Two separate pre-grant oppositions under Section 25(1) of the Patents Act, 1999(“Act”) were filed before the Opposition Board, Chennai (“Board”) respectively by Natco Pharmaceuticals and Ranbaxy Laboratories Limited both on May 26, 2005 to the patent application No. 1602/MAS/1998 of M/s. Novartis AG for an invention titled “Crystal Modification of A.N.-Phenyt-2-Pyrimidineamine derivative, processes for its manufacture and its use”. Novartis’s application filed in India on July 17, 1998 claimed priority 18th July, 1997 from the corresponding application in Switzerland.
The issues involved in both the pre-grant opposition were more or less identical. In the opposition filed by Ranbaxy the issues involved were of (1) priority claims, (2) anticipation and (3) prohibition of grant of patent under Section 3(d) of the Act. Natco’s opposition, in addition to, priority claims, anticipation and prohibition of grant of patent under Section 3(d), also involved the fourth question obviousness of Novartis’s invention. On January 25, 2006, the Board decided in favour of the opponents on all counts and refused the patent application of Novartis.
Briefly and simply put, the patent application of Novartis claimed the beta-crystal form of the imatinib mesylate. Interestingly, the Invention of the base compound imatinib had already been disclosed in the European Patent in 1993 and its equivalent United States Patent (US Patent).
On anticipation by prior publication, the Board held that the opponents, Ranbaxy and Natco, were correct that the invention of the Novartis has been anticipated by prior art. The opponents succeeded in proving that the salt imatinib mesylate is already known from the prior art publications and that the salt normally exists in the β-form which is the most thermodynamically stable product. To prove this the opponents put on record the following –
(a) The prior US Patent of 1993 and its equivalents that specifically mention imatinib mesylate as the product. Though Novartis argued that the US Patent just disclosed the free base and not the salt, the Board observed and held otherwise stating that claims in the US Patent specifically mentioned the salt prepared from the free base;
(b) Publications such as Nature Medicine (5th May, 1996), Cancer Research (Vol. 56, Issue I, 1996) and Blood (1st November, 1997) wherein imatinib mesylate has been disclosed. Hence, there was no human intervention or ingenuinity in the preparation of beta-crystalline form of the salt imatinib mesylate
Similarly the Board decided in favour of the opponents who were successfully able to prove that the salt imatinib mesylate inherently existed in the β-crystalline form and that it is obvious for a person skilled in the art to prepare corresponding pharmaceutically acceptable salts especially in view of the disclosure provided US Patent of 1993 and its equivalents. To support its claims, the opponents had submitted reports of two reputed government institutions -Indian Institute of Chemical Technology, Hyderabad and Indian Institute of Technology, Delhi. Both IICT and IIT found the salt exists in the β-crystalline form, which is thermodynamically most stable form. These institutes performed the experiments at least ten times and at all times the crystals were found to exist in the β-form. Hence, it was held that the product claims by Novartis were obvious to a person skilled in the relevant art especially as the teaching to prepare the salt already existed in the US Patent and equivalents.
The Board also decided that the priority as claimed by Novartis for its patent application in India from its corresponding Swiss application filed on July 18, 1997 was incorrect and the said priority cannot be claimed. The reason for this is that up till the filing of the patent application by Novartis in India i.e. July 17, 1998, Switzerland was not a convention country. Switzerland became a convention country in September 1998. Interestingly, Novartis despite knowing this position chose to remain quiet and did not amend its application accordingly.
The last issue that was dealt by the Board was the issue of section 3(d) of the Indian Patents Act, 1999. This is a unique Section which appears only in the Indian patent law. Simply put Section 3(d) provides that polymorphs, metabolites, pure forms, salts, esters, derivatives etc cannot be regarded as inventions that are patentable unless these show an “enhanced efficacy”. Further simplifying, a new form a known substance cannot be granted patent in India. In this case, the Board held that the invention of Novartis is “only a new form of known substance”. It was also held that there is no enhancement of the known efficacy of the β-crystal form over the known substances. Hence the Board concluded that the subject matter of this application is not patentable under Section 3(d) of the Patents Act.
Therefore, the Board refused the patent No. 1602/MAS/1998 of Novartis holding it to be contrary to section 3(d), prior anticipated, obvious and incorrect priority claimed. Novartis has appealed against the order as well as challenged the constitutional validity of Section 3(d) in the High Court of Chennai. The matter is sub judice.
The lessons that can be learnt from the above situating are-
Patent attorneys must ensure while claiming priority from a country in India, ensure that such country is in fact a convention country.
Corollary of lesson 1 is that the applicant/ patentee should have a patent strategy in place to avoid running into such situations regarding priority. Do not forget, priorities may make or break a patent.
Every country has different domestic laws. Therefore, while filing or after filing (if there is no time) and before the issuance of first Patent Office action, it is imperative for the patent attorneys in the domestic country must revisit the claims to see if the claims are in conformity with domestic laws rather the leave it for the last minute.
