Patent Docs

Conference & CLE Calendar

December 30, 2012

January 2-5, 2013 – National CLE Conference (Law Education Institute, Inc.) – Snowmass, Colorado

January 10, 2013 – China's Patent Regime and its Quest to Become an
Innovation Economy (The George Washington
University Law School and Fordham University School of Law) – Washington, DC

January 22, 2013 – Top Patent Law Stories of 2012 (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00 to
11:15 am (CT)

January 22, 2013 – Patent Term Adjustments and Extensions: Recent Developments —
Leveraging Exelixis, Other Court
Decisions and Recent USPTO Rule Changes to Maximize PTAs and PTEs (Strafford) – 1:00 – 2:30 pm (EST)

January 23-24, 2013 – The Comprehensive Guide to Patent Reform*** (American Conference
Institute) – New York, NY

January 29, 2013 – Combined Customer Partnership Meeting
of TC3700 and TC1600 (U.S. Patent and Trademark Office) – Alexandria, VA

January
29-30, 2013 – Biotech & Pharma Patent Litigation*** (C5) – Amsterdam, Netherlands

February 20-22, 2013 – Intensive Patent Law Seminar (Chisum Patent Academy) – New York, NY

February
26-27, 2013 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

February 27-28, 2013 – Life Sciences
Collaborative Agreements and Acquisitions*** (American Conference
Institute) – New
York, NY

***Patent Docs is a media partner of this conference or CLE
Biotech & Pharmaceutical Patenting 2013

December 28, 2012

IBC Legal will be
holding its 21st annual Biotech & Pharmaceutical Patenting conference on February
26-27, 2013 in Munich, Germany. Conference
highlights include:

• Benefit from the
latest trends in patent protection strategies and competitive patent filing;
• Hear from WIPO,
EPO, EC, industry players and the cream of legal advisors internationally;
• Analyze recent
cases and their practical implications on attendees' everyday work in Europe
and the US;
• Understand the
challenges of tactical biotech and pharmaceutical patenting including second
medical use and internet crimes;
• Explore the
application of SPCs to extend patent life including Neurim;
• Deal with
competition law issues in patenting effectively and commercially; and
• Obtain
cutting-edge advice and insights on crucial legal developments like injunctions
and Solvay.

In particular, IBC
Legal faculty will offer presentations on the following topics:

• Developments in
European Patent Law in the last 12 months;
• Keynote from European
Patent Office — Heli Pihlajamaa, Director Patent Law, European Patent Office;
• Special address
— Henri Piffaut, DG Competition, European Commission;
• WIPO address — Tom
Bombelles, Global Challanges Division, WIPO;
• Patent Protection
and prodrugs;
• Prior public use
in clinical trials;
• Patents and biosimilars;
• Personalized medicines
— What can you achieve?
• Patenting genes
and theranostics;
• The pitfalls of
patent filing in Brazil and protection strategies;
• Developing
countries — The new frontiers;
• Dealing with
competition law issues in patenting;
• Product launches;
• Case study — A
practical, interactive session based on a case study of decision making as
regards defending patents on a limited budget;
• Developments in
damages under the enforcement directive;
• Biotech and
pharmaceutical patenting in the US market;
• The Unified
Patent Court;
• Second medical
use patents and infringement by cross-label use;
• Bolar and research/experimental
use exemptions;
• SPCs masterclass;
and
• Strategies for
maximizing patent life cycles — Exploring the application of SPCs to extend
patent.

A complete brochure
for this conference, including an agenda, detailed descriptions of conference
sessions, list of speakers, and registration form can be obtained here.

