What is a Patent?

• Patent: A Intellectual Property is an exclusive legal right granted to an inventor or assignee for a new invention. It prevents others from making, using, selling, or distributing the invention without permission for a specific period, usually 20 years from the filing date.

Benefits of Patents:

• Exclusive Rights – The patent holder can monopolize the invention for commercial use.
• Limited Duration – Typically valid for 20 years, after which it enters the public domain.
• Territorial Protection – Patents are granted on a country-by-country basis (e.g., Indian Patent, U.S. Patent).Disclosure Requirement – The inventor must publicly disclose how the invention works in the patent document.
• Disclosure Requirement – The inventor must publicly disclose how the invention works in the patent document.

Types of Patents in Pharmaceuticals

Pharmaceutical patents protect different aspects of a drug or medical innovation, allowing companies to recover R&D costs and maintain market exclusivity. Below are the main types of patents used in the pharmaceutical industry:

1. Drug Compound Patents (Active Ingredient Patents)

• Protect the new chemical entity (NCE) or active pharmaceutical ingredient (API).
• Considered the strongest form of protection because generics cannot be made without infringing the patent.
• Example: Lipitor (atorvastatin) by Pfizer – Patent protected the statin molecule used for lowering cholesterol.

📌 Importance: Prevents others from making the same drug for 20 years from filing.

2. Formulation Patents (Dosage Form or Composition Patents)

• Covers specific formulations, drug delivery systems, or combinations.
• Even if the API patent expires, a new formulation patent can extend exclusivity.
• Example: OxyContin (oxycodone) – Purdue Pharma patented a controlled-release formulation to extend exclusivity.

📌 Importance: Helps in evergreening (extending monopoly beyond API patent).

3. Process Patents (Manufacturing Patents)

• Protects innovative methods of producing a drug.
• Other companies can manufacture the same drug but must use a different process.
• Example: Synthetic production of Insulin – Several patented processes exist for making human insulin.

📌 Importance: Common in India (before 2005, India only allowed process patents).

4. Polymorph Patents

• Protects different crystalline forms of the same drug.
• Different polymorphs can improve stability, solubility, or bioavailability.
• Example: Novartis’ Glivec (imatinib mesylate) – Rejected in India under Section 3(d) for lack of enhanced efficacy.

📌 Importance: Used to extend patent life but can be challenged under strict patent laws.

5. Combination Patents (Fixed-Dose Combinations – FDCs)

• Protects new combinations of known drugs.
• Improves patient compliance (e.g., single-pill regimens).
• Example: HIV/AIDS treatments combining multiple antiretrovirals (e.g., Tenofovir + Emtricitabine + Efavirenz).

📌 Importance: Provides additional exclusivity even if individual drugs are off-patent.

6. Biologic & Biosimilar Patent

• Covers biopharmaceuticals (e.g., monoclonal antibodies, gene therapies).
• Biologics are highly complex, requiring multiple patents on structure, formulation, and production.
• Example: Humira (adalimumab) by AbbVie – Had over 100 patents, delaying biosimilars for years.

📌 Importance: Makes it harder for biosimilars to enter the market.

7. Second Medical Use Patents (Repurposing Patents)

• Covers new therapeutic uses of an existing drug.
• Example: Aspirin was originally for pain relief but later patented for cardiovascular protection.

📌 Importance: Allows new patents on old drugs, sometimes controversial.

Patentability Criteria

To be granted a patent, an invention must be:
✔ Novel – Must be new and not disclosed publicly before filing.
✔ Inventive (Non-obvious) – Should have a technical advancement beyond existing knowledge.
✔ Industrial Applicability – Must be useful in an industry (e.g., pharmaceuticals, electronics).

WIPO vs. Indian Patent System: Key Differences and Comparisons

The World Intellectual Property Organization (WIPO) and India’s Patent System operate under different frameworks but are interconnected through international agreements. While WIPO sets global standards for patent protection, India’s patent system follows national laws that balance innovation with public interest, especially in pharmaceuticals.

1. What is WIPO?

The World Intellectual Property Organization (WIPO) is a specialized UN agency responsible for global intellectual property (IP) policies, treaties, and cooperation among countries. It administers the Patent Cooperation Treaty (PCT), which simplifies international patent filing.

WIPO’s Role in Patents

• Administers the PCT System, allowing inventors to file a single patent application for multiple countries.
• Establishes global patent norms through treaties like the Paris Convention and TRIPS Agreement.
• Provides technical assistance to countries in strengthening their patent laws.

2. Indian Patent System Overview

India’s patent system is governed by the Indian Patents Act, 1970 (amended in 2005 to comply with TRIPS). It is administered by the Controller General of Patents, Designs & Trade Marks (CGPDTM) under the Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce & Industry.

Key Features of Indian Patent Law

• Patent Term: 20 years (same as WIPO standards).
• Patentability Criteria: Invention must be novel, inventive, and industrially applicable.
• Pre- and Post-Grant Opposition: Allows challenges to patent applications, promoting public interest.
• Compulsory Licensing: India grants compulsory licenses for essential drugs if:
  • The patented drug is not available at an affordable price.
  • The patent holder does not manufacture it in India.
  • A national emergency arises.

Read More:

1. Patent: A Intellectual Property
2. Patent Expiration Timelines in Different Countries
3. Patent Process in India: A Step-by-Step Guide
4. The Bolar Exemption in Patent: A Strategic Advantage for Generic and Biosimilar Development
5. Paten Classification in ANDA & Para IV
6. Quality Assurance
7. Formulation Developments