Patent Docs

Data Exclusivity Follow-up: More of the Same

January 18, 2010

By Kevin E. Noonan —

The efforts of the Obama Administration and
Congressman Henry Waxman to reduce the term of the data exclusivity period
contained in the House and Senate versions of the health care reform bill (12
years) has been noticed by others. The basic story is the same, but each new report adds some additional
information.

Last Thursday, Alan Fram wrote an article for The Washington Post regarding the meeting
between Congresswoman Anna Eshoo (D-CA) and the President as reported in
BioCentury last Saturday (see "Snatching Defeat from the Jaws of Victory?"). The story was reported with substantial identity in
BioCentury and the Post, but the Post added that the day after the reported
set-to between the President and the Congresswoman, a letter was sent to
Speaker Pelosi and Majority Leader Reid by "39 patient groups and research
universities . . . backing the 12-year period." These groups recognized that "12 years of protection
would balance patients' access to the drugs with incentives for companies to
develop more of them."

John Carrol, in a FierceBiotech article, reported on the
story last Friday. The report
contained no new information, but did provide this political analysis:

It's hard to see, though, how Obama
and Waxman could cobble together enough support from members of their own party
to make a switch at this point. Waxman was handed what amounted to a public
rebuke by Democrats on his own committee when they voiced their support of 12
years of data protection. With all the other compromises built into the reform
bill to garner a solid majority of lawmakers, where are the votes in Congress
to buck the outspoken backers of a bill cherished by biotech?

Finally, TIME
Magazine, in a story last Friday by Karen Tumulty, reported on a possible basis
for the President's position on data exclusivity: a 2008 report by Robert
Shapiro, a former Clinton administration official, on the effects of generic
competition in the biologics area (Dr. Shapiro's report was discussed on Patent Docs in February 2008; see "Dr. Robert Shapiro Discusses Follow-on Biologics Report"). The report appears to be completely results-oriented, to the effect that
"generic versions of the
top 12 categories of biologics whose patents have expired or will expire soon
could save Americans up to $108 billion in the first 10 years and as much as $378
billion over two decades." Unfortunately, the story as originally reported erroneously stated that
the 12-year data exclusivity period would run after patent protection had
expired (i.e., consecutively). Ms.
Tumulty even emphasized this error in an on-line comment. In response, Congresswoman Eshoo,
through a spokesperson, attempted to correct the record, stating (accurately): "The
patent and data exclusivity run concurrently." Ms. Tumulty further "clarified" the record as
follows:

A more precise way to describe this is
a period of "data exclusivity" (that is, use of the data used to
develop the drug) guaranteed separate and apart from the patent. The amount of
time we are talking about differs from drug to drug, because of the varying
amounts of time that it can take to test a drug and win regulatory approval. For instance: If a drug comes to market with, say, five years left on its
patent, this bill would give it an additional seven years.

Congresswoman Eshoo's spokesman
made the point more clearly:

To further clarify, just like chemical
drugs, biologics have a 20-year patent protection from the date the patent is
filed. Data exclusivity begins the date the FDA approves a drug or biologic,
running concurrently with whatever patent protection may be left at that time
(generally this is about 12 years, according to the CBO).

The tumult over the data exclusivity period in
biologics is put in context by a report by Ben Hallman in The Am Law Litigation
Daily on a study from Adam Greene of RBS Capital Markets. The report involves statistics from
ANDA litigation, arguably the most significant legal legacy of Congressman
Waxman's seminal generic drug legislation for small molecule drugs. Mr. Greene looked at 370 ANDA
litigations over the past 10 years and reported on outcomes. (Patent Docs will provide a more
detailed analysis of the report in a later post.) Of the 370 lawsuits, 54% (200) either were dropped by the
generic company or settled (presumably some of which involved "pay-for-delay"
arrangements opposed by, inter alia, the Federal Trade Commission). Of the remainder, the results were
about even: 82 cases were won by
the generic drugmaker and 89 by the branded drugmaker. The report states that the motivation
for ANDA litigation is the 180-day exclusivity period that rewards the first
ANDA filer, stating:

[I]t's
easy to see why generic firms focus on first-to-file opportunities. Settlements
provide clarity for the company and shareholders, and we see them as a win-win
for the generic and brand company.

