In our last post on HIV patent cases in India, we promised to bring you a more comprehensive analysis of the Nevirapine patent rejection. So here it is:
The patent application by BI claimed the ARV (anti retroviral), Nevirapine, as a “hemi-hydrate solution”. More specifically, the patent claimed a composition containing an aqueous solution of nevirapine hemihydrate of particle size between 1-150 micron.
The key advantage claimed by BI related to the particle size which made it more stable and enabled longer storage. The particle size was advantageous to maintain stability of the solution. And the solution was useful for kids who normally find it difficult to take other dosage forms of Nevirapine.
Pursuant to a pre grant opposition filed by AIDS patients groups, the Assistant Controller, NR Meena rejected the patent on grounds of lack of inventive step, lack of “efficacy” under section 3(d) and lack of “synergy” under section 3(e).
It is interesting to note that counsel for the opposition (Anand Grover of Lawyers Collective) stressed the fact that the since the invention related to an "essential" medicine, a patent issued would have a debilitating impact on “access”. Therefore it was imperative that the patent office subject such patent applications to a "strict" patentability standard/threshold.
To buttress his point, he cited the Madras High Court decision in the Novartis case, TRIPS and the Doha Declaration, all of which made clear that countries had flexibilities in devising patent regimes that adequately catered to “public health” concerns. He also referred extensively to Carol Correa's "Guidelines for the Examination of Pharmaceutical Patents: A Public Health Perspective".
The Asst Controller attempts to dispose of these “policy” style arguments quickly by noting that TRIPS and other arguments relating to “public health” are not specific “specific grounds” that one can cite in an opposition. Interestingly however, he goes on to qualify all the above submissions by Grover as “matters of law”. In other words, he appears to have accepted the proposition that the patents covering essential medicines ought to be construed “strictly” as a matter of law.
His proposition paves the way for differential “patentability” standards at the patent office in respect of "essential" medicines. This is over and above the differential standards built in by Parliament into statute such as section 3.d (which applies mainly to pharma and agro chemical inventions).
However, it bears noting that this standard is likely to be applicable only to "essential" medicines and not all pharma patents. Therefore, a patent application relating to a new variant of the Viagra drug is not likely to attract the same kind of sympathy by the Indian patent office (in fact, the patent office may deploy a liberal standard of patentability to intentionally keep prices high!).
Here are some quick points that I prepared that may qualify as a “summary” of the decision:
On Novelty (and "Mosaicing")
The opposition cited a number of prior art documents which they alleged “anticipated” BI’s patent application. The patent office however disagreed, stating that no single document, by itself, contained all the prior art necessary to anticipate. In pertinent part, the office held that for the purpose of “anticipation” one cannot “mosaic” different documents and claim that they anticipate the patent.
On "Inventive Step" (Non Obviousness)
Although the patent office ruled against the opposition on the "novelty" issue, they held in their favour in so far as "inventive step" was concerned. The Asst Controller appears to suggest that one may “mosaic” different prior art for the purpose of establishing lack of inventive step. And based on all the prior art cited, the patent office held that a skilled person could have put them together to arrive at the claimed “invention” (a composition containing an “aqueous suspension of nevirapine hemihydrate”). The patent office also hinted that the reduction in particle size could be achieved by milling or other conventional methods. And that there was nothing novel or inventive about the method here.
Section 3(d): No Comparative Data
As mentioned earlier, the key advantage claimed by BI was in terms of the particle size which made it more stable and enabled longer storage (i.e. particle size was advantageous to maintain stability of the solution. And the solution was very useful for kids who normally find it difficult to take other dosage forms of Nevirapine). However, the patent office still ruled against BI on section 3(d).
The key reason underlying the patent office rejection on this count was because no evidence had been submitted that would have enabled the patent office to compare the efficacy of the claimed invention against an earlier known substance. In other words, one has to necessarily show “comparative advantage” and explicitly compare the invention against an earlier known substance. This point by the patent office demonstrates the importance of submitting some data (whether clinical trial, in vitro, scientific publications etc) that would help establish that the "efficacy" of the claimed invention was superior to an already known substance/composition. It is not enough to merely allege such increase in efficacy or hope that the patent office will so intuit from the other evidence/submissions.
