By
Donald Zuhn —

Reflecting
upon the events of the past twelve months, Patent
Docs presents its third annual list of top biotech/pharma stories.  For 2009, we identified ten top stories
that we covered on Patent Docs last year.  Today, we count down stories #10,
#9, and #8.  On Sunday, we will
present stories #7, #6, and #5, and on Monday, we will count down the top four
stories of 2009.  As with the 2008
list and
2007 list, links to our
coverage of these 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.

#10 — President Obama
Ushers in Change

On
January 20, 2009, Barack Hussein Obama was sworn in as the 44th President of
the United States.  The election of
President Obama came in at #8 on our list of top stories for 2008 ("#8 — Impact
of Presidential Election on U.S. Patent Practice"),
and at the time, we speculated that the direction the new Administration would
take with the USPTO would likely be a top story for 2009.  President Obama's greatest impact on
U.S. patent practice came via his nominations for Secretary of Commerce (Washington
Governor Gary Locke) and Undersecretary of Commerce for Intellectual Property
and Director of the U.S. Patent and Trademark Office (IBM Vice President and Assistant
General Counsel of Intellectual Property Law David Kappos). The new
Administration also took an active role in both the patent reform and follow-on
biologics debates.

One day after
being sworn in, President Obama acted swiftly to stall implementation of any rulemaking
by the outgoing Bush Administration, and in March, asked the Director of the
Office of Management and Budget (OMB) to produce a set of recommendations for a
new Executive Order on Federal regulatory review.  President Obama also satisfied one of his campaign pledges in
March when he reversed limits imposed by the Bush Administration on embryonic
stem cell research.  As the economy
rebounds from the Great Recession, the President's impact on U.S. patent
practice could be even greater in 2010.

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

•
"NIH Releases New Stem Cell Rules," July 7, 2009
•
"Gary Locke Confirmed as New Secretary of Commerce," March 26, 2009
•
"President Obama Reaffirms Faith in Science," March 11, 2009
•
"President Obama to Lift Stem Cell Limits on Monday," March 8, 2009
•
"White House Seeks Comments on Rulemaking and Rule Enforcement
Policy," March 5, 2009
•
"Center for American Progress Report a Mixed Bag of Recommendations to
Obama Administration," February 11, 2009
•
"BIO CEO Outlines Challenges for Obama Administration," January 22,
2009
•
"Obama Acts to Limit New Federal Rules," January 21, 2009

#9 — After Much Debate,
Patent Reform Takes Backseat to Economic Crisis

The
current patent reform debate has been ongoing since 2005, and but for the worst
economic crisis since the Great Depression, Congress may well have passed patent
reform legislation during 2009.  As
late as November, patent reform's biggest proponent, Senate Judiciary Chairman Patrick Leahy
(D-VT), wrote that patent
reform's "time is now." 
In October, the Republican General Counsel of the Senate Judiciary
Committee, Joseph Matal, told attendees at the BIO IP Counsels Committee Conference that there was a 70-80%
chance the Senate would pass a bill in 2009.

Congress got off to a
quick start on patent reform in 2009, with both the Senate and House
introducing bills on March 3rd. 
Shortly thereafter, the Senate Judiciary Committee heard testimony
regarding its efforts to reform U.S. patent law from Steven Appleton, Chairman
and CEO of Micron Technology, Inc.; Philip Johnson, Chief Intellectual Property
Counsel for Johnson & Johnson; David Kappos, Vice President and Assistant
General Counsel of Intellectual Property Law and Strategy for International
Business Machines Corp.; Taraneh Maghamé, Vice President of Tessera, Inc.; Herbert
Wamsley, Executive Director for the Intellectual Property Owners Association;
and Mark Lemley, the William H. Neukom Professor of Law at Stanford Law School.

In April, the Senate patent reform bill
(S. 515) was voted out of the Judiciary Committee after Senators Leahy, Arlen
Specter (R-PA), and Dianne Feinstein (D-CA) were able to reach an agreement on a damages
provision that would provide for a gatekeeper approach, in which a court would determine
the Georgia-Pacific factors to be
considered by the jury in determining damages.  Later that month, the House held its own hearing on patent
reform, receiving testimony from David Simon, Chief Patent Counsel for Intel,
Inc.; Philip Johnson, Chief Intellectual Property Counsel for Johnson &
Johnson; John Thomas, Professor at Georgetown University Law School; Jack
Lasersohn, Partner with the Vertical Group; Dean Kamen, DEKA Research and
Development Inc.; Mark Chandler, Senior Vice President for Cisco; and Bernard
Cassidy, Senior Vice President and General Counsel for Tessera Inc.  Last year, patent reform came in at #3
on our top stories list ("#3 — Patent Reform Stalls in the Senate"),
and this year, we could have simply reused the heading from 2008.  However, in the Senate's defense, there should be little dispute that other more pressing matters required the body's focus in 2009.