These results are consistent with those reported by Matthew J. Higgins
and Stuart J.H. Graham in Science
last year ("Balancing
Innovation and Access: Patent Challenges Tip the Scales"; see "Maybe Hatch-Waxman Data Exclusivity Isn't So Good for Traditional Drugs After All").

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

• "Snatching Defeat from the Jaws of Victory?" January 17, 2010

•
"Follow-on Biologics News Briefs – No. 11," December 30, 2009
•
"Follow-on Biologics News Briefs – No. 10," November 30, 2009
•
"House Health Care Bill Includes Biosimilar Licensure Pathway,"
November 3, 2009
•
"12 Senators Write in Support of 12-Year Data Exclusivity Period,"
November 3, 2009
•
"Four Senators Write in Support of 12-Year Data Exclusivity Period,"
October 19, 2009
•
"Governors Send Letter to Congressional Leaders in Support of 12-Year Data
Exclusivity Period," October 2, 2009
•
"Follow-on Biologics News Briefs – No. 8," August 19, 2009
•
"House Committee Approves Health Care Reform Bill Calling for 12-Year
Exclusivity Period," July 31, 2009
•
"Follow-on Biologics News Briefs – No. 5," July 19, 2009
•
"House Subcommittee Holds Hearing on Follow-on Biologics," July 14,
2009
•
"Senators Champion 12-Year Data Exclusivity in Senate," July 14, 2009
•
"Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period,"
July 9, 2009
• "White House Recommends 7-Year Data Exclusivity Period for Follow-on
Biologics," June 26, 2009
•
"No One Seems Happy with Follow-on Biologics According to the FTC,"
June 14, 2009
•
"Third Follow-on Biologics Bill Introduced in 111th Congress," April
1, 2009
•
"Second Follow-on Biologics Bill Is Introduced in House," March 18,
2009
•
"Waxman Introduces Follow-on Biologics Bill," March 11, 2009
•
"Congressman Waxman Tells GPhA Meeting that Hatch-Waxman Model Will Work
for Follow-on Biologics," February 25, 2009
Snatching Defeat from the Jaws of Victory?

January 17, 2010

Obama Administration Pushes for Lower Data Exclusivity Period

By Kevin E. Noonan —

The Obama administration is reported to be pushing
for a lower data exclusivity period than the 12-year period contained in both the
House and Senate versions of the
health care reform bill. This latest twist was reported by Steve Usdin in BioCentury on Saturday. According to the report, the President
informed Congressional Democratic leaders of his opposition in a meeting at the
White House last week. Specifically, on Wednesday, Congresswoman Anna Eshoo (D-CA) asked the
President whether he supported the 12-year data exclusivity period in the
bill. Characteristically
forthright, the President is reported to have replied: "As a matter of
fact, I don't." The
Congresswoman, who succeeded in having the 12-year period added to the final bill
over the objections of the Chairman of the House committee, fellow Californian
Henry Waxman, is reported to have sharply responded to the news. She particularly objected to having the
"deal" brokered between the Obama Administration and the
pharmaceutical industry (wherein the "contribution" of the industry
to healthcare reform is capped at $80 billion) be "sacrosanct" while
the administration objected to one of the few aspects of the reform measure where there is
agreement between the House and Senate versions. The President's answer was not specific, alluding to "good
policy."

The report contains speculation that Congressman
Waxman (at left) is trying to get a victory on this issue at the 11th hour
(having failed miserably during debate on the bill). Other speculation includes that this is an issue where the
President could assuage some of the criticism from the left that he had
conceded too much to the pharmaceutical industry. Or perhaps the President's stance comes from his inner
policy wonk.

Regardless of motivation, the stance has raised a
firestorm. Billy Tauzin (at right), president
and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) was
motivated to threaten to withdraw "months of unstinting support" for the healthcare reform bill
should the President prevail on Speaker Pelosi and Majority Leader Reid to
reduce the data exclusivity term. Mr. Tauzin also was reported to have notified PhRMA's board members that the group "could
not support the bill [if the data exclusivity
term was reduced]" (emphasis in original). Congressman
Waxman responded with characteristic combativeness, saying that "[t]he
brand name drug companies are threatening to block health care reform for
millions of Americans unless they receive virtually permanent immunity from
generic competition." Besides
being deficient in mathematics ("12 years" can be the same as "permanent"
only on Capitol Hill or to a politician trapped in 2-year re-election cycles),
Congressman Waxman fails to consider that permanent immunity from generic
competition is the status quo. If
he cares as much as he professes, he might consider that getting this
health care bill passed should take priority; changes in data exclusivity term, if warranted, can wait for
another day. Congressman Waxman's
position was echoed by Teva Pharmaceuticals (or, more precisely, by their
lobbyists, Cuneo Gilbert & LaDuca), saying that "[a]ccess to affordable health care must not be held
hostage by the pharmaceutical industry in this way."