Section 3(d): Therapeutic Efficacy
More importantly, the patent office held that the only advantage cited was that a reduction in particle size permitted longer storage. According to them, this did not constitute an increase in “therapeutic” efficacy. In pertinent part, they stated that: “Improved particle size stability means that someone who is able to make aqueous solution of Nevirapine Hemihydrate can store it for longer in the shelf. However the “therapeutic” effect of Nevirapine, whether in hemihydrate or anhydrous form or whether administered in aqueous, tablet, parenteral or any other dosage form would remain the same”.
From the above, it can be seen that the patent office is likely to insist upon “therapeutic efficacy” in future cases. And not just any kind of advantage claimed for the drug sought to be patented, such as an increase in heat stability, manufacturing efficiencies etc.
Needless to say, in construing efficacy to mean "therapeutic efficacy", the Indian patent office was merely following the Madras High Court decision in this regard. And as per our constitutional structure, it is bound to follow the rulings of the High Courts. I have elaborated on this aspect in a recent article and I extract the relevant portion below:
“First, it is important to appreciate that while certain acts of the patent office qualify as “purely administrative,” others could be said to be of a “quasi judicial” nature. Whilst determining whether an application meets the criteria of patentability, the patent office could be said to be performing a quasi-judicial role.
Since the patent controller is a “tribunal” (at least when deciding on whether or not something is patentable), it will be bound by the supervisory jurisdiction of the High Court under Article 227. And in much the same way as the IPAB, it is bound by decisions of the High Court.”
The article then goes on to question the assumption that the term "efficacy" in section 3(d) necessarily means "therapeutic efficacy". Not least because the section applies to agro-chemicals as well—and it seems downright stupid to ask if a variant of an existing pesticide demonstrates greater therapeutic efficacy than its known predecessor! We had also blogged on this aspect here.
The article notes:
"While some of the suggestions in this paper are immediately implementable, other issues will necessarily involve a more detailed empirical/policy investigation. One such issue is the definition of efficacy: ought “efficacy” to be restricted to only therapeutic efficacy, or should it be widely defined to encompass non therapeutic advantages as well, such as heat stability, manufacturing efficiencies etc? This issue will, in many ways, determine the scope of protection of incremental pharmaceutical inventions in India. Illustratively, if efficacy is restricted to only “therapeutic” efficacy, new drug delivery mechanisms, a category of inventions in which Indian companies are particularly proficient, will fall out of the scope of protection."
Notwithstanding any of the above, unless the ruling of the Mad HC is challenged, it is here to stay. And future patent office decisions will continue to insist upon "therapeutic" efficacy. Interestingly, a recent update of the patent office manual quotes the Madras High Court definition of “efficacy,” as well. I will comment more elaborately on the patent office manual and its implications for the Novartis case in a later post.
Section 3(e): No Synergy
The patent office also held against BI on section 3(e), which prohibits patents to any "substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof". In other words, unless a combination of individual elements produces some "synergy", the said combination is not patentable. The patent office rules that the claimed composition by BI did not demonstrate additional synergy, when combined. However, the reasoning was not very detailed in this regard.
Patent Eligbility vs Patentability
I had mentioned in the earlier post that of all the commentaries pertaining to this case, I would recommend the post by IMAK, where Tahir succinctly explains the decision. In particular, Tahir takes issue with the patent office reasoning, whereby patentability criteria such as "novelty and "inventive step" are looked at first, prior to assessing the section 3(d) issue. He notes that:
"If any criticism can be levelled at the decision, it is from a practice point of view. As with the Novartis/Gleevec decision, the patent offices seem intent to go through the novelty, inventive step tests first before considering what are not inventions under the Patents Act i.e s3(d) and s3(e). Logically, and as evidenced in case law from other jurisdictions, the patent office should deal whether a patent application even meets the threshold of an invention, as set out in s3 of the Indian Patents Act, before moving on. Therefore, s3d should be applied first."
