Patent Docs

Gene Patenting: Australian Potpourri

December 28, 2009

By Kevin E. Noonan —

Gene patenting, and proposed bans on the practice,
have garnered several newspaper reports and responses from professional groups
around the world.

Australian
Senate Panel Debates Gene Patenting

The Community Affairs Committee of the Australian
Senate is investigating whether genes should be patentable in that country,
according to a December 12th report in The Australian ("Patently tricky dispute drags on: who owns your genes"). The
debate was sparked, according to a report, by a letter from Genetic
Technologies (GTG), a Melbourne testing lab, to eight public pathology
laboratories regarding its rights to testing the BRCA1 and BRCA2 genes, under
an exclusive license from Myriad Genetics. The report notes that any aggressive enforcement of GTG's
licensed rights under the Australian patents may have been stayed by a change
in the company's board of directors, as well as the uncertainty created by the
lawsuit in New York brought by the ACLU over the corresponding U.S. patents.

The Senate panel held six public "inquiries"
from March through September 2009, and received 72 primary and several
additional submissions from various individuals and groups. Predictably, the account reports that
these submissions fall into two groups: those that contend that gene patenting under Australian law is proper
and is having the desired effects of promoting investment and access, and those
who contend that it is ethically wrong to permit genes to be patented. Another important aspect of the debate
in Australia is its international commitments and agreements, which would
prevent Australia from "going it alone."

The opposition bases its arguments on purported ethical
concerns, and additionally proposes a "middle ground" based on
copyright, wherein "[a]nyone who wants to use your IP must tell you and
pay you," according to Luigi Palombi (at left), a gene patenting opponent and
Australian National University patent law expert. Ironically, this idea is the reverse of the canard spouted
by the late author Michael Crichton in the op-ed pages of The New York Times, to the effect
that gene patent holders could ask individuals for infringement damages because
their cells were using the patented genes. (For anyone not reading this space, that assertion is
false.) It is hard to imagine how
the scheme proposed by Professor Palombi would encourage or even permit
development of genetic-based technologies in Australia.

One other academic is cited in the piece, Professor
Laurie Zoloth (at right) of Northwestern University. Two quotations stand out: first, she asserts as an argument against gene patenting that it would
be like "[p]atenting the sun." This phrase, the title of a biography of Dr. Jonas Salk and his
development of the polio vaccine, loses some of its rhetorical force when one
realizes that Dr. Salk tested his vaccine on the children in a local
home for the mentally retarded, with little if any oversight and neither
parental or any other kind of informed consent. One of the reasons genetic technologies are so
cost-intensive is that such practices, as well as other, more well-known consequences
of lax regulation like the Thalidomide and diethylstilbestrol disasters,
resulted in more stringent regulatory oversight. Accordingly, the cost of bringing a new drug or therapy to
market is much higher in view of these requirements, but the alternative is
unthinkable. This is particularly
the case for genetic testing having the consequences of detecting BRCA1 or
BRCA2 mutations. Patents on genes
support the investment needed to ensure that the genetic tests that come to
market are reliable, and that we don't develop the genetic equivalent of "patent"
medicines.

The other quote from Professor Zoloth that stands
out is her assertion that genetic information should be part of a "creative
commons" that is freely available to all comers, and that "[e]ventually
the work will be commercialized," purportedly being the role of venture
capitalists and philanthropy. The
depths of misunderstanding in this statement are chilling: first, the information relating to genes is
part of the "creative commons" insofar as anyone wants to use that
information. The proof of this
statement is in the nearly 3,500 scientific journal publications that can be
accessed from public databases like PubMed merely by typing "BRCA1"
or "BRCA2" into the search engine. The latest of these papers was published this fall,
something directly contrary to the assertions that gene patenting inhibits
basic research. If that were the
case, the number of these publications would have decreased dramatically once
the patents were granted. And if that
were the case, it would not have been the conclusion of every single study done
to date that patenting has not had an inhibiting effect on genetic
research. And, of course, the blasé
statement from Professor Zoloth that "[e]ventually the work will be
commercialized" ignores the realities that nothing will be commercialized
that cannot be protected (unless her use of the word "eventually" is
in the historical sense). While it
may be true that such things would "eventually" happen, it is
undoubtedly true that under a gene patenting ban they would happen much more
slowly, if at all. In human terms,
that means less diagnostic and therapeutic advances and more suffering. Funny position for a bioethicist to be
taking.

The Australian Senate panel has postponed its
report, originally due in November until March 18, 2010. It's possible that the committee has
realized that the issue is more complicated than simply deciding gene patenting
is "wrong." Perhaps it
will realize in the ensuing months that gene patenting is necessary, and
beneficial, for Australia and the rest of the world.

Australian
Patent Attorneys Attempt to Inject Rationality Into Gene Patenting Debate

A panel put on by the Institute of Patent and
Trademark Attorneys of Australia (IPTA) strongly supported gene patenting in
Australia, saying the ban proposed by opponents would "bring the
Australian biotech industry to its knees," according to independent reports
by the Australian AP and Australian Life
Scientist ("Ban drives 'biotech industry to its knees'"). The reason: the difficulties in attracting
investment without patent protection, according to Trevor Davies, IPTA
councilor. "[I]f biological
materials couldn't be patented . . . there is a likelihood that important
advances in medicine would not be realized in Australia because there wouldn't
be patent protection," he said.

