Patent Docs

Patent Profile: OncoGenex Announces Issuance of Patent for Antisense Cancer Therapeutic

September 8, 2009

By Donald Zuhn —

Last month, OncoGenex Pharmaceuticals,
Inc. announced
that the U.S. Patent and Trademark Office had issued U.S. Patent No. 7,569,551. The '551 patent is
directed to a method of enhancing cancer cell chemo- or radiation-sensitivity using
an antisense oligodeoxynucleotide targeted against the testosterone-repressed
prostate message-2 (TRPM-2) gene. The inventors found that that
administration of TRPM-2 antisense oligodeoxynucleotides can reduce the
expression of TRPM-2, and as a result enhance the sensitivity of cancer cells
to chemotherapeutic agents or radiotherapy either in vitro and in vivo. While the '551 patent is assigned to
the University of British Columbia, Oncogenex
notes that it has exclusively licensed the patent.

According to the biopharmaceutical company's
announcement, the '551 patent encompasses methods for
treating cancers that express the protein clusterin (the historical name for
TRPM-2) using Oncogenex's lead cancer drug candidate, OGX-011 (also known as
custirsen sodium), or any other clusterin antisense oligonucleotide, in
combination with any chemotherapeutic agent or radiation therapy. Oncogenex President and CEO Scott
Cormack stated that the '551 patent "expands [the company's] intellectual
property estate for treating clusterin-expressing cancers using antisense
therapy and provides us with a broad patent that applies well beyond prostate
cancer."

The Onogenex release also notes that OGX-011
utilizes antisense technology licensed from Isis Pharmaceuticals, and that OncoGenex
and Isis partnered in the discovery and initial development of OGX-011. Last year, OncoGenex and Isis amended
their agreement involving OGX-011 to provide OncoGenex with sole rights to the
molecule and sole responsibility for its development, subject to financial
obligations to Isis. The company's
website states that preliminary data in a Phase 2 clinical trial evaluating
OGX-011 in combination with second-line chemotherapy in patients with hormone
refractory prostate cancer has shown that retreatment with docetaxel in
combination with OGX-011 may reverse docetaxel resistance and improve patient
survival. OGX-011 is also being
tested for use in the treatment of non-small cell lung cancer and breast
cancer.

The '551 patent issued from U.S.
Application No. 09/967,726, filed September 28, 2001, which is a
continuation-in-part of U.S. Application No. 09/913,325, filed August 10, 2001,
which is a national stage application of International Application No.
PCT/US00/0487, filed February 25, 2000, and claims the benefit of U.S.
Provisional Application No. 60/236,301, filed September 28, 2000. Independent claims 1 and 36 of the '551
patent recite:

1. A method for enhancing the chemo- or radiation sensitivity
of cancer cells in an individual suffering from a cancer that expresses TRPM-2
in amounts different from normal tissue of the same type, comprising treating
the individual with either chemotherapy or radiation therapy and administering
to the individual a composition comprising an oligonucleotide targeted to
TRPM-2 and effective to inhibit expression of TRPM-2 by cancer cells during at
least a portion of the time that the chemotherapy or radiation therapy is active
against cancer cells.

36. A method for treating a cancer which expresses TRPM-2 before
or after treatment with a chemotherapy agent, comprising administering to an
individual suffering from the cancer a chemotherapeutic agent which is at least
partially effective against the cancer and a an oligonucleotide which is
targeted to TRPM-2 and reduces the amount of TRPM-2 in cancer cell.
Changes in USPTO Senior Management

September 8, 2009

By Christopher P. Singer —

In a press release
issued last week, the U.S. Patent and Trademark Office announced that current Commissioner for Patents, John Doll, has indicated
that he plans to retire from the agency on October 2, 2009. USPTO Director David Kappos has nominated
Robert Stoll (at right), a current USPTO executive, to take over Mr. Doll's position as Commissioner
for Patents. Mr. Stoll has been
with the USPTO for 27 years, and has held a number of management positions
including Supervisory Patent Examiner, Executive Assistant to the Assistant
Secretary of Commerce and Commissioner of Patents and Trademarks, Administrator
of the Office of Legislative and International Affairs, and Director of
Enforcement.