Although I see some merit in Tahir’s point, I wonder whether what he suggests is pragmatic. Would it be possible for the patent office to completely rule on section 3.d, without looking into issues of "novelty" and "non obviousness" at all? In a recent article, already referred to earlier, we’ve recommended as below:
“Section 3(d) may be construed as a refinement of patentability criteria to cater for “ever-greening” – a specific problem inherent in pharmaceutical innovations. More specifically, the “enhanced efficacy” criterion can be seen as refinement of “non- obviousness” principles, i.e. most forms of existing pharmaceutical substances are deemed obvious, unless they demonstrate increased “efficacy.” At some level, section 3(d) could also be said to embody a utility test, i.e. unless the new form has significantly enhanced utility over and above what existed before in the art, it is not patentable.
Under the present scheme of the Indian Patents Act, section 3(d) is part of a section that begins with the phrase “the following are not inventions within the meaning of this Act…” In other words, any pharmaceutical invention that does not comply with section 3(d) represents excluded patentable subject matter, i.e. section 3(d) is structured as a patent eligibility test and not as a patentability test. At a conceptual level and drawing from the patenting practices of most member states, one can draw a distinction between “patent eligibility” and “patentability.”
“Patent eligibility” broadly refers to the requirement that a subject matter for which a patent is sought be inherently suitable for patent protection, in the sense of falling within the scope of subject matter that patent law prima facie exists to protect. In most jurisdictions, patent eligibility manifests itself in the term “invention,” i.e. a poem, though new, non-obvious and useful is still not patentable, as it is not an “invention.” The term “patentability,” on the other hand, refers to those set of principles that inform the requirements that must be satisfied for a patent eligible subject matter (i.e. an invention) to be granted a valid patent. Principally they are the requirements of novelty, inventive step (non-obviousness), utility (industrial applicability) and sufficient description.
By mandating that a new form without increased efficacy would not amount to an “invention,” section 3(d), in effect, constitutes a patent eligibility standard. Although this is more a matter of form than substance and is not likely to make an impact on the outcome of the case, it will influence the stage at which the examination is conducted. Being a patent eligibility standard, an examination is conducted right at the start. Compare this with a non-obviousness or inventive step examination, which is done at a later stage. Since an examination under section 3(d) is likely to call into question some of the very same issues used in a non-obviousness determination, it may help to explicitly state section 3(d) as a “patentability” criterion rather than a patent eligibility criterion.”
Apart from a non-obvious determination referred to above, section 3(d) calls into question issues of “novelty”. The section states in pertinent part that only those "new forms" that demonstrate significantly enhanced efficacy over and above a "known substance" will be patentable. This issue comes up quite starkly in the Novartis case, with the question being: What is the "known" substance against which the Novarits beta crystalline application has to be compared for assessing efficacy?
As noted in a previous post, the various steps involved in the allegedly inventive process are:
) Synthesizing imatinib as its free base, a compound that was patented in the US, EU and several other countries. However, this could not be patented in India, owing to the fact that in 1993, India did not provide product patents for pharmaceutical substances.
ii) Converting the free base to a particular salt form, imatinib mesylate, by adding methanesulfonic acid.
iii) Crystallising the imatinib mesylate to obtain the beta crystalline form, which is allegedly the most stable polymorphic form of the salt. A patent application was filed for this and it is this application that is the subject matter of dispute.
iv) Formulating the beta crystalline form of imatinib mesylate into a pharmaceutically useful drug, Glivec.
While rejecting the patent application on grounds of section 3(d), the patent office does not make clear as to what the "known" substance in this case is. Would the “known” substance be the imatinib free base (in relation to which it is far easier to show increased efficacy) or the later salt, imatinib mesylate? Or the alpha crystalline form of imatinib mesylate?
