Indian patent law

Delhi HC Strikes Down AstraZeneca Patent, Upholds Rejection

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Delhi High Court ruling upholding patent rejection for AstraZeneca sustained-release Exenatide formulation under Section 3d

The Delhi High Court delivered a decisive verdict against pharmaceutical titans Amylin Pharmaceuticals and AstraZeneca. The court upheld the rejection of their patent application for a sustained-release diabetes injection. This pivotal ruling reinforces India’s strict standards for inventive step and enhanced efficacy. It sends a clear warning: routine modification will not secure a monopoly.

The Exenatide Formulation: A High-Stakes Battle

The legal challenge centered on Patent Application No. 1498/DELNP/2011. This application sought protection for a specific formulation of Exenatide, a blockbuster drug managing Type 2 diabetes. The formulation was designed as a one-component injectable microsphere system. This system was meant to simplify treatment. The applicants claimed it offered practical advantages over existing multi-component kits.

The initial rejection came from the Assistant Controller of Patents and Designs. The Controller argued the invention failed on two critical counts. The High Court, after meticulous review, firmly agreed with the Patent Office.

The First Strike: Lack of Inventive Step

The primary ground for refusal was the lack of inventive step under Section 2(1)(ja) of the Patents Act. This legal standard demands true technical advancement.

The High Court affirmed the Controller’s core finding: the invention was obvious to any Person Skilled In The Art (PSITA). The court argued that the claimed formulation was merely a predictable combination of existing knowledge .

  • Prior Art Combination: The invention simply utilised a known pre-mixed formulation (containing Exenatide and a stability agent like sugar) and integrated it into a known micro sphere delivery system.
  • Routine Improvement: This combination, the court reasoned, was an expected step. It involved no surprising technical effect. It constituted nothing more than “mill on the run” improvement, according to patent jurisprudence. The change lacked the necessary creative spark to merit a 20-year exclusive right.

The Second Barrier: India’s Efficacy Hurdle

The judgement also invoked India’s most powerful safeguard against ever greening: Section 3(d) of the Patents Act.

This section bars the patenting of a new form of a known substance unless it demonstrates significantly enhanced therapeutic efficacy. Mere discovery of a new form is insufficient. It must offer a substantial biological or clinical benefit to the patient.

The applicants stressed the convenience of their one-component system. They highlighted easier administration and better shelf-life. However, the court strictly interpreted the law. It deemed these practical, non-therapeutic benefits inadequate.

The High Court confirmed the Controller’s position: Technical convenience does not equate to enhanced therapeutic efficacy. The applicants failed to provide sufficient comparative data proving their new formulation worked better in the body than the existing drug. This failure to clear the Section 3(d) hurdle proved fatal to the application.

The Applicants’ Defence: Arguments Dismissed

Amylin and AstraZeneca mounted a fierce defence. They contested the use of prior art.

  • Teaching Away: They argued some prior art actually discouraged polymer-based micro spheres, implying their solution was unexpected.
  • Specific Carrier: They claimed their specific use of a non-aqueous carrier, comprising triglycerides of C6 to C12 fatty acids, was nowhere disclosed in a single document.

The High Court dismantled these arguments. It held that the prior art, when read by an expert, provided a clear road map to the claimed invention. The failure to secure a patent rested on the lack of a genuine inventive breakthrough, not on legal technicalities.

Repercussions: A Global Wake-Up Call

This landmark verdict sends an unmistakable message to the global pharmaceutical industry.

It solidifies India’s role as a sovereign state determined to protect public health. The High Court judgement firmly validates the rigorous standards set by Indian patent law.

  1. Generic Market Boost: The decision clears the landscape. It reduces uncertainty for Indian generic manufacturers planning future production of affordable Exenatide versions.
  2. Section 3(d) Power: It confirms Section 3(d) as a pivotal guardian against monopolies based on minor chemical or formulation changes.
  3. Mandatory Disclosure: Innovators seeking protection in India must now meet the highest standard. They must provide definitive proof of enhanced therapeutic efficacy.

