, however, the House of Representatives passed the "2010 Supplemental
Appropriations Act" (H.R. 4899) after inserting a provision (among a host
of other provisions) that would allow the Federal Trade Commission (FTC) to
"initiate a proceeding . . . against the parties to any agreement
resolving or settling, on a final or interim basis, a patent infringement
claim, in connection with the sale of a drug product," wherein the
agreement has "anticompetitive effects." The pay-for-delay or reverse payment provision, entitled the
"Preserve Access to Affordable Generics Act," also provides a number
of factors to be considered when determining whether an agreement has
anticompetitive effects.

The full text of the House amendment
to the appropriations bill has been made available on the House Committee for
Appropriations website. According to an Intellectual Property
Organization Association (IPO) report,
the House pay-for-delay provision is "almost identical" to the
standalone "Preserve Access to Affordable Generics Act" (S.369)
introduced by Sen. Herb Kohl (D-WI) in February of 2009 (see "Bill to Prohibit Reverse Payments Introduced in the
Senate"). The Senate bill states that
"settlements which include a payment from a brand name manufacturer to a
generic manufacturer to delay entry by generic drugs are anti-competitive and
contrary to the interests of consumers," and therefore, was intended "to
prohibit payments from brand name to generic drug manufacturers with the
purpose to prevent or delay the entry of competition from generic drugs."

In
a press release
issued by the House Committee on Appropriations, the Committee noted that the
House amendment would add an extra $22.8 billion to the Senate appropriations bill,
which would provide a total of $45.5 billion in discretionary funding for FY 2010. According to the Committee's release,
the Senate's $45.5 billion would include $37.12 billion for U.S. troops in Iraq
and Afghanistan, $5.1 billion for FEMA disaster relief, $2.9 billion for Haiti,
$162 million for the Gulf Coast oil spill, $13 billion in mandatory funding for
Vietnam veterans exposed to Agent Orange, and over $600 million for other
domestic needs. The $22.8 billion
provided by the House amendment would provide $10 billion for an Education
Jobs Fund to help save 140,000 education jobs for the next school year, funding
for Pell Grants, summer youth jobs, the Pigford and Cobell settlements, border
security, innovative technology energy loans, schools on military
installations, additional Gulf Coast oil spill funding, emergency food
assistance, a new soldier processing center at Fort Hood, and program integrity
investments. The House amendment
also calls for $23.5 billion in offsets to hold spending over the next ten years
to the level requested by President Obama.

The
House Committee on Appropriations also provides a summary
of the House amendment on its website. Among
the "Other Provisions" slipped into the bill via the House amendment is the Preserving Access
to Affordable Generic Drugs provision, which the Committee contends will:

[S]trengthen
the Federal Trade Commission's ability to restrict lucrative "pay for
delay" payments by brand-name drug manufacturers to their generic
competitors to delay the manufacture and marketing of more affordable generic
drugs to consumers. In 2009, an
FTC study found that a ban on these lucrative sweetheart drug industry deals
would save American consumers $35 billion over 10 years. CBO estimates that with the provision
in this bill, the federal government will save more than $2.4 billion over 10
years in lower drug costs for Medicare, Medicaid, military and veterans' health
programs.

The
IPO noted in its report on the House appropriations amendment that the
organization opposes legislation banning pay-for-delay agreements because "existing
antitrust case law is sufficient to protect competition against the improper
expansion of a patent owner's right to exclude as a result of a settlement." A recent Patent Docs series on pay-for-delay agreements reaches a similar
conclusion (see "Reverse
Payments in Generic Drug Settlements" – Part I,
Part II,
Part III,
Part IV). The IPO also notes in its report that
the Senate is likely to take up the appropriations bill, with the House amendment,
after returning from its July 4th recess on July 12.

On
Friday, the Generic Pharmaceutical Association (GPhA) released
a statement saying that the organization was "extremely disappointed that the
U.S. House of Representatives adopted language in the War Funding Bill (H.R.
4899) that will delay consumer access to affordable medicines by severely
restricting drug patent litigation settlements." Noting that "[m]ore than a decade of evidence shows
that patent settlements actually help bring lower-cost generic drugs to market
much sooner than patent expiration dates," the GPhA declared that "add[ing]
a drug patent settlement restriction to the must-pass War Funding Bill is a
clear display of politics over policy." The group warned that "[t]he unintended consequence of
these restrictions on settlements will significantly harm the millions of
Americans who rely on generic drugs and are awaiting the availability of new
generics," and urged the Senate to remove the provision and instead give
it the "serious, thoughtful consideration" it deserves.
AMP v. USPTO after Bilski v. Kappos