Notwithstanding this defect, is is important to appreciate that for the purpose of section 3(d), one has to necessarily make a determination of what amounts to a "known" substance: a determination that will inevitably call into question issues of "novelty".
Conclusion
As mentioned in the last post, the most significant portion of the patent office decision appears to be the implicit finding that when an application claims an "essential medicine", patentability criteria have to be interpreted "strictly". Perhaps this could mean that if the meaning of the term "efficacy" is uncertain, the patent office would give it a stricter/narrower construction, limiting it to "therapeutic" efficacy, rather than opening it up to a more liberal interpretation. In short, this decision paves the way for patent offices to treat “essential medicine” cases differently.
Secondly, the patent office is likely to continue with construing efficacy as "therapeutic efficacy". Unless such a construction is challenged in court. Lastly, the Nevirapine decision teaches us that unless data is submitted to compare an earlier known substance against the claimed form, an applicant is likely to fail the section 3(d) test.
Would love to hear from our readers on what they think might be the implications of this decision for future pharma cases. Also, if I have missed out on or overlooked some aspect of this decision that you think deserves mention, please do let me know.
The patent application by BI claimed the ARV (anti retroviral), Nevirapine, as a “hemi-hydrate solution”. More specifically, the patent claimed a composition containing an aqueous solution of nevirapine hemihydrate of particle size between 1-150 micron.
The key advantage claimed by BI related to the particle size which made it more stable and enabled longer storage. The particle size was advantageous to maintain stability of the solution. And the solution was useful for kids who normally find it difficult to take other dosage forms of Nevirapine.
Pursuant to a pre grant opposition filed by AIDS patients groups, the Assistant Controller, NR Meena rejected the patent on grounds of lack of inventive step, lack of “efficacy” under section 3(d) and lack of “synergy” under section 3(e).
It is interesting to note that counsel for the opposition (Anand Grover of Lawyers Collective) stressed the fact that the since the invention related to an "essential" medicine, a patent issued would have a debilitating impact on “access”. Therefore it was imperative that the patent office subject such patent applications to a "strict" patentability standard/threshold.
To buttress his point, he cited the Madras High Court decision in the Novartis case, TRIPS and the Doha Declaration, all of which made clear that countries had flexibilities in devising patent regimes that adequately catered to “public health” concerns. He also referred extensively to Carol Correa's "Guidelines for the Examination of Pharmaceutical Patents: A Public Health Perspective".
The Asst Controller attempts to dispose of these “policy” style arguments quickly by noting that TRIPS and other arguments relating to “public health” are not specific “specific grounds” that one can cite in an opposition. Interestingly however, he goes on to qualify all the above submissions by Grover as “matters of law”. In other words, he appears to have accepted the proposition that the patents covering essential medicines ought to be construed “strictly” as a matter of law.
His proposition paves the way for differential “patentability” standards at the patent office in respect of "essential" medicines. This is over and above the differential standards built in by Parliament into statute such as section 3.d (which applies mainly to pharma and agro chemical inventions).
However, it bears noting that this standard is likely to be applicable only to "essential" medicines and not all pharma patents. Therefore, a patent application relating to a new variant of the Viagra drug is not likely to attract the same kind of sympathy by the Indian patent office (in fact, the patent office may deploy a liberal standard of patentability to intentionally keep prices high!).
Here are some quick points that I prepared that may qualify as a “summary” of the decision:
On Novelty (and "Mosaicing")
The opposition cited a number of prior art documents which they alleged “anticipated” BI’s patent application. The patent office however disagreed, stating that no single document, by itself, contained all the prior art necessary to anticipate. In pertinent part, the office held that for the purpose of “anticipation” one cannot “mosaic” different documents and claim that they anticipate the patent.
On "Inventive Step" (Non Obviousness)
Although the patent office ruled against the opposition on the "novelty" issue, they held in their favour in so far as "inventive step" was concerned. The Asst Controller appears to suggest that one may “mosaic” different prior art for the purpose of establishing lack of inventive step. And based on all the prior art cited, the patent office held that a skilled person could have put them together to arrive at the claimed “invention” (a composition containing an “aqueous suspension of nevirapine hemihydrate”). The patent office also hinted that the reduction in particle size could be achieved by milling or other conventional methods. And that there was nothing novel or inventive about the method here.
