What are the questions that determine the various infringement issues of any valid patent. Elaborate with cases.

Infringement of a patent occurs when a person or entity makes, uses, sells, or distributes a patented invention without the permission of the patent holder. Indian patent law, governed by the Patents Act, 1970, and its subsequent amendments, outlines specific provisions regarding patent infringement. The determination of whether infringement has occurred involves evaluating various issues, including the validity of the patent, scope of claims, and whether the alleged act of infringement falls within the boundaries of the patent holder’s exclusive rights. In this context, there are several critical questions that determine the infringement issues of any valid patent.

1. Is the Patent Valid?

Before an infringement claim can be brought, it must first be established that the patent is valid. If the patent is found to be invalid, there can be no infringement, as the patent holder does not have exclusive rights over the invention. Validity is one of the central issues in infringement cases, and several factors are considered:

• Novelty: The patent must be novel and not anticipated by prior art. If the alleged infringing product or process was anticipated by prior art, the patent may be invalid. A case to note here is the Novartis AG v. Union of India (2013), where the Supreme Court of India held that the beta-crystalline form of imatinib mesylate, a cancer drug, lacked inventive step and was not patentable.

• Inventive Step: Even if the invention is novel, it must involve an inventive step that is not obvious to a person skilled in the art. In Daimler-Benz AG v. Tristar Trading (1993), the Delhi High Court emphasized that the claimed invention should not be obvious in light of prior art.

• Utility: The invention must be useful, i.e., capable of industrial application. In the case of Bayer Corporation v. Union of India, the court ruled that the patent on a method for producing a drug was not valid because it lacked a specific utility.

• Disclosure: The patent application must disclose the invention sufficiently to allow others to _________ ______ ______ ____ ________ _________ _________ ___ ____.
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