The panel, made up of patent lawyers, biotech
entrepreneurs, and academics, analogized the importance of patents for
biotechnology with mining leases in the mining industry, and reminded listeners
that the cost of "transforming a promising field of research into a
market-ready product — like a life-saving medical test — was about a billion dollars." Without patent protection, the panel
said that biotech or pharma companies simply would not support investment in
this work. Banning gene patents
would "remove the incentive for people to invest," according to
University of Melbourne patent law professor Andrew Christie (at left). Professor Christie rebutted the
frequently-heard complaint that patenting genes somehow gives patent-holders "control"
over an individual's body, saying in effect nobody "owns you."

Dr. Tania Obranovich (at right), a patent attorney and former
research scientist, stated that permitting gene patenting encourages private
investment which facilitates bringing therapies to market. She reminded the audience that
Gardisil, the cervical cancer vaccine, would not have gotten to market without
protection of certain human papilloma virus genes. Dr. Obranovich also contended that gene patents do not
inhibit basic research.

The panel made one concession to the protests of
the anti-gene patenting crowd: they supported a change in Australian law to clarify that basic genetic
research using patented genes would not constitute an infringing act, based on
some uncertainty in how Australian law has been interpreted by the courts.

Australian
Cancer Researcher Against Patenting Genes

Professor Ian Frazer (at right), President of Cancer Council
Australia (as well as former Australian of the Year and inventor of the
cervical cancer vaccine) wrote an article in The Australian in August critical
of gene patents ("Sharing genes is patently obvious: gene patent inquiry"). Professor Frazer
is entitled to his opinion, of course (although it is unlikely that the
cervical cancer vaccine is unpatented), but his arguments would be more
persuasive if fewer of his statements in support of them were less fantastical.

For example, Professor Frazer contends that "there is no more invention in isolating and
characterising biological material that exists in our bodies, using existing
research techniques, than in collecting and arranging a set of postage stamps." Even insofar as this statement can be
interpreted as commenting on advances in biotechnology over the past
twenty-five years, it ignores (even rhetorically) the difference between a gene
in a chromosome and an isolated copy (typically a cDNA copy) of that gene. While the Human Genome Project has set
forth thousands of previously-unknown open reading frames in chromosomal DNA
(sections that could, but do not necessarily, encode for protein), the apt
analogy is not with postage stamps. It is with a parts list for an automobile, in which you try to assemble
it without being able to look under the hood. While the amount of genetic information obtained over the
past decade has been monumental, it is inchoate with regard to the function, if
any, of most of it. This will
preclude patentability for many genes, but it should not preclude
patent-eligibility. Second, Professor Frazer states, "claiming a
monopoly on the use of a particular gene sequence in an already existing
diagnostic test method can lead to restricted public access to vital diagnostic
services." Ignoring the
rhetorical flourish of "monopoly," there
is no "already existing diagnostic test method" for diagnosing a
particular disease, or propensity for contracting a disease, in the absence of
the "particular gene sequence." Even then, the mere existence of the gene sequence is not enough: a sufficiently high correlation must be
established so that the result of an assay for a particular mutation reliably
indicates that a patient does, or does not, have a higher likelihood of disease
than the "wildtype" population. Identifying the sequence, establishing the correlation and satisfying
regulatory requirements that would prevent unreliable tests from coming to
market requires investment, which requires some way to increase the likelihood
for a return on that investment. Patents do that.

Professor Frazer's argument, as he develops it, is
rooted in a mistaken belief that permitting genes to be patented will inhibit
basic research. He alleges that
permitting genes to be patented can eliminate "the competitiveness and information sharing essential
to the development of genetic therapies," which therapies he conceded
should be rewarded by a patent. He
cautions against restricting use of patented genes in research, which could "delay
the development and testing of truly inventive and practical uses of the gene
and its protein product for diagnosis and therapy." The problem with this argument is there
is no evidence for it: study after
study has shown that patenting does not restrict research use of patented genes, and even the most notorious of the
patented genes, BRCA1 and BRCA2, have been the subject of almost 3,500 research
papers published in the scientific literature in the face of patents on those
genes.

Professor Frazer also says that the "collegial tradition of sharing raw data among
researchers must be allowed to continue unfettered so new technologies can be
developed to benefit all." Maybe science is practiced differently in Australia, but the
collegiality of data sharing in academia is typically severely limited to data
already submitted to a scientific journal for publication. Ironically, patenting (including gene
patenting) fosters collegiality since it establishes a legal priority date for
an inventor's invention.

The Professor also
cites "Pasteur's immunology discoveries" and "Florey's
penicillin antibiotic" as examples of inventions "gifted to humankind
for global benefit." On the
contrary, Louis Pasteur patented what was commercially-valuable to him in the
19th century (improved yeast strains for winemaking) and the tragedy
of Florey's "gift" of penicillin is well-know to have required World
War II for its commercial development under government grants; prior to the war
no pharmaceutical company would commercialize penicillin precisely because
there was no patent protection to stimulate investment.

Professor Frazer
ends his piece by recommending that, until gene patenting is banned in
Australia, "non-commercial use of gene sequence information should be
encouraged for research and diagnostic purposes." Ironically, if Australia bans gene
patents such "non-commercial use" is all Australians are going to
have.

