Background
Amgen, a U.S.-based company that makes medicines from natural substances like proteins, created a medicine called romiplostim, sold as Nplate. This medicine mimics a natural body signal (a hormone called thrombopoietin, or TPO) that tells your body to produce platelets — tiny components in your blood that help stop bleeding by forming clots. It’s vital for people with a condition called immune thrombocytopenic purpura (ITP), where the body mistakenly attacks its own platelets, causing low counts and bleeding risks.
Medicines like romiplostim, made from living sources, are delicate. They can break down or clump together if not handled carefully, much like milk curdling outside the fridge. To solve this, Amgen developed a way to freeze-dry the medicine (a process called lyophilization), turning it into a stable powder that’s easier to store, ship, and mix with water for use later.
Amgen applied for a patent in India on 9 September 2008, under application number 5857/CHENP/2008, titled “Lyophilized Therapeutic Peptibody Formulations.” They described a specific dry mix: the main medicine (romiplostim, structured as Formula V in their papers) showing the mix stays stable, doesn’t clump, and that the additives work together better than alone.
Patent Office Proceedings
Amgen asked the Indian Patent Office to review their application. On 20 July 2013, the office issued a First Examination Report (FER), raising objections under Sections 3(d), 3(e), and 2(1)(ja) of the Patents Act, 1970. These rules block patents for things like reusing known methods, simple mixes without special effects, or ideas that aren’t creative enough compared to existing documents (called prior arts D1–D6.).
Amgen responded, narrowing their claims to focus on Formula V, which covered 52 slight variations of the main medicine part. Then, Intas Pharmaceuticals Limited objected on 18 July 2016, under Sections 25(1)(e) (obviousness), 25(1)(f) (not an invention), and 25(1)(g) (incomplete explanation).
After hearings, the Assistant Controller rejected the application on 31 March 2023, citing Section 2(1)(ja) (not creative), Section 3(d) (reusing known methods), Section 3(e) (simple mix), and Section 10(4) (not fully explained). They pointed to prior arts and said there was no proof of real improvement.
Amgen appealed to the Madras High Court under Section 117A of the Patents Act, 1970, which allows challenging patent rejections.
The Core Dispute
The core issue was whether Amgen’s dry medicine mix qualified as a patentable invention under the Indian Patents Act, 1970. Patents are granted only for ideas that are new, involve an inventive step, and can be used industrially, but certain rules block patents for specific cases. The court had to answer four key questions:
- Section 3(d): Did Amgen’s method for making the dry mix just reuse an old, known process without adding anything new?
- Section 3(e): Was the mix just a simple blend of known ingredients that don’t work together in a special way to create a better result?
- Section 2(1)(ja): Would an average expert in medicine-making (called a person skilled in the art, or PSITA) find this mix obvious by looking at old documents (prior arts D1–D5)?
- Section 10(4): Did Amgen explain their idea fully and clearly in their application, especially since it could apply to 52 variations, but they only tested one?
Amgen argued their mix was unique for their medicine, their tests showed the ingredients teamed up to prevent spoiling and clumping, picking the right additives and amounts was a creative challenge, and their explanation was enough with one example representing the group. The opponents (the Patent Office and Intas) countered that it was obvious by combining old documents, just a simple mix, and not fully explained for all variations.
Court’s Reasoning
The Hon’ble judge began by explaining in simple terms how medicines from living sources are fragile, need injections (not pills), and why choosing additives is like solving a puzzle—each medicine needs its own perfect recipe. Below is a summary of how the court handled each legal issue, keeping the law’s language intact.
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Rejection under Section 3(d): Mere Use of a Known Substance
Section 3(d) of the Patents Act, 1970, says you can’t patent “the mere use of a known substance” unless it creates a new product or uses a new ingredient. The Assistant Controller rejected claim 9 (the method for preparing and drying the mix with specific additives and amounts), saying it was just using the old freeze-drying process, pointing to prior art D4 (which mentioned the medicine) and general knowledge.
The court examined claim 9 and disagreed. It found no prior art showed exactly how to dry this specific medicine with these additives in these amounts. Prior art D4 mentioned freeze-drying vaguely, saying compositions “may be in dried powder, such as lyophilized form,” but gave no steps or details. Prior art D5 described drying a different substance but had no method steps. The court concluded that claim 9’s process, with its specific additives and amounts, wasn’t just reusing a known method—it added something new. Thus, the rejection under Section 3(d) was not sustainable.
