Fwd: [Ip-health] RE: MASHELKAR REPORT

Wed Jan 17 13:59:01 2007

--
[ Picked text/plain from multipart/alternative ]
>
> Charles Clift
> >-- Original Message --
> >Date: Wed, 17 Jan 2007 10:58:28 -0300
> >From: "Luis Nogues" <luisnogues@gmail.com>
> >To: "charlesclift@tiscali.co.uk" <charlesclift@tiscali.co.uk>
> >Subject: Re: [Ip-health] RE: MASHELKAR REPORT
> >
> >
> >Dear Sir
> >
> >I put my observation in CAPITAL LETTER.
> >
> >
> >On 1/16/07, charlesclift@tiscali.co.uk <charlesclift@tiscali.co.uk>
> wrote:
> >>
> >>
> >>
> http://www.managingip.com/default.asp?page=3D9&PubID=3D198&SID=3D671455&I=
SS=3D23218&LS=3DEMS117111
> >>
> >>
> >> NB Mashelkar Report
> >> http://www.ipindia.nic.in/ipr/patent/mashelkar_committee_report.doc
> >>
> >>
> >>
> >>
> >> Indian panel opposes patent law plans
> >> Peter Ollier, Hong Kong
> >>
> >> A government-appointed panel of IP specialists has concluded that
> India's
> >> patent law would not comply with the TRIPs Agreement if it limited the
> >> granting
> >> of patents to new chemical entities.
> >>
> >> The Indian Ministry of Commerce appointed five IP academics to a panel
> >in
> >> April 2005 to consider whether more changes should be made to the
> >> country's
> >> newly-amended Patent Act.
> >>
> >> In particular, the panel ? the Technical Expert Group on Patent Law
> Issues
> >> ? was asked if the country could limit the grant of patents for
> >> pharmaceutical
> >> substances to new chemical entities and still meet its TRIPs
> obligations.
> >> It also examined whether India could exclude micro-organisms from
> >> patenting.
> >>
> >> The group was led by R A Mashelkar, former head of the Council of
> >> Scientific
> >> and Industrial Research.
> >>
> >> The panel's report was published over the weekend. In it, the authors
> >> compared
> >> Article 27 of TRIPs to India's Patent Act.
> >>
> >> Article 27 of TRIPs says that patents should be available to "any
> >> inventions,
> >> whether products or processes".
> >> SINCE ONLY FEW LAWS HAVE A DEFINITION OF INVENTION (ARGENTINA HAS) AND
> >> SINCE TRIPS DOES NOT DEFINE WHAT INVENTION IS, ERGO THIS DEFINITION IS
> >OPEN
> >> TO THE GOVERMENTS AND IT SHOULD NOT VIOLATE TRIPS.
> >
> >
> >
> >REGARDING SECTION 3(D) THIS ARTICLE DOES NOT VIOLATE TRIPS.
> >ARGENTINA HAS ALSO ONE OR TWO ARTICLES IN HIS LAW REGARDING NOS THIS
> ISSUE
> >BUT OTHERS LIKE "IS NOT PATENTABLE BUSINESS METHODS, OR SCULPTURES OR TH=
E
> >FORM OF PRESENTATION OF INFORMATION".
> >
> >LETS SAY THAT *IF* THIS ARTICLES (THOSE OF THE ARGENTINE PATENT LAW  OR
> OR
> >3(D) OF THE INDIAN PATENT ACT) WERE NOT WRITTEN, THE ISSUE WOULD BE THE
> >SAME: AS THERE IS NO INVENTIVE STEP (ONLY A DISCOVERY IN THE CASE OF
> SECTION
> >3(D)) THE ARGENTINE PATENT OFFICE AN THE INDIA PATENT OFFICE MUST NOT
> GRANT
> >PATENT FOR SCULPTURE, DISCOVERY OF NEW PROPERTY OR NEW USE OF A KNOWN
> >SUBSTANCE, ETC.
> >
> >BUT I BELIEVE THAT IS TRUE THAT THERE MUST BE GUIDELINESS TO PREVENT
> >GRANTING PATENT SUCH AS THOSE OF SECTION 3(D) OR ARTICLES 6 AND 7 OF THE
> >ARGENTINE PATENT LAW.