Perhaps the President should consider the likely,
and threatened, consequences of his position. For example, the Massachusetts Biotechnology Council (MassBio) is threatening to "attempt
to derail Democrat Martha Coakley's bid to replace Edward Kennedy in the U.S.
Senate" unless the Administration provided reassurances that the final
version of the bill contains the 12-year data exclusivity period. The article in BioCentury puts the number of biotech industry workers in
Massachusetts at about 45,000, certainly enough to influence the election. This position would be a
reversal; recently, BIO President
and CEO, Jim Greenwood, attended a fundraising dinner for Ms. Coakley, and
Robert Coughlin, MassBio's president and CEO, was reported to have warned both
Speaker Pelosi and Majority Leader Reid that MassBio would actively oppose Ms.
Coakley's election if the data exclusivity term was lowered from the present 12
years. Failing to hold the
Massachusetts Senate seat for the Democrats would wreck havoc on the
legislative calculations for getting a health care bill passed.

The report notes that a compromise is possible,
specifically a term of 10 years. Earlier in the process, investors in the biotechnology sector and
biotech company executives are said to have privately conceded that a 10-year
term would be acceptable, similar to the term in Europe. However, that was then, and it is
possible (if not likely) that expectations have been raised sufficiently for a
10-year term to no longer be possible.

The report notes, ironically, that there are other
provisions in the bill, such as ones involving how the Food and Drug
Administration will review applications for biosimilar drugs (for example,
involving formal rulemaking) that would delay institution of a biosimilar
approval pathway for "a minimum of two to three years" after the
legislation is enacted (if ever).

While this may simply be a case of "politics
as usual," it seems to be as
inept as it is unnecessary. After
all the time and effort (as well as political capital) this administration and
Congress have expended in trying to pass health care reform, it would be worse
than a shame if the petty politics of political preference and prerogative were
to prevent its passage.

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

•
"Follow-on Biologics News Briefs – No. 11," December 30, 2009
•
"Follow-on Biologics News Briefs – No. 10," November 30, 2009
•
"House Health Care Bill Includes Biosimilar Licensure Pathway,"
November 3, 2009
•
"12 Senators Write in Support of 12-Year Data Exclusivity Period,"
November 3, 2009
•
"Four Senators Write in Support of 12-Year Data Exclusivity Period,"
October 19, 2009
•
"Governors Send Letter to Congressional Leaders in Support of 12-Year Data
Exclusivity Period," October 2, 2009
•
"Follow-on Biologics News Briefs – No. 8," August 19, 2009
•
"House Committee Approves Health Care Reform Bill Calling for 12-Year
Exclusivity Period," July 31, 2009
•
"Follow-on Biologics News Briefs – No. 5," July 19, 2009
•
"House Subcommittee Holds Hearing on Follow-on Biologics," July 14,
2009
•
"Senators Champion 12-Year Data Exclusivity in Senate," July 14, 2009
•
"Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period,"
July 9, 2009
• "White House Recommends 7-Year Data Exclusivity Period for Follow-on
Biologics," June 26, 2009
•
"No One Seems Happy with Follow-on Biologics According to the FTC,"
June 14, 2009
•
"Third Follow-on Biologics Bill Introduced in 111th Congress," April
1, 2009
•
"Second Follow-on Biologics Bill Is Introduced in House," March 18,
2009
•
"Waxman Introduces Follow-on Biologics Bill," March 11, 2009
•
"Congressman Waxman Tells GPhA Meeting that Hatch-Waxman Model Will Work
for Follow-on Biologics," February 25, 2009
Court Report

January 17, 2010

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.

Monsanto Co. et al. v. Slusser
4:10-cv-00075; filed January 14, 2010 in the
Eastern District of Missouri

• Plaintiffs: Monsanto Co.; Monsanto Technology,
LLC
• Defendant: Kevin Slusser

Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric
Genes for Transforming Plant Cells Using Viral Promoters," issued October
4, 1994) and RE39,247 ("Glyphosate-tolerant
5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006)
based on defendant's use of soybean seed produced from earlier planted Roundup
Ready® soybean seed. View the
complaint here.