Section 3(d): No Comparative Data
As mentioned earlier, the key advantage claimed by BI was in terms of the particle size which made it more stable and enabled longer storage (i.e. particle size was advantageous to maintain stability of the solution. And the solution was very useful for kids who normally find it difficult to take other dosage forms of Nevirapine). However, the patent office still ruled against BI on section 3(d).
The key reason underlying the patent office rejection on this count was because no evidence had been submitted that would have enabled the patent office to compare the efficacy of the claimed invention against an earlier known substance. In other words, one has to necessarily show “comparative advantage” and explicitly compare the invention against an earlier known substance. This point by the patent office demonstrates the importance of submitting some data (whether clinical trial, in vitro, scientific publications etc) that would help establish that the "efficacy" of the claimed invention was superior to an already known substance/composition. It is not enough to merely allege such increase in efficacy or hope that the patent office will so intuit from the other evidence/submissions.
Section 3(d): Therapeutic Efficacy
More importantly, the patent office held that the only advantage cited was that a reduction in particle size permitted longer storage. According to them, this did not constitute an increase in “therapeutic” efficacy. In pertinent part, they stated that: “Improved particle size stability means that someone who is able to make aqueous solution of Nevirapine Hemihydrate can store it for longer in the shelf. However the “therapeutic” effect of Nevirapine, whether in hemihydrate or anhydrous form or whether administered in aqueous, tablet, parenteral or any other dosage form would remain the same”.
From the above, it can be seen that the patent office is likely to insist upon “therapeutic efficacy” in future cases. And not just any kind of advantage claimed for the drug sought to be patented, such as an increase in heat stability, manufacturing efficiencies etc.
Needless to say, in construing efficacy to mean "therapeutic efficacy", the Indian patent office was merely following the Madras High Court decision in this regard. And as per our constitutional structure, it is bound to follow the rulings of the High Courts. I have elaborated on this aspect in a recent article and I extract the relevant portion below:
“First, it is important to appreciate that while certain acts of the patent office qualify as “purely administrative,” others could be said to be of a “quasi judicial” nature. Whilst determining whether an application meets the criteria of patentability, the patent office could be said to be performing a quasi-judicial role.
Since the patent controller is a “tribunal” (at least when deciding on whether or not something is patentable), it will be bound by the supervisory jurisdiction of the High Court under Article 227. And in much the same way as the IPAB, it is bound by decisions of the High Court.”
The article then goes on to question the assumption that the term "efficacy" in section 3(d) necessarily means "therapeutic efficacy". Not least because the section applies to agro-chemicals as well—and it seems downright stupid to ask if a variant of an existing pesticide demonstrates greater therapeutic efficacy than its known predecessor! We had also blogged on this aspect here.
The article notes:
"While some of the suggestions in this paper are immediately implementable, other issues will necessarily involve a more detailed empirical/policy investigation. One such issue is the definition of efficacy: ought “efficacy” to be restricted to only therapeutic efficacy, or should it be widely defined to encompass non therapeutic advantages as well, such as heat stability, manufacturing efficiencies etc? This issue will, in many ways, determine the scope of protection of incremental pharmaceutical inventions in India. Illustratively, if efficacy is restricted to only “therapeutic” efficacy, new drug delivery mechanisms, a category of inventions in which Indian companies are particularly proficient, will fall out of the scope of protection."
Notwithstanding any of the above, unless the ruling of the Mad HC is challenged, it is here to stay. And future patent office decisions will continue to insist upon "therapeutic" efficacy. Interestingly, a recent update of the patent office manual quotes the Madras High Court definition of “efficacy,” as well. I will comment more elaborately on the patent office manual and its implications for the Novartis case in a later post.
