By Donald Zuhn —

Reflecting upon the events
of the past twelve months, Patent Docs
presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that
were covered on Patent Docs last year
that we believe had (or are likely to have) the greatest impact on
biotech/pharma patent practitioners and applicants.  Today, we count down stories #15 to #12, and
then throughout the week, we will work our way towards the top three stories of
2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), 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
anything we included, please let us know.

15.  USPTO
Continues Efforts to Cut Application Backlog and Pendency

In November, the U.S.
Patent and Trademark Office released its Performance and Accountability Report
for Fiscal Year (FY) 2012, which indicated that the Office had met all of its
annual performance targets.  For one of
those targets — average total pendency — the Office not only hit its target
by achieving a 32.4-month pendency (versus the target of 34.7 months), but it
surpassed the average pendency achieved in each of the three previous fiscal
years.  The Office also noted that
despite an increase in application filings (565,566 in FY 2012 versus 537,171
in FY 2011), the number of applications awaiting action dropped from 690,967 in
FY 2011 to 633,812 in FY 2012 (the fourth consecutive year that the number of applications
awaiting action had dropped) and the total number of pending applications decreased
from 1,168,928 in FY 2011 to 1,157,147 in FY 2012.  However, despite the improving numbers, the
Office has continued to seek ways in which to cut the application backlog and
application pendency.  One issue on which the Office has focused its attention recently is the rising number of Requests for Continued
Examination (RCEs).  Earlier this month,
the Office published a notice in the Federal Register (77 Fed. Reg. 72830)
seeking public feedback on RCE practice. 
The notice, which indicated that the Office has a backlog of
more than 90,000 applications that have not been examined since an RCE was
filed, described some of the Office's efforts to reduce the RCE backlog, including
the Quick Path Information Disclosure Statement (QPIDS) pilot program and the
After Final Consideration Pilot (AFCP). 
Not surprisingly, the notice does not discuss the Office's efforts to
decrease RCE filings by raising the cost of filing a first RCE to $1,200 (from
the current fee of $930), and further raise the cost of filing subsequent RCEs
to $1,700, a proposal that the Patent Public Advisory Committee (PPAC) has
called "illogical."  Comments to
the Office's notice can be submitted until February 4, 2013 (see link below for information regarding
the submission of comments).

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

• "USPTO Seeks Public
Feedback on RCE Practice," December 13, 2012
• "USPTO News Briefs,"
June 21, 2012
• "USPTO Announces
Quick Path Information Disclosure Statement (QPIDS) Pilot Program," May
10, 2012
• "USPTO to Assess
After Final Consideration Pilot Program," April 5, 2012

14.  USPTO
and Applicants Deal with Intersection of Patent and Copyright Law

In January, the Office of
the General Counsel for the U.S. Patent and Trademark Office issued a
memorandum in
response to several inquiries the Office had received concerning copyright
infringement and the use of non-patent literature (NPL) in the examination
process.  In that memo, USPTO General
Counsel Bernard Knight, Jr. deemed the following practices to be protected by
the doctrine of fair use:  (1) the Office's
practice of making copies of copyrighted NPL and providing such copies to an
applicant in the course of patent examination; (2) the Office's practice of providing
certified copies of entire file histories, including copyrighted NPL, to
members of the public for a fee; and (3) the copying of copyrighted NPL by
patent applicants and their attorneys and the submission of those copies to the
USPTO pursuant to the USPTO's disclosure requirements.  The memo was timely given separate lawsuits
brought by a publishing company against two law firms in February.  (Because one of the firms is McDonnell Boehnen
Hulbert & Berghoff LLP, where the Patent
Docs authors and contributors work, Patent
Docs has not provided any coverage of these cases.  However, former MBHB attorney Dennis Crouch
has covered the cases on his Patently-O weblog; see here
and here,
for example.)

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

• "USPTO Issues Memo
on Use of Non-Patent Literature During Examination," January 23, 2012

13.  Congress
Works to "Correct and Improve" Leahy-Smith America Invents Act

On November 30, Rep. Lamar
Smith (R-TX) introduced a bill (H.R. 6621) entitled "To correct and
improve certain provisions of the Leahy-Smith America Invents Act and title 35,
United States Code."  Demonstrating
that you cannot judge a bill by its title, the legislation contained provisions having
nothing to do with any of the AIA's provisions, including one that would have
effectively eliminated patent rights for the ~200 pending U.S. patent
applications having a filing date prior to June 7, 1995 (when legislation
enabling the provisions to the Uruguay Rounds of the General Agreement on
Tariffs and Trade (GATT) were enacted). 
This section, however, was replaced with a provision requiring a report
to Congress on the status of pre-GATT applications before the House passed the
bill by a 308-89 vote, and even that changed section was replaced with a
clerical amendment in the Senate version of the bill.  Following passage of the further amended bill
by the Senate, the bill stalled back at the House when Rep. Bobby Scott (D-VA)
objected to a vote on the grounds that a quorum was not present.

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

• "The Status Quo
Reigns in Senate's Version of H.R. 6621," December 30, 2012
• "Congressional
Corrections Regarding H.R. 6621," December 20, 2012
• "Congressional Misunderstandings
(Apparently) Motivate H.R. 6621," December 20, 2012
• "The Plot Thickens
around H.R. 6621," December 18, 2012
• "Pre-GATT Patent
Applications Threatened by Lamar Smith's H.R. 6621," December 6, 2012

12.  Federal
Circuit Defines Presumption of Enablement for Prior Publications

On July 27, the Federal
Circuit issued a decision in In re Antor
Corp. that increased the burden on proving patentability created by prior
art references for patent applicants and patentees by defining a presumption of
enablement not only for prior patents and published patent applications but
also for all prior printed publications, regardless of source of provenance.  The Antor
decision is likely to have important implications for practitioners attempting
to provide patent protection for biotechnology-based inventions.  This is because the inventiveness of
biotechnology inventions is often assessed in view of prior art produced by
university researchers, and it is a feature of some of this art that portions
therein are reserved for what can most kindly be called discussions of possible
future implications and applications of a scientific result (or unkindly, unsupported flights of fancy).  However, the presence of such language in
scientific references such as journal articles not expressly provides a much
more robust source of prior art, insofar as anything said in a prior art
printed publication now falls expressly within the presumption that it is
enabled.  While in many cases this will
not pose an insurmountable challenge, it can be expected at the very least to
increase the difficulties and cost of obtaining patents, and to open up a host
of new prior art for use in invalidity defenses.

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

• "In re Antor Media
Corp. (Fed. Cir. 2012)," August 20, 2012

Image of New Year's Eve
ball drop for 2012 in Times Square
(above) by Replytojain, from the Wikipedia Commons under the Creative Commons
Attribution-ShareAlike 3.0 Unported
license.