Patent Docs

Court Report

February 8, 2010

By Sherri Oslick —

A
note to our readers: In an effort to catch up with recently filed
biotech and pharma cases following a brief hiatus, Patent Docs presents this additional installment of Court Report.

Eli Lilly and Company v. Fresenius Kabi Oncology PLC
1:10-cv-00147; filed February 4, 2010 in the
Southern District of Indiana

Infringement of U.S. Patent Nos. 4,808,614 ("Difluoro
Aantivirals and Intermediate Therefore," issued February 18, 1989) and
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 Fresenius'
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.

Pfizer Inc. et al. v. Mylan Pharmaceuticals Inc.
1:10-cv-00085; filed February 3, 2010 in the
District Court of Delaware

• Plaintiffs: Pfizer Inc.; Pfizer Pharmaceuticals LLC; Pfizer Ireland
Pharmaceuticals; Pfizer Ltd.; CP Pharmaceuticals International CV
• Defendant: Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent No. 6,455,574 ("Therapeutic
Combination," issued September 24, 2002) following Mylan's filing of an
ANDA to manufacture a generic version of Pfizer's Caduet® (atorvastatin calcium
– the active ingredient in Lipitor®, and amlodipine besylate – the active
ingredient in Norvasc®, used to treat high cholesterol in combination with
treating hypertension, angina, and/or coronary artery disease). View the complaint here.

Celsis In Vitro, Inc. v. Xenotech, LLC et al.
1:10-cv-00681; filed February 1, 2010 in the
Northern District of Ilinois

• Plaintiff:
Celsis In Vitro, Inc.
• Defendants: Xenotech, LLC; Sekisui Chemical Co. Ltd.; Sekisui Medical Co.
Ltd.

Infringement of U.S. Patent No. 7,604,929 ("Cellular
Compositions and Methods for Their Preparation," issued October 20. 2009)
based on defendants' manufacture and sale of hepatocyte products, such as
CryoXTreme, as well as providing in vitro
drug testing services using pooled cryopreserved
hepatocytes. View the complaint here.

Alcon Research, Ltd. et al. v. Sandoz Inc.
1:10-cv-00106; filed January 27, 2010 in the
Southern District of Indiana

• Plaintiffs: Alcon Research, Ltd.; Alcon Laboratories, Inc.; Alcon
Pharmaceuticals, Ltd.; Kyowa Hakko Kirin Co., Ltd.
• Defendant: Sandoz Inc.

Infringement of U.S. Patent Nos. 5,641,805 ("Topical
Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June
24, 1997), 6,995,186 ("Olopatadine Formulations for Topical
Administration," issued on February 7, 2006), and 7,402,609 (same title,
issued July 22, 2008) following a Paragraph IV certification as part of Sandoz's
filing of an ANDA to manufacture a generic version of Alcon's Pataday®
(olopatadine hydrochloride ophthalmic solution, used to treat ocular itching
associated with allergic conjunctivitis). View the complaint here.

Abbott Laboratories et al. v. Teva Pharmaceutical Industries
Ltd. et al.
1:10-cv-00057; filed January 22, 2010 in the
District Court of Delaware

• Plaintiffs: Abbott Laboratories; Abbott Respiratory LLC
• Defendants: Teva Pharmaceutical Industries Ltd.; Teva Pharmaceuticals USA
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 Teva'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.

Takeda Pharmaceutical Co. et al. v. Aurobindo
Pharma Ltd. et al.
2:10-cv-00319; filed January 19, 2010 in the
District Court of New Jersey

• Plaintiffs: Takeda Pharmaceutical Co.; Takeda Pharmaceuticals
North America, Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Takeda Pharmaceutical Company Limited et al. v. Aurobindo
Pharma Limited et al.
1:10-cv-00247; filed January 13, 2010 in the
Southern District of New York

• Plaintiffs: Takeda Pharmaceutical Co.; Takeda Pharmaceuticals
North America, Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October
12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same
title, issued December 26, 2000), 6,172,090 (same title, issued January 9,
2001), 6,211,205 (same title, issued April 3, 2001), 6,271,243 (same title,
issued August 7, 2001), and 6,303,640 (same title, issued October 16, 2001)
following a Paragraph IV certification as part of Torrent's filing of an ANDA
to manufacture a generic version of Takeda's Actos® (pioglitazone
hydrochloride, used to treat type II diabetes). View the New Jersey complaint here.

Ortho-McNeil-Janssen Pharmaceuticals, Inc. v. Lupin
Pharmaceuticals, Inc. et al.
2:10-cv-00322; filed January 15, 2010 in the
District Court of New Jersey

• Plaintiff: Ortho-McNeil-Janssen Pharmaceuticals, Inc.
• Defendants: Lupin Pharmaceuticals, Inc.; Lupin Ltd.