Section 3(e): No Synergy
The patent office also held against BI on section 3(e), which prohibits patents to any "substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof". In other words, unless a combination of individual elements produces some "synergy", the said combination is not patentable. The patent office rules that the claimed composition by BI did not demonstrate additional synergy, when combined. However, the reasoning was not very detailed in this regard.
Patent Eligbility vs Patentability
I had mentioned in the earlier post that of all the commentaries pertaining to this case, I would recommend the post by IMAK, where Tahir succinctly explains the decision. In particular, Tahir takes issue with the patent office reasoning, whereby patentability criteria such as "novelty and "inventive step" are looked at first, prior to assessing the section 3(d) issue. He notes that:
"If any criticism can be levelled at the decision, it is from a practice point of view. As with the Novartis/Gleevec decision, the patent offices seem intent to go through the novelty, inventive step tests first before considering what are not inventions under the Patents Act i.e s3(d) and s3(e). Logically, and as evidenced in case law from other jurisdictions, the patent office should deal whether a patent application even meets the threshold of an invention, as set out in s3 of the Indian Patents Act, before moving on. Therefore, s3d should be applied first."
Although I see some merit in Tahir’s point, I wonder whether what he suggests is pragmatic. Would it be possible for the patent office to completely rule on section 3.d, without looking into issues of "novelty" and "non obviousness" at all? In a recent article, already referred to earlier, we’ve recommended as below:
“Section 3(d) may be construed as a refinement of patentability criteria to cater for “ever-greening” – a specific problem inherent in pharmaceutical innovations. More specifically, the “enhanced efficacy” criterion can be seen as refinement of “non- obviousness” principles, i.e. most forms of existing pharmaceutical substances are deemed obvious, unless they demonstrate increased “efficacy.” At some level, section 3(d) could also be said to embody a utility test, i.e. unless the new form has significantly enhanced utility over and above what existed before in the art, it is not patentable.
Under the present scheme of the Indian Patents Act, section 3(d) is part of a section that begins with the phrase “the following are not inventions within the meaning of this Act…” In other words, any pharmaceutical invention that does not comply with section 3(d) represents excluded patentable subject matter, i.e. section 3(d) is structured as a patent eligibility test and not as a patentability test. At a conceptual level and drawing from the patenting practices of most member states, one can draw a distinction between “patent eligibility” and “patentability.”
“Patent eligibility” broadly refers to the requirement that a subject matter for which a patent is sought be inherently suitable for patent protection, in the sense of falling within the scope of subject matter that patent law prima facie exists to protect. In most jurisdictions, patent eligibility manifests itself in the term “invention,” i.e. a poem, though new, non-obvious and useful is still not patentable, as it is not an “invention.” The term “patentability,” on the other hand, refers to those set of principles that inform the requirements that must be satisfied for a patent eligible subject matter (i.e. an invention) to be granted a valid patent. Principally they are the requirements of novelty, inventive step (non-obviousness), utility (industrial applicability) and sufficient description.
By mandating that a new form without increased efficacy would not amount to an “invention,” section 3(d), in effect, constitutes a patent eligibility standard. Although this is more a matter of form than substance and is not likely to make an impact on the outcome of the case, it will influence the stage at which the examination is conducted. Being a patent eligibility standard, an examination is conducted right at the start. Compare this with a non-obviousness or inventive step examination, which is done at a later stage. Since an examination under section 3(d) is likely to call into question some of the very same issues used in a non-obviousness determination, it may help to explicitly state section 3(d) as a “patentability” criterion rather than a patent eligibility criterion.”
Apart from a non-obvious determination referred to above, section 3(d) calls into question issues of “novelty”. The section states in pertinent part that only those "new forms" that demonstrate significantly enhanced efficacy over and above a "known substance" will be patentable. This issue comes up quite starkly in the Novartis case, with the question being: What is the "known" substance against which the Novarits beta crystalline application has to be compared for assessing efficacy?
