The grant of interim injunction in a lawsuit pertaining to the infringement of patent is always a complex matter. There are various factors that the court has to consider while granting interim injunctions. These factors are closely tied to the nature and purpose of the patent protection system, the goals for promoting innovation and the interests of end-users.

For a start, the age of the patent plays an important role. The courts will have to make a distinction if the patent is relatively old or a new one. In case of an old patent, emphasis will be laid on whether the patentee has made efforts to commercialize the invention after its grant or not.

If he has been passive and not exploited the invention, then the court may decide to not grant an interim injunction as the failure to commercialize the invention implies that the patent holder is not being materially affected or prejudiced by the potential infringer. However, for a new patent, the court may be more inclined to grant an interim injunction, as the patentee still requires sufficient time to explore the commercial benefits of the invention.

Besides, in the case of a selection patent, disclosure and coverage are aspects that the Hon'ble Court considers to grant the interim injunction. If a Patent is covered under a prior art, would there be specific disclosure of the subsequent Patent, in order to defeat the subject matter Patent by virtue of prior art? Below are the essential particulars of the subject matter case, along with the rationalization presented by the Honorable Court.

The Subject Matter Suit Patent::
On 05.10.2010, the Plaintiff was awarded Patent IN 243301 titled as 8-(3 AMINOPIPERIDIN 1 YL)-XANTHINE COMPOUNDS, with priority dating back to 21.08.2002.

This patent pertained to the subject matter of the suit. In 2012, linagliptin Tablets were introduced in the Indian market, which were covered by the suit patent.

The Genus Patent:

The Plaintiff had previously been granted a genus patent, IN 227719, for XANTHINE COMPOUNDS with the Markush formula.

The patent had expired on 21.02.2022. The suit patent falls under the cover of the Markush Patent IN 227719, and it is a selection patent.

The Contention Of Defendants In Brief:
The Defendants claimed that the Plaintiff is attempting to prolong the monopoly for linagliptin products through the subject matter Suit Patent, even though its validity had already lapsed in a previous Patent dated February 21, 2022.

The Contention Of Plaintiff In Brief:
The Plaintiff argued that the subject matter Patent is an old patent and should be given due weightage. Additionally, the Defendant did not file any opposition to the patent either before or after its grant.

Further, the Plaintiff stated that the alleged Genus Patent IN 227719 was published on 06.09.2002, which means it cannot be considered as prior art as the priority date of publication of the subject matter Suit Patent is earlier - 21.02.2002.

The Judgement:
Vide subject matter Judgement, the injunction order passed in the subject matter Suit was vacated.

The Reasoning Of The Hon'ble Judge:

1. Section 13 (4) of the Patent Act 1970, which deals with the grant of patents, makes no distinction between old and new patents.
2. This means that there is no difference in the validity of a patent based on when it was granted.
    
3. However, the existence of a patent for six year or more than that does not automatically mean that it is valid. The six-year rule, which requires an opponent to prove the invalidity of a patent after six years have passed since the date of its grant, does not grant any presumption of validity in favor of the patent.
    
4. Or in the other word it can be safely said that the Six year rule cannot grant presumption of validity in favour of Grant of Patent.
    
5. Moreover, there can be no presumption of validity simply because a patent is old. The validity of a patent is determined by its claims and the evidence presented to support them, not by its age.
    
6. In this patent dispute, it was found that the substantial part of the chemical structure claimed in Claim 1 of the subject matter patent IN 243301 and Claim 1 of the Genus Patent IN 227719 is the same. This means that there is substantial overlap between the two patents, raising questions about the novelty and inventiveness of the subject matter patent.
    
7. Similar assertions have been made with respect to Linagliptin, a pharmaceutical product that falls within the scope of Claims 2, 3, 5, 6, and 7 of the genus patent. This raises further questions about the validity of the subject matter patent, as it may have been anticipated or obvious in light of the earlier patent.
    
8. The subject matter patent also discloses two other pharmaceutical products titled 'Xanthine Compounds' and '8-(3-Aminopiperidin-1-yl)-Xanthine Compounds.' However, the disclosure of these products may not be sufficient to distinguish the subject matter patent from the earlier genus patent, as the latter also covers xanthine compounds.
    
9. It is important to note that there can be no distinction between the coverage of a patent and its disclosure. If a patent is covered by an earlier patent, it does not matter whether it was specifically disclosed in the earlier patent or not. This means that the subject matter patent may be invalid if it covers the same invention as the earlier genus patent, even if the latter did not explicitly disclose the subject matter of the former
    
10. The validity of a patent is determined by its claims and the evidence presented to support them. The existence of an earlier patent that covers the same invention may render a later patent invalid, regardless of whether the earlier patent explicitly disclosed the subject matter of the later patent. Therefore, it is important to conduct a thorough analysis of the patent landscape before applying for or enforcing a patent.
     
11. The plaintiff argued that these statements could not be relied upon in any way, as they were not relevant to the case at hand. However, the court was not convinced by this argument, noting that a party should not be allowed to take a contrary stand before different forums. In other words, if the plaintiff had made statements or admissions that contradicted their arguments in court, they could not simply ignore those statements and expect to be taken seriously.
     
12. The plaintiff had relied heavily on the opinions of experts to support their case, but the court noted that this opinion would need to be evaluated properly at the trial stage before any definitive conclusions could be drawn.
    
    It is submitted that the debate over the reliability and objectivity of expert testimony in patent litigation is a longstanding one, as it is often difficult to determine the unbiased opinion of an expert who may themselves be affiliated with the party presenting them.
     