Infringement of U.S. Patent No. 6,214,815 ("Triphasic
Oral Contraceptive," issued April 10, 2001) following a Paragraph IV
certification as part of Lupin's filing of an ANDA to manufacture a generic
version of Ortho-McNeil's Ortho Tri-Cyclen Lo® (norgestimate and ethinyl
estradiol, used for oral contraception). View the complaint here.
Court Report

February 7, 2010

By Sherri Oslick —

A note to our readers: Patent Docs apologizes to our readers for the recent Court Report hiatus. This Court Reporter was away at trial and has just now been able to come up for air. We will catch our readers up in the next few postings. Patent Docs thanks our readers for their patience.

Novartis AG v. Kappos
1:10-cv-00164; filed January 29, 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.
7,569,337 ("Coumarins Useful as Biomarkers," issued August 4,
2009). View the complaint here.

Cephalon, Inc. et al. v. Sandoz Inc.
1:10-cv-00175; filed January 26, 2010 in the
District Court of Colorado

• Plaintiffs: Cephalon, Inc.; Cephalon France
• Defendant: Sandoz Inc.

Cephalon Inc. et al. v. Sandoz Inc.
1:10-cv-00055; filed January 22, 2010 in the
District Court of Delaware

• Plaintiffs: Cephalon, Inc.; Cephalon France
• Defendant: Sandoz Inc.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. 7,297,346 ("Pharmaceutical Formulations of Modafinil,"
issued November 20, 2007), RE37,516 ("Acetamide Derivative Having Defined
Particle Size," issued January 15, 2002), and 7,132,570 ("Method for
the Production of Crystalline Forms of Optical Enantiomers of Modafinil,"
issued November 7, 2006) following a Paragraph IV certification as part of
Sandoz's filing of an ANDA to manufacture a generic version of Cephalon's
Nuvigil® (armodafinil, used to improve wakefulness in patients with excessive
sleepiness associated with obstructive sleep apnea/hypopnea syndrome,
narcolepsy, and shift work sleep disorder). View the Colorado complaint here.

Purdue Pharma Products LP et al. v. Anchen Pharmaceuticals Inc.
8:10-cv-00103; filed January 22, 2010 in the
Central District of California

• Plaintiffs: Purdue Pharma Products LP; Napp
Pharmaceutical Group LTD
• Defendant: Anchen Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,591,452 ("Controlled
Release Formulation," issued January 7, 1997) and 6,326,027 (same title,
issued December 4, 2001) following a Paragraph IV certification as part of
Anchen's filing of an ANDA to manufacture a generic version of plaintiffs'
Ryzolt® (controlled-release tramadol hydrochloride, used to treat moderate to
moderately severe chronic pain). View the complaint here.

Cephalon, Inc. v. Kappos
1:10-cv-00131; filed January 22, 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.
7,566,805 ("Modafinil Compositions," issued July 28, 2009). View the complaint here.

Purdue Pharma Products LP et al. v. Lupin Ltd. et al.
1:10-cv-00049; filed January 21, 2010 in the
District Court of Delaware

• Plaintiffs: Purdue Pharma Products LP; Napp
Pharmaceutical Group Ltd.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals
Inc.

Infringement of U.S. Patent Nos. 6,254,887 ("Controlled
Release Tramadol," issued July 3, 2001) and 7,074,430 ("Controlled
Release Tramadol Tramadol [sic] Formulation," issued July 11, 2006)
following a Paragraph IV certification as part of Lupin's filing of an ANDA to
manufacture a generic version of plaintiffs' Ultram® ER (tramadol
hydrochloride, used to treat moderate to moderately severe chronic pain). View the complaint here.

Galderma Laboratories LP et al. v. Tolmar Inc.
1:10-cv-00045; filed January 21, 2010 in the
District Court of Delaware

• Plaintiffs: Galderma Laboratories LP; Galderma
SA; Galderma Research and Development SNC
• Defendant: Tolmar Inc.

Infringement of U.S. Patent No. 7,579,377 ("Administration
of 6-[3-(1-adamantyl)-4methoxyphenyl]- 2-naphthoic Acid for the Treatment of Dermatological
Disorders," issued August 25, 2009) following a Paragraph IV certification
as part of Tolmar's filing of an ANDA to manufacture a generic version of
Galderma's Differin® gel (adapalene, used in the topical treatment of acne vulgaris). View the complaint here.

Pfizer Inc. et al. v. Teva Parenteral Medicines Inc. et al.
1:10-cv-00037; filed January 15, 2010 in the
District Court of Delaware

• Plaintiffs: Pfizer Inc.; Pharmacia Corp.;
Pharmacia & Upjohn Co.; Pharmacia & Upjohn LLC; Pharmacia &
Upjohn Co. LLC; C P Pharmaceuticals International CV
• Defendants: Teva Parenteral Medicines Inc.; Teva
Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 5,688,792 ("Substituted
Oxazine and Thiazine Oxazolidinone Antimicrobials," issued November 18,
1997) following a Paragraph IV certification as part of Teva's filing of an
ANDA to manufacture a generic version of Pfizer's Zyvox® (linezolid, used to
treat bacterial infections). View
the complaint here.