As noted in a previous post, the various steps involved in the allegedly inventive process are:
) Synthesizing imatinib as its free base, a compound that was patented in the US, EU and several other countries. However, this could not be patented in India, owing to the fact that in 1993, India did not provide product patents for pharmaceutical substances.
ii) Converting the free base to a particular salt form, imatinib mesylate, by adding methanesulfonic acid.
iii) Crystallising the imatinib mesylate to obtain the beta crystalline form, which is allegedly the most stable polymorphic form of the salt. A patent application was filed for this and it is this application that is the subject matter of dispute.
iv) Formulating the beta crystalline form of imatinib mesylate into a pharmaceutically useful drug, Glivec.
While rejecting the patent application on grounds of section 3(d), the patent office does not make clear as to what the "known" substance in this case is. Would the “known” substance be the imatinib free base (in relation to which it is far easier to show increased efficacy) or the later salt, imatinib mesylate? Or the alpha crystalline form of imatinib mesylate?
Notwithstanding this defect, is is important to appreciate that for the purpose of section 3(d), one has to necessarily make a determination of what amounts to a "known" substance: a determination that will inevitably call into question issues of "novelty".
Conclusion
As mentioned in the last post, the most significant portion of the patent office decision appears to be the implicit finding that when an application claims an "essential medicine", patentability criteria have to be interpreted "strictly". Perhaps this could mean that if the meaning of the term "efficacy" is uncertain, the patent office would give it a stricter/narrower construction, limiting it to "therapeutic" efficacy, rather than opening it up to a more liberal interpretation. In short, this decision paves the way for patent offices to treat “essential medicine” cases differently.
Secondly, the patent office is likely to continue with construing efficacy as "therapeutic efficacy". Unless such a construction is challenged in court. Lastly, the Nevirapine decision teaches us that unless data is submitted to compare an earlier known substance against the claimed form, an applicant is likely to fail the section 3(d) test.
Would love to hear from our readers on what they think might be the implications of this decision for future pharma cases. Also, if I have missed out on or overlooked some aspect of this decision that you think deserves mention, please do let me know.
Dear Shamnad,
ReplyDeleteThe claims relate to a composition comprising nevirapine hemihydrate in a particular size range and water. The claims do not relate to only nevirapine hemihydrate in a particular size range.
Section 3 d relates to new form of known compounds being non patentable (if not efficacious than the known substance)…The applicant has claimed the composition…. Even though the activity of the composition is due to nevirapine hemihydrate, it (nevirapine hemihydrate) has not been claimed and I am not very sure if S 3d applies to compositions, which is one of the grounds on which the application has been rejected…..
Regards,
Dear Anon,
ReplyDeleteThanks for comment. I'm not sure why you stress the first point. The post clearly stated "More specifically, the patent claimed a composition containing an aqueous solution of nevirapine hemihydrate of particle size between 1-150 micron."
Did I mis-characterise the claim?
As for second point on section 3(d), don't you think that the patent office may have construed the claimed composition to be a "combination"--a term specifically used in section 3(d)?
Dear Shamnad,
ReplyDeleteYou didn�t mis-characterise the claim�neither my intention was this�.anyways you are right I missed on the �combination� part�.thanks�
Regards,
Thanks Anon,
ReplyDeleteYou've raised an interesting point about section 3(e). And one needs to ask: at the policy level, does it make sense to have "compositions" within section 3(d), when we already have section 3(e)?
I guess the statute is making sure that even if a composition exhibits synergy, it may still not be more efficacious than a prior substance/composition. Net result of course is that all the NDDS are subject to section 3(d) and now have to prove increased "therapeutic" efficacy. Under this strict standard, even the much toutued Cipro-OD invention by Ranbaxy will not qualify.
taking the case of a pharmaceutical can there be a presumption that purified form will automatically be therapeutically more effective? then - is efficacy as in the section and purified form as in the explanation to 3(d)- in antithesis?
ReplyDeleteRegards.
stupid questions merit no response?
ReplyDeleteanother one..
will 3(d) apply in reverse? as in.. if X is patented..then would salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives be covered under the same patent (with all having the same period of protection) and be protected from infringers for 20 yrs?