On
New Year's Eve, we kicked off our third annual list of top biotech/pharma
stories by counting down the first three of the top ten stories covered on Patent Docs in 2009 (see "Top Stories of 2009: #10, #9,
and #8"). Today, we count down stories #7, #6,
and #5, and tomorrow, we will present last year's top four stories. As with the 2008 list
and 2007 list, links to
our coverage of the 2009 top stories (as well as a few links to articles on
related topics) have been provided in case you missed the articles the first
time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list
or disagree with our rankings, please let us know.
When
President Obama was elected as the 44th President of the United States on
November 4, 2008, patent practitioners and applicants had to believe that the end
was near for an old USPTO administration that seemed to care little about the people
who were paying all of those patent fees.
As a result of the many serious issues that confronted the President on
the day he began his term, it took a while for the President to get all of his
people in place. By the end of
March, however, Gary Locke was confirmed as Secretary of Commerce, and on
August 7th, David Kappos was confirmed as Under Secretary of Commerce for
Intellectual Property and Director of the USPTO.
For information regarding this and other related topics, please see:
•
"USPTO Launches Interactive Patent Pendency Model," December 27, 2009
•
"USPTO Announces Changes to PKI Certificate Usage Policy," December
21, 2009
•
"USPTO Requests Comments on Enhancement of Patent Quality," December
13, 2009
•
"USPTO Implements Patent Application Backlog Reduction Stimulus
Plan," December 7, 2009
•
"USPTO Issues Notice to Remove Claims and Continuations Rule Changes from
CFR," December 3, 2009
•
"KSR: Additional Guidance Forthcoming from the USPTO," November 25,
2009
•
"Director Kappos Joins Blogger Ranks," November 12, 2009
•
"USPTO Proposes Patents Ombudsman Pilot Program," November 12, 2009
•
"USPTO Schedules Roundtable Discussion on Worksharing," October 22,
2009
•
"USPTO Expands First Action Interview Pilot Program," October 5, 2009
•
"USPTO Proposes Changes to Count System," October 1, 2009
•
"USPTO Seeks Comments Regarding Sequence Listing Rules," September
24, 2009
•
"Changes in USPTO Senior Management," September 8, 2009
•
"Keeping $118 in Your Pocket," August 21, 2009
•
"New Director to Be Sworn in on Thursday," August 12, 2009
•
"Senate Judiciary Committee Hears from Director Nominee," July 29,
2009
•
"Senate Judiciary Committee to Consider Kappos Nomination on
Wednesday," July 28, 2009
•
"USPTO Announces A 'No Decision' Regarding Annual Practitioner Fee,"
July 22, 2009
•
"Annual Fee for Registered Practitioners May Be Delayed," July 20,
2009
•
"Secretary Locke Appoints Godici to Assess USPTO Challenges," July 7,
2009
•
"Kappos Nomination Supported by Industry and Patent Groups," June 23,
2009
•
"Patent Office Extends Comment Period Regarding Deferred
Examination," June 18, 2009
•
"President Obama to Nominate David Kappos as USPTO Director," June
18, 2009
•
"USPTO Posts Comments on Deferred Examination," June 11, 2009
•
"Docs at BIO: Panel Offers Suggestions for Fixing the USPTO," May 20,
2009
•
"Patent Office Extends Deferred Examination Comment Period," March 9,
2009
•
"Comments on Deferred Examination Due by February 26th," February 13,
2009
•
"Patent Office Hosts Roundtable on Deferred Examination: The
Proponents," February 15, 2009
•
"Patent Office Hosts Roundtable on Deferred Examination: The
Opposition," February 12, 2009
•
"Patent Office Announces Agenda and Participants for Deferred Examination
Roundtable," February 9, 2009
•
"Patent Office Calls Continuing Education Pilot Program a Success,"
February 3, 2009
•
"USPTO Schedules Roundtable Discussion on Deferred Examination,"
January 27, 2009
•
"U.S. Chamber of Commerce Provides Detailed Recommendations to New
Administration Regarding
USPTO," January 8, 2009
#6 -- House and Senate
Pass Health Care Bills Containing Follow-on Biologics Provisions
On
Christmas Eve, the Senate passed the Patient Protection and Affordable Care Act
(H.R. 3590) by a 60-39 vote. The
bill provides for an approval pathway for biosimilar biological products, which
would preclude a biosimilar application from being approved "until the
date that is 12 years after the date on which the reference product was first
licensed." In addition, the
Senate bill would offer an additional 6 months of exclusivity for the use of
reference products "in the pediatric population." The Senate's action came a little more
than a month after the House passed the Affordable Health Care for America Act
(H.R. 3962) by a narrow five-vote margin (220-215). The House bill provides a similar licensure pathway in which
a biosimilar application is precluded from being approved "until the date
that is 12 years after the date on which the reference product was first
licensed," and an additional 6 months of exclusivity is provided for the
use of reference products "in the pediatric population."