Boram Pharm. Co. Ltd. v. Life Technologies Corp.
1:10-cv-00031; filed January 14, 2010 in the
District Court of Delaware

Infringement of U.S. Patent No. 7,319,001 ("High
Throughput System for Producing Recombinant Viruses Using Site-Specific
Recombination," issued January 15, 2008) based on Life Technologies'
manufacture and sale of its BaculoDirect Baculovirus Expression System under
its Invitrogen brand. View the
complaint here.

Daiichi Sankyo Inc. et al. v. Impax Laboratories Inc.
1:10-cv-00032; filed January 14, 2010 in the
District Court of Delaware

• Plaintiffs: Daiichi Sankyo Inc.; Genzyme
Corp.
• Defendant: Impax Laboratories Inc.

Infringement of U.S. Patent Nos. 5,607,669 ("Amine
Polymer Sequestrant and Method of Cholesterol Depletion," issued March 4,
1997) and 5,693,675 ("Alkylated Amine Polymers," issued December 2,
1997) following a Paragraph IV certification as part of Impax's filing of an
ANDA to manufacture a generic version of plaintiffs' Welchol® (colesevelam
hydrochloride, used to treat primary hyperlipidemia and type 2 diabetes
mellitus). View the complaint here.
USPTO Budget Request for FY 2011 and Perspectives from the Patent Community

February 7, 2010

By Christopher P. Singer —

On February 1, 2010, the U.S. Patent and Trademark Office issued a press release announcing President Obama's $2.3 billion budget request
for the USPTO for fiscal year 2011.

According to the statement, the amount of the
budget request is intended to support and achieve the strategic objectives of
the five-year plan for the USPTO as mapped out by Director Kappos and Commerce
Secretary Locke. Specific goals
include reducing application pendency and the existing application backlog,
improving patent quality, enhancing IP protection and enforcement, and
upgrading the Office's IT infrastructure and tools in order to achieve total
electronic processing in patents and trademark IT systems. As first
steps, the PTO plans to make progress toward these goals by restructuring
management and workflow processes and hiring 1,000 patent examiners (search for
positions here
in each of fiscal year 2011 and 2012, specifically targeting former patent examiners
and current IP professionals to increase initial examiner productivity.

The USPTO will continue to provide additional
details concerning its five-year plan later this year. The breakdown of the FY 2011 $2.3
billion budget includes forecasting almost $2.1 billion in fee collections,
with the remainder (about $224 million) to come from interim fee
increases. The press release also
notes that a section of the budget request relates to the administration's
continuing support of "granting the USPTO fee-setting authority [rather than Congress] as a
significant part of a sustainable funding model that would allow the director
to propose and set fees in a manner that better reflects the actual cost of
USPTO services."

On Tuesday, the Intellectual Property Owners
Association (IPO) paid particular attention to the fee setting authority
provision of the budget, noting in one of its "Daily News" items that, "the
USPTO would be authorized to raise existing statutory fees in 2011 by rule with
no limits specified." The item clarified further that the IPO has
consistently opposed prior proposals that would allow the USPTO to set its own
fees. IPO Executive Director Herb
Wamsley (at left) was quoted in the article and characterized the fee-setting provision as "a
blank check for the USPTO to raise fees that would open the door to increases
far higher than 15 percent."

On Wednesday, Hal Wegner (at right) put the focus on the IPO's
commentary concerning the proposed budget in his widely-read e-mail newsletter,
stating that in order for real improvement to be made in the USPTO, the patent
community would need to support the Administration in its many efforts,
including "fee flexibility in the coming year." In his criticism of the IPO's comments
against the proposed budget, he noted that the patent community can play an
important role in providing constructive criticism and simple suggestions to
help improve Office procedures, "but it is yet another matter to fail to
support important initiatives so necessary for fixing a broken system."

While it may well be that there is no real need to
shift the fee setting authority from Congress to the USPTO, it also seems very
unlikely that the agency would necessarily abuse such authority if it was
granted. In light of the effect
that the recession has had on the Office's revenue, the administration should
be well aware that applicants are fully prepared to make decisions based on
economic necessity. Further, we
can look to the recent example of the interim fix the PTO has provided to
patentees for requesting PTA reconsideration in certain patents based on the
recent Wyeth decision. The Office has provided a simple form
for making the request. And,
rather than attempting to associate the request with a processing fee such as
outlined in 37 C.F.R. § 1.705 ($200), the Office requires no fee for filing the
request. So it would seem that the
current administration is not simply driven by maximizing fees and exploiting
every revenue opportunity.
USPTO Extends Period for Public Comment and Period of Effectiveness for Recent Programs

February 7, 2010

By
Sarah Fendrick —

The U.S. Patent and Trademark Office has extended the
time for public comment for two recent Office initiatives and has extended the period
of effectiveness for a third Office initiative.

Extension
of Period for Comments on Enhancement in the Quality of Patents

In December 2009, the USPTO
published a notice in the Federal Register seeking public comment on the
enhancement in quality of patents. Specifically, the Office solicited public comment with respect to potential
methods that may be employed by applicants and the USPTO to enhance the quality
of issued patents, to identify appropriate indicia of quality, and to establish
metrics for the measurement of the indicia. The USPTO recently extended
the deadline for public comment until March 8, 2010.