The judgement affirms that patent rights are statutory creations, not inherent rights. They must fall within the four corners of the Patents Act. The court successfully prevented the undue extension of a pharmaceutical monopoly, ensuring that only true innovation receives legal protection. The fight for accessible diabetes treatment gains ground.

India’s New Trade Deal Safeguards Generic Drug Industry, Rejects Patent Extensions and Data Exclusivity

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India has reaffirmed its commitment to affordable medicines and public health safeguards in its latest Free Trade Agreement (FTA), signed on **July 24**. The government announced that the deal does **not include provisions** for **patent term extensions** or **data exclusivity**, commonly sought by multinational pharmaceutical companies to extend their market monopolies.

The **Ministry of Commerce and Industry** clarified that critical sections of the **Indian Patents Act, 1970** — notably **Section 3(d)** and **Section 3(b)** — will remain fully protected under the FTA. These provisions are key to India’s rejection of “**evergreening**” practices, which involve patenting minor modifications of existing drugs to delay generic competition.

> 🔗 [Section 3(d) – Indian Patents Act](https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Patent_Amendment_Act_2005.pdf)

**Section 3(d)** allows patents only for new drug forms that demonstrate **enhanced efficacy**, while **Section 3(b)** restricts patents for inventions that are **contrary to public interest** or lack significant therapeutic benefit.

> “India’s patent regime remains intact. There is no obligation under the new agreement to extend patent terms or introduce data exclusivity for pharmaceuticals or agrochemicals,” the ministry said in an official release.

The government emphasized that the FTA **does not include**:

* **Patent term extensions** to compensate for regulatory delays.
* **Data exclusivity** that would prevent Indian regulators from using innovator data to approve generics.
* **Patent linkage**, which ties drug approval to patent status.
* **Automatic injunctions** that delay generic entry during litigation.

> 🔗 [Understanding Data Exclusivity – WHO](https://www.who.int/news-room/questions-and-answers/item/intellectual-property-data-exclusivity)

These exclusions are a win for India’s **USD 25 billion generic drug industry**, which supplies nearly **50% of its pharmaceutical output** to global markets, including **life-saving drugs for HIV/AIDS, tuberculosis, and cancer** in low- and middle-income countries.

> 🔗 [India’s Generic Pharmaceutical Sector – Brookings](https://www.brookings.edu/articles/the-indian-pharmaceutical-industry/)

The deal follows similar resistance by India during talks with the **European Free Trade Association (EFTA)** — comprised of **Switzerland, Norway, Iceland, and Liechtenstein** — where India successfully opposed attempts to insert stricter IP protections in their FTA finalized in **March 2023**.

> 🔗 [EFTA–India FTA Overview](https://www.efta.int/free-trade/Free-Trade-Agreement/India)

Pressure to include such IP provisions often comes from countries with large pharmaceutical industries, including the **UK** and **Switzerland**, home to global players like **AstraZeneca**, **GlaxoSmithKline (GSK)**, **Novartis**, and **Roche**.

However, India’s stance remains consistent with its obligations under the **World Trade Organization’s (WTO) TRIPS Agreement**, which does not require countries to implement **data exclusivity** or **patent extensions**. Experts argue that such measures are “**TRIPS-plus**” provisions that go beyond international norms.

> 🔗 [WTO TRIPS Agreement](https://www.wto.org/english/tratop_e/trips_e/trips_e.htm)

India also draws strength from the **Doha Declaration on TRIPS and Public Health (2001)**, which affirms the right of WTO members to protect public health and promote access to medicines.

> 🔗 [Doha Declaration – WTO](https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm)

“This agreement reinforces India’s role as the ‘pharmacy of the developing world’ by ensuring that domestic laws prioritize **access to affordable medicines** over extended monopolies,” said a Delhi-based trade policy expert.

The FTA will undergo legislative procedures before coming into effect, expected within the next year. For now, the government’s firm stance is seen as a strategic move to protect its pharmaceutical export economy and uphold public health imperatives.