Photograph of the Australian Senate Parliament House (above) by Chensiyuan, from the Wikipedia Commons under the Creative Commons license.
Court Report

December 27, 2009

By Sherri Oslick —

About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.

Abbott Laboratories, Inc. et al. v. Apotex Inc. et al.
1:09-cv-07968; filed December 22, 2009 in the
Northern District of Illinois

• Plaintiff:
Abbott Laboratories, Inc.; Abbott GmbH & Co. KG
• Defendants:
Apotex Inc.; Apotex Corp.

Infringement
of U.S. Patent No. 5,436,272 ("Treatment of Obesity, issued July 25, 1995)
following a Paragraph IV Certification as part of Apotex's filing of an ANDA to
manufacture a generic version of Abbott's Meridia® (sibutramine hydrochloride,
used to treat obesity). View the compliant here.

Schering Corp. v. Apotex Inc. et al.
1:09-cv-07923; filed December 22, 2009 in the
Northern District of Illinois

• Plaintiff: Schering Corp.
• Defendants: Apotex Inc.; Apotex Corp.

Schering Corp. v. Apotex Inc. et al.
3:09-cv-06373; filed December 18, 2009 in the
District Court of New Jersey

• Plaintiff:
Schering Corp.
• Defendants:
Apotex Inc.; Apotex Corp.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. 5,837,699 ("Use of Mometasone Furoate for Treating Upper
Airway Passage Diseases," issued November 17, 1998), 6,127,353 ("Mometasone Furoate
Monohydrate, Process for Making Same and Pharmaceutical Compositions,"
issued October 3, 2000), and 6,723,713 ("Use of Mometasone Furoate for
Treating Upper Airway Passage Diseases," issued April 20, 2004) following
a Paragraph IV certification as part of Apotex's filing of an ANDA to
manufacture a generic version of Schering's Nasonex® (mometasone furoate monohydrate metered
nasal spray, used to treat diseases of the upper airways, including allergic
and nonallergic rhinitis). View
the N.D. Illinois complaint here.

Depomed, Inc v. Lupin Pharmaceuticals, Inc. et al.
1:09-cv-03406; filed December 21, 2009 in the
District Court of Maryland

• Plaintiff:
Depomed, Inc
• Defendants:
Lupin Pharmaceuticals, Inc.; Lupin Ltd.

Infringement of U.S. Patent Nos. 6,723,340 ("Optimal
Polymer Mixtures for Gastric Retentive Tablets," issued April 20, 2004),
6,635,280 ("Extending the Duration of Drug Release Within the Stomach
During the Fed Mode," issued October 21, 2003), 6,488,962 ("Tablet
Shapes to Enhance Gastric Retention of Swellable Controlled-Release Oral Dosage
Forms, issued December 3, 2002), and 6,340,475 ("Extending the Duration of
Drug Release Within the Stomach During the Fed Mode," issued January 22,
2002) following a Paragraph IV certification as part of Lupin's filing of an
ANDA to manufacture a generic version of Depomed's Glumetza® (metformin
hydrochloride extended release tablets, used to improve glycemic control in
adults with type 2 diabetes mellitus). View the complaint here. [NB: Depomed previously filed suit for the same cause of action against
Lupin in the Northern District of California, as noted in the December 7, 2009 edition of "Court Report."]

Abbott Laboratories v. Sandoz, Inc.
3:09-cv-06402; filed December 21, 2009 in the
District Court of New Jersey

Abbott Laboratories v. Sandoz Inc.
1:09-cv-00972; filed December 18, 2009 in the
District Court of Delaware

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent No. 5,453,510 ("Neuromuscular Blocking Agents," issued
September 26, 1995) following a Paragraph IV certification as part of Sandoz's
filing of an ANDA to manufacture a generic version of Abbott's Nimbex® (cisatracurium
besylate, used as a skeletal muscle relaxant). View the Delaware complaint here.

Schering Corp. et al. v. Mylan Pharmaceuticals Inc. et
al.
1:09-cv-00167; filed December 18, 2009 in the
Northern District of West Virginia

• Plaintiffs:
Schering Corp.; MSP Singapore Co. LLC
• Defendants:
Mylan Pharmaceuticals Inc.; Mylan Inc.

Schering Corp. et al. v. Mylan Pharmaceuticals Inc. et
al.
2:09-cv-06383; filed December 16, 2009 in the
District Court of New Jersey

• Plaintiffs:
Schering Corp.; MSP Singapore Co. LLC
• Defendants:
Mylan Pharmaceuticals Inc.; Mylan Inc.

The complaints in these cases are substantially
identical. Infringement of U.S.
Patent Nos. RE37,721 ("Hydroxy-Substituted Azetidinone Compounds Useful as
Hypocholesterolemic Agents," issued May 28, 2002) and 5,846,966 ("Combinations
of Hydroxy-Aubstituted Azetidinone Compounds and HMG CoA Reductase Inhibitors,"
issued December 8, 1998) following a Paragraph IV certification as part of
Mylan's filing of an ANDA to manufacture a generic version of MSP's Vytorin®
(ezetimibe and simvastatin, used to treat hyperlipidemia). View the New Jersey complaint here.