Written
comments can be sent to patent_quality_comments@uspto.gov
or can be submitted by mail addressed to: Mail Stop Comments — Patents, Commissioner for
Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kenneth
M. Schor and Pinchus M. Laufer.

Rules
of Practice Before the Board of Patent Appeals and Interferences in Ex Parte
Appeals; Extension of Comment Period on Potential Modifications to Final Rule

At
the end of 2009, the USPTO published an advance notice of proposed rule making
on potential modifications to rules governing practice before the Board of
Patent Appeals and Interferences (BPAI) in ex parte patent appeals. The USPTO has now extended
the deadline for the public to submit comments on the potential rule
modifications. The new deadline is
5 p.m. (EST) on February 26, 2010.

Written
comments on potential modifications to the final rule should be sent by
electronic mail message over the Internet addressed to BPAI.Rules@uspto.gov or by
mail addressed to: Mail Stop Interference, Director of the United States Patent
and Trademark Office, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the
attention of Linda Horner, BPAI Rules.

Extension
of the Patent Application Backlog Reduction Stimulus Plan

The
USPTO has extended
the patent application backlog reduction stimulus plan on a temporary
basis. Under this program, a
small entity applicant may have an application accorded special status for examination
if the applicant expressly abandons another copending unexamined application. The plan has been extended until June
30, 2010. After that deadline, the USPTO
will consider whether to open the program to all applicants or discontinue the program
altogether depending on the results.

For
additional information on these topics, please see:

• "USPTO
to Hold Public Meeting on January 20th to Discuss Appeals Rules Changes,"
January 13, 2010
• "USPTO
Requests Comments on Enhancement of Patent Quality," December 13, 2009
• "USPTO
Implements Patent Application Backlog Reduction Stimulus Plan," December
7, 2009
Conference & CLE Calendar

February 7, 2010

February 9, 2010 – Patent
Prosecution: Best Practices for Reducing Costs While Improving Patent
Quality (Technology
Transfer Tactics) – 1:00 – 2:30 PM (EST)

February
17-18, 2010 – Biotech & Pharmaceutical Patenting (IIR) – Munich, Germany

February 24-25, 2010 – 2nd Expert Forum on ITC Litigation &
Enforcement (American Conference
Institute) – New York, NY

March 1-2, 2010 – 4th Annual Patent Law Institute (Practising
Law Institute) – New York, NY

March 2-4, 2010 – 6th Annual Biosimilars Conference (Visiongain) – Boston,
MA

March 17-18, 2010 – 18th Forum on Biotech Patenting (C5) – Munich,
Germany

March 18-19, 2010 – 4th Summit on Biosimilars and
Follow-on Biologics*** (Center for
Business Intelligence) – Washington, DC

March 22-23, 2010 – 4th Annual Patent Law Institute (Practising
Law Institute) – San Francisco,
CA

March 24-25, 2010 – FDA Boot Camp*** (American Conference
Institute) – New York, NY

March 30,
2010 – "The Bilski Decision: Expert Strategies to Manage Its Impact on University IP" (Technology
Transfer Tactics) – 1:00 – 2:30 PM (EST)

April 7-10, 2010 – 25th
Annual Intellectual Property Law Conference (American Bar
Association Section of Intellectual Property Law) – Arlington,
VA

April 27-28, 2010 – 4th Annual Paragraph IV Disputes*** (American Conference
Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Paragraph IV Disputes Conference

February 5, 2010

American Conference
Institute (ACI) will be holding its 4th Annual Paragraph IV Disputes conference
on April 27-28, 2010 in New York, NY.
The conference will allow attendees to:

• Identify patents
for small molecules and small proteins that may be ripe for a Paragraph IV
challenge;
• Recognize an ANDA
applicant's initial obligations and reevaluate Orange Book tactics;
• Incorporate post-KSR obviousness considerations into
Paragraph IV litigation strategies;
• Develop a plan of
action for Notice Letter delivery and Post-Notice Letter deliberations;
• Master techniques
for drafting the initial Paragraph IV pleadings;
• Understand the
criteria for 180-day exclusivity and the circumstances under which it may be
forfeited;
• Appreciate the
significance of generic versus generic actions for brand names and generics;
• Navigate the
intricacies of litigation with multiple ANDA filers;
• Spearhead
discovery dilemmas, optimize the use of experts, and perfect Markman timing; and
• Weigh the options
over an at risk launch.

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

• Pre-suit due
diligence strategies in anticipation of the Paragraph IV challenge;
• Assessing the
ANDA applicant's initial obligations;
• New takes on
obviousness: Pre-suit
considerations for brand-names and generics;
• Throwing down the
gauntlet: The Paragraph IV notice
letter — delivery and receipt;
• Let the games
begin: The start of the Paragraph
IV law suit — Pleadings and considerations;
• Exploring
exclusivity and forfeiture dilemmas relative to Paragraph IV litigation;
• A view from the
bench on Paragraph IV litigation;
• A closer look at
generic versus generic law suits;
• Litigating with
multiple ANDA filers: Brand name
and generic perspectives;
• FTC keynote: Pay for delay settlements;
• Recent decisions
impacting Paragraph IV challenges and motion practice;
• Discovery
strategies and pre-trial maneuvering tactics for brand names and generics; and
• Assessing danger
and mitigating liabilities associated with injunctions and "at risk
launches."

