Journal of Intellectual Property Rights Vol 17, May 2012, pp 256-261
IPR News ─ General
countries are doubtful about the future of ACTA.
Despite the rough ride, ACTA certainly is not yet
EU Parliament’s draftsman urges ACTA rejection
dead. All EP committees still have to vote on the
British MEP David Martin (rappoteur for EP
respective opinions, and the plenary of the
Committee on International Trade), in charge of
Parliament is expected to vote in mid-June 2012
steering the Anti-Counterfeiting Trade Agreement
(http://www.euractiv.com, http://www.ip-watch.org).
(ACTA) through the European Parliament, recently
said that he would urge lawmakers to reject the
Kenya set to repeal controversial anti-counterfeit law
controversial treaty. He cited fears that the Agreement
Kenya’s High Court has ordered a review of a
could discourage generic drug supplies to developing
controversial anti-counterfeit law enacted in 2008 on
countries, and presented an outdated concept of
the grounds that it could interfere with the supply of
intellectual property. Mr Martin made the legitimate generic medicines to patients. The 2008 announcement following a three-hour debate on Anti-Counterfeiting Act has been under fire since ACTA in the European Parliament organized by the
before it was passed with critics claiming that it was
Socialist group. The event was streamed to up to
too much of a blunt instrument to handle the
1,300 viewers online and prompted intense activity on
complexities of the counterfeit and substandard
Twitter. Besides, rapporteurs to two other committees
medicines trade. The Act defined counterfeiting as an
of the European Parliament (legal and industry and
intellectual property breach of a protected good,
trade) have also tabled reports on the plurilateral
which can include ‘the manufacture, production,
ACTA. While Socialist and Green MEPs have already
packaging, re-packaging, labelling or making,
voiced their opposition to ACTA, the overall position
whether in Kenya or elsewhere, of any goods whereby
of the Parliament is less clear. The Parliament’s
those protected goods are imitated in such manner and
approval is necessary to ratify the international to such a degree that those other goods are identical or agreement. The EU executive, which has referred
substantially similar copies of the protected goods.’
ACTA to the European Court of Justice, invited In theory, this could encompass legitimate generic the Parliament not to vote until the court rules.
copies of drugs that are on-patent anywhere overseas.
The ACTA seems to have suffered further setback,
Given that the vast majority of drug patents are not
since now appears that the Group of 8 may have
registered in developing countries like Kenya, there
signalled a shift to a narrower approach on intellectual
had been fears that enforcement of the Act could
property rights at its recently concluded meeting. In a
reduce the range of generic medicines available to
‘Non-paper on intellectual property rights protection’,
doctors and their patients. That was acknowledged by
by G8 leaders who met in Washington DC, there was
the High Court, with Judge Mumbi Ngugi saying in
a narrower focus on counterfeit products and drugs.
her ruling that ‘the Act is vague and could undermine
The non-paper, which is not part of the official
access to affordable generic medicines since [it]
statement of the G8 foreign ministers, proposes a failed to clearly distinguish between counterfeit and ‘G8 initiative to strengthen enforcement against generic medicines.’ counterfeiting and piracy’ (an integrated warning
The High Court has called on Kenya’s Parliament
system, stronger penalties and border seizure to review the Act and remove ambiguities that could possibilities), a ‘G8 initiative to support voluntary
result in arbitrary seizures of generic medicines
best practices for securing global supply chains’ and a
under the pretext of fighting counterfeit drugs. The
‘G8 initiative to promote pharmaceutical drug safety.’