Mr. Kappos also named Margaret ("Peggy")
Focarino (at left) the Deputy Commissioner for Patents. Ms. Focarino has been with the USPTO for more than 32 years,
and has held positions including supervisory patent examiner, technology center
director, and Deputy Commissioner for Patent Operations. As the Deputy Commissioner, Ms.
Focarino had oversight of the agency's patent examining corps. She implemented a new approach to
training examiners, and supported telework programs for patent examiners and
technical support staff.

According to the press release, U.S. Commerce
Secretary Gary Locke expressed support for Mr. Stoll's nomination and is
expected to appoint him once Mr. Doll officially retires.

If appointed, Mr. Stoll will serve as Commissioner for
a term of five years.
USPTO Says Some Requests for PTA Reconsideration Are Premature

September 7, 2009

By Sydney Kokjohn —

We recently received a
dismissal of a Request for Reconsideration of Patent Term Adjustment
Determination under 37 C.F.R. § 1.705(b). The Request was filed solely on the basis that the Patent Office had
taken more than three years to issue the patent. The patent application was filed on December 7, 2005. Thus,
a patent should have issued by December 7, 2008. A Request for Continued Examination (RCE) was filed on February
16, 2009, thus cutting off from that date any additional patent term for
failure to issue the patent within three years under 37 C.F.R. § 1.702(b).

The Patent Office notice stated:

Knowledge of the actual
date the patent issues is required to calculate the amount, if any, of
additional patent term patentee is entitled to for Office failure to issue the
patent within 3 years. See § 1.702(b). (This is true even where a request for
continued examination (RCE) was filed). The computer will not undertake the § 1.702(b)
calculation until the actual date of issuance of the patent has been
determined. Likewise, the computer will not calculate any further Office delay
under § 1.702(a)(4) or applicant delay under § 1.704(c)(10) until the actual
date of issuance of the patent has been determined. As such, the Office can not
make a determination on the correctness of the patent term adjustment until the
patent has issued.

Requesting
reconsideration of the patent term adjustment to be indicated on the patent
under 37 CFR 1.705(b) based on the initial determination of patent term
adjustment and a projected issuance date of the patent (or even the filing date
of the request for continued examination) is premature. Accordingly, it is
appropriate to dismiss as premature such a request.

Rather than file an
application for patent term adjustment under 37 CFR 1.705(b) contesting the 37
CFR 1.702(b) calculation at the time of the mailing of the notice of allowance,
applicant is advised that they may wait until the time of the issuance of the
patent and file a request for reconsideration of the patent term adjustment
pursuant to 37 CFR 1.705(d). As the USPTO does not calculate the amount of time
earned pursuant to 37 CFR 1702(b) until the time of the issuance of the patent,
the Office will consider any request for reconsideration of the patent term
adjustment due to an error in the calculation of 37 CFR 1.702(b) to be timely
if the request for reconsideration is filed within two months of the issuance
of the patent. However, as to all other bases for contesting the initial
determination of patent term adjustment received with the notice of allowance,
applicant must timely file an application for patent term adjustment prior to
the payment of the issue fee.

Even though filing an RCE
effectively cuts off any additional patent term for failure to issue a patent
within three years, the Patent Office's computers will not calculate delay
under 37 C.F.R. § 1.702(b) (or 1.702(a)(4) or 1.704(c)(10)) until after the
actual date of issuance has been determined.

The Office of Patent
Legal Administration indicated that it plans to issue a statement regarding
this matter. In the meantime,
a simple reading of the rules does not instill much confidence that a Request for
Reconsideration of Patent Term Adjustment Determination when an RCE has been
filed will not be considered untimely under 37 C.F.R. 1.705(d) if the Request
is filed after the patent issues. Section 1.705(d) states:

If there is a revision to
the patent term adjustment indicated in the notice of allowance, the patent
will indicate the revised patent term adjustment. If the patent indicates or
should have indicated a revised patent term adjustment, any request for
reconsideration of the patent term adjustment indicated in the patent must be
filed within two months of the date the patent issued and must comply with the
requirements of paragraphs (b)(1) and (b)(2) of this section. Any request for reconsideration under this
section that raises issues that were raised, or could have been raised, in an
application for patent term adjustment under paragraph (b) of this section
shall be dismissed as untimely as to those issues.

