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wherein the polymorphic form is crystalline, having an X-ray powder diffraction pattern (CuKa) comprising peaks at about 7.552, 10.339, 11.159, 12.107, 14.729, 15.329, 15.857, 16.824, 17.994, and 18.344, 19.444, 19.764, 20.801, and 22.414 o 20.
5. The polymorphic form as claimed in claim 4, wherein the X-ray powder diffraction pattern (CuKa) is substantially as shown in FIG.56
“15. The pharmacological/biological activity plays a crucial role since it suggests uses of the compound in a particular medicinal activity. The present and D1, D2 compounds has anti inflammatory activity. It is pertinent to note that the anti- inflammatory activity of TX 63682 (suppression of NO release by RAW 264.7 shows an excellent assay results than the presently claimed polymorphic form compound. The table in page no 46 of D3 discloses the NO IC50 of TX63682 is 1.1, relative NO IC50 0.65 are clearly indicates the higher activity of TX63682 than the RTA 408. This coherent thread leading from the prior art by adding a methyl group to arrive at the present claimed compound is obvious to a person skilled in the art. It will be more appropriate, when a more active prior art compound is known and then the comparison of the present compound shall be made with that compound. It is routine to a person skilled in the art to conduct various additional activity assays in pharmacokinetics and pharmadynamics test of similar prior art compounds and its crystals/polymorphs. In fact both the prior art citations are done using the https://www.mhc.tn.gov.in/judis same routine experiments. These routine experiments are employing a common general knowledge of a skilled person in the art and make conventional trial and error experimentations. Moreover, each crystalline form has its own X-ray diffraction pattern.

This X-ray diffraction pattern is inherent property of each crystalline compound without an intervention of the applicant. In this regard I differ with the ISA written opinion and the applicant argument that these additional activity in other assays do not considered as technical advance as compared to the existing more anti-inflammatory activity compound Tx63682. It is obvious to a person skilled in the art by reading D2 page 100, VII. Examples and particularly D3 page 38 and 46, crystalline non solvate form cannot be considered as new entity involving inventive since non solvate are do not contain toxic solvents as well as crystalline forms are typically more stable than amorphous form. In view of the above discussion I agree with the examiner's opinion, it is evident that different polymorphic form can be obtained without any inventive merit, by routine techniques. In absence of any superior/ surprising effect compared to the known form of an existing drug, making of a new polymorph of a drug should be considered as obvious https://www.mhc.tn.gov.in/judis to the person skilled in the art in view of documents D2 and particularly D3. Since the polymorphic form compound itself not inventive, the composition using the polymorphic form do not have any significance without any inventive features. Hence the present application amended claims 1-7 are not inventive under section 2(1)(j)(a) of Patent Act 1970.”

24. Turning to conclusions (iv) and (vi), these conclusions are untenable because RTA 408 is not a known substance and, therefore, the polymorphic forms thereof cannot be treated as obvious. Besides, the x-ray powder diffraction pattern is a means to identify the polymorph and not a technical advancement. In paragraph 18 above, the asserted advancements over the existing knowledge is set out. Since Forms A and B are not polymorphic forms of a known substance for reasons discussed earlier, Section 3(d) does not apply and enhanced efficacy over the known substance need not be shown. I am conscious that it is prudent to tread with circumspection while considering a subsequent and separate patent claim for polymorphic forms because of the potential for ever-greening. On the facts of this case, however, I https://www.mhc.tn.gov.in/judis find that patent protection, if granted, only exceeds that of the parent compound by about one year. Although D3 did not qualify as prior art when RTA 408 was granted a patent, for reasons set out in the preceding paragraphs, D3 does not detract from the technical advancement of the claimed invention or render it obvious. In those circumstances, the polymorphic forms are also entitled to a patent provided there is clear identification and enablement. In the claims, each polymorphic form is identified by the distinct x-ray powder diffraction pattern and melting point. The methods of production of Forms A and B are also fairly described in internal pages 90 and 91 of the complete specification. Therefore, there is sufficient merit in claims 1-6.