For information regarding this and other related topics, please see:
•
"Follow-on Biologics News Briefs - No. 11," December 30, 2009
•
"Two Physicians Want Congress to Close 'Evergreening' Loophole in FOB
Legislation," December 3, 2009
•
"Follow-on Biologics News Briefs - No. 10," November 30, 2009
•
"Follow-on Biologics News Briefs - No. 9," November 5, 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
•
"Follow-on Biologics Data Exclusivity Debate Scorecard - Part III,"
November 1, 2009
•
"Follow-on Biologics Data Exclusivity Debate Scorecard - Part II,"
October 29, 2009
•
"Follow-on Biologics Data Exclusivity Debate Scorecard - Part I,"
October 28, 2009
•
"Time Magazine on Data Exclusivity Debate," October 27, 2009
•
"Four Senators Write in Support of 12-Year Data Exclusivity Period,"
October 19, 2009
•
"PhRMA Supports Follow-on Biologics Regulatory Pathway Providing 12-Years
of Data Exclusivity," October 19, 2009
•
"Maybe Hatch-Waxman Data Exclusivity Isn't So Good For Traditional Drugs
After All," October 18, 2009
•"NEJM Authors Say Five Years of Data Exclusivity Would Be
Sufficient," October 15, 2009
•
"Governors Send Letter to Congressional Leaders in Support of 12-Year Data
Exclusivity Period," October 2, 2009
•
"Roll Call Authors Unite against Current Follow Biologics
Legislation," September 20, 2009
•
"BIO Top Brass Meet the Press," September 9, 2009
•
"Deloitte White Paper Addresses Unintended Consequences of Follow-on
Biologic Regulatory Pathway," August 27, 2009
•
"Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on
Biologic Drugs," August 24, 2009
•
"AEI Presents Follow-on Biologic 'Reality,'" August 20, 2009
•
"Follow-on Biologics News Briefs - No. 8," August 19, 2009
•
"BIO CEO Makes Case for 12-Year Data Exclusivity Period," August 16,
2009
•
"Follow-on Biologics News Briefs - No. 7," August 5, 2009
•
"Patents and Data Exclusivity: It Ain't Necessarily So," August 2,
2009
•
"House Committee Approves Health Care Reform Bill Calling for 12-Year
Exclusivity Period," July 31, 2009
•
"Follow-on Biologics News Briefs - No. 6," July 28, 2009
•
"Follow-on Biologics News Briefs - No. 5," July 19, 2009
•
"Former House Economist Testifies at Follow-on Biologics Hearing,"
July 16, 2009
•
"The Risk of Biogenerics," July 15, 2009
•
"House Subcommittee Holds Hearing on Follow-on Biologics," July 14,
2009
•
"Senators Champion 12-Year Data Exclusivity in Senate," July 14, 2009
•
"NVCA Study Supports 12-Year Data Exclusivity Period," July 13, 2009
•
"NCHC Sends Letter on Biosimilars to Senate Health Committee," July
9, 2009
•
"Senator Kennedy Weighs in on Biosimilar Data Exclusivity Period,"
July 9, 2009
•
"BIO CEO Provides Update on Follow-on Biologics Legislation," July 8,
2009
•
"Follow-on Biologics News Briefs - No. 4," June 29, 2009
• "White House Recommends 7-Year Data Exclusivity Period for Follow-on
Biologics," June 26, 2009
•
"Future Drug Sales Predictions Highlight Importance of Follow-on Biologics
Legislation," June 21, 2009
•
"AEI Believes Advantages of Longer Data Exclusivity Period Outweigh
Disadvantages," June 18, 2009
•
"No One Seems Happy with Follow-on Biologics According to the FTC,"
June 14, 2009
•
"Uncertain Future for Waxman Follow-on Biologics Bill," June 9, 2009
•
"Docs at BIO: Panel Addresses Follow-on Biologics Policy," May 25,
2009
•
"BIO IP Policy Briefing," May 11, 2009
•
"CHI CEO on Patent Reform and Follow-on Biologics Legislation," April
28, 2009
•
"Follow-on Biologics News Briefs - No. 3," April 27, 2009
•
"Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics
Legislation," April, 22, 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
•
"BIO Meets the Press," February 26, 2009
•
"Congressman Waxman Tells GPhA Meeting that Hatch-Waxman Model Will Work
for Follow-on Biologics," February 25, 2009
•
"Follow-on Biologics News Briefs - No. 2," February 18, 2009
•
"Teva CEO Predicts Passage of Follow-on Biologics Bill in 2009,"
January 2, 2009
#5 -- Supreme Court Hears
In re Bilski
In
November, the Supreme Court heard oral argument in In re Bilski. The
potential impact of the Supreme Court's decision in Bilski on the biotech/pharma industry seems to have been somewhat lessened,
however, by the Court's reluctance to take the opportunity to address the patent-eligibility of
diagnostic methods claims. In
addition, in SEptember, the Federal Circuit alleviated concerns in the industry with its decision in Prometheus
Laboratories, Inc. v. Mayo Collaborative Services. Of course, depending on what the
Supreme Court says in Bilski, the case could very well vault all the way to the top of next year's
list.
•
"Supreme Court Bilski Argument," November 9, 2009
•
"Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir.
2009)," September 16, 2009
•
"BIO Top Brass Meet the Press," September 9, 2009
•
"BIO Files Amicus Brief in Bilski," August 13, 2009
•
"The Supreme Court, In re Bilski and the Lingering Question of LabCorp v.
Metabolite," June 1, 2009
•
"Author of Nature Article Provides Rebuttal; Patent Docs Provides
Surrebuttal," March 26, 2009
•
"Genetic Diagnostic Testing: The "Anti-Commons" Revisited?"
March 25, 2009
•
"Applying In re Bilski to Diagnostic Method Claims," February 5, 2009
•
"Bilski and Aventis Petition for Certiorari from the Supreme Court,"
January 29, 2009
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