The registration
fee for the conference is £1,499. Those
registering by January 25, 2013 will receive a £100 discount. Those interested in registering for the
conference can do so here,
by e-mailing professionalcustserv@informa.com, by calling +44 (0)20 7017 5503,
or by faxing a registration form to +44 (0)20 7017 4746.
Spread of Laboratory-generated Antibiotic Drug Resistance in Chinese Rivers

December 27, 2012

By
Kevin E. Noonan —

A
generation ago, Jeremy Rifkin famously convinced the Cambridge city council to
ban genetic engineering in that city, using the fear of "tinkering"
with nature and producing a "superbug" that would hurt the public
health and thereby (for a time) reduced progress in biological research at
Harvard and elsewhere in the city environs. Mr. Rifkin was not alone in his
concern over potential problems from recombinant DNA; indeed, the scientist who
first produced a recombinant plasmid, Paul Berg (Jackson et al.,
1972, "Biochemical Method for Inserting New Genetic Information into DNA
of Simian Virus 40: Circular SV40 DNA Molecules Containing Lambda Phage Genes
and the Galactose Operon of Escherichia coli," Proc.
Natl. Acad. Sci. U.S.A. 69(10): 2904-09),
was instrumental in organizing a conference in 1975 on the issue at Asilomar,
California, which resulted in guidelines (both physical and biological) from
the National Institutes of Health for the safe practice of the new technology (Guidelines
for research involving recombinant DNA molecules," 41 Fed. Reg. 27911-43 (1976)). But in
the intervening decades, widespread distribution of laboratory-derived recombinant
DNA introduced into the environment has not been reported as a threat to humans
or the environment.

Until
now, that is. In a report in the journal
Environmental Science and Technology
entitled "A Survey or Drug Resistance bla
genes Originating from Synthetic Plasmid Vectors in Six Chinese Rivers,"
scientists from Sichuan University and the Chinese Institute of Health and
Environmental Medicine report that drug resistance genes (specifically, the
beta-lactamase (bla) gene that
provides resistance to ampicillin) have been detected in the Pearl, Yangtze,
Yellow, Hai He, Sunggari, and Huangpu rivers in mainland China (Chen et al., 2012, Environ. Sci. Technol. 46(24): 13448–54). These rivers drain the majority of the
Chinese mainland in all provinces and have the cities of Guangzhou, Nanjing, Ji'nan,
Tianjin, Harbin, and Shanghai, respectively, along their banks. The authors took samples from these rivers
containing naturally occurring bacteria and assayed using polymerase chain
reaction (PCR) and a variant, quantitative real-time PCR, to assess the
frequency with which beta-lactamase DNA could be detected. The assay was specific for the bla gene that comprises most recombinant
plasmid strains, such as pBR322 (one of the oldest and most widespread plasmids
used for molecular biological research) as well as pUC19. PCR was performed using three pairs of "universal"
primers for the bla gene as well as
sequencing primers used for detecting exogenous DNA in cloning sites in the
plasmid vectors. In addition, the
bacterial isolates obtained from the river samples were assayed for antibiotic
resistance using assays recommended by the U.S. Clinical Laboratory Standards
Institute.

Plasmid-derived
bla-encoding DNA was detected in all
six rivers assayed, detected using both the "universal" primers as
well as the plasmid sequencing primers (the latter results further supporting
the conclusion that the samples were of laboratory origin). The detection rate varied from 21.9% (in the
Hai He River samples) to 36.4% (in the Yangtze River samples), and the total
copy number of bla copies in the
samples ranged from 6.7 +/- 5.0 x 10¹copies/mL (in the Yellow River
samples) to 4.6 +/- 0.6 x 10³ copies/mL (in the Pearl River
samples). The Pearl and Hai He rivers
showed the widest spectrum of cephalosporin resistance from the bla gene present in bacterial samples,
extending to 3rd- and 4th-generation drugs like
cefotaxime and cefoperazone, while the spectrum was narrower (e.g., cefalotin, cephazolin,
cefmetazole, and cefoxitin) in samples from the other rivers tested. Sequence analysis confirmed that sequences "neighboring"
the bla sequences detected in the
river samples "most frequently represented artificial or synthetic
constructs, including cloning, expression, shuttle, gene-fusion, and gene trap
vectors" derived from recombinant laboratory plasmid vectors, most
strongly with pBR322.

Abstract, Chen et al., 2012.