Two additional
workshops will be offered before and after the conference. A pre-conference workshop, entitled
"Hatch- Waxman Boot Camp — A Primer on IP Basics and Regulatory Fundamentals,"
will be offered on April 26, 2010.
During this workshop, ACI's faculty will offer presentations on the
following topics:

• A guide to the
essentials of the FDA approval process for drugs and biologics for life
sciences patent lawyers;
• Patent and IP
overview for drugs and biologics:
Hatch-Waxman, trade dress, and more;
• Patent and
non-patent exclusivity;
• Bioequivalence
and the "same active ingredient" vis-à-vis patentability; and
• Exploring
pharmaceutical patent extensions:
Patent Term Adjustment and Patent Term Restoration.

In addition, a
post-conference workshop, entitled "The Master Class on Settling Paragraph
IV Disputes: Brand-Name and
Generic Perspectives," will be offered from 9:00 am to 12:30 pm on April
29, 2010. In this workshop, ACI
faculty will explore the best practices for reaching and finalizing settlements
that the parties and the FTC can live with.

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

The registration
fee for the conference is $2,195 (conference alone), $3,090 (conference and
pre-conference workshop), $2,795 (conference and post-conference workshop),
$3,590 (conference and both workshops), or $1,395 (pre-conference workshop
alone). Those registering by
February 19, 2010 will receive a $300 discount, and those registering before
March 26, 2010 will receive a $200 discount. Those interested in registering for the conference can do so
here, by calling
1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of the Paragraph IV Disputes conference.
BIO Comes out Swinging against SACGHS Report – Updated

February 4, 2010

By
Donald Zuhn —

In
a press conference held earlier today, the Biotechnology Industry Organization
(BIO) expressed concern about recommendations to be issued on Friday with a
report on gene patents. The report,
entitled "Gene Patents and Licensing Practices and Their Impact on Patient
Access to Genetic Tests," is being issued by the Secretary's Advisory
Committee on Genetics, Health and Society (SACGHS), which is charged with
advising the Secretary of Health and Human Services on human health and
societal issues raised by the development and use of genetic technologies.

BIO
did not stand alone in opposing the report's recommendations at the press
conference. Appearing with and in support of BIO President
and CEO Jim Greenwood were former Senator Birch Bayh, co-author of the Bayh-Dole
Act; Dr. Brian Stanton, a member of the SACGHS Task Force on Intellectual Property
and Access to Genetic Testing; Dr. Jim Davis, Executive Vice President, General Counsel and Secretary of Human Genome
Sciences, Inc.; and Dr. Jon Soderstrom, the Managing Director of the Office of Cooperative Research at Yale University.

Mr.
Greenwood (at left) began by noting that the while the SACGHS report indicates that gene
patents and licensing practices have not had an adverse impact on patient
access to genetic tests, the Committee will nevertheless be making
recommendations that "would undermine the U.S. patent system and the
Bayh-Dole technology transfer system that have served our nation so
well." However, despite the
success of the U.S. patent system and the Bayh-Dole model, the BIO CEO observed
that:

Unfortunately, there are academic and
other critics who view the private property rights granted by Bayh-Dole in
federally supported research with suspicion, if not outright hostility. Despite all evidence to the contrary,
they persist in believing that the U.S. patent system and the Bayh-Dole Act
hamper patient access to the very life-saving therapies and diagnostics that
these systems make it possible to develop in the first place.

Mr.
Greenwood contended that the Committee's recommendations "would discourage
investment in biotech innovation, hobble the transfer of federally-funded
research, undermine university research programs, and harm patients who are
waiting for life-saving therapies and diagnostics yet to be developed."

Senator
Bayh (at right) bemoaned the need to once again respond to "a small number of
determined critics who want to send us back to a time when it appeared that
American innovation was on its last legs and our economy was in deep
distress." The former Indiana
Senator explained that prior to enactment of the Bayh-Dole Act, the federal
government owned all of the patents that resulted from federally funded
research. During Senate Judiciary
Committee hearings on the legislation, the Committee reported that "it
could not find a single instance where the old policies had resulted in even
one drug being developed when the government owned the patents." Moreover, despite investing more than
$30 billion in taxpayer dollars, the Committee found that before Bayh-Dole, some
28,000 patents were "gathering dust on the shelves of the Patent and
Trademark Office." After
enactment of the Act, however, more than 6,000 new companies were founded on
university inventions, more than 4,000 new products came on the market
(including 153 new drugs, vaccines, or in
vitro devices), at least 279,000 new jobs were created between 1996 and
2007, and over $457 billion was added to the country's gross national
product. Senator Bayh contended
that history has shown that the SACGHS recommendations, which he believed would roll back
the advances made under Bayh-Dole, "would have a disastrous impact on the
American economy."

