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Glochem Industries Ltd v/s Cadila Healthcare

Case Laws in legal field is one of the best source of understanding a particular section or law. Casw law is the backbone of legal system. So, in this we'll focus on "Glochem Industries Ltd Vs Cadila Healthcare Ltd" which is about PATENT. The patent application procedure, which is a component of intellectual property law, as well as how patent infringement is handled are all governed by patent law.

The Bombay High Court held that "Section 3 (d) consists of all fields including the field of pharmacology. Further, in this case, the court held that "the test to decide whether the discovery is an invention or not? It is on the patent applicant to show that the discovery has resulted in enhancement of known therapeutic efficacy of the original substance and if the discovery is nothing other than the derivative of a known substance, then, it must be shown that the properties in derivatives are significantly different in terms of efficacy. So under this sub-section, the very discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance will not be treated as an invention.

Respondent No. 1 submitted a response to the agent in response to an objection by the applicant of this document. The above response statement was supported by the affidavit and certain inclusions received by the petitioner on or around November 18, 2008. The petitioner was later informed by contact from Respondent No. 4 of this case that the opponent's agent would continue on February 1, 2009. The petitioner appeared through an agent at a hearing at the respondent # 4's office, but during the hearing, the petitioner's agent was specific to challenge the respondent # 1's response.

It is alleged that you were not allowed to call the document. Similarly, the applicant's agent was not given the opportunity to verbally refute Respondent # 1's allegations, and the applicant's agent requested permission to submit a written discussion, which was granted. rice field. Following the above approval, a written discussion was submitted to Defendant's Office # 3 by Defendant's representative on June 1, 2009. Respondent No. 4 dismissed the applicant's statement of appeal in the appealing decision of July 1, 2009, for the reasons set forth in this decision. Duplicate the relevant excerpt from the disputed order that addressed the current dispute. The same thing is like this:

Section 3 (d): Claims 1 to 3 of the present invention relate to crystalline clopidogrel besilate. Crystalline clopidogrel besilate is pure, fluid, easy to handle, chemically stable (hygroscopic) and can be used on an industrial scale (a few full specifications). , Page 5). To support this and comply with the requirements of Section 3 (d) of the 1970 Patent Act, Applicants have submitted stability study data sheets for disulfates (Schedules 5 and 9) and besilates (Schedule 6). Was submitted together with the response form. With reports on the stability and comparative pharmaceutical properties of solvates (toluene and diozane) and crystalline clopidogrel besylate (Appendix 13 and 14).

Data from the stability study of clopidogrel bisulfate show that increased levels of inactive metabolites reduce the effectiveness of bisulfate by reducing the therapeutic dose in the long run (Appendix 5). ). Acidic impurities are also increasing in heavy sulfate tablets (Appendix 9). On the other hand, surprisingly, the crystalline clopidogrel besylate of the present invention was not detected in any of the three lots with inactive metabolites for 6 months (Appendix 6). Therefore, the cropidogrel crystalline besilate of the present invention is advantageous in terms of increasing the shelf life of the cropidogrel heavy sulfate.

The stability report in Appendix 13 shows that the cropidogrel crystalline besilates of the present invention are compared to the solvated (toluene and dioxane) forms of cropidogrel crystalline besilates (cited by opponents) after 2 months. But it shows that it is more free-flowing and stable.The comparative data on pharmaceutical properties provided in Appendix 14 show that the solvate (toluene and dioxane) forms of clopidogrel crystalline vesylate are more cardiotoxic compared to the clopidogrel crystalline vesylate of the present invention. Crystalline copvesylate is nontoxic up to a concentration of 50 �M, but the toluene-dissolved form was toxic at 5 �M and the dioxane-dissolved form was toxic at 25 �M. Therefore, crystalline clopidogrel besylate has been shown to be better and more beneficial in terms of toxicity compared to the solvated form.

Considering the beneficial effect of the clopidogrel crystalline vesylate of the present invention on the known clopidogrel heavy sulfate and the beneficial effect of the clopidogrel vesylate on the solvate form in various characterization embodiments, the clopidogrel crystalline vesylate of the present invention Compounds can be considered patentable and are not patentable. Based on Section 3 (d) of the 1970 Patent Act.