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

•
"Patent Reform Efforts Opposed by Small Business Group," December 16,
2009
•
"Senator Leahy: 'Time Is Now' for Patent Reform," December 2, 2009
•
"Patent 'Reform' May Happen This Year, After All," October 27, 2009
•
"Commerce Department Brass Weighs in on Patent Reform," October 14,
2009
•
"Obama Administration Weighs in Supporting Patent 'Reform,'" October 6, 2009
•
"Tech Companies Send Letter on Patent Reform to Secretary Locke,"
September 17, 2009
•
"A Response to Mr. Brill, and a Modest Proposal Regarding Inequitable
Conduct," June 3, 2009
•
"Former House Economist Sets Sights on Inequitable Conduct 'Reform,'"
June 2, 2009
•
"Docs at BIO: Patent Reform Super Session," May 26, 2009
•
"More on House Patent Reform Hearing," May 12, 2009
•
"BIO IP Policy Briefing," May 11, 2009
•
"House Judiciary Committee Holds Hearing on Patent Reform," April 30,
2009
•
"House Judiciary Committee (Finally) Releases Witness List for Patent
Reform Hearing," April 29, 2009
•
"CHI CEO on Patent Reform and Follow-on Biologics Legislation," April
28, 2009
•
"Dickinson and Figg on Patent Reform," April 16, 2009
•
"Not Everyone Thinks 'Patent Reform' is a Great Idea," April 7, 2009
•
"Senate 'Patent Reform' Bill (S. 515) Voted out of Judiciary
Committee," April 2, 2009
•
"Some (But Not All) Amendments Introduced in 'Patent Reform' Bill,"
April 1, 2009
•
"'Progress' on Senate 'Patent Reform' Bill," March 31, 2009
•
"Senate Judiciary Committee Discusses S. 515 at Executive Business
Meeting; Adopts "Technical" Amendment GRA09350," March 26, 2009
•
"IPO Board Opposes USTPO Fee Increases and Willful Infringement Provision
of Reform Bill," March 26, 2009
•
"ABA IP Section Seeks Inequitable Conduct Reform," March 23, 2009
•
"Senator Kyl Introduces Alternative to Leahy Patent Reform Bill,"
March 19, 2009
•
"MAPP Economist Advises Congress on Damages Provision," March 17,
2009
•
"Senate Judiciary Committee Places Patent Reform Bill on Agenda,"
March 15, 2009
•
"More Response to New Patent Reform Legislation," March 12, 2009
•
"Senate Judiciary Committee Holds Hearing on Patent Reform," March
10, 2009
•
"Senator Specter Seeks Resolution of Issues before Vote on Patent Reform
Bill," March 5, 2009
•
"Senate Judiciary Committee Releases Witness List for Patent Reform
Hearing," March 4, 2009
•
"Senate and House Introduce New Patent Reform Legislation," March 3,
2009
•
"BIO Meets the Press," February 26, 2009
•
"Patent Reform Bill to Be Introduced on Monday . . . Maybe," February
25, 2009
•
"Manufacturing Alliance Sends Letter on Patent Reform to President
Obama," February 10, 2009
•
"Science Progress Tackles Patent Reform," January 21, 2009
•
"Heritage Foundation Offers Patent Reform Proposals to the New
President," January 20, 2009
•
"Manufacturing Alliance on Patent Policy: Apportionment of Damages
Provision Will Have Adverse Effects," January 15, 2009
•
"BIO Gives President-elect Obama Its Ideas on Patent Reform," January
6, 2009

#8 — Federal Circuit
Decides In re Kubin

The
Federal Circuit began the year by hearing oral argument in In re Kubin, and less than three months later issued its decision.  In summarizing the CAFC's decision, Patent Docs author Kevin Noonan wrote that:

[T]he
Federal Circuit not only affirmed the finding by the Board of Patent Appeals
and Interferences that Kubin's invention was obvious, but in the process
decided that the Supreme Court had overturned the Federal Circuit's In re Deuel
decision.  This outcome is
sufficiently disappointing in itself; the reasoning is all the more so.

One
interesting aspect of the Kubin oral
argument involved an exchange between Judge Rader and USPTO Associate Solicitor
Janet Gongola regarding the Office's motivation for revising Example 11 of the
new Written Description Training Materials (which were issued in March 2008).  Judge Rader essentially accused the
USPTO of revising Example 11 so that it would no longer be detrimental to the
Office's position in Kubin.

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

•
"Is Everything Obvious?" April 26, 2009
•
"The Non-obviousness of DNA," April 13, 2009
•
"In re Kubin (Fed. Cir. 2009)," April 5, 2009
•
"In re Kubin: The Obviousness of DNA," January 14, 2009
•
"Kubin Panel Questions Motivation behind Reversal in New Written
Description Training Materials," January 8, 2009
•
"In re Kubin to Be Argued before the Federal Circuit on Thursday,"
January 7, 2009