July 6, 2010

By Kevin
E. Noonan —

After
issuing its decision in Bilski v. Kappos,
the Supreme Court granted certiorari,
vacated the Federal Circuit's decision below, and remanded to the appellate
court two cases related to medical diagnostic claims: Prometheus
Laboratories, Inc. v. Mayo Collaborative Services and Classen
Immunotherapies, Inc. v. Biogen Idec. These cases have the
most-developed case law regarding the question of patent-eligibility for
diagnostic method claims, and thus can be expected to provide the Federal
Circuit with ample opportunity to craft the type of analytical framework
envisioned by the Supreme Court when it left the development of the law in this
area to the Federal Circuit (in the first instance, at least).

It is
another case, however, that may provide the first instance for the Federal
Circuit to "make law" under Bilski v. Kappos. That case is Association
of
Molecular Pathology v. U.S. Patent and Trademark Office (aka the Myriad
case). As a reminder, method
claims from the following U.S. Patents were invalidated by the District Court
Judge Robert W. Sweet's decision: U.S. Patent Nos. 5,747,282; 5,709,999; 5,710,001; 5,753,441;
and 6,033,857. These patents are assigned to Myriad Genetics, the University of Utah Research
Foundation, and the National Institutes of Health (the '282, '001 and '441
patents); Myriad Genetics, Centre de Recherche du Chul, and the Japanese Cancer
Institute (the '999 patent); and Myriad Genetics, Endo Recherche, HCS R&D
Ltd. Partnership, and the University of Pennsylvania (the '857 patent). All but the '857 patent claims priority to an application filed August 12,
1994; all but the '857 patent will expire (upon timely payment of
maintenance fees) in 2015 (the '857 patent expires March
2017).

The
following method claims have (for now) been invalidated:

For the '282
patent:

20.
A method for screening potential cancer therapeutics which comprises:
growing a transformed eukaryotic host cell containing an altered BRCA1 gene
causing cancer in the presence of a compound suspected of being a cancer
therapeutic, growing said transformed eukaryotic host cell in the absence of
said compound, determining the rate of growth of said host cell in the presence
of said compound and the rate of growth of said host cell in the absence of
said compound and comparing the growth rate of said host cells, wherein a
slower rate of growth of said host cell in the presence of said compound is
indicative of a cancer therapeutic.

For the '999
patent:

1.
A method for detecting a germline alteration in a BRCA1 gene, said alteration
selected from the group consisting of the alterations set forth in Tables 12A,
14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or
BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from
mRNA from said human sample with the proviso that said germline alteration is
not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ
ID NO:1.

For the '001
patent:

1.
A method for screening a tumor sample from a human subject for a somatic
alteration in a BRCA1 gene in said tumor which comprises comparing a first
sequence selected form the group consisting of a BRCA1 gene from said tumor
sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from
said tumor sample with a second sequence selected from the group consisting of
BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor
sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a
difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said
tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from
said nontumor sample indicates a somatic alteration in the BRCA1 gene in said
tumor sample.

For the '441
patent:

1.
A method for screening germline of a human subject for an alteration of a BRCA1
gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA
from a tissue sample from said subject or a sequence of BRCA1 cDNA made from
mRNA from said sample with germline sequences of wild-type BRCA1 gene,
wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the
sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from
wild-type indicates an alteration in the BRCA1 gene in said subject.

And for
the '857 patent:

1.
A method for identifying a mutant BRCA2 nucleotide sequence in a suspected
mutant BRCA2 allele which comprises comparing the nucleotide sequence of the
suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence,
wherein a difference between the suspected mutant and the wild-type sequences
identifies a mutant BRCA2 nucleotide sequence.

2. A
method for diagnosing a predisposition for breast cancer in a human subject
which comprises comparing the germline sequence of the BRCA2 gene or the
sequence of its mRNA in a tissue sample from said subject with the germline
sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an
alteration in the germline sequence of the BRCA2 gene or the sequence of its
mRNA of the subject indicates a predisposition to said cancer.