Dr.
Stanton, who served on the SACGHS task force, informed reporters that the
Committee's report "has no evidence of harm, and yet it still calls for
changes." Among the changes,
the one that has garnered the most attention is a proposal to exempt gene
patents from infringement liability.
While Dr. Stanton acknowledged that the task force did identify a few
isolated instances of harm that need to be addressed, he noted that the task
force also determined that "the court systems and the systems of checks
and balances that are built into the fabric of the patent system were more than
capable of addressing problems on a case by case basis." Dr. Stanton also noted that the report
contains a letter of dissent from three members of the full Committee, who
interestingly, were the only members having direct experience in both business
and law as it relates to intellectual property and the private sector
development of products and services.

Dr.
Davis used HGS' experience with the human gene bliss to illustrate the importance and value of gene patents. He recalled that when the company first
identified the gene, it did not know whether its value would lie in
diagnostics, as a target to generate small molecule therapeutics, in its
encoded protein, or in antibodies directed to that protein. However, thirteen years after HGS
identified the gene, the company turned this knowledge into a drug for use in
the treatment of lupus, which Dr. Davis noted was the first new lupus
therapeutic to be developed in the past 50 years. Over the course of the drug's developmental period, HGS
spent some $2 billion on a number of programs, the majority of which failed
after reaching the clinic or which never made it out of the lab.
Noting that for every success story, ten to twenty drug candidates "die
in the clinic" and another one to two hundred never reach the clinic, Dr. Davis
asked where the investment dollars would come from if companies were prevented
from securing patents at an early stage as HGS did with bliss. Declaring that
"patents matter," Dr. Davis pointed out that the entire
biotech/pharma industry was built on the practice of licensing patents, a
system that "provides enough of an incentive for each of us to find our
own products in our own way."
Observing that the U.S. has one of the strongest and most well-funded
biotech industries in the world, Dr. Davis contended that this was due in no
small part to the U.S. patent system.

Dr.
Soderstrom (at left) started by pointing out that the Bayh-Dole Act "really
transformed the entire way that we, as universities, interact with the
commercial sector," and as a result, helped create a whole new industry. He noted that an annual survey conducted by the Association of University Technology Managers (AUTM) indicated that AUTM members had gone from
issuing dozens of licenses more than twenty years ago to issuing over 5,000
licenses in 2009 alone. Dr.
Soderstrom also noted that over the past twenty years, patents licensed by AUTM members
led to the development of more than 10,000 new products. Significantly, Dr. Soderstrom stated
that prior to Bayh-Dole, not a single drug had been developed using Yale's
own patent technology, and that since the passage of the Act, five drugs based on
Yale patents had made it to market and eighteen more are in clinical trials
today. Based on his involvement in
the formation of some 35 biotech companies over the last decade, and in the raising
of more than $450 million in venture funding, Dr. Solderstrom bluntly declared
that:

It's hard, and if people think it's easy, they're fooling themselves. And if
they think that companies are investing just out of charity, they're really
deluding themselves as well. What
companies demand is the ability to protect their investment.

Returning
to the SACGHS recommendations, Dr. Solderstrom admitted that what frightens him
is that the recommendations are "essentially a reconstitution of the world
as is it existed before 1980."

During
the question and answer portion of the press conference, Dr. Davis argued that although
the SACGHS report only singles out gene patents, "it's really gene patents
that are the foundation of the biotech industry," explaining that gene patents have led to
the development of both diagnostic and therapeutic products. Senator Bayh then asked "if it
starts here [with gene patents], where will it go next?" Dr. Solderstrom observed that while the
report presents empirical evidence showing that gene patents have no adverse
impact on patient access to genetic testing, "the recommendations would
have you believe that there is a problem and they're going to fix it." He also used a drug initially developed
at Wayne State University with federal funds to illustrate the difference
between public and private sector funding of drug development, noting that the NIH
provided about $150,000 for initial development of the compound and that BMS
spent about $350 million to get the drug to market as a part of an HIV cocktail. Dr. Stanton concluded the press conference by
saying that although he was a member of the task force, he "would not take
ownership, authorship, or credit for the language, content, or components of
this report," and in fact had submitted a dissenting opinion.

BIO has made a podcast of the entire press conference available here.

