Construction of Claims for infringement of Patent Registration

Construction of Claims for infringement of Patent

Patent is defines as an invention. The person, who invented the invention, wants to register it on the Register of patents and also protect them from others. Patent Registration is an important Intellectual property, which holds the rights of the patentee. A patent is a new invention it may be a product or method which contain new inventive ideas and new concepts when compared to the already existing one. Here, we are going to discuss the construction of claims for infringement of patent.

Now I shall deal with the plaintiff’s attempt to show infringement and how the same does not discharge the onus of proof one by one. The plaintiffs have attempted to establish infringement on the basis of what has been written by the defendant on its packaging of the drug which is Erlotinib Hydro-chloride and what has been declared by the defendant before the authority. It has been contended that the defendant has not made any reference any polymorphic version of the compound anywhere on the product and therefore this court should find that the onus as to establishment of the infringement to be proved. I think the existence of the said fact by itself does not establish infringement. It must be remembered that the present claim of the plaintiffs is premised in the right of the plaintiffs in the patent of a chemical compound, therefore the infringement of the same has to be established by corresponding chemical analysis of the defendant’s product and not by mere comparison of the labels, stripes or what is written thereon to show that there is an infringement. The said description of the defendant’s product nowhere indicates as to which form of the compound, the defendant is making. The defendant has categorically stated, it making Polymorphic B version which corresponds to the Tarceva product, to which the plaintiff has not lead any direct evidence, therefore the mere comparison of trade description, label, drug approvals are insufficient to arrive at the conclusion as to infringement of what is claimed in the suit patent.  If at all there is a material to record which suggests that the defendant is making generic version of Tarceva product, even the same by itself nowhere establishes infringement. This is due to the reason that the defendant has been able to show by x-ray diffraction as to what contained in Tarceva is the polymorphic version B of the compound. Thus, again the plaintiff’s argument on this count fails and cannot enable this court to assume infringement in the manner stated by the plaintiffs due to the reason that in the prayer, the plaintiffs sought injunction against the defendant in any manner infringing the legal rights in the drug Tarceva. In paragraph 11 of the plaint, it is specifically stated that the plaintiffs are manufacturing the drug under the process of patented product. The said statement apparently untrue as it is evident as per material available on record that they are marketing the product under new version of Polymorphic B for which the plaintiffs have patent registration in India. The plaintiffs’ contention that the defendant has not mentioned about the polymorphic B version of the compound at any time earlier  by placing reliance upon drug approvals, patent applications and all other places in tabular form to show the alleged admissions. The answer of mine to this contention would be again that the plaintiffs have to first establish infringement on the basis of what is contained in the defendant’s product and not what the defendant claims to be doing. The defendant might have been inspired by ongoing drug of the plaintiffs in the market which in fact the defendant is doing as the defendant stand before press and media is clear that the defendant is intending to launch the generic version of Tarceva Drug. In case, the plaintiffs were able to prove before court that the defendant’s products are not Polymorphic B version but under the patented product of suit patent, the position would have been different. However, until the plaintiff explains who is a patentee and is under duty to explain what exactly is contained in the drug and how the patent is being infringed in the said product by taking from what is contained in the drug, the defendant cannot be imposed the responsibility of remaining in non-denial mode. The question of admission and non-denial would come when the plaintiffs explain everything as to constituents of the plaintiff’s drug and whether the same corresponds with the construction of claims of the suit patent which is clearly missing in the instant case. Therefore, the said alleged admissions are inconsequential for the purposes of the discharge of the plaintiffs onus of the proof. Further, the admissions which the plaintiffs are setting up are not the ones which are clear and unambiguous. There are chains of the facts which are to be established in order to show an infringement. Mere identification of chemical structure of the compound by the witness and reading along with the fact that the earlier in the written statement there was no reference of Polymorphic B version made by the defendant and to say that would lead to clear admission on the part of the defendant that what the defendant is actually making is the drug under the suit patent will not actually making is the drug under the suit patent will not actually establish infringement. This more so, when the defendant is disputing such position till date in the arguments as well as there is a reference of the polymorphic versions in the counter claim. In these circumstances, the admissions which the plaintiffs are setting up are not clear and unambiguous to draw such inference. This reasoning is in addition to the finding above which is more crucial that the plaintiffs being  a patentee have to inform fully as to what contained in the drug and whether the same corresponds with the suit patent. The argument of the plaintiffs that one compound has the ability to remain in two or more  Ploymorphic forms by stating that the compound will remain the same and its form shall change, the said argument again does not explains as what was the role of the reactants while arriving at the polymorphic version B and how the said properties of the products under both the polymorphic are same. The positive evidence should come from the plaintiffs that the role of such reactants is inconsequential. But that is not so done in the present case, thus, the more explanation that the compound will remain the same and only the alignment will change by citing the example of the apple is inconceivable in absence of the deposition specific to the instant case. I think chemical science is not so easy to propound a theory like this which is that the substance shall remain a substance but only alignment of the chemicals makes lots of difference in the products, their forms, characteristics. Learned counsel for the plaintiffs himself asked that the question in cross-examination from defendants witness that diamond and graphite are two Polymorphic versions of the carbon in the cross examination. If the plaintiffs have obtained the patent of the carbon and thereafter attempted to obtain the patent diamond separately by showing the working upon the carbon, the infringement has to be measured from by comparing the rights under the diamond patent vise-versa the product of the defendant and not by simply placing relying on the fact that the plaintiffs have obtained carbon patent and as the diamond contains carbon, therefore it will infringe carbon patent. This is due to the reason that the diamond is different in form, composition and its features than the mere carbon. Therefore, unless the plaintiffs explain from the purposive construction of the claim that the inventor intended at the time of framing of the patent to include such substance be it diamond in an example or Polymorphic B form of the suit patent in the construction of the suit patent, the said onus of the plaintiffs is not discharged. In the present case, the plaintiffs have not adduced any positive construction evidence to show the role of the major or minor reactant. On the Contrary, the US’221 Patent specification reveals that there are number of steps involved in arriving at the Polymorphic version B. Therefore, the argument of the plaintiffs about the construction of claims that the compound patent will take care of the Polymorphic version in absence of the positive evidence is rejected.

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