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<font size="-1">the reasoning about section3(d) and its application
should be included in the suggested, near-time reforms of the
patent system as proposed by Pirate Parties. spicyip has written
quite a lot about the patent law section3(d) in india and its
application is all but sensible (for instance, it is not extended
to chemicals that are not pharmaceuticals, probably because the
indian industry for chemicals is closer to being an originator
industry than not - same controversy existsaround data exclusivity
in the india/EU FTA, if one believes present india business
statistics). <br>
<br>
well. the basis for the exception is sound, and it could very well
be applicable within the EPC-zone (for instance). the last
evaluation is biochemical patents in sweden was 2006, so there may
be another one underway.<br>
<br>
/a<br>
</font><br>
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<th valign="BASELINE" align="RIGHT" nowrap="nowrap">Subject: </th>
<td>[SPICY IP] Application of Orphan Drug Act to section 3(d)?</td>
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<th valign="BASELINE" align="RIGHT" nowrap="nowrap">Date: </th>
<td>Mon, 18 Jul 2011 00:08:12 -0700 (PDT)</td>
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<th valign="BASELINE" align="RIGHT" nowrap="nowrap">From: </th>
<td>Rajiv Kr. Choudhry <a class="moz-txt-link-rfc2396E" href="mailto:rajiv.choudhry@gmail.com"><rajiv.choudhry@gmail.com></a></td>
</tr>
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<th valign="BASELINE" align="RIGHT" nowrap="nowrap">Reply-To:
</th>
<td><a class="moz-txt-link-abbreviated" href="mailto:rajiv.choudhry@gmail.com">rajiv.choudhry@gmail.com</a></td>
</tr>
<tr>
<th valign="BASELINE" align="RIGHT" nowrap="nowrap">To: </th>
<td><a class="moz-txt-link-abbreviated" href="mailto:spicyip@googlegroups.com">spicyip@googlegroups.com</a></td>
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<br>
<br>
<a moz-do-not-send="true"
href="http://upload.wikimedia.org/wikipedia/commons/thumb/0/0a/Spot_the_difference.png/500px-Spot_the_difference.png"
imageanchor="1" style="clear: left; float: left; margin-bottom:
1em; margin-right: 1em;"><img moz-do-not-send="true"
src="http://upload.wikimedia.org/wikipedia/commons/thumb/0/0a/Spot_the_difference.png/500px-Spot_the_difference.png"
width="320" border="0" height="176"></a><br>
<div style="text-align: justify;">Long post follows:</div>
<div style="text-align: justify;">In an earlier <a
moz-do-not-send="true" href="http://goo.gl/h4PD3">post</a>, I
had discussed providing for a numerical quantifier for section
3(d) of our patents act and in <a moz-do-not-send="true"
href="http://goo.gl/52S67">another</a> discussed of the
possibility using an exclusionary definition of the term efficacy
as relates to the act.<span style="mso-spacerun: yes;"> </span>This
post provides a summary of definitions used in US Orphan Drug Act
(ODA) to determine whether a drug is same or similar to another.<span
style="mso-spacerun: yes;"> </span>This discussion is helpful
to the Indian context because of two reasons: (1) the definitions
as provided by the ODA consider similar issues as faced by our
Controllers/Courts regarding defining efficacy for same or similar
drugs, and (2) they have been applied and tested to specific cases
and hence their impact and relative certainty can be measured.<span
style="mso-spacerun: yes;"> </span></div>
<br>
<div class="MsoNormal" style="text-align: justify;">The ODA was
enacted by US Congress to help a relatively small number of
consumers who suffer from a rare disease as there was not enough
incentive for research and development (“R&D”) for those small
number of consumers suffering from rare diseases.<span
style="mso-spacerun: yes;"> </span>The ODA provided an
incentive to pharmaceutical company manufacturing drug to help
those few individuals affected by any one (rare) disease or
condition to overcome the financial losses.<span
style="mso-spacerun: yes;"> </span>The incentive was a seven
year market exclusivity for discovery of new orphan drugs.<span
style="mso-spacerun: yes;"> </span>Specifically, a drug is
an "orphan drug" if it is for a "rare disease or condition" that
effects fewer than 200,000 patients in the United States or for
which there is no reasonable expectation that the cost of
developing the drug for a disease will be recovered from sales in
the United States.<span style="mso-spacerun: yes;"> </span><a
moz-do-not-send="true" href="http://goo.gl/Uz7lz">FDA definition</a>.</div>
<div class="MsoNormal" style="text-align: justify;">A little bit of
science and history:<span style="mso-spacerun: yes;"> </span>Prior
to the development of recombinant proteins by the biotechnology
industry, simple (and smaller) chemical structures provided a
basis for most drugs and two drugs were considered the same if
they had the same active moiety.<span style="mso-spacerun: yes;">
</span><a moz-do-not-send="true" href="http://goo.gl/ezF64">See
definitions</a>. <span style="mso-spacerun: yes;"> </span>“Active
moiety means the molecule or ion, excluding those appended
portions of the molecule that cause the drug to be an ester, salt