An
interesting ancillary result reported in the paper was that tetracycline
resistance-conferring DNA was also detected in samples from all six rivers, and
some river samples also showed genes that provided resistance to other commonly
used laboratory antibiotic selection markers such as gentamicin. Detection of gene sequences encoding
tetracycline resistance is consistent with detection of pBR322, which was
engineered to contain a tetracycline resistance gene as well as the bla gene. The authors also report that detection of
high levels of laboratory plasmid-derived antibiotic resistance genes in the
Pearl River was consistent with the levels of antibiotic pollution know to
exist in that river from human and animal sources.

This
report raises serious questions, of course, over the consequences of widespread
use of antibiotic resistance-encoding genetic elements. It is particularly disturbing because genetic
engineering is not limited to the lab anymore, being used in such technologies
as biofuels, agriculture, and bioremediation. The risk of antibiotic resistance gene contamination of the environment
has been recognized previously and steps taken to minimize it; for example,
Monsanto has developed vectors encoding other markers such as lacZY for use in its recombinant seed. These efforts take on greater significance,
and relevance for human and animal well-being, in view of this latest report.
USPTO Issues Final Rule Implementing Micro Entity Status

December 26, 2012

By Donald
Zuhn —

Last week,
the U.S. Patent and Trademark Office published a notice in the Federal Register
(77 Fed. Reg. 75019)
issuing the Office's final rule implementing the micro entity provision of § 10
of the Leahy-Smith America Invents Act.
The notice concerns rules changes that provide procedures for claiming micro
entity status, paying patent fees as a micro entity, notifying the Office of
loss of micro entity status, and correcting fees paid erroneously in the micro
entity amount. According to the notice,
the rules changes implementing the micro entity provision of the AIA will take
effect on Tuesday, March 19, 2013 (the first-inventor-to-file provisions of AIA
§ 3 take effect on Saturday, March 16, 2013).

With respect
to the payment of fees as a micro entity, the notice indicates that "[c]ertain
patent fees set or adjusted under the fee
setting authority in the AIA will be reduced by seventy-five percent for
micro entities" (emphasis added).
In other words, as the notice explains, "[t]he micro entity
provisions of 35 U.S.C. 123 are currently in effect," but "no patent
fee is currently eligible for the seventy-five percent micro entity reduction
as no patent fee has yet been set or adjusted under section 10 of the
Leahy-Smith America Invents Act." Thus,
under the AIA's fee setting authority provisions, micro entities would have to
wait until 45 days after the Office issues its final rule on the fee schedule to
obtain the benefit of a 75% reduction in fees.
Given the effective date for the rules changes implementing the micro
entity provision of the AIA, a final rule on the new fee schedule is likely to
be published prior to February 1, 2013.

As for the
rules changes, the notice indicates that a provision is being added to the
rules that specifies the requirements to qualify as a micro entity, and that
this provision tracks the statutory requirements for a micro entity set forth
in § 10 of the AIA. The notice also
indicates that the provision also specifies procedures relating to micro entity
status that largely track the regulatory requirements and procedures in 37 C.F.R.
§ 1.27 for small entity status. In
particular, applicants claiming micro entity status will be required to file a certification
of entitlement to micro entity status (for which forms will be provided by the
Office). Such certification will only
need to be filed once in an application — although an applicant must be
entitled to such status on the date that any fee is paid. Procedures for notifying the Office of loss
of micro entity status and correcting payments of patent fees paid erroneously in
the micro entity amount will track the corresponding small entity provisions
for notifying the Office of loss of small entity status and correcting payments
of patent fees paid erroneously in the small entity amount.

While the
notice states that "[t]he Office does not plan to provide advisory
opinions on whether a particular entity is entitled to claim micro entity
status," the notice provides some discussion of the requirements contained
in 35 U.S.C. § 123 at pages 75021-22. A
discussion of the specific rules changes is provided next (at pages 75022-25),
and is followed by comments submitted in response to the Office's notice of
proposed rulemaking (see "USPTO
Issues Proposed Rules for Implementing Micro Entity Status")
and the Office's responses to those comments.
President Obama Names 2012 National Medal of Science and National Medal of Technology and Innovation Recipients

December 26, 2012

By Kevin E. Noonan —

Last
Friday, the White House released the names of the 2012 recipients of the
National Medal of Science and the National Medal of Technology and
Innovation. In the press release, the
President said he was "proud to honor these inspiring American innovators"
and that:

They represent the ingenuity and imagination
that has long made this country great — and they remind us of the enormous
impact a few good ideas can have when these creative qualities are unleashed in
an entrepreneurial environment.

