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.  On Monday, Tuesday,
and Wednesday we counted
down stories #15 to #4, and today we count down 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.

3. 
Implementation of Leahy-Smith America Invents Act Continues

The U.S. Patent and
Trademark Office began the year by publishing five notices of proposed
rulemaking in January to implement various provisions of the Leahy-Smith
America Invents Act.  Another four
notices of proposed rulemaking and a practice guide for proposed trial rules
were published in February.  Over the
summer, the Office issued three more notices of proposed rulemaking and a
guidance document on the first-inventor-to-file (FITF) provisions of the AIA.  In July, the Office began issuing final rules
to implement AIA provisions, with the final rules corresponding to the notices
of proposed rulemaking issued earlier in the year.  By mid-August, the Office had issued eight
final rules and a patent trial practice guide. 
The Office also held a roundtable in September to obtain public input on
issues relating to the Office's proposed rules to implement the
first-inventor-to-file provisions of the AIA. 
In February, the Office started to exercise its new fee setting
authority under the AIA by submitting a proposed fee schedule to the Patent
Public Advisory Committee (PPAC), with the PPAC holding two public hearings on the
proposed schedule.  In September, the PPAC
issued a report on the proposed schedule, which the Director considered before
publishing a notice setting and adjusting certain patent fees.  The publication of the proposed fee schedule
initiated a 45-day comment period, which ended in November.  The Office is expected to publish a final
notice on fees in the coming weeks, with the fee schedule taking effect 45 days
after publication (to provide Congress with an opportunity to review the
schedule).  Earlier in the year, the
Office issued AIA-mandated reports on the prior user rights defense provisions
of the AIA and on international patent protections for small businesses.  While the Office collected public comments on
genetic diagnostic testing and held two public hearings on the matter, the
Office was unable to meet the deadline for submitting its AIA-mandated report
on genetic diagnostic testing to Congress (and, in fact, has scheduled a
roundtable on January 10 to discuss the topic further).  The Office also opened its first satellite
office in Detroit, and after considering public input on locations for
additional satellite offices, announced that it would be opening three
additional offices in Dallas, TX; Denver, CO; and California's Silicon Valley.  Throw in a series of AIA roadshows, webinars,
and a Twitter chat, and it has been a busy year for the Office as it implements changes brought about by the AIA, and for applicants and practitioners as
they try to keep up with these changes. 
And FITF is only 72 days away.

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

• "USPTO Issues Final
Rule Implementing Micro Entity Status," December 26, 2012
• "USPTO News
Briefs," December 20, 2012
• "USPTO to Hold
Roundtable on Genetic Diagnostic Testing," December 4, 2012
• "IPO Submits
Comments on Proposed Fees," November 14, 2012
• "USPTO Holds Live
Chat on AIA," November 13, 2012
• "USPTO News
Briefs," October 30, 2012
• "PPAC Issues Report
on USPTO Patent Fees Proposal," October 9, 2012
• "Rules Changes
Implementing the Inventor's Oath or Declaration Provisions of the AIA,"
October 4, 2012
• "More on USPTO's
Proposed New Fees – Part II," September 19, 2012
• "More on USPTO's
Proposed New Fees," September 11, 2012
• "USPTO Proposes New
Patent Fees and CPI Adjustments to Certain Fees," September 6, 2012
• "USPTO News
Briefs," September 5, 2012
• "USPTO News
Briefs," August 27, 2012
• "USPTO Issues
Several Final Rules for Implementing AIA Provisions," August 15, 2012
• "USPTO Issues Final
Rule to Implement Miscellaneous Post Patent Provisions of AIA," August 8,
2012
• "USPTO Issues Final
Rule for Implementing Statute of Limitations Provisions for Office Disciplinary
Proceedings," July 31, 2012
• "USPTO Issues Final
Rule for Preissuance Submissions," July 25, 2012
• "USPTO to Open Three
More Satellite Offices," July 2, 2012
• "Docs at BIO:
Session on Prior User Rights as a New IP Option," June 20, 2012
• "USPTO Report on
Genetic Testing Delayed," June 18, 2012
• "BIO International
Convention 2012 Preview – Part III: BIO and the America Invents Act," June
14, 2012
• "USPTO Issues
Proposed Rules for Implementing Micro Entity Status," June 4, 2012
• "USPTO News
Briefs," May 23, 2012
• "USPTO Posts
Comments on Genetic Diagnostic Testing," May 22, 2012
• "USPTO Posts
Comments on Proposed Fees Changes," March 19, 2012
• "A Glimpse under the
Hood: How the USPTO Proposes to Adjust Patent Fees," March 14, 2012
• "USPTO Proposes Fees
Changes," March 1, 2012
• "USPTO News
Briefs," February 20, 2012
• "USPTO Holds First
Hearing on "Second Opinion" Genetic Testing," February 16, 2012
• "Patent Docs Author
Testifies at Genetic Diagnostic Testing Hearing," February 16, 2012
• "USPTO to Hold
Hearing on Genetic Diagnostic Testing," February 15, 2012
• "USPTO Proposes More
Rules for Implementing AIA Provisions," February 13, 2012
• "USPTO Issues
Proposed Rulemaking for Supplemental Examination Provisions of AIA,"
February 8, 2012
• "PPAC to Hold Public
Hearings on Proposed Fee Schedule," February 1, 2012
• "Interpreting 35
U.S.C. § 102 under the America Invents Act," January 31, 2012
• "USPTO Proposes
Rules Changes for Implementing AIA Provisions — Oath or Declaration
Provisions," January 30, 2012
• "USPTO News Briefs,"
January 26, 2012
• "USPTO News
Briefs," January 18, 2012
• "USPTO Issues Report
on Prior User Rights," January 17, 2012
• "USPTO Proposes
Rules Changes for Implementing AIA Provisions — Statute of Limitations
Provisions for Office Disciplinary Proceedings," January 16, 2012
• "USPTO Proposes
Rules Changes for Implementing AIA Provisions — Preissuance Submissions
Provision," January 12, 2012
• "USPTO Proposes
Rules Changes for Implementing AIA Provisions — Miscellaneous Post Patent
Provisions," January 11, 2012