Alza Corp. et al. v. Kremers Urban LLC et al.
1:10-cv-00023; filed January 8, 2010 in the
District Court of Delaware

• Plaintiffs: Alza Corp.; Ortho-McNeil-Janssen
Pharmaceuticals Inc.
• Defendants: Kremers Urban LLC; KUDCO Ireland
Ltd.

Infringement of U.S. Patent Nos. 6,919,373 ("Methods
and Devices for Providing Prolonged Drug Therapy," issued July 19, 2005)
and 6,930,129 (same title, issued August 16, 2005) following a Paragraph IV
certification as part of Kremers' filing of an ANDA to manufacture a generic
version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention
deficit hyperactivity disorder). View the complaint here.

Allergan Inc. v. Sandoz Inc.
1:10-cv-00024; filed January 8, 2010 in the
District Court of Delaware

Infringement of U.S. Patent Nos. 5,688,819 ("Cyclopentane
Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents,"
issued November 18, 1997) and 6,403,649 ("Non-acidic Cyclopentane
Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents,"
issued June 11, 2002) following a Paragraph IV certification as part of Barr's
filing of an ANDA to manufacture a generic version of Allergan's Lumigan®
(0.03% bimatoprost ophthalmic solution, used to treat lower intraocular eye
pressure in people with open-angle glaucoma or ocular hypertension). View the complaint here.

AstraZeneca Pharmaceuticals LP et al. v. Teva
Parenteral Medicines Inc. et al.
1:10-cv-00018; filed January 7, 2010 in the
District Court of Delaware

• Plaintiffs: AstraZeneca Pharmaceuticals LP;
AstraZeneca UK Ltd.; AstraZeneca AB
• Defendants: Teva Parenteral Medicines Inc.; Teva
Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 6,744,122 ("Formulation,"
issued August 10, 2004) and 7,456,160 (same title, issued November 25, 2008) following
a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture
a generic version of AstraZeneca's Faslodex® (fulvestrant, used to treat metastatic
hormone receptor-positive breast cancer). View the complaint here.

Teva Women's Health, Inc. v. Lupin, Ltd. et al.
2:10-cv-00080; filed January 6, 2010 in the District
Court of New Jersey

• Plaintiff: Teva Women's Health, Inc.
• Defendants: Lupin, Ltd.; Lupin Pharmaceuticals
Inc.; Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 7,615,545 ("Oral
Contraceptives to Prevent Pregnancy and Diminish Premenstrual Symptomatology,"
issued November 10, 2009) following a Paragraph IV certification as part of Lupin's
filing of an ANDA to manufacture a generic version of Teva's LoSeasonique®
(ethinyl estradiol and levonorgestrel, used as oral contraception). View the complaint here.
Conference & CLE Calendar

January 17, 2010

January 20, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Los Angeles & San Francisco

January 21, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Birmingham, Boston, Philadelphia & Pittsburgh

January 20-21, 2010 – Life Sciences IP
Due Diligence (American Conference
Institute) – New York, NY

January 25, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Atlanta & Seattle

January 25-26, 2010 – European Pharmaceutical Regulatory Law Boot
Camp (American Conference
Institute) – New York, NY

January 26-27,
2010 – Advanced In-House Counsel Forum on China IP Law (C5) – Shanghai, China

January 27-30, 2010 – Mid-Winter Institute (American
Intellectual Property Law Association) – La Quinta, CA

January 27-28, 2010 – Pharma & Biotech Patent Litigation (C5) – Amsterdam, Netherlands

January 28, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Memphis

January 29, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Wilmington

February 4, 2010 – "Are Genes Patentable?" (Intellectual Property Litigation Committee, American Bar Association) – Chicago

February 4, 2010 – Bay Area Pharma and Life Sciences IP Summit (Fish
& Richardson and Berkeley Center for Law & Technology) – San Mateo, CA

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 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

***Patent Docs is a media partner of this conference or CLE
Summit on Biosimilars and Follow-on Biologics

January 15, 2010

The Center for
Business Intelligence (CBI) will be holding its 4th Summit on Biosimilars and
Follow-on Biologics on March 18-19, 2010 in Washington, DC. At the Summit, CBI's faculty will offer
presentations on the following topics:

• Understand the developing biosimilars
framework in the United States and European Union;
• Biologics similarity — How will this
be defined? (panel discussion);
• FDA update on the scientific issues
associated with evaluating FOB submissions;
• Update on healthcare reform policy
and implications for bio/pharma;
• From the Hill — Biosimilars
legislative perspectives (panel discussion);
• European monoclonal antibody draft
guidance — What will this mean for the U.S.?
• Update on reimbursement systems,
benefit design implications and clinical/patient safety considerations for
biosimilars;
• Understand provider perspectives on
the use of biosimilars;
• Lessons learned from Hospira's EU
biosimilar experiences;
• Partnering with biobetters to
facilitate approval and increase product update;
• The biosimilars business model —
Opportunities and pitfalls;
• Follow-on perspective; and
• Innovator perspective.

A complete agenda
for the Summit on Biosimilars and Follow-on Biologics can be found here (Day
One)
and here (Day Two). A brochure for this conference can be
requested here.

The registration
fee for the conference is $2,095.
Attendees registering on or before January 22, 2010 will receive a $400
discount off the registration fee, and attendees registering a group of three
individuals will receive a fourth registration for free. Those interested in registering for the
conference can do so here,
by calling 1-800-817-8601, or by e-mail at cbireg@cbinet.com.

Patent Docs is a media partner of CBI's Summit on Biosimilars and Follow-on
Biologics.
ABA IP Roundtables on Gene Patenting

January 15, 2010

The
Intellectual Property Litigation Committee of the American Bar Association
(ABA) Section of Litigation will be holding a number of luncheon roundtable
discussions at various locations around the country to address the
question: "Are Genes
Patentable?" Roundtables have
been scheduled on the following dates at the following locations:

• January
20, 2010 – Los Angeles & San Francisco
• January
21, 2010 – Birmingham, Boston, Philadelphia & Pittsburgh
• January
25, 2010 – Atlanta & Seattle
• January
28, 2010 – Memphis
• January
29, 2010 – Wilmington
• February
4, 2010 – Chicago
• Date
to be determined – Houston, Minneapolis, Nashville, Palo Alto & Washington,
DC

Patent Docs author Kevin
Noonan will be moderating the Chicago roundtable. The hosts and moderators for the other roundtables can be
found here. Information regarding the site, time,
possibility of securing CLE credit, and whether lunch is being provided at each
roundtable can also be obtained at the above link. A 17-page program discussion outline for the roundtable can
be obtained here.
Bay Area Pharma and Life Sciences IP Summit

January 15, 2010

Fish
& Richardson and the Berkeley Center for Law & Technology will be
holding the Bay Area Pharma and Life Sciences IP Summit in San Mateo, CA on
February 4, 2010. Registration for
the event opens at 11:30 am (PT), and at noon, Suzanne Michel, Deputy Director
for the Office of Policy Planning at the Federal Trade Commission, will give a
keynote luncheon presentation entitled:
"Impact of Healthcare Legislation on Pharmaceutical Patent
Litigation Settlements and Follow-on Biologics." Following the keynote, a series of panel discussions will
address the following topics:

•
Hot Topics in Bio/Pharma Litigation
•
Product Life Cycle Management
•
Early Stage IP Strategies

Panelists
will include:

•
Debra Condino, Vice President and Chief Intellectual Property Counsel,
Allergan, Inc.
•
Frank Grassler, Vice President – Intellectual Property, Gilead Sciences, Inc.
•
Kurtis MacFerrin, Lead IP Counsel – Litigation, Life Technologies
•
Gerald Suh, Chief Patent Counsel, Metabolex, Inc.
•
D. Jeffery Grimes, General Counsel, Aradigm Corp.

A
cocktail reception will follow the panel discussions at 5:00 pm. While there is no registration fee,
those interested in attending the Summit should e-mail Roxanne Smith by January
28, 2010 at rks@fr.com. Additional information regarding the
Summit can be obtained here.
AIPR Reiterates Opposition to Patent Reform Legislation

January 14, 2010

By
Donald Zuhn —

On
Tuesday, the American Innovators for Patent Reform
(AIPR) announced
that it was joining with the Small Business Coalition on Patent Legislation in
opposing patent reform legislation currently before Congress. The AIPR specifically opposes the
inclusion of apportionment of damages, post-grant opposition, and first-to-file
provisions in any patent reform bill that might make its way to the Senate or
House floor for a vote. Last fall,
the AIPR had issued a statement
regarding its opposition to the post-grant review provision in particular.