The
recipients and a brief note of their areas of study or achievements are as
follows:

National
Medal of Science

Allen Bard – chemistry, electrochemistry
Sallie Chisholm – oceanography, study of Prochlorococcus
Sidney Drell – theoretical physics, arms control
Sandra Faber – astronomy and astrophysics, black
holes
Sylvester Gates – theoretical physics,
supersymmetry
Solomon Golomb – mathematics, electrical
engineering, Tetris
John Goodenough – solid state physics; mechanical
engineering, lithium batteries
Frederick Hawthorne – inorganic chemistry; boron
hydrides
Leroy Hood – molecular biologist; automated DNA
sequencing, oligo synthesis
Barry Mazur – mathematics, topology
Lucy Shapiro – developmental biology, Caulobacter
Anne Treisman – cognitive psychology, integration
theory of attention

National
Medal of Technology and Innovation

Frances Arnold – chemical engineering, directed
protein evolution
George Carruthers – physics, UV cameras for NASA
lunar missions
Robert Langer – engineer, polymeric and microscale
drug delivery
Norman McCombs – mechanical engineering, pressure
swing absorption systems
Gholam Peyman – retinal surgeon, LASIK eye surgery
Art Rosenfeld – physicist, fluorescent lamps
Jan Vilcek – physician, cytokines (TNF and
interferon)

Sadly,
most of these men and women are unknown to most Americans. Perhaps this honor will change that somewhat.
Happy Holidays from Patent Docs

December 24, 2012

The authors and contributors of Patent Docs wish their readers and families a Happy Holidays. Publication of Patent Docs will resume on December 26th.
News from Abroad: Speculation Invalidates Invention?

December 23, 2012

By Jon Gowshall —

Over
the past few years the UK patents courts have moved closer to the approach of the
European Patent Office (EPO) on inventive step. In particular, the UK courts
have started to acknowledge the importance of expectation of success when
dealing with obviousness. A recent
decision (MedImmune Limited v Novatris
Pharmaceuticals UK Limited) reinforced this shift in approach. It also showed how the court considered the
effect of speculative prior art in an obviousness objection.

The Case

MedImmune
was the owner of a patent directed to the use of antibody phage displays to
select antibody fragments and isolate their corresponding DNA. The judge in the England and Wales High Court
(Patents Court) decided that the patent lacked inventive step. The England and Wales Court of Appeal upheld
this decision.

Professor
Smith, the leader in the field, generated the two pertinent pieces of prior
art. The first was a paper published by
Professor Smith and his greater history student, Steve Parmley. This document disclosed a method of using a phage
display to identify peptides of interest. The authors expressed reservations over the ability of the display to be
used for larger proteins.

Subsequently
Professor Smith gave a presentation at a conference. During that presentation Professor Smith
raised the idea that his phage display procedures might be used to screen
antibody libraries. He explained that he
was intending to do this, and he was very hopeful that it he could make it
work.

The Judgement

The
Court of Appeal followed the High Court judge's reasoning on obviousness.

Both
courts agreed that the claimed invention was inventive over the earlier Smith
and Parmley paper. The courts looked at
the expectation of success in using the disclosed phage display to identify
antibodies. The paper expressed concerns
over possibly using the technology with larger proteins. Antibodies are such larger proteins. Therefore the court decided that the claimed
technology was inventive over this paper, because the worker would have no
reasonable expectation that the technology described in the paper could be used
for antibodies.

However,
both courts agreed that the claims were obvious in the light of the paper and Professor
Smith's subsequent conference presentation.
The courts acknowledged that Professor Smith had not carried out any of
the work. However, they both decided
that it was a sufficient spur that he, a leader in the field, had suggested the
application of the technology to antibodies, and was positive about the
eventual outcome. The courts also took
into consideration that the surrounding technology had moved on between the
publication of the paper and the conference giving the skilled person more
confidence about using the technology as suggested by Professor Smith in his
presentation.