> >
> >Section 3(d) of India's patent act clarifies what is not patentable. The
> >> exceptions include: "the mere discovery of a new form of a known
> substance
> >> which does not result in the enhancement of the known efficacy of that
> >> substance,
> >> the mere discovery of any new property or new use for a known
> substance,
> >> and the mere use of a known process, machine or apparatus ? unless tha=
t
> >> process
> >> results in a new product or employs at least one new reactant."
> >>
> >> In its report, the panel says that this part of Indian patent law mean=
s
> >> that
> >> a new form of a known substance would not be patentable "unless it
> differs
> >> significantly in properties with regard to efficacy". It concludes tha=
t
> >> this
> >> section does not comply with TRIPs. YES IT DOES AS I EXPLAINED.
> >>
> >> Using the US Food and Drug Administration's definition of a new
> chemical
> >> entity as "a drug that contains no active moiety that has been approve=
d
> >by
> >> the FDA in any other application," the panel decided that limiting
> grants
> >> to new chemical entities, and excluding new forms of crystals and
> >> polymorphs,
> >> if they are patentable, would not be TRIPs compliant. TRIPS NOTHING
> SAYS
> >> ABOUT THIS. IF THEY BELIEVE OTHER THING THEN I SUGGEST TO GO TO A
> PANEL.
> >>
> >> Pravin Anand, a partner of Anand and Anand, described the report as "a
> >> fantastic
> >> report, good for innovation".
> >>
> >> India is one of the world's largest centres of generic drug
> manufacturing,
> >> and the report will come as a blow to the industry. The authors were,
> >> however,
> >> careful to distinguish between "incremental innovations" (developments
> >> that
> >> build on the value of a patented product) and "ever-greening"
> (extending
> >> the life of a patent by making inconsequential changes).
> >
> >
> >HOW DID THEY DISTINGUISH "INCREMENTAL INNOVATIONS" OF "EVER GREENING"?.
> >EXAMPLE: THERE ARE SMALL INCREMENTAL, MEDIUM, HIGH, ETC. INCREMENTAL. IF
> >YOU
> >GIVE PATENT TO SMALL INCREMENTAL OR MEDIUM (TO PUT A PARAMETER) YOU ARE
> >MAKING "EVER GREENING". (FOR INSTANCE IF YOU GIVE PATENTS FOR NEW USES O=
F
> >THE SAME THING. THIS IS A DISCOVERY)
> >
> >DEVELOPED COUNTRIES HAVE AND WANTS FOR DEVELOPING COUNTRIES SMALL
> >STTANDARDS FOR INVENTIVE STEP. SO THE CAN RECIEVE FRIVOLOUS PATENTS.
> >
> >BUT DEVELOPING COUNTRIES MUST HAVE HIGH STANDARDS.
> >
> >AND THIS IS NOT IN CONFLICT WITH TRIPS.
> >
> >DEVELOPING COUNTRIES MUST BE VERY CAREFULL WITH THIS ISSUE.
> >
> >The authors recommend that the government formulate detailed guidelines
> to
> >> prevent the granting of frivolous patents. YES, BUT NOT THE KIND THEY
> >> WANT..
> >>
> >> Annex IV of the report supports the case for allowing incremental
> >> innovations
> >> to be granted patent protection in India by detailing the number of PC=
T
> >> applications
> >> filed by Indian pharmaceutical companies concerning different forms of
> >the
> >> same substance. ITS ALL RIGHT AND THIS IS BECAUSE OTHER LAWS (MOSTLY
> >> DEVELOPED COUNTRIES) ADMIT THIS TIPE OF INVENTIONS. IT IS NOT A PROBLE=
M
> >OF
> >> THE INDIAN PHARMACEUTICAL COMPANIES.
> >>
> >> India's newly-revised patent law has caused controversy among many
> >> multinational
> >> pharmaceutical companies. Novartis went to court in May 2006 to
> challenge
> >> the Indian Patent Office's decision to refuse to grant a patent for it=
s
> >> cancer-treating
> >> drug Glivec. In its lawsuit, Novartis claims that Section 3(d) of the
> >> Indian
> >> Patents Act, does not comply with TRIPs.
> >>
> >> Despite pressure from humanitarian organization M=E9decins Sans
> Fronti=E8res
> >> (MSF), the Swiss company has not backed down. The next hearing in the
> case
> >> is scheduled for January 29 at the Chennai High Court.