Section 1.705(b) requires
that the request be filed "no later than the payment of the issue fee." As filing an RCE cuts off additional
patent term, it seems that any request for additional patent term in the case
of an RCE could be raised under
1.705(b). Nevertheless, this
dismissal indicates that the Patent Office's computers do not calculate any
delay for failing to issue a patent within three years under 1.702(b) until the
date of issuance of the patent has been determined.

In addition to a
dismissal of the request as premature, note that another possible disadvantage
of filing a request for additional patent term for failure to issue a patent
within three years prior to the issuance of the patent is that the patent may
issue later due to the time it takes the Patent Office to consider the
request. However, 37 C.F.R. §
1.704(e) indicates that filing a request for patent term adjustment under
1.705(b) "will not be considered a failure to engage in reasonable efforts
to conclude prosecution."
Court Report

September 7, 2009

By Sherri Oslick —

About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.

King Pharmaceuticals Inc. et al. v. Sandoz Inc.
2:09-cv-04513; filed September 1, 2009 in the
District Court of New Jersey

• Plaintiffs: King Pharmaceuticals Inc.; King
Pharmaceuticals Research and Development, Inc.; Elan Corporation, PLC.; Elan
Pharma International Ltd.
• Defendant: Sandoz Inc.

Infringement of U.S. Patent No. 6,066,339 ("Oral
Morphine Particulate Formulation," issued May 23, 2000) following a
Paragraph IV certification as part of Sandoz's filing of an amendment to its
ANDA (adding additional dosage forms) to manufacture a generic version of King's
Avinza® (morphine sulfate extended release capsules, used for the once-daily
treatment of moderate-to-severe chronic pain). View the complaint here.

Centocor Ortho Biotech, Inc. v. Abbott GmbH & Co., KG
1:09-cv-01653; filed August 28, 2009 in the
District Court of the District of Columbia

Review of the decision of the Board of Patent
Appeals and Interferences awarding priority of invention to Abbott in the
interference between U.S. Patent Application No. 10/912,994 ("Anti-IL-12 Antibodies,
Compositions," filed August 6, 2004), assigned to Centocor and U.S. Patent
No. 6,914,128 ("Human Antibodies That Bind Human IL-12 and Methods for
Producing," issued July 5, 2005), assigned to Abbott. View the complaint here.

Centocor Ortho Biotech, Inc. v. Abbott GmbH & Co., KG
1:09-cv-01654; filed August 28, 2009 in the
District Court of the District of Columbia

Declaratory judgment of non-infringement and
invalidity of U.S. Patent Nos. 6,914,128 ("Human Antibodies That Bind
Human IL-12 and Methods for Producing," issued July 5, 2005) and 7,504,485
("Human Antibodies that Bind Human IL-12," issued March 17, 2009)
based on Centocor's manufacture, use, and sale of its Stelara product
(ustekinumab, anti-IL-12 antibody). View the complaint here.

Bristol-Myers Squibb Co. et al. v. Mylan Pharmaceuticals Inc. et
al.
1:09-cv-00651; filed August 28, 2009 in the
District Court of Delaware

• Plaintiffs: Bristol-Myers Squibb Co.; Bristol-Myers
Squibb Pharma Co.
• Defendants: Mylan Pharmaceuticals Inc.; Matrix
Laboratories Ltd.; Matrix Laboratories Inc.

Infringement of U.S. Patent No. 6,673,372 ("Crystalline
Efavirenz," filed January 6, 2004) following a Paragraph IV certification
as part of Mylan's filing of an ANDA to manufacture a generic version of BMS'
Sustiva® (efavirenz, used to treat HIV infection). View the complaint here.

King Pharmaceuticals Inc. et al. v. Teva Parenteral Medicines
Inc. et al.

1:09-cv-00652; filed August 28, 2009 in the
District Court of Delaware

• Plaintiffs: King Pharmaceuticals Inc.; Meridian
Medical Technologies Inc.
• Defendants: Teva Parenteral Medicines Inc.; Teva
Pharmaceuticals USA Inc.