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Rejection under Section 3(e): Mere Admixture Without Synergy
Section 3(e) blocks patents for “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof.” This means a mix where the parts just do their usual jobs, adding up normally, isn’t patentable. The mix must show synergy—where the whole is better than the sum of the parts, like ingredients in a cake that create a unique flavor together.
The Assistant Controller said Amgen’s mix was a simple blend because they didn’t provide data comparing the mix before and after drying to prove better stability. The court rejected this, saying Section 3(e) doesn’t always require before-and-after drying data. The goal is to show the ingredients interact to produce a result greater than their individual effects. Amgen’s tests (Tables 39–41) did this:
- Table 39: Showed that using at least 1.5% sucrose (a stabilizer) reduced chemical breakdown at high temperatures, while less sucrose led to more spoiling. High amounts of another additive (mannitol) alone didn’t help.
- Tables 40 and 41: Showed that adding polysorbate-20 (a clumping preventer) kept clumping under 0.1%, compared to much higher clumping without it. Tests used different medicine amounts (0.5 mg/mL and 0.3 mg/mL), but this didn’t matter for proving the additive’s teamwork.
The Controller argued the different amounts made the data weak, but the court said the tests’ purpose was to show synergy (polysorbate-20’s effect on clumping), not to compare amounts. Unlike prior art D3, which aimed to increase substance concentration, Amgen’s goal was stability, so before-and-after drying data wasn’t needed. The court found clear synergy, setting aside the Section 3(e) rejection.
3. Lack of Inventive Step under Section 2(1)(ja)
Section 2(1)(ja) requires an “inventive step”—a feature that makes the invention not obvious to a person skilled in the art (PSITA), defined as an average medicine-making expert with common knowledge but no extraordinary creativity. The Controller said the mix was obvious based on prior arts D1–D5 (D6 and D7 weren’t used in the appeal).
The court played the role of the PSITA and analyzed each prior art:
- D1–D3: D1 (Amgen’s work on a different binder) didn’t mention this medicine or drying. D2 (Amgen’s modified proteins) discussed combining parts for longer life but not drying. D3 focused on drying to increase concentration, not stability, so a PSITA wouldn’t apply it here. These didn’t make the mix obvious alone or together.
- D4: Amgen’s own document on the same medicine (including the exact structure, SEQ ID 1017) for ITP treatment. It mentioned dry forms and additives like sucrose but vaguely, without specific drying steps, additive types, or amounts. A PSITA couldn’t reach Amgen’s mix from D4 or D1–D4.
- D5: Described drying a different substance (IL-12, for cancer) with similar additives: 2% sucrose, 4.15% mannitol, 0.02% polysorbate-20, and a buffer at pH 5.6. The Controller suggested combining D4 and D5, but the court disagreed. The substances were different (IL-12 is a paired helper for cancer; romiplostim is a fused piece for platelets). D4 didn’t suggest looking at D5. Scientific literature showed 6–16 options for each additive type, making selection a complex puzzle with thousands of combinations. No standard recipe exists, and a common clumping preventer (polysorbate-80) differed from Amgen’s choice (polysorbate-20).
The court concluded that choosing these additives and exact amounts for this medicine wasn’t obvious — it took creative work. The Section 2(1)(ja) rejection was unsustainable.
Insufficiency under Section 10(4)
Section 10(4) requires a patent application to fully and clearly describe the invention, including the best method known, so others can recreate it. Amgen’s Formula V covered 52 variations of the medicine’s core part, but tests (Tables 39–41) only showed one (SEQ ID 1017). The court noted that these variations differ in structure, affecting how they behave. Without guidance for the other 51, the application didn’t fully enable them. However, the tested variation (and its close family, SEQ ID 1012–1017) was well-explained. The court partly upheld this objection, narrowing the patent to cover only the tested variation (SEQ ID NO. 459).
Final Decision
The Madras High Court allowed Amgen’s appeal under Section 117A, setting aside the Assistant Controller’s rejection order dated 31 March 2023. The patent application was sent back for approval, but with amendment. This ruling is a milestone for medicine patents in India. It shows that courts will protect creative solutions in complex fields like biologics if they demonstrate real teamwork between ingredients and aren’t obvious combinations of old ideas. However, inventors must fully explain their work, especially for broad claims with many variations.
Disclaimer & Authorship
The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
