4. A pharmacist invented a medicine for cold and cough in 1999 and got it patented in 2002. In 2008 he made a remarkable improvement in that medicine to treat not only cold and cough but also fever. How can he protect such improvement? Advice.

1. Facts of the Case

In 1999, a skilled pharmacist created a novel medicinal formulation to treat cold and cough. He diligently documented his process, filed for a patent, and was granted one in 2002 under the Indian Patents Act, 1970. The medicine gained recognition for its effectiveness and was widely used in the market.

Years later, in 2008, the same pharmacist made a significant enhancement to the original formulation. The improved version could now also treat fever, making it a broader and more effective remedy. The enhancement resulted from additional research and clinical trials, which proved its extended therapeutic value.

Now, the pharmacist wants to ensure legal protection for this improved version of his original medicine. He seeks advice on whether such an enhancement qualifies for patent protection and, if so, how to secure it under Indian patent law.

2. Issues of the Case

The situation raises the following important legal and practical issues:

• Can an improvement or modification to an already patented invention be patented again?
• What are the conditions under Indian law for granting a patent for an enhancement or improvement?
• Does the improved formulation qualify as a “new invention” or an “incremental invention”?
• What is the legal process for protecting such an improved version of a previously patented drug?

These questions form the basis of determining whether the pharmacist can enjoy exclusive rights over the improved medicine.

3. Legal Principles and Case References

a. Relevant Statute: The Patents Act, 1970 (as amended)

The Indian Patents Act allows inventors to protect not only completely new inventions but also improvements or modifications of existing inventions—provided they meet certain legal criteria.

Key Sections:

• Section 2(1)(j): Defines an invention as a new product or process involving an inventive step and capable of industrial application.
• Section 2(1)(ja): Describes inventive step as a feature that makes the invention non-obvious to a person skilled in the art.
• Section 3(d): Excludes “mere discovery of a new form of a known substance” unless it results in enhancement of known efficacy.
• Section 54: Specifically provides for “patents of addition”, allowing patent protection for improvements or modifications of an already patented invention.

A patent of addition does not require novelty in the strict sense like an original patent, but it must involve an inventive step and add technical value to the original invention.

b. Patent of Addition: What It Means

A patent of addition allows the original patentee to protect an improvement or modification of their existing invention. This is useful when:

• The improvement is made after the original patent was granted
• The patentee is the same person who made the original invention
• The improvement is functionally related to the main invention

The term of a patent of addition ends with the original patent, and no separate renewal fee is required.

c. Relevant Case: Novartis AG v. Union of India (2013)

In this landmark case, the Supreme Court of India interpreted Section 3(d) strictly, holding that incremental changes to known medicines must show therapeutic efficacy enhancement to qualify for patent protection.

Though Novartis failed in securing a patent for its improved version of Imatinib, the judgment clarified how improvements in pharmaceutical products are evaluated in India.

d. Another Supporting Case: F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (2008)

The Delhi High Court discussed the importance of showing inventive steps and industrial applicability even in modified pharmaceutical products. The court emphasized the importance of distinguishing between genuine improvements and minor tweaks.

4. Judgment and Advice

In the given scenario, the pharmacist made a substantial improvement in the original medicine by expanding its utility from treating cold and cough to also curing fever. This enhancement adds clear therapeutic value and is not a mere cosmetic or trivial change.

Based on the provisions of Indian patent law, particularly Section 54, the pharmacist can and should apply for a patent of addition. Here’s what he needs to do:

Recommended Legal Steps:

1. File for a Patent of Addition:
   Submit a patent application describing the improved composition, its enhanced efficacy, and the process involved.
2. Link to Original Patent:
   The application must clearly reference the original patent granted in 2002.
3. Show Inventive Step:
   Demonstrate how the improvement required creative input beyond existing knowledge, and how it resulted in an improved formulation.
4. Provide Evidence of Enhanced Efficacy:
   Include clinical or lab data showing how the improved drug treats fever, in addition to cold and cough.
5. Time the Application Well:
   The patent of addition can be filed any time during the life of the original patent.

Resulting Legal Protection:

• The pharmacist will get exclusive rights to manufacture, use, sell, and license the improved medicine.
• The improved invention remains protected until the expiration of the original patent (i.e., 20 years from 2002—up to 2022).
• No separate renewal fee is required for the patent of addition.

Had the pharmacist developed the improvement after 2022, he would need to file a fresh patent application and satisfy the full criteria of novelty, inventive step, and industrial applicability.