If
the Federal Circuit merely applies the rubrics (such as they may be) of the
Supreme Court's Bilski decision to
these claims, it seems that only claim 20 of the '282 patent clearly falls
within the scope of the machine-or-transformation (MOT) test. The claim requires growth of
transformed human cell in the presence or absence of a test compound. "Transformation" (or to put
it another way, "the hand of man") could be found either in the
production of a transformed eukaryotic host cell or the growth of such a cell in the presence of a test compound. Since neither the transformed host cell (which should remain patentable per se under the Court's Chakrabarty decision) nor growth in the
presence of a test compound would occur without human intervention, recitation
of these elements in the claim could be enough for the Federal Circuit to
reverse the District Court's decision based on principles enunciated by the
Supreme Court in Bilski and other
precedent. This result would also
serve not to "disturb the settled expectations of the patent community" (Festo Corp. v. Shoketsu Kinzoko Kogyo Kabutshiki Co., 122 S. Ct. 1831, 1841 (2002)), since such claims are not unique to this
patent but form the basis for many screening method patents (see, for example, U.S. Patent Nos.
7,736,862; 7,727,731; 7,700,822; 6,960,558; 6,682,920; and 5,344,846, as well
as 1760 other such patents).

The other
claims may not fare as well, in view of language that tracks more closely with
the claims in the patents at issue in the Classen
and Laboratory
Corp. v. Metabolite Labs., Inc. (LabCorp) cases (thereby raising
issues relating to form and substance in determining whether an invention is
patent-eligible). Each of Myriad's
remaining claims invalidated by the District Court recite "comparing"
steps that are not expressly tied to determining the genetic sequence of an
individual's BRCA1 or BRCA2 genes. Specifically:

• "analyzing
a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a
sequence of BRCA1 cDNA made from mRNA from said human sample" (claim 1, '999
patent)

• "comparing
a first sequence selected form the group consisting of a BRCA1 gene from said
tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA
from said tumor sample with a second sequence selected from the group
consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from
said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample"
(claim 1, '001 patent)

• "comparing
germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said
subject or a sequence of BRCA1 cDNA made from mRNA from said sample with
germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type
BRCA1 cDNA" (claim 1, '441 patent)

• "comparing
the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type
BRCA2 nucleotide sequence" (claim 1, '857 patent)

• "comparing
the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue
sample from said subject with the germline sequence of the wild-type BRCA2 gene
or the sequence of its mRNA" (claim 2, '857 patent)

Arguments could
certainly be made that in each case the patient sample sequence must be
determined, which would involve the "transformative" steps of obtaining
the sequence (involving inter alia
cloning or amplifying patient-specific genomic or cDNA and sequencing the DNA,
all involving multiple chemical transformations). However, the question may be framed with regard to whether
these claims require such transformative steps, or whether they are broad
enough to encompass mere comparison of sequences previously obtained; under this analysis, the sequence steps
may be viewed as mere "data gathering" and hence not satisfy the MOT
test.

Alternatively,
even if these claims are not sufficiently transformative to satisfy the MOT
test, the Supreme Court's Bilski decision provides another avenue for the
Federal Circuit to reverse the District Court's decision that these claims are
not patent-eligible. This analysis
comes from the portion of the majority opinion (joined by Justice Scalia)
instructing that its prior precedent (specifically the Benson/Flook/Diehr trilogy) reinforced the principle
that abstract ideas are not patent-eligible subject matter. The task for the Federal Circuit, then,
would be to determine whether these Myriad claims were sufficiently broad to
claim an abstract idea or a "broad concept" that would "wholly pre-empt"
a law of nature, or as in Diehr be "an application of a law of nature"
to a process and thus be worthy of patent protection.

One distinction
that can be drawn in this regard is that in Bilski (and Diehr) the "law
of nature" (hedging in Bilski, the Arrhenius equation in Diehr) were known in the prior art; indeed, the majority opinion in Bilski found that Bilski's claims were
directed towards "basic concept of hedging, or protecting against risk: 'Hedging is
a fundamental economic practice long prevalent in our system of commerce and
taught in any introductory finance class,'" citing (now Chief) Judge Rader's
dissent in In re Bilski, 545 F. 3d,
at 1013. In Myriad's claims the "law
of nature," the presence of a specific mutation at a specific position in
the nucleotide sequence of the BRCA1 or BRCA2 gene, was unknown prior to its elucidation by the Myriad inventors. (On the other hand, a claim to a single
nucleotide polymorphism (or SNP) itself could encompass the "natural
phenomenon" or "law of nature" itself and have precisely the
preclusive effect disparaged by the Court in Bilski and earlier precedent.)