13. In the subject matter case, Linagliptin was disclosed and covered in the earlier Genus Markush Patent. Hence the Plaintiff can not be allowed to extend its monopoly on the basis of subject matter Suit Patent.
     
14. One of the most significant arguments made by the defendant in this case related to the alleged "evergreening" tactics of the plaintiff. Evergreening refers to the practice of seeking multiple patents in order to extend a monopoly on a particular product, thereby allowing the patent holder to prevent competition for a longer period of time.
     
15. In this case, the defendant argued that the plaintiff was attempting to use multiple patent applications to extend their monopoly on a diabetes drug called Linagliptin. The court agreed with this argument, noting that the drug had already been disclosed and covered in an earlier Genus Markush Patent, and that the plaintiff should not be allowed to extend their monopoly on this basis.
    
    It is submitted that the issue of evergreening is a contentious one in the patent world, with some arguing that it allows pharmaceutical companies to abuse the patent system for their own profit, while others believe that it is a necessary protection for investment in research and development.
     
16. Section 3 (d) of the Patent Act 1970 has been specifically incorporate to reduce the chances of evergreening.
     
17. Another important consideration in this case was the fact that the plaintiff was not manufacturing the subject matter drugs in India, but was instead seeking to reap the benefits of their patent by collecting royalties. The defendant argued that the balance of convenience should lie in their favour, as they could be compensated in monetary terms.
     
18. The court agreed with this argument, noting that the plaintiff could be compensated for any damages they suffered as a result of the infringement, whereas the defendant would be irreparably harmed by an injunction preventing them from manufacturing or selling their products.
     
19. The court also considered the element of public interest in the case. The subject matter drug, Linagliptin, was used for the treatment of diabetes, and the court noted that the public interest in ensuring access to affordable medicine for those suffering from diabetes outweighed any potential harm to the plaintiff's interests. This consideration was a key factor in the court's decision to vacate the injunction and allow the defendant to continue manufacturing and selling their products.
     
20. In light of all these arguments, the Hon'ble Single Judge concluded that the subject matter patent was prima facie vulnerable, meaning that it was open to challenge on a number of different grounds.
     

The Concluding Note:
This matter pertain to a case of Selection Patent, where Markush Chemical Compound was disclosed in Earlier Patent of Plaintiff. Let us see , what is selection Patent.

A selection patent involves a situation where a large genus of things is described in a patent application and the inventor selects a part of that genus to claim protection. In this case, the Court has to pay particular attention to the extent of the disclosure made by the patentee, and whether the invention claimed in the patent is a true representative of the invention described in the original patent. If the claimed invention is described in the original patent, then the patentee would not be granted an interim injunction.

The recent judgement of the Hon'ble High Court of Delhi fully examined the intricacies of patent law while granting interim injunctions. In this case, the plaintiff had sought an interim injunction against the defendant for infringing on its selection patent. The plaintiff had argued that its patent represented an improvement over the prior art technology, and therefore, should be given the highest level of protection.

The Court observed that the plaintiff had not made significant contributions towards improving the prior art technology. At the same time, the Court felt that the patentee had made the necessary disclosure in the Prior art. There can not be any difference between the disclosure and coverage. If a Patent is covered in prior art and it need not be disclosed with specific reference. In the subject matter case, the subject matter Patented Drug was covered in the prior genus patent , hence the Court did not consider the patent to be worthy of the highest level of protection of injunction.

Next, the Court considered the expert opinion presented by the plaintiff. The plaintiff had relied on an expert's opinion stating that the defendant's product had infringed on the patentee's invention claimed in the patent. The Court cautioned that expert opinions regarding patent infringement should always be handled with care and that effect of the same has to be evaluated at the trial stage.

The Court also assessed the concept of evergreening and its bearing on the case. The plaintiff had been accused of trying to extend the life of the patent beyond the stipulated term by filing other related patents.

The Court observed that patent law explicitly permits a patent holder to file additional patents, provided they can show that the new invention is significantly different from the original patented invention.

The Court further added that the patent system needs to provide sufficient incentive to innovators to encourage different and new innovations. Evergreening could not allowed to be encouraged.

The decision of the High Court of Delhi has set important guardrails for the decision-making process of Indian Courts while granting Interim Injunctions in patent infringement cases. It has stressed the importance of considering all the relevant factors before reaching a decision.

It is submitted that this case highlights some of the complexities of patent law and the many issues that can arise in disputes over intellectual property. This judgment is a useful point of reference for patent owners and potential litigants seeking to understand the Court's attitude to patent disputes.

The Case Law Discussed:

Case Title: Boehringer Ingelheim Pharma GMBH & Co K.G. Vs Vee Excel Drugs and Pharmaceuticals Private Limited and Ors

Judgment date: 29.03.2023
Case No: CS(COMM) 239/2019
Neutral Citation No. 2023:DHC:2272
Name of Court: High Court of Delhi
Name of Hon'ble Justice: Amit Bansal, H.J.

Note:
Though vide the afore mentioned Judgement , more than one Suits were disposed of by the Hon'ble Single Judge. However , for ease in reference , detail of only one case has been mentioned.

Disclaimer:
This information is being shared in the public interest. It should not be treated as a substitute for legal advice as there may be possibility of error in perception, presentation and interpretation of facts and the law involved therein.

Written By: Ajay Amitabh Suman, IPR Advocate, Hon'ble High Court of Delhi
Ph no: 9990389539, Email: [email protected]