If there are any amendments/changes/corrections that require to be carried out, then such changes must be immediately carried out to avoid any third party alleging that fraud has been committed by the applicant/patentee.
Before filing an application the patent attorney should honestly inform the applicant the problems that the application may face in India.
The issues involved in both the pre-grant opposition were more or less identical. In the opposition filed by Ranbaxy the issues involved were of (1) priority claims, (2) anticipation and (3) prohibition of grant of patent under Section 3(d) of the Act. Natco’s opposition, in addition to, priority claims, anticipation and prohibition of grant of patent under Section 3(d), also involved the fourth question obviousness of Novartis’s invention. On January 25, 2006, the Board decided in favour of the opponents on all counts and refused the patent application of Novartis.
Briefly and simply put, the patent application of Novartis claimed the beta-crystal form of the imatinib mesylate. Interestingly, the Invention of the base compound imatinib had already been disclosed in the European Patent in 1993 and its equivalent United States Patent (US Patent).
On anticipation by prior publication, the Board held that the opponents, Ranbaxy and Natco, were correct that the invention of the Novartis has been anticipated by prior art. The opponents succeeded in proving that the salt imatinib mesylate is already known from the prior art publications and that the salt normally exists in the β-form which is the most thermodynamically stable product. To prove this the opponents put on record the following –
(a) The prior US Patent of 1993 and its equivalents that specifically mention imatinib mesylate as the product. Though Novartis argued that the US Patent just disclosed the free base and not the salt, the Board observed and held otherwise stating that claims in the US Patent specifically mentioned the salt prepared from the free base;
(b) Publications such as Nature Medicine (5th May, 1996), Cancer Research (Vol. 56, Issue I, 1996) and Blood (1st November, 1997) wherein imatinib mesylate has been disclosed. Hence, there was no human intervention or ingenuinity in the preparation of beta-crystalline form of the salt imatinib mesylate
Similarly the Board decided in favour of the opponents who were successfully able to prove that the salt imatinib mesylate inherently existed in the β-crystalline form and that it is obvious for a person skilled in the art to prepare corresponding pharmaceutically acceptable salts especially in view of the disclosure provided US Patent of 1993 and its equivalents. To support its claims, the opponents had submitted reports of two reputed government institutions -Indian Institute of Chemical Technology, Hyderabad and Indian Institute of Technology, Delhi. Both IICT and IIT found the salt exists in the β-crystalline form, which is thermodynamically most stable form. These institutes performed the experiments at least ten times and at all times the crystals were found to exist in the β-form. Hence, it was held that the product claims by Novartis were obvious to a person skilled in the relevant art especially as the teaching to prepare the salt already existed in the US Patent and equivalents.
The Board also decided that the priority as claimed by Novartis for its patent application in India from its corresponding Swiss application filed on July 18, 1997 was incorrect and the said priority cannot be claimed. The reason for this is that up till the filing of the patent application by Novartis in India i.e. July 17, 1998, Switzerland was not a convention country. Switzerland became a convention country in September 1998. Interestingly, Novartis despite knowing this position chose to remain quiet and did not amend its application accordingly.
The last issue that was dealt by the Board was the issue of section 3(d) of the Indian Patents Act, 1999. This is a unique Section which appears only in the Indian patent law. Simply put Section 3(d) provides that polymorphs, metabolites, pure forms, salts, esters, derivatives etc cannot be regarded as inventions that are patentable unless these show an “enhanced efficacy”. Further simplifying, a new form a known substance cannot be granted patent in India. In this case, the Board held that the invention of Novartis is “only a new form of known substance”. It was also held that there is no enhancement of the known efficacy of the β-crystal form over the known substances. Hence the Board concluded that the subject matter of this application is not patentable under Section 3(d) of the Patents Act.
Therefore, the Board refused the patent No. 1602/MAS/1998 of Novartis holding it to be contrary to section 3(d), prior anticipated, obvious and incorrect priority claimed. Novartis has appealed against the order as well as challenged the constitutional validity of Section 3(d) in the High Court of Chennai. The matter is sub judice.
The lessons that can be learnt from the above situating are-
Patent attorneys must ensure while claiming priority from a country in India, ensure that such country is in fact a convention country.
Corollary of lesson 1 is that the applicant/ patentee should have a patent strategy in place to avoid running into such situations regarding priority. Do not forget, priorities may make or break a patent.
Every country has different domestic laws. Therefore, while filing or after filing (if there is no time) and before the issuance of first Patent Office action, it is imperative for the patent attorneys in the domestic country must revisit the claims to see if the claims are in conformity with domestic laws rather the leave it for the last minute.
If there are any amendments/changes/corrections that require to be carried out, then such changes must be immediately carried out to avoid any third party alleging that fraud has been committed by the applicant/patentee.
Before filing an application the patent attorney should honestly inform the applicant the problems that the application may face in India.
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