Image of Senator Bayh courtesy of Indiana University.
Biotech/Pharma Docket

February 4, 2010

By Suresh Pillai —

Settlement Announced in Focalin® Infringement Suit

Celgene,
Novartis Pharmaceuticals,
and Teva Pharmaceuticals
have filed three separate stipulations in the U.S. District Court for the
District of New Jersey that will, if approved by the Court, put an end to all
claims among the parties. The long
running dispute stemmed from Teva's plan to market a generic version of Focalin®
XR,
an attention deficit hyperactivity disorder drug. At issue was whether Teva infringed the plaintiff's
patents covering Focalin®, U.S. Patent Nos. 5,908,850;
6,355,656;
6,528,530;
5,837,284;
and 6,635,284. Between 2004 and 2007, Celgene (as the
patent owner) and Novartis (as the exclusive licensee) filed four lawsuits
against Teva alleging infringement (see "Court Report," January 2,
2007). Each cause of action stemmed from Abbreviated New Drug Applications filed by Teva with the FDA in which Teva
sought regulatory approval to market and manufacture generic versions of
Focalin®. Each of the plaintiffs'
complaints alleged that because each generic was a bioequivalent of the
patented drug, containing the same active ingredients, routes of
administration, dosage form, proposed labeling, and indication and usage as the
patented drug, Teva was liable for infringement. Terms of the settlement have not been disclosed.

Generic Drug Makers Seek to Remove AstraZeneca LP
as Party in Crestor® Suit

A group of generic drug makers, all defendants in a
patent infringement suit over the cholesterol drug Crestor®,
have argued that one of the named plaintiffs, AstraZeneca,
lacks the requisite standing to bring suit. In their motion to dismiss filed with the U.S. District
Court for the District of Delaware, defendents Teva Pharmaceuticals, Apotex,
Mylan Pharmaceuticals, Sun Pharmaceuticals Industries,
Par Pharmaceuticals,
Aurobindo Pharma,
and Cobalt Pharmaceuticals stated that because AstraZeneca, one of the four named plaintiffs in the case, merely shares a license to
market Crestor®, AstraZeneca lacks standing to pursue infringement
claims. The original litigation
commenced in December 2007 when AstraZeneca filed suit against some of the
defendants who had filed Abbreviated New Drug Applications seeking permission
to market and manufacture generic versions of Crestor® (see "Court Report,"
December 16, 2007). In its suits, AstraZeneca alleges
that the defendants' products would infringe U.S. Patent No. RE37,314.

Settlement Announced in TroVax® Suit

Bavarian Nordic and
Oxford BioMedica have entered into cross-licensing agreements as part of a settlement that ends
all litigation between the two companies over BioMedica's alleged infringement
of Bavarian's patents covering a method of delivering recombinant
vaccines. The original litigation
commenced in 2008, when Bavarian filed suit in the U.S. District Court for the
Southern District of California, alleging that BioMedica's development of its TroVax® vaccine infringed U.S. Patent Nos. 6,761,893;
6,913,752;
7,335,364;
and 7,459,270.

The settlement follows BioMedica's failed bid for
an interlocutory appeal to the Court of Appeals for the Federal Circuit to
address issues of subject matter jurisdiction (see "Biotech/Pharma Docket,"
July 7, 2009). The settlement also clears the way for
BioMedica to exploit TroVax®, as the settlement grants BioMedica licenses for
the four patents-in-suit, all of which are related to the MVA-BN virus, a key
factor in the smallpox vaccine and an effective delivery vector for vaccines
against other diseases. In
exchange, Bavarian will have a license to related poxvirus patents owned by
BioMedica partner Sanofi-Aventis.
GSK Announces “Open Innovation” Strategy to Combat Neglected Tropical Diseases

February 3, 2010

By
Donald Zuhn —

In January, GlaxoSmithKline announced
a series of initiatives for developing new medicines to combat diseases that
disproportionately affect the world's poorest countries. The initiatives, which comprise GSK's
"open innovation" strategy, were outlined in a speech
given by GSK Chief Executive Andrew Witty to the Council on Foreign Relations on
January 20th. These initiatives
include:

•
Making more than 13,500 malaria compounds freely available;
•
Establishing new collaborations for sharing IP for treating neglected tropical diseases;
•
Pledging to create a sustainable pricing model for a malaria candidate vaccine;
•
Providing $8 million in seed funding for an "open lab"; and
•
Awarding African Malaria Partnership grants totaling $2.5 million.

GSK described the
collection of potential malaria drugs as having been obtained following a screen of its pharmaceutical
compound library of more than two million molecules for those that might
inhibit the malaria parasite Plasmodium
falciparum. The company noted
that it took five scientists a year to identify the more than 13,500 compounds
that GSK is now making freely available.
GSK also noted that it would make the chemical structures and
associated assay data freely available to the public via scientific websites.

With
respect to the company's goal to share IP for neglected tropical diseases, GSK said that
it was handing the administration of the tropical diseases patent pool it
developed last year to an independent third party, BIO Ventures for Global
Health (BVGH). Last March, GSK
formed the patent pool to aid in the discovery and development of new medicines
for the treatment of sixteen neglected tropical diseases (as defined by the
U.S. Food and Drug Administration), including tuberculosis, malaria, blinding
trachoma, buruli ulcer, cholera, dengue/dengue haemorrhagic fever, racunculiasis,
fascioliasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic
filariasis, onchocerciasis, schistosomiasis, soil transmitted helminthiasis,
and yaws. In August, Alnylam
Pharmaceuticals contributed more than 1,500 of its RNA interference (RNAi)
patents to the pool (see "Alnylam
to Donate RNAi Patents to Patent Pool"). Mr. Witty (at left) told the Council that the pool "was never meant to be a 'GSK pool'," and therefore, that he was "delighted" to be able to hand its administration over to BVGH. Both GSK and BVGH have also entered
into an agreement with the Emory Institute for Drug Discovery (EIDD) to join
the patent pool and further open up knowledge, chemical libraries, and other
assets in the search for new medicines for neglected tropical diseases. In addition, GSK will be collaborating with
iThemba Pharmaceuticals to identify new medicines for treating tuberculosis.