Therefore, the opposition's objection that it cannot be invented or patented under the law is unacceptable.

5. Against this background, the current overview is submitted and raises some questions. However, during the petition's trial, the attorney appearing at the petition limited his claim to the context of Article 25 (1) (f), primarily related to Article 3 (d) of the Act. He pointed out the following points:
  1. There was no legal or acceptable evidence submitted by Defendant No. 1 to support the allegation.
  2. Respondent No. 1 does not show that disclosure of new forms of patent-filed known substances leads to improved known therapeutic effects.
  3. Defendant's Fourth Authority did not consider the above points and, in fact, ruled an objection to the misunderstanding and misuse of Article 3 (d) of the Act.
6. On the other hand, Defendant No. 1 upheld the decision in appeal, arguing that Defendant No. 4 took into account all relevant facts in responding to the current dispute. There is no obvious mistake by respondent No. 4. In addition, the court may not challenge Defendant No. 4's opinion on technical issues. The petitioner was submitted to have had a fair opportunity to file an opposition, and Respondent No. 4 addressed the opposition raised by the petitioner and made the same judgment on the proposal. According to Respondent No. 1, the petitioner has an alternative and effective remedy that he can rely on. It has been submitted that the appeal after the appeal has been granted will continue to be available under Article 25 (2) of the Act. You may even resort to an appeal demanding the cancellation of suomoto's patent under Article 64 of the Act. In addition, the applicant may counterclaim the cancellation or invalidation of a patent in a proceeding that the patentee may file under Article 104 of the Act. Even for that reason, the court should hesitate to consider the current proceedings.

7. After considering competing inputs, first address the final objection. The applicant may take remedial action in the form of a post-granting opposition or cancellation of Suo-moto and filing a counterclaim, as suggested by the respondent, but if the applicant is correct, this in itself. Is not the basis for not suing the applicant. Their complaint that the authorities have made obvious or judicial errors in considering the representation of the objection, or that the objection was determined on the basis of an obvious misunderstanding and the incorrect application of relevant legal provisions. This is because the law provides for an appeal against a pre-grant opposition under Article 25 (1) of the Act. If such legal remedies are provided, the authorities will consider the legal framework, comply with the principles of natural law, and consider the representative by opposition before granting in accordance with Article 25 (1).

I have a duty. It is not necessary to consider the petitioner's allegation that the pre-grant appeal is qualitatively different from the post-grant appeal. According to the applicant, the responsibility for demonstrating the opposition before grant lies with the patent applicant that the claimed invention leads to an improvement in the known efficacy of the claimed substance. On the other hand, in a post-grant opposition, the opponent must demonstrate that the claimed invention does not result in a known improvement in the effectiveness of the claimed substance. The Preliminary Objection of Respondent No. 1 states that this court does not have jurisdiction to consider a written application under Article 226 of the Constitution of India against the authorities' decision on the appeal of Article 25 (1). It doesn't mean anything. Whether the court should consider a written application is a matter of caution and discretion. Given the facts in this case, we do not believe it appropriate to disobey the petitioner at the threshold up to this point.

8. Now, let us return to the first discussion raised on behalf of the petitioner. This means that there is no legal or acceptable evidence on which Respondent No. 4 was able to answer the current dispute. Article 77 of the Act states that the patent examiner should have the authority of a particular civil court relating to the summoning and enforcement of witnesses, the discovery of documents, the acquisition of evidence of affidavits, and the preparation of examination committees. I'm assuming. Witnesses of the document will be transferred. In addition, Article 79 of the Act follows the rules regarding the method of obtaining evidence and the authority of its administrator, and in the procedure under the law in front of the administrator, the evidence shall be an affidavit without instructions separately specified by the administrator.

It stipulates that it must be due to. In fact, it is at the discretion of the administrator whether to obtain verbal evidence in lieu of or in addition to the affidavit evidence or to allow the parties to cross-examine the content of the affidavit. In this case, the applicant allegedly did not submit an affidavit. Without such evidence, Respondent No. 4 would not have been able to see the material submitted by Respondent No. 1 who was the applicant. Respondent No. 1 submitted an expert affidavit dated October 14, 2008, along with the response, and attached certain annexes to the affidavit, but the document was not certified. In other words, neither the expert affidavit nor the attachment to the affidavit can be used to resolve the dispute.