It is clear that Myriad's method claims raise many of the same
issues of patent-eligibility as in Classen
and LabCorp. How the Federal Circuit resolves those
issues, and whether the Supreme Court is more willing to let the Federal
Circuit make these decisions under Chief Judge Rader than it was under Chief
Judge Michel, will determine the extent to which genetic diagnostic claims
remain patent-eligible. And
consequently whether "unforeseen innovations," like personalized
medicine, will be developed under the patent regime (with enabling disclosure
attendant thereto) or be limited to alternative protections (such as trade secret)
for which disclosure is antithetical and with all the resulting costs and
disadvantages thereof. Which path
is taken will determine the rate, scope, and benefits of such new technology for
at least a generation.
Court Report

July 5, 2010

By Sherri
Oslick —

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

Genzyme Corp. v. Impax Laboratories, Inc.
1:10-cv-01791; filed July 1, 2010 in the District
Court of Maryland

Genzyme Corp. v. Sandoz, Inc.
1:10-cv-01715; filed June 25, 2010 in the District
Court of Maryland

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent No. 5,667,775 ("Phosphate-Binding Polymers for Oral Administration,"
issued on September 16, 1997) following a Paragraph IV certification as part of
defendants' filing of an ANDA to manufacture a generic version of Genzyme's
Renvela® (sevelamer carbonate, used for the control of serum phosphorus in
patients with chronic kidney disease on dialysis). View the Sandoz complaint here.

Wyeth, LLC v. Intellipharmaceutics International Inc. et al.
1:10-cv-05072; filed July 1, 2010 in the Southern
District of New York

• Plaintiff: Wyeth, LLC
• Defendants: Intellipharmaceutics International
Inc.; Intellipharmaceutics Corp.; Intellipharmaceutics Ltd.

Wyeth LLC v. Intellipharmaceutics International Inc. et al.
1:10-cv-00561; filed June 30, 2010 in the District
Court of Delaware

• Plaintiff: Wyeth LLC
• Defendants: Intellipharmaceutics International
Inc.; Intellipharmaceutics Corp.; Intellipharmaceutics Ltd.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. 6,274,171 ("Extended release formulation of venlafaxine
hydrochloride," issued August 14, 2001), 6,403,120 (same title, issued
June 11, 2002), and 6,419,958 (same title, issued July 16, 2002) following a
Paragraph IV certification as part of Intellipharmaceutics' filing of an ANDA
to manufacture a generic version of Wyeth's EFFEXOR® XR (venlafaxine
hydrochloride, extended release, used to treat depression). View the Delaware complaint here.

Merck Sharp & Dohme Corp. v. Kappos
1:10-cv-01110; filed June 30, 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.
7,326,708 ("Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor,"
issued February 5, 2008). View the
complaint here.

Eli Lilly and Company v. Actavis Totowa LLC et al.
1:10-cv-00836; filed June 30, 2010 in the Southern
District of Indiana

• Plaintiff: Eli Lilly and Company
• Defendants: Actavis Totowa LLC; Actavis Elizabeth
LLC

Infringement of U.S. Patent No. 5,464,826 ("Method
of Treating Tumors in Mammals with 2',2'-difluoronucleosides," issued
November 7, 1995) following a Paragraph IV certification as part of Actavis'
filing of an ANDA to manufacture a generic version of Lilly's Gemzar® (gemcitabine
hydrochloride for injection, used to treat non-small cell lung cancer,
pancreatic cancer, breast cancer, and ovarian cancer). View the complaint here.

Celsis In Vitro, Inc. v. CellzDirect, Inc. et al.
1:10-cv-04053; filed June 29, 2010 in the Northern
District of Illinois

• Plaintiff: Celsis In Vitro, Inc.
• Defendants: CellzDirect, Inc.; Invitrogen
Corp.

Infringement of U.S. Patent No. 7,604,929 ("Novel
Cellular Compositions and Methods for Their Preparation," issued October
20, 2009) based on defendants' use in drug testing services and sale of pooled
multi-cryopreserved hepatocyte products produced from infringing processes and
methods. View the complaint here.

Schering Corp. et al. v. Mylan Pharmaceuticals Inc. et
al.
1:10-cv-00099; filed June 29, 2010 in the Northern
District of West Virginia

• Plaintiffs: Schering Corp.; MSP Singapore
Co., LLC
• Defendants: Mylan Pharmaceuticals Inc.; Mylan,
Inc.

