What happens when two drug companies sell almost similar medicines but only one of them holds a patent?
In pharmaceutical patent infringement cases, Indian courts examine whether the accused product or process falls within the scope of the patent claims. Depending on the case, issues such as validity and public interest including access to affordable medicines, may also become relevant.
This article explains how Indian courts compare competing drug products, the importance of claim construction, the evidence considered in pharmaceutical patent infringement cases and the key factors that may affect an infringement assessment.
What Is Pharmaceutical Patent Infringement?
Pharmaceutical patent infringement occurs when an individual or company makes, uses, sells, offers for sale and imports a patented drug formulation or manufacturing process without the patent owner’s permission.
Patent infringement in India is primarily governed by the Patents Act, 1970. Section 48 makes provision for the rights of a patentee. The rights of a patentee are the starting point for determining whether an unauthorized act involving a patented product or process falls within those exclusive rights.
In India, if such an activity constitutes infringement, it depends upon the rights conferred by the patent and the scope of the claims. The courts then compare the claims of the patent to the drug product or process at issue.
The key question is whether the claims cover the relevant features or limitations. The case depends upon the patent, evidence and facts involved.
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How Indian Courts Compare Competing Drug Products: A Step-by-Step Process
Indian courts generally take a claims centric approach while analyzing competing drug products. The process typically begins with claim construction followed by a comparison of the accused product with the relevant claim elements.
Step 1: Understand the Claim
The first step is to construe the language of the claims and ascertain the scope of protection they afford. It considers the terms, words and limitations in the claims.
This helps to define the scope of the patent before looking at the accused product. The court then examines the features and limitations of the drug as described in the patent and the need for technical evidence.
Step 2: Identification of Critical Product Features
The comparison may require a close review of the competing drug’s composition and other technical features. Courts may look at what a drug is made of. That includes the active ingredients, the inactive ones, how the drug is formulated and, where it matters, how much of each component it contains.
These details are then checked against the limitations in the patent claims. Having the same active ingredient is not always enough to prove infringement, because a claim may also require specific structural, compositional or technical features.
Step 3: Compare the drug product to the patent claims
Then the court looks to see whether the competing drug falls within the patent claims. The analysis focuses on how the product relates to the claimed invention.
It does not rely only on the medicine’s purpose, appearance or general similarity. Instead, the court checks if the product meets the relevant requirements of the patent claims.
Step 4: Analyzing Each Element of the Patent Claim
The court compares features of the claim, the claim elements and limitations to features of the competing drug. This involves looking at the specific features and limitations described in the claim and weighing them against the relevant features of the product.
The infringement analysis takes all relevant factors into account. If any element necessary for the claim is missing, the product might not be covered by that claim.
Step 5: Evaluation of the Technical and Scientific Evidence
The court may consider technical and scientific evidence to understand the properties of the competing drug and the manner in which it is manufactured.
This could include laboratory results, technical data, formulation details or manufacturing information as the case may be.
This evidence can explain complicated scientific issues that are not clear from the patent documents. The court considers it together with the claims and the facts of the case.
Patent documents, product labels, regulatory records, expert evidence and where appropriate, manufacturing information may also be taken into consideration by the court.
Step 6: Process Patent Infringement and Section 104A
Section 104A of the Patents Act, 1970 may be applicable in case the dispute concerns a process patent. Subject to the statutory requirements, the court may require the defendant to establish that the process used to obtain an identical product is different from the patented process.
The provision also recognizes the need to protect manufacturing and commercial secrets.
What Courts Consider in Patent Infringement Cases?
When a court looks at a patent infringement claim, it does not rely on just one thing. First, it checks who owns the patent and whether it has been challenged by anyone. Then it works out what the claims actually mean and compares them with the accused product or process.
The type of patent also matters, as does the validity of the patent and any defenses raised by the accused party. Section 64 of the Patents Act, 1970 sets out grounds on which a patent may be revoked, while Section 107 makes the grounds available under Section 64 relevant as defenses in an infringement suit.
Not every use of a patented pharmaceutical invention during the patent term amounts to infringement.
Under Section 107A of the Patents Act, 1970, an exception is provided for certain acts done for the purposes reasonably related to the development and submission of information required under laws regulating the manufacture, construction, use, sale or import of products.
What Remedies Are Available in a Patent Infringement Case?
If a court determines that a patent has been infringed, it may provide the patentee with several different types of relief. The Patents Act, 1970, under section 108, provides that the court may issue an injunction that would restrain the other party from continuing with the infringing activity.
The patentee may also seek damages and an account of profits. Damages cover the loss the patentee suffered while an account of profits looks at what the infringer earned. The court may go further too.
It can order that infringing goods and the materials or tools mainly used to make them be seized, forfeited or destroyed. What it orders depends on the facts of each case.
How Does Public Interest Affect Pharmaceutical Patent Cases?
Medicines affect people’s health, so courts sometimes look beyond the two companies in the case. Whether patients can access a drug and afford it can become an important consideration in a patent dispute.
However, public interest does not take the place of the primary question of if the other drug or process is within the patent claims. It usually becomes important later when the court decides what relief to give.
For example, a court may think carefully before stopping a cheaper version of a medicine that many people depend on every day.
Conclusion
Pharmaceutical patent infringement cases in India depend on the patent claims of the accused product or process or the evidence available in the case. Courts do not simply decide infringement based on whether two medicines appear similar. They examine whether the relevant features of the accused product fall within the scope of the patent claims.
Evidence such as lab reports, expert opinions and technical documents can be used to help judges reach a fair decision. Depending on the circumstances of the case, public health and access to medicines may also be relevant.
The key lesson for drug companies is to draft strong patent claims, keep proper technical records and check existing patents before launching a product.
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