Infringement of U.S. Patent No. 7,449,012 ("Automatic
Injector," issued November 11, 2008) following a Paragraph IV
certification as part of Teva's filing of an ANDA to manufacture a generic
version of Meridian's EpiPen® Auto-Injector (epinephrine, used to treat
anaphylaxis). View the complaint here.
Conference & CLE Calendar

September 7, 2009

September 13-15, 2009 – 2009 Annual Meeting (Intellectual Property Owners Association) – Chicago, IL

September 14-15, 2009 – 3rd Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) – National Harbor, MD

September 15-16, 2009 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 17, 2009 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – New York, NY

September 21-22, 2009 – 2009 World Stem Cell Summit*** – Baltimore, MD

September 21-22, 2009 – Patent Litigation 2009 (Practising Law Institute) – San Francisco, CA

September 23-25, 2009 – 10th Annual Generic Drugs
Summit on the Business of Biosimilars (Institute for
International Research) – Boston, MA

September 30-October 1, 2009 – Biotech Patents*** (American Conference Institute) – Boston, MA

October 5-6, 2009 – Patent Litigation 2009 (Practising Law Institute) – McLean, VA

October 7-8, 2009 – Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) – New York, NY

October 14, 2009 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

October 15-16, 2009 – Patent Litigation 2009 (Practising Law Institute) – Chicago, IL

October 20-21, 2009 – 17th Forum on Biotech Patenting (C5) – London,
United Kingdom

October 22-23, 2009 – Pharmaceutical Congress on Paragraph IV Disputes*** (Center for Business Intelligence) – Philadelphia, PA

October 26-28, 2009 – Intellectual Property Counsels' Committee (IPCC) Fall Conference & Meeting (Biotechnology Industry Organization) – Washington, DC

October 28-29, 2009 – Patent Opinion Writing Boot Camp*** (American Conference Institute) – Philadelphia, PA

November 9-10, 2009 – Patent Litigation 2009 (Practising Law Institute) – Atlanta, GA

November 9-11, 2009 – Developing
IP Strategies for Crystalline Forms*** (International
Quality & Productivity Center) – London,
England

November 12-13, 2009 – Paragraph IV on Trial*** (American Conference
Institute) – New York, NY

November 16-17, 2009 – Patent Litigation 2009 (Practising Law Institute) – New York, NY

November
17-18, 2009 – Structuring,
Negotiating, and Managing Pharma/Biotech Collaborative Agreements (American Conference
Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
VC CEO Believes Biotech Is Entering Golden Era

September 6, 2009

By
Donald Zuhn —

In
the August issue of Life Science Leader
Magazine, Randal Kirk, Chairman and CEO
of the venture capital firm Third Security, LLC, writes that while some 600 to 800 life
science companies are expected to go out of business or be absorbed by other
companies within the next two years, biotech is at the edge of "a golden
era of valuable discoveries that forever will revolutionize its
foundation" ("At the Outset of the Golden Era of Biotech"). According to Mr. Kirk, however, this
golden era of biotechnology will be quite different from any previous stage of
the industry's development.

Not
surprisingly, one impetus of change in the biotech industry will be the economic
recession. Mr. Kirk (at left), however, argues
against the "common misconception that the industry has suffered a setback
similar to that of others — largely due to the poor economy — and that, with
recovery in the general economy the industry eventually will return to normal." He suggests that "the
biotech industry will not return to a state that we recently knew as 'normal,'"
and instead will "morph[] into a new state." A "new state" of biotechnology is required,
Mr. Kirk contends, because "much of the biotech industry is based on
flawed logic and processes that in the cruel light of day reveal themselves to
have been chasing specious objectives with an overabundance of poorly directed
capital." With the economic
woes leading to a withdrawal of venture funding, and many in the industry pointing
to inadequate funding as the problem, Mr. Kirk notes that "the more
obvious lesson seems to have gone largely unlearned: We have been creating too little value."

According
to Mr. Kirk, the real problem with the biotech industry can be traced to its
dependency on the healthcare industry, the latter of which "lacks critical
feedback mechanisms that are normal to other consumer industries in a
market-based economy." Mr.
Kirk notes that because the consumption decisions of healthcare consumers have
been divorced from their payment obligations as a result of third-party payment
systems, the healthcare industry lacks incentives to produce higher quality
products (i.e., more effective
treatments) at lower costs. Mr.
Kirk argues that "the healthcare industry has actually been selling a
product that is quite different from what may reasonably be termed 'healthcare'
and that product is called 'hope,'" adding that "[a]s a product, hope
offers considerable profit opportunity." As an example, Mr. Kirk points to "many of the cancer
therapies that gross billions of dollars per year today [but] only manage to move
overall survival rates by an average of a few weeks and are largely ineffective
for the majority of patients who take them."