GSK
also outlined a pricing strategy it has developed for the malaria candidate vaccine
RTS,S, which is currently in Phase III trials in seven African countries. The company noted that the drug, if
shown to be effective, would be priced so as to recover the cost of its
development plus a small return intended to be fully reinvested into research
and development of second-generation malaria vaccines or vaccines for other
neglected tropical diseases.

The
company's "open lab" initiative would provide research space for up
to 60 scientists at GSK's research center at the Tres Cantos Campus in Spain. The Tres Cantos Campus is dedicated to
the research and development of new medicines for diseases of the developing
world.

In
outlining the company's open innovation strategy, Mr. Witty told the Council
that GSK wanted "to be a company that is truly a partner in addressing the
healthcare challenges in the world's poorest countries, no matter how difficult
they are. A restless company,
never satisfied with what it has achieved, but always looking for ways of doing
more."
Letter to Congressional Leaders Seeks Patent Protections

February 2, 2010

By
Donald Zuhn —

In
a letter sent to Speaker of the House Nancy Pelosi (D-CA), House Majority
Leader Steny Hoyer (D-MD), and House Minority Leader John Boehner (R-OH)
earlier today, Representatives Mike Michaud (D-ME), Don Manzullo (R-IL), Dana
Rohrabacher (R-CA), and Marcy Kaptur (D-OH) urged the House leaders to "remember
the importance of patent protections" as the House begins the process of
crafting legislation to promote job creation. Noting the "persistently high"
unemployment rate and "slow economic recovery," the bipartisan group
of lawmakers sought "to underscore the importance of protecting U.S.
intellectual property standards as a way to help U.S. businesses and create U.S.
jobs." According to the
letter's signatories, a key aspect of economic growth would be "strong
patent protections that ensure the patent application process is efficient and
fair for big and small companies alike."

The
four lawmakers expressed dissatisfaction with the House's last patent reform
effort, a controversial bill (H.R. 1908) that was passed by the House in
September 2007 (see "Patent
'Reform' Bill Passes House of Representatives"). Interestingly, that bill, which was
passed by a 220-175 vote, received strong support from Democrats (who voted 160-58
in favor of the bill) and little support from Republicans (who voted 117-60
against the bill). Calling the
House's prior effort "misguided," the lawmakers noted that they had
"strong objections" to the bill because it "would not have
improved the quality of patents or reduced the cost of patent
litigation." Instead, the
bill "would have increased uncertainty among patent holders; reduced
patent value; reduced investment in research and development; and, therefore,
further hindered the development of U.S. manufacturing." The four lawmakers also noted that they
had opposed the House (H.R. 1260) and Senate (S. 515) bills introduced last
March (see "Senate and House Introduce New Patent Reform Legislation"),
saying that the bills were "troubling for a number of reasons." Despite the efforts of Senator Dianne
Feinstein (D-CA) to rework the damages provision in S. 515 to codify the
fifteen Georgia-Pacific factors (see "Senate 'Patent
Reform' Bill (S. 515) Voted out of Judiciary Committee"),
the letter's signatories contend that "there are still several hurdles to
an acceptable bill."

According
to the lawmakers, the primary "hurdles" are an apportionment-centric
system of patent damages that "ignores the fact that current patent
protections adequately take into account apportionment concerns and would
reduce the overall value of patents," and an expansion of administrative
challenges to patents (via post-grant review and expanded inter partes reexamination) that "seem[s] wholly unnecessary,
given [that the changes to the patent system] will not reduce patent litigation
and that the U.S. Patent and Trademark Office (PTO) already has a reexamination
process." The four lawmakers
also believe that the expansion of administrative challenges will "allow
foreign competitors to easily and cheaply challenge U.S. patents." Other possible hurdles include the move
to a first-to-file system and changes to willful infringement. The lawmakers contend that "Congress
should hear from each affected group and consider their input carefully through
open hearings." It should be
noted that both the Senate and House held hearings on patent reform last year,
the Senate Judiciary Committee holding its hearing on March 10 (see "Senate Judiciary Committee
Holds Hearing on Patent Reform")
and the House Judiciary Committee holding its hearing on April 30 (see "House Judiciary Committee
Holds Hearing on Patent Reform").

The
letter concludes by stating that:

Reliable intellectual property
protections are critical to incentivizing American companies to research,
develop, and manufacture goods in the United States. In addition, they are imperative for protecting our U.S.
businesses in the face of our foreign competitors. As such, strong patent protection policy must be a crucial
part of our economic recovery, and we look forward to working with you to
ensure that it is.

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