Hoffmann-La
Roche Inc. v. Roxane Laboratories, Inc. et al.
2:09-cv-06335;
filed December 15, 2009 in the District Court of New Jersey

•
Plaintiff: Hoffmann-La Roche Inc.
•
Defendants: Roxane Laboratories,
Inc.; Boehringer Ingelheim Roxane, Inc.

Infringement of U.S. Patent No. 5,472,949 ("N4-(Substituted-Oxycarbonyl)-5'-Deoxy-5-Fluorocytidine
Compounds, Compositions and Methods of Using Same," issued December 5, 1995)
following a Paragraph IV certification as part of Roxane's filing of an ANDA to
manufacture a generic version of Roche's Xeloda® (capecitabine, used to treat
breast and colorectal cancer and Dukes' C Stage III colon cancer). View the complaint here.
USPTO Launches Interactive Patent Pendency Model

December 27, 2009

By
Sarah Fendrick —

On
December 18, 2009, the U.S. Patent and Trademark Office announced the launch of an interactive patent
pendency model (PPM). The PPM
enables users to see how overall application pendency is affected by the number of examiner hires per year, the amount of overtime worked, and
patent filing levels. In one example, the model shows that an additional
1,000 examiners hired between 2010-2012 could reduce the backlog from 719,000 to
just over 470,000 by the end of 2012. Alternatively, if no new examiners were hired and no overtime was
allowed, the current backlog could increase to 1,651,000, and the first action
pendency would increase from 25 months to 67 months.

The
PPM was established to further the USPTO's efforts to increase transparency and
to reduce patent pendency. In the Office's press release regarding the launch of the PPM, USPTO Director David Kappos
stated "[i]n our ongoing effort to operate with a high level of
transparency, we are launching an interactive Patent Pendency Model so that our
stakeholders can fully appreciate the variables that affect the pendency of
applications."

The PPM webpage can be
found in the Patent statistics area of the USPTO Web site.
Conference & CLE Calendar

December 27, 2009

January 6-10, 2010 – 27th
Annual National CLE Conference (Law Education Institute, Inc.) – Vail, CO

January 20-21, 2010 – Life Sciences IP
Due Diligence (American Conference
Institute) – New York, NY

January 25-26, 2010 – European Pharmaceutical Regulatory Law Boot
Camp (American Conference
Institute) – New York, NY

January 26-27,
2010 – Advanced In-House Counsel Forum on China IP Law (C5) – Shanghai, China

January 27-28, 2010 – Pharma & Biotech Patent Litigation (C5) – Amsterdam, Netherlands

February 9, 2010 – Patent
Prosecution: Best Practices for Reducing Costs While Improving Patent
Quality (Technology
Transfer Tactics) – 1:00 – 2:30 PM (EST)

February 24-25, 2010 – 2nd Expert Forum on ITC Litigation &
Enforcement (American Conference
Institute) – New York, NY

March 2-4, 2010 – 6th Annual Biosimilars Conference (Visiongain) – Boston,
MA

***Patent Docs is a media partner of this conference or CLE
Happy Holidays from Patent Docs

December 24, 2009

The authors and contributors of Patent Docs wish their readers and families a Happy Holidays. Publication of Patent Docs will resume on December 27th.
Monsanto Announces New Policy Regarding Roundup Ready® Seeds

December 23, 2009

By Kevin E. Noonan —

In what may be considered a softening (or at least
a change) in its approach to protecting its patented technology, Monsanto
announced that it would not enforce any contractual provisions regarding its Roundup Ready®
transgenic seed (that preclude growers from replanting genetically-engineered
seeds) once the patents on that technology expire in 2014. Monsanto also announced that the
company would stop collecting royalties from licensees at the same time. These actions, by a company renowned
for stringently enforcing its intellectual property rights, may reflect a sober
and prudent conformity with the current political and regulatory climate.

The announcement addresses, and alleviates, what
farmers have expected (if not feared) regarding Monsanto's recombinant seeds,
particularly soybeans. The
situation facing Monsanto after 2014 is similar to one that has faced
pharmaceutical companies when a company's main product goes off-patent. Generally the answer has been further
innovation, which has sometimes taken the form of providing an improved version
of the original drug. Examples
include AstraZeneca's Nexium® that took the place of the related Prilosec® (S-omeprazole rather than racemic
omeprazole), and several other drugs that have used this strategy for their
drugs (albeit perhaps none so successfully).

Monsanto has pursued a similar strategy for its
Roundup Ready® transgenic seed products. These seeds contain an exogenous bacterial gene, encoding an
enol pyruvate shikimate-3-phosphate synthase (EPSPS) gene from the microbe Agrobacterium tumefaciens
that confers resistance to glyphosate, an herbicide sold by Monsanto under the
name Roundup®. Over 90% of all
soybean acres planted in the U.S. use this herbicide to increase yield and as a
consequence are planted with Roundup Ready® seed. For its soybean embodiments, Monsanto has developed a
second-generation seed, termed Roundup Ready 2®, having a 7-11% higher yield per
planted acre. The same gene has
been introduced into these seeds but the transgene has integrated into a
different chromosomal site. Until
Monday's announcement, farmers feared that Monsanto would force them to switch
to Roundup Ready 2® seeds, at a higher cost, in part by preventing them from
using the original Roundup Ready® transgenic seeds.