Mr. Kirk therefore suggests that the solution to the biotech industry's problems will be
to rededicate itself to "providing constantly improved value to the
consumer." In other words,
"[c]ompanies should be focusing on adding genuine value to the maturation
process of the health care industry by developing technologies that produce a higher
quality product at lower cost."
For example, Mr. Kirk argues that clinical trial expenses for ineffective
therapeutic candidates could often be avoided by performing "a simple
proof-of-concept study [to] determine if the underlying premise — that the
product candidate could achieve its therapeutic goal — was valid or not."

Mr.
Kirk concludes his article by suggesting that a handful of disciplines will
lead the biotech industry into its new golden era: "Within the life science fields, the most promising
space includes molecular biology, cellular biology, and genetics, and the
intersection of the three."
He notes that "[t]his space is accruing intellectual capital at
such a fast rate that . . . the quantum of what is known is
doubling every 2-3 years." Drawing an analogy between where the biotech
industry currently stands and the place where the semiconductor and software
industries were in 1980, Mr. Kirk states that "[j]ust
as GUI screens, object oriented code, data base software, optical fiber and
many other science-based technologies became established as fairly fixed
concepts in the development of a meteoric increase in productivity for those
industries, biotech today is on the verge of identifying the technologies and
motifs that will be the bases of its growth hereafter." He
also notes that the analogy is more than casual, stating that while the biotech
industry spent its first 30 years focusing on genes, their modification, and
the processing of their output, the industry is beginning to shift its focus to
non-transcribed portions of the genome.
Mr. Kirk writes that "researchers now understand that the
regulatory domains act as logical controllers, and, indeed, that DNA is nature's
logic controller."

Mr.
Kirk will be speaking at the 2009 Mid-Atlantic Bio Conference on November 4-6,
2009, where he plans to discuss the impact of the economy on the biotech
industry, offer more thoughts on the next wave of advancements in the biotech
industry, and provide predictions regarding the future direction of the industry.
Developing IP Strategies for Crystalline Forms Conference

September 4, 2009

International
Quality & Productivity Center (IQPC) will be holding its 5th Annual Developing
IP Strategies for Crystalline Forms conference from November 9-11, 2009 in London,
England. The conference will provide:

• An international
case law update for the EU, U.S., and India;
• A judicial review
presentation from Alastair Wilson QC, Joint Head of Chambers, Hogarth Chambers;
• A review of the
EC competition commissions report and scrutinize how organizations may have to
change;
• A pharmaceutical
extensions of patent exclusivity Focus Day, to help attendees maximize patent
wealth;
• Information
regarding how applications have changed over the last 12 months, and how companies
need to adapt to gain first time patent approval.

In particular, the
conference and Focus Day will offer presentations on the following topics:

• Opening
keynote: International IP;
• Formulating a
robust blueprint strategy for patent applications;
• Analyzing the
utility of your patent;
• Scientist perspective:
Strategy for first time patent approval;
• Maximizing
crystalline form and polymorph patent wealth: European perspective;
• European Patent
Office: Filing and approval and
how applications have changed in the last 12 months;
• The Glivec
polymorph case in India: History
and current status;
• Ensuring
effective lifecycle management of your patent;
• U.S. case law update:
Judicial decisions impacting
crystalline forms patent strategy;
• UK judicial overview;
• Polymorph patenting
and the doctrine of inherent anticipation: The U.S. perspective;
• Roundtable discussion:
Process claims vs. product claims;
• A generics perspective;
• European case law
update;
• European Commission,
Directorate General for Competition;
• Effective interaction
between IP and regulatory affairs;
• Recent cases and
legislative changes concerning supplementary protection certificates in the UK;
• Discussion session: SPCs and patent term extensions —
Target's for litigation;
• Extending your
patent lifecycle: An agrochemical
perspective;
• Gaining pediatric
exclusivity in Europe.

The agenda for the Developing
IP Strategies for Crystalline Forms conference can be found here (Day 1),
here (Day 2), and here (Focus Day). A complete brochure for this conference, including an
agenda, list of speakers, and registration form can be downloaded here.