2.  Supreme
Court Grants Certiorari in AMP v. Myriad

Six days after issuing its
decision in Mayo Collaborative Services
v. Prometheus Laboratories, Inc., the Supreme Court issued an Order
granting the petition for writ of certiorari
in Association for Molecular Pathology v.
Myriad, vacating the judgment, and remanding the case back to the Federal
Circuit for further consideration in light of the Mayo decision.  As we noted
yesterday, the Federal Circuit decided on remand that claims to isolated human
DNA satisfy the requirements of 35 U.S.C. § 101, with each member of the panel
issuing opinions that tracked their earlier opinions (the Federal Circuit's
decision placed #5 on our 2012 list of top stories).  In September, the American Civil Liberties
Union (ACLU) and Public Patent Foundation (PubPat) again filed a petition for certiorari with the Supreme Court, which
the Court granted on November 30.  The
Court's grant was limited to the first question presented — whether human genes
are patent-eligible — and the Court denied certiorari
on the other two questions (thus letting stand the Federal Circuit's
determination that screening methods using genetically transformed cells are
patent-eligible under the Court's Mayo v.
Prometheus precedent, and that a declaratory judgment plaintiff must cite
actual injury to have standing).  The Supreme Court's grant of certiorari in AMP v. Myriad ensures that this case will be a top story again in 2013.

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

• "Supreme Court
Grants Cert in AMP v. Myriad," November 30, 2012
• "Myriad Files
Responsive Brief Opposing Certiorari,"
November 29, 2012
• "AMP v. Myriad Briefed and Distributed
for Conference – Update," November 19, 2012
• "AMP v. Myriad Briefed and Distributed
for Conference," November 13, 2012
• "Plaintiffs (Again)
File Certiorari Petition in Myriad Case," September 25, 2012
• "Patent Eligibility
and Biology," August 23, 2012
• "The Proper Scope of
DNA (or 'Gene') Patent Claims," August 1, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On
Research?" July 29, 2012
• "The Aussies Are At
It Again," June 14, 2012
• "Supreme Court
Remands Myriad Case," March 26,
2012

1.  Supreme
Court Issues Decision in Mayo v.
Prometheus

On March 20, the Supreme
Court unanimously held in Mayo
Collaborative Services v. Prometheus Laboratories, Inc. that claims
directed to the relationship between the concentrations of blood metabolites
and response to a therapeutic drug were invalid for "effectively claim[ing]
underlying laws of nature themselves." 
In the nine months since the Supreme Court issued its decision,
applicants and practitioners have tried to gauge the impact of the decision and
have asked whether claims perceived to be directed to "laws of
nature" can, in fact, be written to pass Constitutional muster.  The U.S. Patent and Trademark Office
responded to the Mayo decision by
issuing preliminary guidance on the day after the decision, and then followed
up with interim guidance in July.  It did
not take the lower courts long to apply Mayo,
with the District Court for the District of Columbia in SmartGene, Inc. v. Advanced Biological Laboratories SA invalidating
diagnostic method claims in view of Mayo
only ten days after the Supreme Court issued its decision.  In November, the Federal Circuit made its
"first" attempt to implement the Supreme Court's jurisprudence
on the scope of patent eligibility for diagnostic method claims in PerkinElmer, Inc. v. Intema Ltd. (we did not count the Federal Circuit's decision on remand in AMP v. Myriad, as the diagnostic method claims in that case had
already been held patent-ineligible under the
"machine-or-transformation" test set forth in In re Bilski).  As we wrote
at the time, PerkinElmer stands as
the most recent cautionary tale of how diagnostic methods claims must be
crafted — narrow, specific, encompassing particular assaying and detection
steps, and encompassing some (any) patentable feature other than the naturally
occurring correlation between a marker and disease.  Whether this will be sufficient to render the subject matter of such
claims as patent-eligible remains an open question.

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

• "PerkinElmer Inc. v. Intema Ltd. (Fed.
Cir. 2012)," November 20, 2012
• "Patent Eligibility
and Biology," August 23, 2012
• "Chief Judge Rader
(Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons,'"
August 6, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29,
2012
• "USPTO Issues
Interim Guidance Regarding Mayo v.
Prometheus," July 5, 2012
• "BIO International
Convention 2012 Preview: BIO and the Prometheus
Supreme Court Case," June 5, 2012
• "Do Diagnostic
Method Claims Fall under the Safe Harbor of 35 U.S.C. § 287(c)?" April 11,
2012
• "SmartGene, Inc. v. Advanced Biological
Laboratories SA (D.D.C. 2012)," April 10, 2012
• "USPTO Issues
Preliminary Guidance on Mayo v.
Prometheus," March 27, 2012
• "Mayo Collaborative Services v. Prometheus
Laboratories — What Should We Do? (or Can These Claims Be Saved?),"
March 26, 2012
• "Mayo Collaborative Services v. Prometheus
Laboratories — What the Court's Decision Means," March 22, 2012
• "Mayo Collaborative Services v. Prometheus
Laboratories — What the Supreme Court Said," March 21, 2012
• "Early Reaction to
Supreme Court Decision in Mayo v.
Prometheus," March 20, 2012
• "Mayo Collaborative Services v. Prometheus
Laboratories, Inc. (2012)," March 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.