The announcement was more significant than it might
be otherwise (since a patentee's right to royalties typically ends with the
expiration of its patents) because, in addition to its patent rights, Monsanto
has also staunchly enforced contractual provisions protecting its seeds. Recombinant seed purchasers have been
required to sign a "Technology Agreement" ("the Agreement"),
agreeing to pay a one-time license fee of $6.50 per bag, and agreeing not to
plant themselves, or supply to others, "saved" seeds, i.e., seeds produced from the originally
purchased seeds. This system ensures that farmers purchase and license
Roundup Ready® soybean seeds each planting seasons.

Over the past 10 years, Monsanto has filed suit 125
times against individual farmers it accused of infringing its patents, including
U.S. Patent Nos. 5,352,605
and No. 5,633,435
(RE39,247)
related to its recombinant seed technology. Only eight of
these lawsuits have gone to trial, while in the remainder, the accused
infringer agreed to settlements that generally included an admission of
liability. Monsanto has been
awarded $21.6 million in its victorious lawsuits, and The Center for Food
Safety estimates that Monsanto has received between $85 million and $160
million in settlements, which remain confidential. Monsanto has said that
it has donated these monies to charity.

One remaining concern are licenses required by
certain countries to permit importation of recombinant grain and other
foodstuffs, licenses maintained at present by Monsanto. The company has announced that it will
maintain these until 2017, but should they be permitted to expire thereafter,
these countries may not permit importation of Roundup Ready® soybeans.

Monsanto's actions come on the heals of a
Department of Justice investigation into "potential anti-competitive conduct," due in part
to allegations by DuPont in counterclaims asserted in lawsuits between the
companies, to the effect that Monsanto has committed antitrust violations. The American Antitrust Institute has
also recommended federal investigation of Monsanto's "anti-competitive"
conduct. With the change of
administration has come a more stringent attitude regarding investigation if
not prosecution of such alleged conduct, even by patentees (whose exclusive
rights are, by nature, anti-competitive); the current DOJ antitrust division no
longer subscribes to the more patent-friendly (or at least
patent-accommodating) stance taken by the Bush administration (see "U.S. FTC and DOJ Release Report on Relationship between Patent Law and Antitrust Law").

Or perhaps Monsanto is aware that, even if they are
lawfully exercising the patent franchise, an argument can be made that at
present patentees must tread lightly, since the tide (of public perception,
Congressional understanding, and jurisprudential consistency) has turned against
them. Every 30 years or so (the
1940's, 1970's, and today) we seem to forget the nature, value, and utility of
patenting. We are in such a
period now, which is ironic since the economy depends on patent protection
today more than ever before, to protect nascent technology while at the same
time promoting its disclosure. As
things now stand, if Monsanto's actions prevent another distracting episode of
patent-bashing it may be worth it for the company and the rest of us.

For additional information regarding this topic, please see:

• "Monsanto Announces Latest Lawsuit Settlement over Roundup Ready Soybean Seed," September 8, 2008
• "Monsanto Co. v. David (Fed. Cir. 2008)," February 6, 2008
• "Court Report," February 3, 2008
• "Court Report," January 28, 2008
• "Court Report," January 13, 2008
• "Court Report," January 7, 2008
• "Supreme Court Fails to Grant Certiorari in Monsanto Co. v. McFarling," January 7, 2008
• "Court Report," December 16, 2007
• "Court Report," November 18, 2007
• "Court Report," October 21, 2007
• "Court Report," July 1, 2007
• "Monsanto Co. v. McFarling (Fed. Cir. 2007)," June 4, 2007
• "Court Report," May 20, 2007
• "Court Report," May 7, 2007
• "Court Report," April 15, 2007
• "Court Report," March 11, 2007
• "Court Report," March 4, 2007
• "Court Report," February 28, 2007
Amgen and Hoffman-LaRoche Settle Mircera® Litigation

December 22, 2009

By Kevin E. Noonan —

The latest
challenge to Amgen's erythropoietin (EPO) franchise ended today, when
Hoffman-La Roche agreed to keep its pegylated derivative of human EPO, Mircera®,
off the market until July 1, 2014. The U.S. Food and Drug Administration granted approval for Roche to market Mircera® in November,
2007 (it has already been approved in Europe and is sold in Austria, Sweden,
Germany, the United Kingdom, and Norway) but the company has been under an
injunction issued by Federal District Court Judge William G. Young pursuant to
a judgment of infringement against Roche at trial (see "Victory for Amgen in District Court Decision" – Part I, Part II, Part III). While the terms
of the settlement are not public, according to Amgen there will be no payments
from either company.

The parties stipulated to final judgment and a permanent injunction against Roche in a paper
filed jointly with the District Court on Monday. In the stipulation, Roche agreed
that the following claims of the patents-in-suit are "valid, enforceable
and infringed by Roche's Mircera® product":

(i)
U.S.
Patent No. 5,756,349 (the '349 patent) claim 7,
(ii) U.S.
Patent No. 5,547,933 (the '933 patent) claims 3, 7-8,
(iii) U.S.
Patent No. 5,955,422 (the '422 patent) claim 1,
(iv) U.S.
Patent No. 5,441,868
(the '868 patent) claims 1 and 2, and
(v) U.S.
Patent No. 5,618,698 (the '698 patent) claims 6-9.