The registration
fees for the conference and focus day are as follows: £1,499 (conference
alone), £849 (focus day), and £2,348 (conference and focus day). Those registering on or before
September 11, 2009 will receive a discount of £100 (conference alone) to £250 (conference
and focus day) off the registration fee and those registering on or before October
2, 2009 will receive a discount of £150 (conference and focus day) off the
registration fee. Those interested
in registering for the conference can do so here.

Patent Docs is a preferred blog of the Developing IP Strategies for Crystalline
Forms conference.
ACI Pharma/Biotech Collaborative Agreements Conference

September 4, 2009

American Conference
Institute (ACI) will be holding its 13th Advanced Forum on Structuring,
Negotiating, and Managing Pharma/Biotech Collaborative Agreements from November
17-18, 2009 in New York, NY. The
conference will allow attendees to:

• Integrate
emerging trends in investment capital and current deal structuring into product
strategies;
• Establish a
strong presence in new and emerging markets;
• Strengthen market
power by ensuring effective due diligence;
• Maximize
profitability through skillful negotiations of critical performance terms;
• Develop
strategies to determine the impact of M&A activity and best position a
company for an acquisition;
• Gain greater
control by drafting clearly defined termination provisions;
• Ensure effective
alliance management; and
• Protect future
rights on emerging technologies such as follow-on biologics.

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

• Predicting future
trends and reviewing emerging strategies from the year's top deals;
• Setting the
stage: Conducting effective and
strategic due diligence;
• Negotiating
essential critical terms with built-in milestones to maximize profitability;
• Integrating
M&A considerations into a collaborations strategy;
• Creating and
implementing critical termination provisions;
• Establishing
governance structures for successful alliance management;
• Negotiating
collaborative research agreements with the U.S. government and academic institutions;
and
• Anticipating
future technologies and incorporating terms into the agreement to protect
future rights.

Two additional
post-conference master classes will be offered on November 19, 2009. The first mast class, entitled: "International Collaborative
Agreements: Navigating and
Managing the Unique Regulatory and Legal Risks of Global Partnerships,"
will be offered from 9:00 am to 12:00 pm, and will provide information
concerning specific legal contractual nuances of India, Asia, and the EU, as
well as avoiding invalidation of restrictive terms, minimizing tax liability,
and negotiating alliances with foreign academic institutions. The second master class, entitled
"The 'Win-Win' Collaborative Agreement: Practical and Ethical Negotiating and Drafting
Strategies," will be offered from 2:00 pm to 5:00 pm, and will provide insights
that attendees can implement into future agreementa to achieve a win-win
successful alliance.

The agenda for the
Pharma/Biotech Collaborative Agreements conference can be found here. A complete brochure for this
conference, including an agenda, list of speakers, and registration form can be
downloaded here.

The registration
fees for the conference and master classes are as follows: $2,195 (conference alone), $2,795
(conference and one master class), and $3,395 (conference and both master
classes). Those registering on or
before September 18, 2009 will receive a $300 discount off the registration fee
and those registering on or before October 23, 2009 will receive a $200
discount off the registration fee.
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.
Paper Declares that with Respect to Drug Innovation, “Europe Is Ahead”

September 3, 2009

By
Donald Zuhn —

A
paper published in the latest issue of the policy journal Health
Affairs disputes the
widely held notion that the United States has eclipsed Europe in terms of pharmaceutical
research productivity. In the
article, entitled "Global Drug Discovery: Europe Is Ahead,"
Dr. Donald Light,
a professor of social medicine in the Department of Psychiatry at the
University of Medicine and Dentistry of New Jersey, reexamined a data set
originally collected by Dr. Henry Grabowski (professor of economics at Duke University) and Richard Wang (director of health services research and policy analysis at AstraZeneca Pharmaceuticals) and concluded that "the
United States never overtook Europe in research productivity."

In
a 2006 Health Affairs paper entitled
"The Quantity And Quality Of Worldwide New Drug Introductions, 1982–2003," Dr. Grabowski and Mr. Wang looked
at all of the 919 new chemical entities (NCEs) approved between 1982 and 2003, and
concluded that "U.S. firms overtook their European counterparts in
innovative performance or the introduction of first-in-class, biotech, and
orphan products." In particular,
the authors compared the number of NCEs discovered in the U.S., Europe, or
Japan between 1982-1992 and 1993-2003, and determined that NCE development was
shifting away from Europe and Japan and towards the U.S. Following a reexamination of this data,
Dr. Light concluded that "Congress and large purchasers are motivating
companies to develop and market drugs that add little value, instead of
rewarding true added value," and that "[t]his is not good for the
long-term vitality of the industry or for those paying too much for too little."