> >>
> >> No official from MSF was available to comment on the panel's report. A
> >> spokesperson
> >> for the Indian Pharmaceutical Alliance, an association of generic
> >> pharmaceutical
> >> manufacturers, told MIP Week by email that there was "hardly any"
> evidence
> >> in the report to support the panel's conclusions. IM SURE THAT THEY
> DONT
> >> UNDERSTAND WHAT A PATENT IS.
> >>
> >> It also pointed out that the panel's report did not refer to a
> submission
> >> by Frederick Abbott, an academic at Florida State University who has
> >> advised
> >> developing countries during TRIPs negotiations at the WTO, which had
> been
> >> arranged by the Alliance.
> >>
> >> On micro-organisms the report says that TRIPs allows the patenting of
> >> those
> >> involving human intervention. Excluding micro-organisms per se from
> patent
> >> protection would therefore violate the TRIPs Agreement.
> >
> >
> >TRIPS SAYS ANYTHING ABOUT HUMAN INTERVENTION (SEE ARTICLE 27.3 B). TRIPS
> >MANDATE TO PATENT MICRO-ORGANISMS.
> >BUT HERE COMES THE QUESTION =BFALL MICROORGANISM?.
> >
> >THE ANSWER IS NO. BUT THEN WHAT KIND OF MICROORGANISM.?
> >ANSWER: THOSE WHO ARE NEW AND INVOLVE STEP.
> >
> >QUESTION: THEN IT IS THE SAME FOR ALL DEVELOPED AND DEVELOPING
> COUNTRIES.?
> >
> >ANSWER: NO. TRIPS DOES NOT GIVE A DETAILED EXPLANATION IN GRANTING
> PATENT.
> >IT LEAVES AN "OPEN DOOR" FOR EACH COUNTRY AND THAT OPEN DOOR IS USED (OR
> >SHOULD BE USED BY BOTH: DEVELOPED AND DEVELOPING COUNTRIES). THIS "OPEN
> >DOOR" IS FOR ALL TRIPS AND NOT ONLY TO THIS ARTICLE.
> >
> >DEVELOPED COUNTRIES IN GENERAL HAS USED THE OPEN DOOR TO SAY REGARDING
> >MICROORGANISM: "IF I FIND IN NATURE A MICROORGANISM AND IS USEFUL THEN I=
T
> >IS
> >PATENTABLE. THERE MERE ACTION OF ISOLATING THE MICROORGANISM MAKE IT
> >PATENTABLE..
> >
> >ON TE OTHER HAND DEVELOPING COUNTRIES MUST SAY "IF I FIND IN NATURE A
> >MICROORGANISM AND IS USEFUL THIS MICROORGANISM IS NOT PATENTABLE BECAUSE=
:
> >FIRST: IT LACK NOVELTY (ALTHOUGH NOBODY KNEW IT WAS THERE. IS THE SAME A=
S
> >FINDING A BUCK IN GOBI DESERT THAT HAS THE DESCRIPTION  A PATENT FILED
> LATER
> >THAN THE PUBLISHED BOOK), AND
> >SECOND: THERE MERE ISOLATION (HUMAN INTERVENTION) DOES NOT MAKE IT
> >PATENTABLE. WHERE IS THE INVENTIVE STEP HERE? IN THE ISOLATION?
> >
> >IN ARGENTINA WE GRANT PATENTS ON MICROORGANISM THAT HAS USEFUL CHANGES I=
N
> >THEIR GENETIC COMPOSITION.
> >
> >THEREFORE THE INDIAN PATENT OFFICE MUST HAVE STRICT GUIDELINEES FOR
> GRANTING
> >PATENTS, AS TODAY THE ARGENTINA HAS.
> >
> >AND ALSO INDIA SHOULD TRY TO PUT A DEFINITION OF INVENTION IN HIS LAW.
> >
> >Luis Nogues
> >Former chief of the Argentine Patent Office.
> >
> >MIP Week welcomes your feedback on this or any other story. Please email
> >> the author with your comments. Letters may be published online.
> >>
> >> This article is FREE access as part of MIP Week
> >>
> >>
> >> ___________________________________________________________
> >>
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> >>
>
>
>
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