Roche also
agreed to dismissal with prejudice of its "claims, defenses and counterclaims." The stipulation was entered by the
court as an order, to which it appended the following:

Except as
allowed under any license agreement reached between the parties, Roche, its
agents, servants, employees, counsel, and all persons and entities acting in
concert therewith, are hereby permanently enjoined for the life of U.S. Patent
No. 5,441,868, U.S. Patent No. 5,547,933, U.S. Patent No. 5,618,698, U.S.
Patent No. 5,955,422 and U.S. Patent No. 5,756,349 from infringing said patents
by the manufacture, importation, sale, offer for sale or non-exempt use of
pegylated Epoetin beta (otherwise referred to as "MIRCERA" or "CERA")
in the United States.

Settlement
eliminates risks for both parties. Amgen sued Roche in a declaratory judgment
action in Massachusetts, asserting six patents: U.S. Patent Nos. 5,547,933; 5,441,868; 5,618,698; 5,955,422 (claim 1); 5,756,349 (claim 7); and 5,621,080 (the '080 patent) On October 23, 2007, a jury found that Mircera®
infringed the '933 patent, the '868 patent, and the '698 patent, and that these
patents, as well as the '422 patent and the '349 patent, were not invalid. (The jury reached neither infringement nor validity of the '080 patent). Specifically, the jury found that Roche's Mircera® infringed claims 3, 7, and 8
of the '933 patent (claim 12 was found not to be literally infringed but
infringed under the Doctrine of Equivalents); claims 1 and 2 of the '868
patent; and claims 6 through 9 of the '698 patent. On October 1, 2008,
Massachusetts District Court Judge William Young ruled (in Amgen's favor for
each) on several post-trial motions, including: 1) affirming the jury's
infringement decision by denying Roche's motion for judgment as a matter of law
(JMOL); 2) reaffirming its pretrial decision to grant summary judgment
regarding infringement of claim 1 of the '422 patent; 3) "explaining"
its reasoning for ruling, also pretrial, that the claims of Amgen's
patents-in-suit are not invalid for obviousness-type double patenting (despite
the intervening Federal Circuit decision in Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc.);
4) denying Roche's motion for JMOL that claim 1 of the '422 patent and claims
3, 7, and 9 of the '933 patent are not invalid for indefiniteness for reciting
the term "human erythropoietin"; and 5) granting Amgen a permanent
injunction barring "Roche, its agents, servants, employees, counsel, and
all persons and entities acting in concert therewith" from infringing the claims
of the patents-in-suit for the remaining life of those patents.

The Federal
Circuit affirmed most of the determinations by the District Court and the jury,
including that the asserted claims of the '868 patent (claims 1 and 2) and the '698
patent (claims 6-9) are not invalid and were infringed, that claims 3, 7,
and 8 of the '933 patent and claim 1 of the '422 patent were infringed, and that
claims 9, 11, 12, and 14 of the '933 patent are not infringed by Mircera®. However, the panel opinion vacated Judge Young's decision that the '933 (claims
3, 7, and 8), '349 (claim 7), and '422 (claim 1) patents are not invalid under
obviousness-type double patenting and remanded this issue to the trial court. The Federal Circuit also vacated the
judgment that claim 7 of the '349 patent was not infringed and remanded for a
new trial on that issue. This
decision put several of Amgen's patents at risk for invalidation under the
Federal Circuit's recent jurisprudence interpreting the scope of the "safe
harbor" of 35 U.S.C. § 121 (Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2008) and Takeda Pharmaceutical Co. v. Doll (Fed. Cir. 2009)). Invalidation of the '933, '349, and '422
patents would have reduced Amgen's patent protection on its various EPO
products (including Aranesp® and Epogen®) from May 2015 to August 2012 (more
than 3 years), which would have a significant (negative) effect on the
corporate bottom line. Thus, by settling, Amgen has avoided invalidation
of these three patents, and Roche has avoided any damages or attorneys' fees
Amgen may have pursued. Roche also
has obtained a date certain for entering the U.S. market with its pegylated EPO
product.

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

• "Obviousness-type Double Patenting after Amgen v. F. Hoffman-La Roche," September 27, 2009
• "Amgen Inc. v. Hoffman-La Roche Ltd. (Fd. Cir. 2009)," September 15, 2009
• "Amgen v. Hoffmann-LaRoche: Remaining Issues," October 13, 2008
• "Amgen v. Hoffmann-LaRoche: Back to the District Court," October 10, 2008
• "Victory for Amgen in District Court Decision – Part III," October 9, 2008
• "Victory for Amgen in District Court Decision – Part II," October 8, 2008
• "Victory for Amgen in District Court Decision – Part I," October 6, 2008
• "BIO Submits Amicus Brief in Amgen v. Hoffman-LaRoche," July 7, 2008
• "How to Avoid a Permanent Injunction: The Lessons of Amgen v. Hoffmann-LaRoche," April 28, 2008
• "Glasses Half-full or Half-empty: Hoffman-LaRoche's Different Interpretation of Pfizer v. Teva," April 15, 2008
• "Hoffmann-LaRoche Can't Wait, Files Notice of Appeal to the Federal Circuit," April 11, 2008
• "Will the Federal Circuit's Pfizer v. Teva Decision Spell the End of Amgen's Patent Rights to Recombinant Human Erythropoietin?" March 31, 2008
• "Court Still Cannot Decide on Amgen's Permanent Injunction," March 26, 2008
• "Amgen Inc. v. International Trade Commission (Fed. Cir. 2008)," March 20, 2008
• "Roche Agrees to Court's Conditions for Modifying Preliminary Injunction," March 20, 2008
• "Roche's Mircera® Remains Off the Market (For Now)," March 2, 2008
Science Progress Article Examines Impact of Gene Patents on Research