Simply
looking at the data collected by Dr. Grabowski and Mr. Wang, Dr. Light noted that
"European research productivity scarcely declined, and Europe continued to
dominate in discovering all NCEs as well as the highly profitable global NCEs,"
adding that "[c]learly, the United States did not overtake Europe in
discovering new chemical entities, and European researchers lost less ground
than either Europeans or Americans believe." (see Light, 2009, Exhibit 1).

Dr.
Light, however, was interested in analyzing this data in view of total research
funding (especially in view of data showing that research investment between 1990
and 2007 grew 5.2 times in the U.S. versus 3.3 times in Europe). In other words, Dr. Light wanted to determine
how much bang for the buck each region was getting. Thus, he compared the proportion of industry R&D funding
in the United States, Europe, and Japan to the proportion of NCEs developed in
each. In his paper, Dr. Light
notes that because annual figures were not available, he used investment
figures for 1990 and 2000 that were reported by member companies to U.S.,
Japanese, and European trade associations, and which were collected by the European
Federation of Pharmaceutical Industries and Associations (see Light, 2009, Exhibit 2).

Dividing
the proportion of NCEs shown in Exhibit 1 by the proportion of R&D
investment shown in Exhibit 2, Dr. Light determined that:

[T]he
United States discovered far fewer NCEs than its proportional share of funding: 0.76 (25.3/33.3) in the first period [1982-1992]
and 0.75 in the second [1993-2003].
Europe's ratio of all NCEs to investment went from 0.99 in the first
period to 1.17 (43.3/36.9) in the second.
Japan's proportionate ratio was the highest: 1.49 in the first period
and 1.36 in the second.

From
this, he contended that "[t]he big news in terms of innovation and
international policy is the low and flat U.S. productivity and the high
Japanese productivity," and further argued that "Grabowski and Wang's
conclusions about U.S. dominance are not supported by their own data." However, in view of the growing
importance of biotech drugs (see, e.g., "BioWorld Reports on the Top
25 Biotech Drugs"
and "Future Drug Sales Predictions Highlight Importance of Follow-on
Biologics Legislation"),
it is interesting to note that Dr. Light's analysis shows that "European
researchers became much more innovative in the second period but did not catch
up with their U.S. counterparts, even though U.S. productivity declined" (see Light, 2009, Exhibit 4).

Looking
forward, Dr. Light suggests that "[g]iven the new institutes in European
countries that bring together applied scientists from industry and academe to
translate discoveries into drugs, such as Top Institute (TI) Pharma in the
Netherlands [which funded Dr. Light's study]; Karolinska Institutet Innovations
in Stockholm, Sweden; and the broader European Innovative Medicines Initiative,
returns on R&D investment in Europe may increase further during the next
decade of 2004-2014." As for
the implications of his study on U.S. drug policy, Dr. Light states that:

Congressional
leaders and others concerned about high prices of new patented drugs will be
heartened by this analysis, because lower European prices seem to be no
deterrent to strong research productivity. A previous analysis using industry-based data showed that
pharmaceutical companies recover all costs and make a good profit at European
prices. Europeans are not
"free riders" on American patients — another myth promoted by
industry that assumes that countries are separate R&D/market silos that
should each pay for themselves.
Cancer Drug Development in The New York Times

September 2, 2009

By Kevin E. Noonan —

The fastest-growing part of the biotech/pharma
industry is anticancer drugs, according to an article in The New York Times
today ("For Profit, Industry Seeks Cancer Drugs"). Written by Andrew
Pollack, one of the paper's senior business and technology writers, the article
highlights the interplay between scientific interest and business opportunity
driving this phenomenon.

The article supports its thesis on the recent rise
in anticancer drugs with some telling statistics: there are "more than twice the number of experimental drugs for heart disease and stroke combined, nearly twice
as many as for AIDS and all other infectious diseases combined, and nearly twice as many as for Alzheimer's and all other neurological diseases combined." This corresponds to 860 anticancer
drugs currently in clinical trials.