However, according to Respondent No. 1, the procedures to be followed in the pre-grant opposition investigation under Article 25 (1) are summarized. The requirement under Article 25 (1) related to Rule 55 is that the applicant must submit a response when submitting an assertion by opposition. Reunion by those who oppose the grant of the patent, or the submission of further documentation or evidence by either the applicant or those who oppose the grant of the patent is foreseen. The purpose of Rule 55 is to resolve pre-grant oppositions quickly, but the post-grant opposition stage provides more sophisticated procedures, as shown in Rules 55A-62.

9. It is not difficult to agree with Respondent No. 1's claim that the investigation attempted at the pre-grant opposition stage is a summary investigation. Nevertheless, this study also requires adherence to the principles of natural law. Moreover, given the plain language of Article 79 of the Act, its application is not limited to investigations under Article 25 (2) of the Act. Section 79, on the other hand, assumes the requirements described in this section for "all steps". According to the law before the person responsible for processing.

That expression certainly includes an investigation under Article 25 (1) of the Act. Moreover, it cannot be overlooked that Article 77 of the Act assumes that the patent administrator is empowered by a particular civil court. As understood in this way, Defendant No. 4 will use any evidence submitted by the plaintiff to answer the issue in the decision of proxy in the opposition proceedings under Article 25 (1) of the Act.

It was expected to first decide if it could be done. .. In addition, the evidence submitted by the applicant must be of a nature that the claimed invention enhances the known validity of the claimed substance and clearly demonstrates that it refutes the objection of the other party. In fact, Respondent No. 4 answered the question in light of Annex 5, 6, 9, 13, and 14, but primarily at the petitioner's request to somehow destroy the above document. I didn't consider it. As far as attachments 5 and 6 are concerned, according to the complainant, these are unique and maliciously created / prepared to mislead the authorities. As far as Appendix 9 is concerned, it was related to tablet stability studies limited to clopidogrel bisulfate only and was not evidence of comparison with tablets containing clopidogrel besilate.

As far as Annex 13 is concerned, it was also unmatched, according to the petitioner. This is because it is related to the comparative stability data of clopidogrel vesylate and solvated toluene and solvated dioxane of the claimed invention. There is no comparison with known existing salts such as heavy sulfate. As far as Appendix No. 14 is concerned, the petitioner disputed the statement regarding the comparative study of the pharmaceutical properties of clopidogrel vesylate and solvated toluene and dioxane in the alleged invention. This is because studies are being conducted on solvated clopidogrel besilate rather than the known heavy sulfate. These objections to the disregard of the above annex were explicitly raised in writing to the authorities, but the authorities did not address these issues at all.

10. Furthermore, according to the applicant, the claimed invention prior to the authorities is Section 3 (d) of the law. Respondent 4 did not address this aspect at all, although it is a judicial fact. The complainant's complaint has weight. Even after careful consideration of the disputed decisions, there is no indication that the applicant's above objections were taken into account by Respondent No. 4. It would have been different if 4 respondents rejected the applicant's allegations with reference to the relevant annex used to answer the issue.

11. The judgment in appeal not only suffers from the above weaknesses, but in the case of Novartis AG v /, in the claimant's allegation that Defendant No. 4 should have taken into account the judgment of the Madras Supreme Court. Also has strengths. s .Union of India & ors. (2007) 4 Reported in Madras Law Journal 1153. In this case, the court considered the implications of the amended clause when considering questions regarding the validity of the amended Act, which amended Article 3 (d) of the Act. H. Section 3 (d). The wording of Section 3 (d) when read in conjunction with Parliamentary debate is believed to clarify that Section 3 (d) displayed in the code is the result of Parliamentary debate and is not just a representation of the provisions. I am. By regulation.

The court then examined the validity of the touchstone clause in Article 14 of the Constitution. In doing so, considering the meaning and explanation of Section 3 (d), it was first noted that the modified section covers not only the field of pharmacology but also other fields. In other words, it is a comprehensive regulation that covers all areas of technology, including the field of pharmacology. She later added that the explanation only helps to understand what the phrase "brings a known increase in effectiveness" means. In the changed part.