December 21, 2009

By Donald Zuhn —

Gene
patenting has been a hotly debated topic for at least the past three years. The subject moved back to the
forefront when Chicago-Kent College of Professor of
Law Lori Andrews and the late Michael Critchton published an article in the November 11, 2006 issue of Parade magazine, in which the two
advocated for a Genetic Bill of Rights that would have included a prohibition on gene
patents (see "Gene Patenting in
the News Again"). The anti-gene patent baton was next
passed to Rep. Xavier Becerra (D-CA), who in February 2007 introduced a bill
(H.R. 977)
in the House that would have prohibited patents from being granted for "a
nucleotide sequence, or its functions or correlations, or the naturally
occurring products it specifies" (see
"The Continuing Threat to Human Gene Patenting"). And the debate was renewed last May
when a group of patients, physicians, academic researchers, and medical
societies filed suit against the U.S. Patent and Trademark Office and Myriad
Genetics, among others, over several patents claiming human BRCA1 and BRC2
genes and methods for detecting mutations in these genes to diagnose a
predisposition to breast and ovarian cancer (see "Association for
Molecular Pathology v. U.S. Patent and Trademark Office").

In
a recent article in Science Progress
entitled "Do Gene Patents Hurt Research?"
Timothy Caulfield, the Canada Research Chair in Health Law and Policy and a
Professor in the Faculty of Law and School of Public Health at the University
of Alberta, added his voice to the discussion. Mr. Caulfield begins the article by asking what the controversy is all
about, and responds that:

While the concerns associated with gene
patents are varied, one has had the most policy traction: the idea that patents on sequences of
genetic information hurt research, especially upstream, basic research. The worry is that patents will hurt
science by making it difficult to acquire the rights to all necessary research
inputs. Research will slow, become
more inefficient and expensive — or researchers will simply avoid doing
research on patented, yet scientifically valuable, genes.

While
Mr. Caulfield (at right) acknowledges that "[a]t first blush, all this [anti-gene
patenting] policy activity seems to make sense: a logical response to a profound social problem [i.e., the
impact of patent tickets or the anti-commons on research]," he quickly
concludes that there is one hitch — in particular, that "[t]here is little evidence
that the problem exists."
Thus, he writes that while "[t]here is lots of social angst,"
there is "no good data showing a widespread patent thicket/anti-commons
phenomenon."

In
support of his conclusion, Mr. Caulfield points to a 2007 study by the American
Association for the Advancement of Science, which found "very little
evidence of an 'anticommons problem'"; a 2005 study for the National
Academy of Sciences, which found that only 1% of scientists surveyed reported
suffering a project delay of more than one month due to patents; his own 2009
study of the Canadian genetic research community, which revealed "lots of
researcher concern about gene patents, but little evidence that they are
actually having a detrimental impact on the research environment"; and
Prof. Chris Holman's 2007 paper on the impact of gene patents on innovation and
access ("The Impact of Human Gene Patents on Innovation and Access: A Survey of Human Gene Patent
Litigation").

Instead of a patent thicket/anti-commons problem,
Mr. Caulfield finds that:

While the apparent disconnect between
policy concern and evidence is a significant dilemma on its own, I think there
is a bigger problem. By focusing
on gene patents, we seem to be downplaying other concerns associated with the
commercialization ethos that increasingly permeates the research environment.

Thus,
he asserts that the real problem is "[c]ommercialization pressure, not
patenting," adding that "at the current time, we need to recognize
that despite all the noise, there is still no solid evidence that gene patents
hurt basic research." Mr.
Caulfield does not discount the possibility that such
evidence may be generated in the future. But he insists
that "arguments for reform must be based on an honest assessment of
available evidence — not on assertions that conflict with the facts." Thus, he sees a need for "more methodologically
robust research on the true benefits and harms of patents," which he
believes "will allow for a more informed debate on the fundamental patent
tradeoff: that is, the granting of
a limited-term monopoly for the benefit of society."

For
additional information on this and other related topics, please see:

•
"Gene Patenting Debate Continues – Round Three," December 17, 2009
• "BRCA Patent Suit to Continue in Southern District of New York," November 2, 2009
• "Empirical
Research Fails to Support Gene Patenting Ban," October 22, 2009
• "Gene
Patenting Debate Continues – Round Two," August 4, 2009
• "The
Unwanted Consequences of Banning Gene Patenting," June 16, 2009
• "Falsehoods,
Distortions and Outright Lies in the Gene Patenting Debate," June 15, 2009
• "Gene
Patenting Debate Continues," June 9, 2009
• "Association for Molecular Pathology v. U.S.
Patent and Trademark Office," May 17, 2009
• "Court Report: Special Edition," May 13, 2009
• "Gene Patenting and
the Wisdom of Judge Lourie," April 12, 2009
•
"Genetic Diagnostic Testing: The "Anti-Commons" Revisited?"
March 25, 2009
• "Science Article
Should Help Allay Gene Patenting Fears," December 17, 2008
•
"The Continuing Threat to Human Gene Patenting," October 16, 2007
•
"Science Fiction in The New York
Times," February 13, 2007
•
"The Continuing Value of Biotech Patenting," February 4, 2007
•
"Anti-Patent (Sullivan?) Malice by The
New York Times," January 29, 2007.
•
"In Support of Gene Patents," December 6, 2006
•
"Gene Patenting in the News Again," December 5, 2006
USPTO Announces Changes to PKI Certificate Usage Policy