judgment also stated that IP rights should not override
Voluntary cooperation in IPR protection through the
the right to life and health. The judgment comes at a
G8 moreover makes sense in the case that the G8
time when the World Health Organisation (WHO) is
also struggling to contend with the controversy about
A second important conclusion of the Controller is
the conflation of IP and public health issues in the
that the failure to meet demand adequately was partly
area of what it refers to as substandard/spurious/
caused by the high price of the product, which made it
falsely-labelled/falsified/counterfeit medical products
unaffordable. While Natco’s counsel referred to
research findings on reasonable estimates of R&D
costs and the per capita incomes of the poor in
Patent News
India to argue that the product was unreasonably
priced, the judgment itself focussed on the issue of
India’s first compulsory licence
unaffordability. Even when assessing this, the
India’s long struggle to ensure access to affordable
fundamental issue was not the fact that Nexavar was
medicines for its people recently took an interesting
being priced at around Rs 2.8 lakh for a month’s
turn. In early March 2012, the Controller General of
dosage of 120 tablets, when Cipla was supplying the
Patents passed an order on an application filed
drug at Rs 30,000 for a month’s treatment, and Natco
by Natco Pharma, headquartered in Hyderabad, was promising the same quantum at Rs 8,800 if
requesting a licence to produce an anti-cancer drug
granted a licence. Rather, starting from the fact that
(sorafenib tosylate), the patent for which is held by
the sale of Nexavar over the previous four years was
the German pharmaceuticals and chemicals giant
only equivalent to a fraction of the public’s estimated
Bayer. It produces and markets the drug under the
requirement of this life-extending treatment, the
brand name Nexavar, which is used in the treatment
Controller General of Patents concluded that the drug
of patients diagnosed as being in the advanced stages
‘was not bought by the public due to only one reason,
of affliction with liver or kidney cancer. Having failed
that is, its price was not reasonably affordable to
to obtain a voluntary licence for manufacture
them’. This is an important precedent, since it
from Bayer, Natco had filed an application under
lays down a condition for assessing affordability.
If enough of a patented drug that is crucial for the
Being the first in itself makes the Nexavar public is not being actually consumed, it must reflect
judgment historic. But there is more to the judgment
the fact that a significant share of patients are not able
than its pioneering character. It is the grounds on
to afford the drug at the price at which it can be sold.
which the Controller of Patents accepted Natco’s
That does warrant invoking the right to issue a
application and rejected Bayer’s opposition that are
also path-breaking. One important ground was the
There are three points the judgment makes.
assessment whether reasonable public requirement
The first is that while importation rather than local
was being met with regard to the supply of Nexavar
manufacture is not a ground for forfeiture of a patent,
through importation. Noting that: (i) over the years,
a country may use the discretionary powers it has
Bayer had imported the drug in volumes that could
when framing patent legislation to make it a ground
have treated only a small fraction (a little above 2 per
for invoking the right to compulsory licensing.
cent) of those who could be credibly assessed as
Second, the understanding of working the patent in
requiring the drug; (ii) that there were years in which
the relevant conventions does not imply working the
no imports were made; and, (iii) that the company
patent on a ‘commercial scale’. And, finally but
was relying only on the import route and not on local
most importantly, ‘mere importation cannot amount to
production to work the patent, the Controller General
concluded that in a physical sense Bayer was not
According to the judgment, ‘a patentee is obliged
working the patent. It was not meeting the condition
to contribute to the transfer and dissemination of the
that ‘the reasonable requirements of the public with
technology, nationally and internationally, so as
respect to the patented invention’ were being to balance rights with obligations. A patentee can satisfied. He also rejected the argument that these
achieve this by either manufacturing the product in
circumstances with respect to supply of Nexavar had
India or by granting a licence to any other person for
to be judged in the context of the fact that
manufacturing in India.’ This conclusion, if sustained,
Cipla, another domestic generic pharmaceuticals is also a precedent with implications that go far manufacturer, has without licence been marketing
sorafenib in India at a price much lower than that
On these grounds the Controller of Patents issued
an order giving Natco the right to manufacture and
sell a generic version of sorafenib tosylate, subject
universities and biotechnology organizations to patent
to pricing it at Rs 8,800 for a monthly dose of genes or other biological facts and relationships, 120 tablets and the payment of 6 per cent royalty on
which were deemed to be observations of natural
the net sales to Bayer (http://www.frontline.in).