(including a salt with hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex, chelate, or clathrate)
of the molecule, responsible for the physiological or
pharmacological action of the drug substance.”<span
style="mso-spacerun: yes;"> </span>This approach of
designating two structures worked well with small molecules
because the chemical structure was a good indicator of a drug’s
chemical syntheses.<span style="mso-spacerun: yes;"> </span>Therefore,
changes to the chemical structure (of the active moiety) would
most likely result in large pharmacologic differences for small
molecules produced by chemical syntheses.</div>
<div class="MsoNormal" style="text-align: justify;">This definition,
however, does not work for large molecules such as recombinant
proteins, polysaccharides or nucleic acids, or genes, or
glycoproteins.<span style="mso-spacerun: yes;"> </span>Living
organisms contain genes, a unit of heredity.<span
style="mso-spacerun: yes;"> </span>Genes consist of
deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). <span
style="mso-spacerun: yes;"> </span>DNA consists of two long
polymers of "nucleotides." <span style="mso-spacerun: yes;"> </span>Nucleotides
are arranged in a DNA molecule and a specific arrangement of the
nucleotides is a "DNA sequence."<span style="mso-spacerun: yes;">
</span>DNA encodes the information that living cells use to build
proteins and other RNA molecules.<span style="mso-spacerun: yes;">
</span>Proteins are essential parts of organisms and participate
in virtually every process within cells.<span style="mso-spacerun:
yes;"> </span>Functions include food digestion, metabolism,
muscle formation, cell signaling, immune responses, etc.<span
style="mso-spacerun: yes;"> </span>Proteins are made from
amino acids using information encoded in genes. <span
style="mso-spacerun: yes;"> </span>Each protein has its own
unique amino acid sequence that is specified by the nucleotide
sequence of the gene encoding this protein. <span
style="mso-spacerun: yes;"> </span>The genetic code is a set of
three-nucleotide sets called codons and each three-nucleotide
combination designates an amino acid. <span style="mso-spacerun:
yes;"> </span>Because DNA contains four nucleotides, the total
number of possible codons is 64.<span style="mso-spacerun: yes;">
</span>Genes encoded in DNA are first transcribed into
pre-messenger RNA (mRNA) by proteins such as RNA polymerase. Most
organisms then process the pre-mRNA (also known as a primary
transcript) using various forms of posttranscriptional
modification to form the mature mRNA, which is then used as a
template for protein synthesis by the ribosome.<span
style="mso-spacerun: yes;"> </span>(Definitions of gene,
protein, nucleic acids, DNA taken and combined from Wikipedia). <span
style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal" style="text-align: justify;">Without a proper
definition of "sameness," any market exclusivity for a gene, a
protein, nucleotide, or a glycoprotein could be completely
valueless, because competitors can easily substitute nucleotides
to create a "different" gene coding for an identical protein.<span
style="mso-spacerun: yes;"> </span>In proteins, there is a
specific problem, because certain individual amino acids are
generally structurally interchangeable (because of their similar
basic structure and net charge) without producing a noticeable
functional effect. </div>
<div class="MsoNormal" style="text-align: justify;">To address the
problems associated with these macromolecules, the ODA restricted
the use of active moiety to small drug molecules and provided that
large drug molecules cannot contain the "same principal molecular
structure."<span style="mso-spacerun: yes;"> </span></div>
<div class="MsoNormal" style="text-align: justify;">Specifically, <a
moz-do-not-send="true" href="http://goo.gl/P98kM">the
definitions</a> provide: </div>
<div class="MsoNormal" style="text-align: justify;">(13) Same drug
means:</div>
<div class="MsoNormal" style="text-align: justify;">(i) If it is a
drug composed of <span style="background: yellow; mso-highlight:
yellow;">small molecules</span>, a drug that contains the <span
style="background: yellow; mso-highlight: yellow;">same active
moiety</span> as a previously approved drug and is intended for
the same use as the previously approved drug, even if the
particular ester or salt (including a salt with hydrogen or
coordination bonds) or other noncovalent derivative such as a
complex, chelate or clathrate has not been previously approved,
except that if the subsequent drug can be shown to be clinically
superior to the first drug, it will not be considered to be the
same drug.</div>
<div class="MsoNormal" style="text-align: justify;">(ii) If it is a
drug composed of <span style="background: lime; mso-highlight:
lime;">large molecules</span> (macromolecules), a drug that
contains the <span style="background: lime; mso-highlight: lime;">same
principal molecular structural features</span> (but not
necessarily all of the same structural features) and is intended
for the same use as a previously approved drug, except that, if
the subsequent drug can be shown to be clinically superior, it