December 21, 2009

By Christopher P. Singer —

In a Notice published in the December 17, 2009
Federal Register (74 Fed. Reg. 66955 ),
the U.S. Patent and Trademark Office announced changes to its previously published
procedures (October 27, 2009 Federal Register Notice, 74 Fed. Reg. 55200) relating to usage of public key infrastructure (PKI) certificates. According to the Notice, the revised
procedures are effective as of December 17, 2009.

As background, the PKI certificate is the unique electronic
code that is provided by the PTO's Electronic Business Center to registered
practitioners and allows for access to Private PAIR and the filing of applications
and follow-on documents through the EFS-Web. The prior PKI subscriber agreement allowed certificate holders to
designate only a single employee or contractor to use the certificate "under
the direction and control" of the holder. By the letter of this rule, it seemed that if more than one
person other than the certificate owner and the single designee were using the
certificate, such usage would be in violation of the user agreement. For practitioners employed by
organizations of any size, or having a limited number of registered
agents/attorneys, this could potentially present a significant bottleneck in
EFS-Web and/or Private PAIR usage, or create an inadvertent violation of terms
of the agreement. In response to the October publication, the Office received a
number of responses, inquiries, and comments from current users of EFS-Web and Private
PAIR. The Office, in response to
the outcry, has decided to expand the PKI usage procedures to allow for the
designation of more than one user other than the certificate holder.

In particular, the newly published procedures allow
for a "reasonable number" of authorized users to have access to and
use a single PKI certificate as long as the usage is under the direction and
control of the PKI certificate holder. The Notice notes that designated users "should be paralegals or
support staff of the certificate holder" specifying that the designee "must
be either an employee of the holder's organization or an employee of a
contractor." The overall
motivation for the change in procedures arises from the desire to "provide
users more flexibility and meet users' needs for multiple concurrent usage of
the USPTO electronic systems." Nevertheless, it is important that each PKI certificate holder directs
the usage of his or her individual certificate, as any submission associated
with a PKI certificate is treated as though it was made by the holder.

One important consideration to keep in mind relates
to restriction on technology export. Particularly technology and software in unpublished patent applications
may be subject to export controls outlined in the Export Administration
Regulations (15 C.F.R. §§ 730-774). The agreement explicitly states, "[i]f a designated employee is not
a U.S. citizen, I understand that the designated employees' access to the
technology and software constitutes an export" and that "[a]ccess to
such technology and software by any person located outside the United States or
by a foreign national inside the United States constitutes an export that may
require a license from the U.S. Commerce Department's Bureau of Industry and
Security ("BIS"). I
agree not to use (and to make sure that each designated employee will not use)
or permit the use of the USPTO certificate in a manner that would violate or
circumvent the Export Administration Regulations."

The Federal Register Notice includes thirteen FAQs
that describe certain hypothetical user arrangements and whether those
arrangements are appropriate under this usage agreement. The Notice concludes by presenting the
actual revised PKI subscriber agreement in full (about one and a half pages).
USPTO Proposes New Procedure for Treating Rejected Claims That Are Not Appealed

December 20, 2009

By Sarah Fendrick —

Last week, the U.S. Patent and Trademark Office published a notice in the Federal Register (74 Fed. Reg. 66097) proposing changes in the
procedure for handling notices of appeal and appeal briefs that identify fewer
than all of the rejected claims as being appealed. Under the change, rejected claims that are identified as not
appealed in a notice of appeal or appeal brief will automatically be deemed
canceled.

Under current procedures, an applicant is not able
to appeal only part of an examiner's decision. Under 37 C.F.R. § 1.113(c), a reply to a final Office action must
include cancellation of each rejected claim or appeal from the rejection of
each rejected claim. Similarly, a
reply to a non-final action must cancel each rejected claim subject to any
ground of rejection not addressed in the reply. See 37 C.F.R. § 1.111(b). Therefore, in order to comply with either provision, an applicant must
file an amendment canceling the non-appealed claim separately from a notice of
appeal or appeal brief. Failure to file an amendment separately will result in an appeal of the
entire examiner's decision.

The change in procedure would allow applicants to
appeal only some of the rejected claims without filing a separate amendment to
cancel the non-appealed claims. The non-appealed rejected claims would be deemed canceled as of the date
on which the notice of appeal or appeal brief was filed.

To have claims automatically canceled, an applicant
must clearly limit the appeal to fewer than all of the rejected claims. If an applicant fails to clearly limit
the appeal to only identified claims or there are inconsistencies regarding
whether all of the rejected claims are appealed, the appeal will be treated as
an appeal of the entire examiner's decision.

The proposed change will be applicable to any
notice of appeal or appeal brief filed under 37 C.F.R. §§ 41.31 and 41.37.

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