Conclusions

The
UK courts continue to adapt their approach on obviousness, to more closely
follow that of the Boards of Appeal of the EPO.
In particular, when they consider inventive step, the UK courts will
look at the expectation of successfully moving from the prior art to the
invention.

This
case also shows that some prior art can be devastating, even if it is merely
speculative, as long as it makes the link between the prior art and invention
with enough authority.

This article was reprinted with permission from Forresters.
Court Report

December 23, 2012

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Bayer Pharma
AG et al. v. Watson Pharmaceuticals Inc. et al.
1:12-cv-01726;
filed December 18, 2012 in the District Court of Delaware

• Plaintiffs:
Bayer Pharma AG; Bayer Intellectual Property GMBH; Bayer HealthCare
Pharmaceuticals Inc.
• Defendants:
Watson Pharmaceuticals Inc.; Watson Laboratories Inc.

Infringement
of U.S. Patent No. 8,071,577 ("Multi-phase Contraceptive Preparation Based
On a Natural Estrogen," issued December 6, 2011) following a Paragraph IV
certification as part of Watson's filing of an ANDA to manufacture a generic
version of Bayer's Natazia® (estradiol valerate and estradiol
valerate/dienogest, used as oral contraception). View the complaint here.

Life
Technologies Corp. et al. v. Promega Corp.
3:12-cv-02992;
filed December 17, 2012 in the Southern District of California

• Plaintiffs:
Life Technologies Corp.; Applied Biosystems, LLC
• Defendant:
Promega Corp.

Declaratory
judgment of non-infringement of U.S. Patent Nos. 5,843,660 ("Multiplex
Amplification of Short Tandem Repeat Loci, issued December 1, 1998), 6,221,598
(same title, issued April 24, 2001), 6,479,235 (same title, issued November 12,
2002), and 7,008,771 (same title, issued March 7, 2006) based on Plaintiff's
anticipated launch of its Authentifiler PCR analysis products. View the complaint here.

Merz
Pharmaceuticals LLC v. Par Pharmaceutical Inc. et al.
1:12-cv-01723;
filed December 17, 2012 in the District Court of Delaware

• Plaintiff:
Merz Pharmaceuticals LLC
• Defendants:
Par Pharmaceutical Inc.; Par Pharmaceutical Companies Inc.

Infringement
of U.S. Patent Nos. 7,638,552 ("Method for Increasing the Bioavailability
of Glycopyrrolate," issued December 19, 2009) and 7,816,396 (same title,
issued October 19, 2010) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic
version of Merz's Cubposa® (glycopyrrolate oral solution, used to reduce
chronic severe drooling in patients aged 3 to 16 years with neurologic
conditions associated with problem drooling (e.g. cerebral palsy)). View the complaint here.

University of
Iowa Research Foundation et al. v. Kappos et al.
1:12-cv-01444;
filed December 14, 2012 in the Eastern District of Virginia

• Plaintiffs:
University of Iowa Research Foundation; Coley Pharmaceutical GmbH; Ottawa
Hospital Research Institute; Pfizer Inc.
• Defendants:
David J. Kappos; Office of General Counsel

Review and
correction of the patent term adjustment calculation made by the U.S. Patent
and Trademark Office for U.S. Patent No. 8,202,688 ("Use of Nucleic Acids
Containing Unmethylated CPG Dinucleotide as an Adjuvant," issued June 19,
2012). View the complaint here.

Genetic
Technologies Ltd. v. Genelex Corp.
2:12-cv-02190;
filed December 14, 2012 in the Western District of Washington

Infringement
of U.S. Patent No. 5,612,179 ("Intron Sequence Analysis Method for
Detection of Adjacent Locus Alleles as Haplotypes," issued March 18, 1997)
based on Genelex's manufacture, use, sale, and offer for sale of DNA testing
services, including paternity, forensics, and phramacogenetic testing. View the complaint here.
Conference & CLE Calendar

December 23, 2012

January 2-5, 2013 – National CLE Conference (Law Education Institute, Inc.) – Snowmass, Colorado