In
December, the Small Business Coalition on Patent Legislation sent a letter to
the U.S. Small Business Administration stating its opposition to the
first-to-file, post-grant review, and USPTO rulemaking provisions in pending
patent reform legislation (see "Patent
Reform Efforts Opposed by Small Business Group"). Only a few weeks earlier, in a letter
to The New York Times, Senate
Judiciary Chairman Patrick Leahy (D-VT) asserted that "[w]e need to create
the legal landscape that allows our innovators to flourish in the new economy,
and we need to do it now" (see "Senator Leahy: 'Time Is Now' for
Patent Reform"). Senator Leahy added that "Congress should not let the controversial issue
of how damages are calculated bog down needed reforms," and noted that
with regard to patent reform, Congress "will make this happen, and America
will invent its way back to prosperity."

In
the AIPR release, the group's founder and President Alexander Poltorak
noted that while Congress had been consumed by the health care reform debate
for most of the past year, and both the Senate (S. 515)
and House (H.R. 1260)
patent reform bills had been put on hold, "there is no doubt that Congress
will again address the Patent Reform Act in 2010, and those who believe that
only strong U.S. patents will insure and protect American innovation must stand
united in opposition to this ill-conceived legislation!" Referring to the letter sent by the the
Small Business Coalition last month, Dr. Poltorak
applauded the group for its efforts "in getting the voice of small business
— traditionally the largest source of new job creation and new technologies —
heard in the halls of Government."

According
to the AIPR website, the group represents a broad constituency of American
innovators and innovation stakeholders, including inventors, engineers,
researchers, entrepreneurs, patent owners, investors, small businesses, and
intellectual property professionals such as patent attorneys, patent agents,
tech transfer managers, and licensing executives.
USPTO to Hold Public Meeting on January 20th to Discuss Appeals Rules Changes

January 13, 2010

By
Sarah Fendrick —

The
U.S. Patent and Trademark Office published a notice in the Federal Register last month (74 Fed.
Reg. 67987) in which the Office announced that it is
considering modifications to rules governing the practice before the Board of
Patent Appeals and Interferences (BPAI) in ex parte patent appeals. The USPTO had previously solicited
public comment in 2007 regarding a proposed rule change for practices before
the BPAI in ex parte patent appeals, and the resulting final rule was to become
effective on December 10, 2008. Due to a number of factors, the final rule was never implemented (see "Patent Office Announces Delay for New Appeals Rules" and "Patent Office to Publish Notice Delaying New Appeals Rules").

As
a result of the previously submitted comments, the USPTO is considering further
change to the final rule to reduce any additional burden introduced by the
final rule. During this
consideration period, the USPTO is seeking public comment on potential
modifications to the final rule. In addition to public comment, the USPTO is conducting a public session
and roundtable on January 20, 2010 from 9:30 a.m. to 12:30 p.m. in connection
with the final rule modification.

Several modifications to
the final rule as published in 73 Fed. Reg. 32937 are being considered. These modifications include:

(1) Deleting portions
of the rule that require the filing of a petition to the Chief Administrative
Patent Judge seeking extensions of time to file certain papers after an appeal
brief is filed in an ex parte appeal or seeking to exceed a page limit; (2)
deleting portions of the rule that require the filing of a jurisdictional statement,
table of contents, table of authorities, and statement of facts in appeal
briefs, a table of contents, table of authorities, and statement of additional
facts in reply briefs, and a table of contents and table of authorities in
requests for rehearing filed in ex parte appeals; (3) deleting portions of the rule that require an
appellant to specifically identify which arguments
were
previously presented to the Examiner and which arguments are new; (4)
deleting portions of the rule that require specific formatting requirements
and page limits for appeal briefs, reply briefs, and requests for rehearing;
and (5) deleting portions of the rule that require appellants to provide a list
of technical terms and other unusual words for an oral hearing.

Written
comments on potential modifications to the final rule can be submitted to the
USPTO until February 12, 2010. Comments can be submitted by electronic mail to BPAI.Rules@uspto.gov or by regular 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.