The scientific reasons
for these efforts stem from the nature of cancer as a disease. Robert Weinberg (at left) from the Whitehead
Institute at MIT is quoted in the article as saying "Cancer is not a
single disease. It's really
dozens, arguable hundreds of diseases." Bert Vogelstein (below right) from Johns Hopkins is quoted as saying that
a typical tumor may have 50-100 genetic mutations, with any two patients having
the same type of cancer having as few as five mutations in common. Accordingly, there are many approaches
and molecular targets for small molecule, immunological, and other avenues for
attacking cancer cells in an effort to find a cure. In addition, the situation is ripe for "personalized
medicine," or efforts to tailor the treatment to the tumor based on the
unique signature of genetic mutations and the corresponding phenotype of an
individual's cancer and the targets for therapeutic intervention expressed by
each individual's tumor.

But this very
complexity is the main reason why cancer remains so daunting after 40 years of
concerted efforts to find a cure. On the one hand, individual cancers even of the same type or in the same
tissue vary dramatically in changes in gene expression, chromosomal
abnormalities, and cancer-associated phenotypes, so that treatments that are
effective for some cancer patients are completely ineffective for others. This has caused the "war on cancer"
to resemble a "grinding war of the trenches," according to an
uncredited quote by a cancer researcher. And intractable clinical situations provide a correspondingly broader
scope of opportunities for new drugs effective against cancer in some portion
of the patient population.

However, on the other
hand, the efficacy of many anticancer drugs is limited at best. The article cites the instance of drugs
like Erbitux® used as a "last ditch treatment for colorectal cancer"
providing on average about 90 days of additional life to patients. And Taceva®, used for treating
pancreatic cancer (a cancer having a 3% 5-year survival rate that hasn't
changed in the past 100 years), extends life for pancreatic cancer patients on
average only 12 days (the basis for its approval by the FDA for this
indication).

Since 1998, when there
were twelve anticancer drugs in the world's 200 medicines having the greatest
sales, the number of anticancer drugs has almost doubled (to 23), and 20 of the
126 drugs having revenues of $1 billion are anticancer drugs. Despite these efforts, however, only a
handful of new anticancer drugs are approved each year (two in 2008, one so far
in 2009). Nevertheless, the article cites studies by IMS Health, a
pharmaceutical market research company, for evidence that "[c]ancer drugs
have been the biggest category of drugs in terms of sales worldwide since 2006
and in the U.S. since 2008."

One factor driving
anticancer drug development is the revenues that can be generated from their
sales, which carry a hefty price tag. Taceva® treatments cost about $3,500 a month, according to the article,
and Erbitux® costs $10,000 per month (with an "extra" cost per
patient averaging $50,000, based on the average length of treatment course). These costs have resulted in ImClone
having revenues of $1.6 billion in 2008 for Erbitux®, revenues that the article
asserts motivated "Eli Lilly & Co. to outbid Bristol-Myers Squibb to
acquire ImClone for $6.5 billion."

While these costs are
exorbitantly high, the article notes that "[p]atients are often desperate,
and insurers risk outrage by denying payments for a[n anti]cancer drug,"
even when there is little chance of benefit from the treatment. "Cancer is such an emotional issue
that the free market doesn't work like it does for bicycle wheels and
umbrellas," according to Robert Erwin, head of the Marti Nelson Cancer
Foundation. Money will flow to
anticancer drugs "[a]s long as the health care system will pay the price." This situation raises special
concerns for the healthcare system as a whole, particularly under the current
economic climate, the pressures to reduce drug costs, and the amount of
investment required to determine whether an anticancer drug lead compound will
come to market. These
circumstances are characterized as "the biggest bubble you've ever seen,"
according to Dr. Mark Ratain (at right), a University of Chicago oncologist.

The confluence of the exponential increase in
genetic information over the past decade and the technical ability to identify
genetic polymorphism and outright mutation with different cancer phenotypes
presents an unprecedented opportunity for developing new anticancer
therapeutics. Mr. Pollack's
article is a reminder that the science is only part of the equation, and that
the economic realities of drug development and the healthcare marketplace will
also have a role in determining how many, and which, of these drugs will be
available for the next generation of cancer patients.

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