January 10, 2013 – China's Patent Regime and its Quest to Become an
Innovation Economy (The George Washington
University Law School and Fordham University School of Law) – Washington, DC

January 22, 2013 – Top Patent Law Stories of 2012 (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00 to
11:15 am (CT)

January 22, 2013 – Patent Term Adjustments and Extensions: Recent Developments —
Leveraging Exelixis, Other Court
Decisions and Recent USPTO Rule Changes to Maximize PTAs and PTEs (Strafford) – 1:00 – 2:30 pm (EST)

January 23-24, 2013 – The Comprehensive Guide to Patent Reform*** (American Conference
Institute) – New York, NY

January 29, 2013 – Combined Customer Partnership Meeting
of TC3700 and TC1600 (U.S. Patent and Trademark Office) – Alexandria, VA

January
29-30, 2013 – Biotech & Pharma Patent Litigation*** (C5) – Amsterdam, Netherlands

February 20-22, 2013 – Intensive Patent Law Seminar (Chisum Patent Academy) – New York, NY

February 27-28, 2013 – Life Sciences
Collaborative Agreements and Acquisitions*** (American Conference
Institute) – New
York, NY

***Patent Docs is a media partner of this conference or CLE
ACI Life Sciences Collaborative Agreements and Acquisitions Conference

December 21, 2012

American Conference
Institute (ACI) will be holding its 17th Advanced Forum on Life Sciences
Collaborative Agreements and Acquisitions from February 27-28, 2013 in New
York, NY. The conference will allow
attendees to:

• Incorporate the
right takeaways from recent deals into your business development strategies;
• Minimize risks
with effective due diligence systems and effective partner selection;
• Structure deals
that are able meet both parties' goals;
• Draft termination
provisions to effectively avoid problems with deals that do not work out;
• Utilize contract
research organizations and other entities to limit R&D expenditures;
• Evaluate and
execute milestone based compensation structures;
• Resolve issues in
collaboration with universities; and
• Negotiate
acquisitions that satisfy your business objectives.

In particular, ACI's
faculty will offer presentations on the following topics:

• Analyzing recent trends in deal-making and
deciphering their implications for your next collaborative agreement;
• Coping with tectonic shifts: Understand how
the America Invents Act and recent case law impact deal-making for life
sciences companies;
• Utilizing well-crafted agreements that develop
fruitful collaborations and produce maximum benefit;
• Employing a smart risk-limiting strategy that
satisfies all parties;
• Seeking and acquiring new sources of research
funding in leaner times;
• Overcoming defects in IP that have the
potential to derail life sciences transactions;
• Mitigating antitrust risks associated with
life sciences alliances and agreements;
• Integrating M&A metrics into your
business development strategy;
• Effective alliance management: Avoiding
missteps and producing workable solutions for the inherent challenges of life
sciences collaborations;
• Entering into collaborative research
agreements with academic institutions;
• Knowing when to leave: Drafting critical
termination provisions; and
• Winning strategies for collaborating with
contract research organizations that deliver superior results.

In addition, an
interactive working group session, entitled "An In-Depth Review of
Collaborative Agreements for Alliance Management Professionals and Attorneys,"
will be offered from 9:00 am to 12:00 pm on March 1, 2013, and a master class,
entitled "Conducting Thorough and
Effective Due Diligence Analysis for Life Sciences M&A and Strategic
Alliances," will be offered from 2:00 to 5:00 pm on March 1, 2013.

The agenda for the Life
Sciences Collaborative Agreements and Acquisitions conference can be found here,
and an agenda for the post-conference workshops can be found here. A complete brochure for this conference,
including an agenda, detailed descriptions of conference sessions, list of
speakers, and registration form can be obtained here.

The registration
fee for the conference is $2,295 (conference alone), $2,895 (conference and one
post-conference workshop), or $3,495 (conference and both post-conference
workshops). Those registering by January
11, 2013 will receive a $300 discount, and those registering by February 8,
2013 will receive a $200 discount. Patent
Docs readers who reference the discount code "PD
200" will receive $200 off the current price tier when registering. Those
interested in registering for the conference can do so here,
by e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480,
or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Life Sciences Collaborative Agreements
and Acquisitions conference.

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