Infringement of U.S. Patent Nos. RE37,721 ("Hydroxy-substituted
Azetidinone Compounds Useful as Hypocholesterolemic Agents," issued May 8,
2002) and 5,846,966 ("Combinations of Hydroxy-Substituted Azetidinone
Compounds and HMG CoA Reductase Inhibitors," issued December 8, 1998)
following a Paragraph IV certification as part of Mylan's filing of an ANDA to
manufacture a generic version of Plaintiffs' Zetia® (ezetimib, used to treat
elevated cholesterol levels). View
the complaint here.

Abbott Laboratories et al. v. Mylan Inc. et al.
1:10-cv-00559; filed June 28, 2010 in the District
Court of Delaware

• Plainitffs: Abbott Laboratories; Abbott
Respiratory LLC
• Defendants: Mylan Inc.; Mylan Pharmaceuticals
Inc.

Infringement of U.S. Patent Nos. 6,129,930 ("Methods
and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia
at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release
Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary
Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for
Reducing Flushing in Individuals Being Treated with Nicotinic Acid for
Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate
Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique
Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic
Component Free Sustained Release Nicotinic Acid Compositions for Treating
Hyperlipidemia and Related Methods Therefor," issued March 14, 2006),
6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating
Hyperlipidemia," issued November 16, 2004), 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 Mylan's filing of an ANDA to manufacture a generic
version of Abbott's Simcor® (niacin extended release / simvastatin tablets,
used to treat hypercholesterolemia). View the complaint here.

Pfizer Inc. et al. v. Mylan Inc. et al.
2:10-cv-03246; filed June 24, 2010 in the District
Court of Delaware

• Plaintiffs: Pfizer Inc.; Pharmacia & Upjohn Co., LLC; Pfizer Health AB
• Defendants: Mylan Inc.; Mylan Pharmaceuticals Inc.

Pfizer Inc. et al. v. Sandoz, Inc.
2:10-cv-03250; filed June 24, 2010 in the District
Court of Delaware

• Plaintiffs: Pfizer
Inc.; Pharmacia & Upjohn Co., LLC; Pfizer Health AB
• Defendant: Sandoz, Inc.

The complaints in these cases are substantially
identical. 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 defendants' 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 Mylan complaint here.

United States of America et al. v. University Medical
Pharmaceuticals Corp.
1:10-cv-00462; filed June 24, 2010 in the Western
District of Texas

• Plaintiffs: United States of America Ex. Rel. Zach Hallstrom
• Defendants: University Medical Pharmaceuticals
Corp.

False marking of certain of defendants' acne
treatment products as containing "patented time-released benzoyl peroxide"
when no such patent exists. View
the complaint here.
Conference & CLE Calendar

July 5, 2010

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
8, 2010 – Bilski Decision (Intellectual Property Owners Association) – 2:00
PM (EDT)

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

July 22, 2010 – "Protect
Your
Patents from Inequitable Conduct Charges" (Technology
Transfer
Tactics) – 1:00
– 2:30 PM (EDT)

July 26-27, 2010 – Advanced
Patent
Prosecution Workshop 2010: Claim Drafting & Amendment Writing (Practising
Law
Institute) – New
York, NY

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

August
5-10, 2010 – 2010
ABA Annual Meeting (American
Bar
Association) – San
Francisco, CA

August
16-17, 2010 – Advanced
Patent
Prosecution Workshop 2010: Claim Drafting & Amendment Writing (Practising
Law
Institute) – San
Francisco,
CA

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

August
25-26, 2010 – FDA
Boot Camp***
(American
Conference
Institute) – San
Francisco, CA

September
1-2, 2010 – 7th
Annual Pharmaceutical Law Summer School (IBC
Legal) – London, UK

September
12-14, 2010 – 2010
Annual Meeting (Intellectual
Property Owners Association) – Atlanta,
GA

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

September
16, 2010 – Developments
in
Pharmaceutical and Biotech Patent Law 2010 (Practising
Law
Institute) – New
York,
NY (Groupcasts to be held in Philadelphia, PA; Pittsburgh,
PA;
Mechanicsburg, PA; New Brunswick, NJ; and Boston, MA)

September
22-23, 2010 – Biosimilars
& Biobetters: Aligning
Business & Science for Success*** (SMi
Conferences) – London, UK