For additional information regarding this topic, please see:

• "Patent Office Announces Delay for New Appeals Rules," December 10, 2008
• "Patent Office to Publish Notice Delaying New Appeals Rules," December 9, 2008
• "Patent Office Issues Appeals Rules Clarification," November 21, 2008
• "More on Ex parte Appeal Rule," October 10, 2008
• "Unhappy with the Ex parte Appeal Rule? Read This Now," October 8, 2008
• "Patent Office Posts Comments on New Appeals Rules," September 11, 2008
• "More on USPTO Rulemaking Practices,"July 21, 2008
• "USPTO Rulemaking Practices Being Called into Question (Again)," July 20, 2008
• "New Appeals Rules Published," June 10, 2008
• "Patent Office to Publish New Appeals Rules on Tuesday," June 9, 2008
Consumer Groups Ask Congress to Add Pay-for-Delay Provision to Health Care Bill

January 13, 2010

By
Donald Zuhn —

On
Monday, the American Antitrust Institute
(AAI) sent a letter
to Speaker of the House Nancy Pelosi (D-CA) and Senate Majority Leader Harry
Reid (D-NV), urging the House and Senate to include provisions in their health
care reform bills that would prohibit exclusion payments in pharmaceutical
patent settlements. These
payments, also known as pay-for delay settlements or reverse payments, are made
by brand name drug companies to generic drug companies in order to delay the
entry of a generic drug into the market.
Co-signatories on the letter included Families USA,
U.S. PIRG, the Consumer Federation of America,
Consumers Union, Community Catalyst,
and the National Legislative Association on Prescription Drug Prices.

In
a press release issued on Monday, the AAI noted that a group of Senators, led
by Sen. Herb Kohl (D-WI) (at left), had tried unsuccessfully to add a pay-for-delay
provision to the Senate health care bill last month. The proposed amendment was based on a bill (S. 369)
Sen. Kohl introduced in February 2009, which would "prohibit payments from
brand name to generic drug manufacturers with the purpose to prevent or delay
the entry of competition from generic drugs" (see "Bill to Prohibit Reverse Payments Introduced in the
Senate"). Last fall, the bill was passed out of
Senate Judiciary Committee by a 12-7 vote (see
"Anti-Reverse Payment Legislation Introduced in the House").

In
its letter to the Speaker and Senate Majority Leader, the consumer advocacy groups seek support
for the pay-for-delay legislation being proposed by Rep. Bobby Rush (D-IL) (at right). The anti-reverse payment provision
being proposed by Rep. Rush is presumably similar to the bill (H.R. 1706) he
introduced in April 2009, which would prohibit brand name drug companies from
compensating generic drug companies for delaying the entry of generic drugs
into the market (see "Senate
Judiciary Committee Acts on Reverse Payments").

The
groups also seek support for a bill (S. 1315)
introduced by Sen. Bill Nelson (D-FL) (at left), which would provide an incentive for multiple
generic manufacturers to challenge patents. The bill, which was introduced in June and then referred to
the Senate Committee on Health, Education, Labor, and Pensions (HELP), would
amend the Federal Food, Drug, and Cosmetic Act to expand the definition of
"first applicant" under the Act to allow a generic drug manufacturer
that is currently considered an applicant subsequent to a brand-name
manufacturer's 180-day exclusivity period to qualify as a first applicant for
purposes of filing an abbreviated application for a new drug. Currently, Sen. Nelson's bill has only
one co-sponsor: Sen. Kohl.

The
AAI letter states that Rep. Rush's and Sen. Nelson's provisions "will help
open up the market for affordable prescription drugs." The letter notes that "[w]hen
patents are weak or illegitimate, drug manufacturers have the opportunity to
challenge those patents and, if successful, to introduce affordable generics to
the market in a shorter timeframe than they otherwise would." However, when a first-to-challenge
generic manufacturer is "paid off by the branded drug manufacturer to stay
out of the market," the generic manufacturer gets to keep its 180-day
exclusivity period, thereby preventing other manufacturers from bringing the
same generic drug to market.
According to the letter, this results in consumer harm. As a result, the letter contends that
reverse payments "should be considered per se illegal: they prevent any generic manufacturer with a legitimate challenge to a patent
from potentially entering the market."

With
regard Sen. Nelson's modification of the 180-day exclusivity period, the letter
argues that "[e]xpanding the exclusivity period is vitally important,
since it removes the barrier to entry that has protected collusive settlements
between brands and first-filing generics." The letter contends that including Sen. Nelson's provision
in the final health reform legislation "would provide a strong complement
to Representative Rush's per se ban on these payments."

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