processes rather than patentable inventions. The cases
in question involved the Mayo Clinic v Prometheus,
USPTO and UKIPO issue preliminary progress
in which the former successfully claimed that a
report on worksharing initiative
diagnostic test using a drug metabolite to help with
A joint report published by the UK Intellectual
dosing could not be patented. Following that case, a
Property Office (UKIPO) and the United States Patent
case involving Myriad’s patents on two genes
and Trademark Office (USPTO) reports that both
associated with breast cancer and ovarian cancer was
offices have been making efficient use of each other’s
sent back to lower courts for consideration. This left
work, which has led to an improvement in the quality
the implication that the Court wanted the patents
of patents being granted. The report also states that
overturned using the reasoning from the Prometheus
patent attorneys could speed up the patenting process
case. It remains to be seen what effect those decisions
by amending patent applications at both offices when
will have on the pharmaceutical and in vitro
Unlike the diagnostic and gene patenting cases, the
investigate ways to reduce patent processing backlogs
case decided in April 2012 will have an immediate
in both countries. Through closer collaboration, both
impact on the makers of generic and branded
parties have improved the efficiency and quality of
pharmaceuticals. The case in question is Caraco
the patent examination process. This was achieved by
Pharmaceuticals, a generics manufacturer, versus
enabling patent examiners from each office to make
Novo Nordisk, who patented and markets the drug
greater use of each other’s work on commonly-filed
Prandin, a blood glucose lowering treatment usually
patent applications. Each office also surveyed its
used in combination with metformin. The case
examiners to assess their perceptions in using the
revolves around a generic maker’s ability to introduce
shared work products, and the results of this survey
a generic drug for uses not indicated on the branded
product’s label. In this case, Caraco argued that
Mr John Alty, Chief Executive Officer of the
Prandin is only indicated and patented for a single
UKIPO, said that it highlighted their continued efforts
use, as a treatment for type II diabetes in combination
to maximize quality and efficiency savings via with metformin. However, it is approved for two worksharing. Mr David Kappos, Under Secretary of
other uses - as a monotherapy and in combination
Commerce for Intellectual Property and Director of
the USPTO, said that the work-sharing effort
The details of this case are very particular, but it
represented a major step forward in the ongoing
has broad implications for the pharmaceutical
cooperation with the UKIPO, and showed good
industry. In order to determine if the generic
results. He added that more efficient and effective use
application does not violate the issued patent, the
of each other’s work would reduce the cost of doing
FDA relies on a description of the patent, known as a
business and help innovators move their products to
use code, provided to the Agency by the originating
market faster, with more predictability and certainty
company. In this case, Caraco argued that Novo, in
amendments to their patent descriptions filed after
Caraco’s ANDA, had provided descriptions of the
US Supreme Court clears the way for generic
Prandin patents that were vague and overly broad,
patent challenges
effectively blocking the generic approval.
The United States Supreme Court lately handed
In the Supreme Court, this case boiled down to an
down another decision affecting patent law in understanding of the intention of Congress when biotechnology. This decision follows a string of
drafting Hatch-Waxman and related laws, and
patent decisions during a Supreme Court session that
interpretation of the specific wording. Although Novo
has featured an unusually large number of cases
had prevailed in Appeals Court by citing specific
involving healthcare. In two separate decisions language of the relevant statutes, the Supreme Court earlier, the Court severely limited the ability of
took a broader view and examined how Congress
intended the generic challenge process to work.
regulatory regime announced in 2011. Since then,
Overall, the purpose of the relevant laws was to
however, negotiations have stalled over who should
encourage and speed-up the approval of generic
bear the cost of the enforcement regime. Under the
drugs. After the ruling, generic manufacturers will
carriers’ anti-piracy regime, the code would be
now be able to challenge the content of patent
registered and enforced by a third-party regulator,
descriptions and, if successful, ultimately force such as the Australian Communications and Media approval of the ANDA. Writing for the Court in a
unanimous decision, Justice Elena Kagan chastised
The Australian Federation Against Copyright Theft
the FDA for using ambiguous or opaque guidelines
(AFACT), which ran the case on the companies’
and forms that lend to the confusion surrounding
behalf, said the ruling was a clear indication that
patent decisions. She also encouraged Congress to act
Australian copyright law was ill-equipped to deal with
quickly to fix this problem in order to avoid excessive
the online environment. The AFACT chief Neil Gane
patent litigation (http://www.healthcarepackaging.com).
said the situation would hinder the convergence of
traditional entertainment and Internet business models,
Copyright and Trademark News
pointing to increasing tension on copyright and access
to content (http://www.theaustralian.com.au).