***Patent Docs is a media partner of this conference or CLE
IPO 2010 Annual Meeting

July 4, 2010

The Intellectual
Property Owners Association (IPO) will be holding its 2010 Annual Meeting on
September 12-14, 2010 in Atlanta, GA.
Among the presentations being offered at the annual meeting are:

• Major recent
updates impacting patent law:
Changes in the landscape;
• False marking of
patent numbers: Litigation spike
or continuing issue?
• The sum of all
fears: Compulsory licensing as an
emerging global IP issue;
• Recent trends in
European practice;
• A new patent
dance: The Biologics Price
Competition and Innovation Act;
• Patent
prosecution;
• Alternatives to
District Court litigation;
• Establishing an
objective value of IP;
• Practical tips
for policing IP portfolios around the world; and
• Ethics session.

In addition, the
Hon. Randall R. Rader, Chief Judge of the U.S. Court of Appeals for the Federal
Circuit, will present the luncheon keynote on September 13, and Kevin Kennedy,
President & CEO of Avaya, Inc., will present the luncheon keynote on
September 14.

A preliminary
program for the meeting and one-day program, including an agenda and
descriptions of the scheduled sessions, can be obtained here. The brochure for the meeting is not yet
available.

The registration
fee for the meeting is $950 for IPO members or $1,450 for attendees who are not
IPO members (attendees registering before July 31 will receive a $100
discount). Those interested in
registering for the meeting can do so here.
PLI Developments in Pharmaceutical and Biotech Patent Law Seminar

July 4, 2010

Practising Law
Institute (PLI) will be holding a seminar entitled "Developments in
Pharmaceutical and Biotech Patent Law 2010" on September 16, 2010 in New
York, NY. Groupcasts
of the New York session will also be held in Philadelphia, PA; Pittsburgh, PA;
Mechanicsburg, PA; New Brunswick, NJ; and Boston, MA. At the
seminar, PLI faculty will discuss:

• The top
pharmaceutical and biotech decisions from 2010;
• Continued
developments in the law governing the patentability of active pharmaceutical
products from the Federal Circuit and District Court perspectives;
• Section 112
developments regarding enablement and written description requirements and how
they apply to compounds, antibodies, nucleic acids, methods of treatment, and
pharmaceutical compositions;
• Section 101
developments on utility and patentable subject matter; and
• How to integrate
changes in the law from 2010 into prosecution strategies and practices.

In particular, PLI
faculty will offer presentations on the following topics:

• Section 101: Redefining patentable subject matter
and utility and the impact on pharmaceutical and biotech patents;
• The age of
written description and enablement;
• Navigating
follow-on biologics legislation;
• Maximizing patent
term: Pointers & pitfalls;
• Recent
developments in the law of patent remedies; and
• Recent changes in
patent prosecution practice.

A detailed program
for the Developments in Pharmaceutical and Biotech Patent Law seminar can be
found here.
The registration fee for the seminar is $1,495. Those interested in
registering for the conference can do so here (New York). Those interested in
registering for the Groupcasts can do so here (Philadelphia, PA), here
(Pittsburgh, PA), here (Mechanicsburg, PA), here (New Brunswick, NJ), or here
(New Brunswick, NJ).
Pharmaceutical Law Summer School

July 4, 2010

IBC Legal will be
holding its 7th Annual Pharmaceutical Law Summer School on September 1-2, 2010
in London. IBC faculty will offer
presentations on the following topics:

• Deal-making in
the pharmaceutical industry — The state of the market;
• Critical
developments in patenting pharmaceuticals and medical devices;
• Combating
counterfeit products and parallel trade;
• Regulatory
round-up: A pan-European
perspective;
• Paediatric &
orphan medicines regulations;
• The U.S. Health
Care Reform Act;
• Successful and
compliant clinical trials;
• Competition law
in the wake of the sector enquiry;
• Marketing and
promotion of prescription medicines;
• Anti-bribery
rules and the pharmaceutical industry;
• Product
liability;
• Contracts and
pharmaceutical law: Early
licensing and R&D;
• Pricing and
reimbursement challenges across Europe;
• The regulator's
perspective;
• Dispute
resolution in the pharmaceutical sector:
NICE case study; and
• Panel
discussion: The future of pharmaceutical
law and regulation.

A complete brochure
for this conference, including an agenda, session descriptions, list of
speakers, and registration form can be obtained here.

The registration
fee is £1761.33 ($2,673.54) for the conference. Attendees registering before August 6, 2010 will receive a
£100 ($151.79) discount. Those
interested in registering for the conference can do so here.