will not be considered to be the same drug. This criterion will be
applied as follows to different kinds of <span
class="Apple-style-span" style="background-color: lime;">macromolecules</span>:</div>
<div class="MsoNormal" style="text-align: justify;">(A) Two protein
drugs would be considered the same if the only differences in
structure between them were due to post-translational events or
infidelity of translation or transcription or were minor
differences in amino acid sequence; other potentially important
differences, such as different glycosylation patterns or different
tertiary structures, would not cause the drugs to be considered
different unless the differences were shown to be clinically
superior.</div>
<div class="MsoNormal" style="text-align: justify;">(B) Two
polysaccharide drugs would be considered the same if they had
identical saccharide repeating units, even if the number of units
were to vary and even if there were postpolymerization
modifications, unless the subsequent drug could be shown to be
clinically superior.</div>
<div class="MsoNormal" style="text-align: justify;">(C) Two
polynucleotide drugs consisting of two or more distinct
nucleotides would be considered the same if they had an identical
sequence of purine and pyrimidine bases (or their derivatives)
bound to an identical sugar backbone (ribose, deoxyribose, or
modifications of these sugars), unless the subsequent drug were
shown to be clinically superior.</div>
<div class="MsoNormal" style="text-align: justify;">(D) Closely
related, complex partly definable drugs with similar therapeutic
intent, such as two live viral vaccines for the same indication,
would be considered the same unless the subsequent drug was shown
to be clinically superior.</div>
<div class="MsoNormal" style="text-align: justify;">FDA regulations
<a moz-do-not-send="true" href="http://goo.gl/P98kM">define</a> a
"clinically superior" drug as:</div>
<div class="MsoNormal" style="text-align: justify;">(3)<span
class="Apple-style-span" style="background-color: lime;">
Clinically superior means that a drug is shown to provide a
significant therapeutic advantage</span> over and above that
provided by an approved orphan drug (that is otherwise the same
drug) in one or more of the following ways:</div>
<div class="MsoNormal" style="text-align: justify;">(i) Greater
effectiveness than an approved orphan drug (as assessed by effect
on a clinically meaningful endpoint in adequate and well
controlled clinical trials). Generally, this would represent the
same kind of evidence needed to support a comparative
effectiveness claim for two different drugs; in most cases, direct
comparative clinical trials would be necessary; or</div>
<div class="MsoNormal" style="text-align: justify;">(ii) Greater
safety in a substantial portion of the target populations, for
example, by the elimination of an ingredient or contaminant that
is associated with relatively frequent adverse effects. In some
cases, direct comparative clinical trials will be necessary; or</div>
<div class="MsoNormal" style="text-align: justify;">(iii) In unusual
cases, where neither greater safety nor greater effectiveness has
been shown, a demonstration that the drug otherwise makes a major
contribution to patient care.</div>
<div class="MsoNormal" style="text-align: justify;"><br>
</div>
<div class="MsoNormal" style="text-align: justify;">It can be seen
that the <span class="Apple-style-span" style="background-color:
lime;"><b>clinical superiority test is based on patient care
rather than basing the test on structural similarity</b></span>.</div>
<div class="MsoNormal" style="text-align: justify;">Hence under our
patent act, section 3(d) may also be interpreted based on similar
guidelines and if appropriate, similar guidelines may be used by
our courts to interpret patent claims for new compounds.</div>
<div class="MsoNormal" style="text-align: justify;">Our readers may
wonder why I keep providing multiple definitions for section 3(d):<span
style="mso-spacerun: yes;"> </span>The reason is
simple-currently there are no guidelines that Assistant
Controllers follow while rejecting or allowing patent claims under
section 3(d).<span style="mso-spacerun: yes;"> </span>Each
Asstt. Controller applies section 3(d) differently and just about
anything is fair game when rejecting applications.<span
style="mso-spacerun: yes;"> </span>The result is a mess.<span
style="mso-spacerun: yes;"> </span>With no clear guideline,
both the patentee and public suffer.<span style="mso-spacerun:
yes;"> </span>Rejection of claims under section 3(d)
differently leads to insufficient incentive to applicants.</div>
<div class="MsoNormal" style="text-align: justify;"><br>
</div>
<div class="MsoNormal" style="text-align: justify;">Image from: <a
moz-do-not-send="true"
href="http://en.wikipedia.org/wiki/Spot_the_difference">http://en.wikipedia.org/wiki/Spot_the_difference</a> </div>
<br>
<br>
--<br>
Posted By Rajiv Kr. Choudhry to <a moz-do-not-send="true"
href="http://spicyipindia.blogspot.com/2011/07/application-of-orphan-drug-act-to.html">SPICY
IP</a> at 7/18/2011 12:38:00 PM
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