Australia called on for piracy solution after regulatory deadlock US Supreme Court steps into copyright case
Copyright holders and Internet companies are
The Supreme Court agreed to decide a copyright
headed for a regulatory deadlock after the Australian
case with important implications for the large and
High Court recently cleared Internet service providers
growing markets in discount and Internet sales. The
of liability for peer-to-peer online movie piracy. The
justices said they will hear an appeal from a Thai
landmark ruling made clear to anti-piracy groups that
student doing graduate work in the United States who
they were extremely unlikely to get remedies to tried to make ends meet by re-selling textbooks that
the problem from the legal system. Both the family and friends first purchased abroad. A jury
telecommunications sector and content owners have
awarded textbook publisher John Wiley & Sons
supported calls for the federal government to step in
US$ 600,000 after deciding that math graduate
and provide a solution. However, the anti-piracy
student, Supap Kirtsaeng, infringed on the company’s
lobby and the telecommunications businesses
want very different approaches from the federal
The issue at the Supreme Court is whether US
copyright protection applies to items that are made
The High Court ruling cleared Perth-based iiNet of
abroad, purchased abroad and then resold in the US
movie industry claims that it had authorized without the permission of the manufacturer. The high
infringement of copyright held by 34 companies when
court split 4-4 when it tried to answer that question in
its customers downloaded movies and television a case in 2010 involving Costco and Swiss watch
programs. Legal experts said the ruling made it clear
maker Omega. The high court has earlier ruled that
that copyright holders would be able to hold ISPs
copyright protections do not apply when the goods are
liable for peer-to-peer online movie piracy only in
made in the US, sold abroad and re-imported. This
Earlier, the anti-piracy groups and carriers
While studying for his undergraduate degree,
including ISPs had been holding confidential Kirtsaeng arranged for family and friends living abroad negotiations overseen by the federal Attorney-
to purchase textbooks and ship them to him. He resold
General’s Department. However, despite the ruling,
the copies on eBay. Eight textbooks sold by Kirtsaeng
the Attorney-General’s Department is expected to
were published by Wiley’s Asian subsidiary. The
facilitate these discussions so that the industry company sued the student in federal court in
continues to work together to find a range of solutions
New York. eBay was among the outside parties urging
the court to hear the case and decide it in Kirtsaeng’s
The Communications Alliance, which has been
favour. Federal judges have come to different
negotiating on behalf of carriers and ISPs, has tried to
conclusions about whether copyright law applies in
secure agreement from content owners to test its co-
Kirtsaeng’s and other cases (http://www.foxnews.com).
Now sound can be protected in Canada
knee joint, eliminating exposure to radiation involved
Everything from the roar of a motorcycle engine to
in CT or MRI and the associated costs. Successful
the sound of sizzling butter could eventually be
knee replacement surgery entails soft-tissue
trademarked in Canada. After a 20-year court battle,
balancing, highly accurate implant positioning,
the Canadian Intellectual Property Office is allowing
and sizing. With the help of 3D modelling
sounds to be trademarked. The decision — announced
technology from Praxim, surgeons can have an
in a recent CIPO ‘Practice Notice’ — was sparked by
enhanced visualization and can better perform the
US entertainment giant Metro Goldwyn Mayer, which
specific procedures within the patient’s anatomy.
applied in 1992 to trademark the lion’s roar heard at
BoneMorphing enables surgeons to devise intra-
the end of its movies. MGM and CIPO reached an
operative surgical plan on the patient’s soft-tissues
agreement that was recently approved by a Federal
and ligament balancing, which is a major mandatory
process prior to knee replacement surgery.