The court clearly states that the explanation works only if the findings are made in the field of pharmacology. Then, with reference to the notified decision, the declaration creates a fiction of the belief that all derivatives of a known substance are considered to be the same substance, unless the properties differ significantly with respect to potency. I paid more attention to.

The amended sections and notes make it clear that in the field of pharmacology, if a discovery is made from a known substance, the patent applicant is obliged to prove that the discovery led to an improvement in the known therapeutic substance. I made it. The effectiveness of this substance. The court further ruled that the annotation emphasized the term "effectiveness."

He determined that this only means that the derivative should exhibit such properties that are significantly different with respect to the potency of the substance from which the derivative is made. Reading the sum and content of the revised description section, a test is provided to determine if the discovery is an invention, and the patent applicant states that the discovery results in an improvement in the known therapeutic activity of the substance. I concluded that I needed to prove that. If the discovery is none other than a derivative of a known substance, it is necessary to demonstrate that the properties of the derivative differ significantly in terms of activity.

12. The complainant's complaint is that Respondent No. 4 denied the complainant's objection for the following reasons:
  1. Clopidogrel heavy sulfate stability study data show a more negative increase in salt concentration.
    • The long-term efficacy of heavy sulfate is reduced by reducing the therapeutic dose.
    • Acidic impurities are increased in heavy sulfate tablets.
  2. On the other hand, the clopidogrel crystalline besilate of the present invention was not detected in the inactive metabolite for more than 6 months. Therefore, it has a longer shelf life than clopidogrel bisulfate.
  3. The crystalline clopidogrel vesylate of the present invention is more free-flowing and stable even after 2 months as compared to the solvated (toluene and diozane) form of crystalline clopidogrel vesylate (cited by the other party).
  4. The solvate (toluene and dioxane) form of crystalline clopidogrel vesylate is more cardiotoxic as compared to the crystalline clopidogrel vesylate of the present invention. Therefore, from a toxic point of view, it is better and more beneficial compared to the solvated form.

13. According to the petitioner, all of these factors evaluated in Respondent No. 4 answer the important question of whether the substances thus discovered have a "better therapeutic effect". Not suitable for. The actual question to be answered was not addressed by Defendant No. 4 in the decision being appealed. I agree with this template. In the light of the Madras High Court ruling, Defendant No. 4 examines whether the factors mentioned in the order of appeal have the effect of increasing the known efficacy of the alleged substance in the context of better therapeutic effects. Should have been. The legislative intent behind the amendments in Section 3 (d) not only recognizes the inventions claimed for its new form or other advantages, but is also superior in some respects. These issues are very important, but respondent No. 4 did not investigate at all.

14. Defendant's first lawyer is J. Mitra & Co. Pvt. Ltd. Relied on the judgment of the Apex Court. Against assistant Patent & Design & Ors controller. (2008) Reported at 10 SCC 368. However, the proceedings addressed the issue of confusion caused by the postponement of the partial entry into force of the 2005 Patent (Amendment) Act. Reject the opposition before making a decision or granting. In fact, the court considered amendments to the law brought about by the introduction of pre-grant opposition under Article 25 (1) of the Act, which was a fundamental change. However, the law that applies after the amendment comes into force only provides a statutory remedy for retroactive issuance. This decision-making relationship does not advance the problem.

15. The petitioner cites the Intellectual Property Appeals Commission's decision on June 26, 2009 Union of India & ors. Allege that the patent is granted on the basis of the complete disclosure of the invention in the description submitted on the priority date of the application. The law prohibits the applicant from granting a patent if it is not disclosed and the discovery of new things, which may or may not be decisive in determining patentability, is delayed. According to the petitioner, the original specifications of respondent # 1 (applicant) did not disclose the matters considered by respondent # 4.

16. To overcome this argument, Respondent No. 1 submitted that such restrictions do not apply to the facts.

Mode of Citation of Section(s)

  • Section 3 (d) of the 1970 Patent Act
  • Section 77

Mode of Citation of Article(s)

  • Article (1)F
  • Article 25 (2)
  • Article 14

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