Legal and marketing experts say the move by CIPO
Designed to direct the surgical plan, the ART is a
could eventually see everything from engine sounds
robotic cutting guide known for its precision. ART
to commercial jingles subject to trademark. However,
enhances the surgeon’s potential to perform more
there are others who feel that though not every
accurate and safer bone cuts with minimal intra-
application is going to get granted, there is certainly
operative time and less complexity. With fewer
going to be a rush of applications to test waters
instruments involved in this procedure, optimization
of logistics in hospitals will be improved and
instrument processing costs will considerably be
Gmail trademark dispute settled in Germany
Google has obtained control of the ‘Gmail’
trademark in Germany, according to the German
Holovisions’ US patent for context-driven search
trademark office, and the legal battle for the related
Holovisions has received US Pat No 8,161,073 for
domain name is also over, according to Google.
its context-driven search. Context-driven search
When Google introduced Gmail in 2004, it quickly
analyzes the semantic context for query phrases in
ran into trademark trouble in the UK and Germany,
web pages or other documents and clusters these
where local companies asserted their rights to the
sources into groups of results with similar meaning.
Gmail trademark, forcing Google to rebrand its This provides results that are organized by query service there as Googlemail.
phrase context. Search users no longer have to wade
The UK case was settled in 2010, but the German
through pages of results to pick out those entries
case dragged on until the ‘Gmail’ trademark was
that relate to the semantic context in which they
transferred from the German company G-mail GmbH
to Google on 13 April 2012, according to a transfer
Present search engines do not produce search results
filing posted by the German Patent and Trademark
that are driven by the major contextual uses of a search
Office (http://www.computerworlduk.com).
input phrase. Accordingly, search results can be a
jumble of different contextual meanings. This makes a
Key Patents
user wade through pages of results (manually scanning
titles, text snippets, and URLs) in order to pick out
Patents for computer and robotic-assisted surgery
those entries that relate to the context for the phrase in
platform
which the user is interested. Context-driven search
Praxim received two patents from USPTO for their
solves this problem in three steps. First, a person
robotic-assisted surgery products and revolutionary
provides an input phrase search query. Second, the
computer platform.The first patent titled ‘System for
search engine identifies sets of substantially-equivalent
determining the position of knee prosthesis’ is related
expanded phrases that are relevant to the input phrase.
to Praxim’s BoneMorphing technology that supports
Third, the search engine provides the person with set-
knee replacement surgery. The second patent, titled
specific summary information concerning these sets of
‘Guiding device for bone cutting’ recognizes
substantially-equivalent expanded phrases. This three-
step method provides search results that are driven,
Based on BoneMorphing, surgeons can intra-
consolidated, and summarized by search phrase context
operatively construct a 3-D model of the patient’s
IIT Delhi gets patent for fabric feel tester
the textile industry used the Kawabata Evaluation
Indian Institute of Technology (IIT), Delhi has been
System (KES), which apart from being very expensive,
a granted patent for ‘fabric feel tester’, an innovative
is a highly technical device which acted as a hurdle for
product developed by the premier academic institute.
extensive use by the industry. The new fabric feel
The new device facilitates quality evaluation of the
tester was would only cost Rs 150,000, compared to
fabric on the industrial level at a much lower price.
the price of Rs 15 million for the KES system
Earlier, in order to evaluate the quality of their fabric,
Application Note VL0801 Which UV transilluminator should be used for preparative DNA work? Armin Günther and Reinhold Horlacher, Trenzyme GmbH, Konstanz, Germany, www.trenzyme.comKarin Widulle, Vilber Lourmat Deutschland GmbH, Eberhardzell, Germany, widulle@vilber.deKeywords: transilluminator, multiband, UV, gel documentation, image acquisition, cloning efficiencyStichworte: UV-Tisch, Mul
12.30 — 14.00 / Sunday 26 September / Manchester Town Hall / Banqueting Room e Demos Grill: An in-conversation Oona King; Krishnan Guru-Murthy, Channel 4 News18.00 — 19.30 / Sunday 26 September / Radisson Hotel / Beecham Room Where next for an active British industrial policy? Bob Ainsworth MP; John Woodcock MP; Dan Roberts, The Guardian; Bob Keen, BAE Systems; Ph