On October 1, 2021, the World Health Organization (WHO) released a new edition of the Model Lists of Essential Medicines and Essential Medicines for Children. The model lists include new cancer treatments, insulin analogues and new oral diabetes medicines, medicines to help people quit smoking, and new antimicrobials to treat severe bacterial and fungal infections. The model rankings are intended to address global health priorities by identifying the most beneficial drugs that should be widely available and cheap. High pricing for new, patented drugs and older medicines, such as insulin, keep some essential treatments out of reach for many patients. Insulin was first discovered as a diabetic treatment 100 years ago.

Interesting Facts about Insulin:
Charles Best, Frederick Banting and James Collip on October 9, 1923, received a patent for “Extract Obtainable from the Mammalian Pancreas or from Related Glands in Fishes, Useful in the Treatment of Diabetes Mellitus, and a Method of Preparing It,” or Insulin, U.S Patent No. 1,469,994.

According to the patent application, obtaining the pure form of insulin was done by: “extracting the internal secretion or hormone from the fresh pancreas of Mammalia, or, from the fresh pancreas of cartilaginous fishes, or, from fresh related glands, (principal islets), of bony fishes, with a solvent capable of preserving the activity of the internal secretion or hormone and then separating it practically free from injurious substances including inert associated gland tissue, proteins, proteolytic enzymes, salts and lipoids”. This discovery was the beginning of a new avenue altogether.

Unfortunately, restricted insulin supplies and high prices are substantial obstacles to therapy in low and middle-income countries. For example, the amount of insulin required for a month in Ghana’s capital, Accra, would cost a worker the equivalent of 5.5 days of pay per month. Whereas, Insulin production was concentrated in a few manufacturing sites, and three firms control most of the global market, leading to exorbitant costs prohibitively expensive for many individuals and health systems.

The decision to list long-acting insulin analogues (insulin degludec, detemir, and glargine) and their biosimilars alongside genuine insulin aims to improve diabetes medication access by broadening the treatment options. Inclusion in the List means that biosimilar insulin analogues may be eligible for WHO’s prequalification programme. However, the WHO prequalification can lead to more quality-assured biosimilars worldwide by reducing prices and providing countries with additional product options.

Long-acting insulin analogues provide patients with additional clinical benefits due to their longer duration of action, which allows blood glucose levels to be maintained for an extended time without needing a booster dosage. They are especially beneficial to people who have dangerously low blood glucose levels when using human insulin. Insulin analogues with more flexibility in timing and dose have improved diabetic patients’ quality of life. On the other hand, human insulin remains a standard treatment for diabetes, and access to life-saving medicine must be enhanced through sufficient availability and affordability.

Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors empagliflozin, canagliflozin, and dapagliflozin are also on the list of second-line treatments for persons with type 2 diabetes. These orally taken drugs have been demonstrated to reduce the risk of death, kidney failure, and cardiovascular events, among other things. Because SGLT2 inhibitors are still proprietary and expensive, WHO has recommended the Medicines Patent Pool to cooperate and increase the access through potential licencing arrangements with patent holders to facilitate generic manufacturing and supply in low and middle-income countries. Improving access to diabetic medicines, such as insulin and SGLT2 inhibitors, is one of the workstreams of the Global Diabetes Compact, established by WHO in April 2021. The recent development is a hot topic among diabetes medicine and health technology makers.

Recently, MSN Labs has released a patented diabetes medication. After DRL, Jardiance stokes the fires of a prospective legal war. Further, MSN Laboratories, based in Hyderabad, announced that they had produced the cheapest versions of Jardiance (Empagliflozin), Boehringer Ingelheim’s top-selling patented anti-diabetes medication (BI).

MSN claimed its Empagliflozin tablets, offered under the brand name ‘EMPAONE,’ will cost Rs 15.90 and Rs 18.90 per 10 mg and 25 mg tablet, respectively, whereas Jardiance’s 10 mg and 25 mg pills will cost Rs 51.3 and Rs 62.2 each capsule. In a press statement, MSN stated, ‘EMPAONE‘ meant to give diabetic patients an affordable and accessible therapeutic choice across India.

EMPAONE’s active pharmaceutical ingredient (API) and final dosage formulation (FDF) were created at the Hyderabad-based drugmaker’s in-house state-of-the-art R&D centre, according to the company. From concept to API development and FDF, the work is entirely indigenous,” MSN added.

According to media reports, Hyderabad-based Dr Reddy’s Labs has launched copies of Jardiance, a valid patent in India, until 2025. Experts predict that the introduction will be contentious and lead to a legal struggle, and BI could file for a temporary restraining order and make a claim. Under licence from BI, Cipla and Lupin also commercialise Empagliflozin.

Recently, the patent titled ‘Treating Diabetes Mellitus using insulin injections with less than daily injection frequency.’ came to light in the year (2017). The patent discloses about an insulin derivative for the treatment of a condition or disease where administration of insulin will be of benefit, comprising administering, to a patient in need thereof, effective dosages of the insulin derivative, wherein said insulin derivative exhibits a prolonged profile of action and wherein said dosages are administered at intervals longer than 24 hours.

The recent development proves that the scientific community is trying to look for alternatives to insulin, and pharma companies are eagle eye watchers to shell out revenue and achieve a monopoly over Diabetes treatment.

Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.

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    Abhishek is an intellectual property Attorney. He specializes in the registration and maintenance of patents, designs, trademarks, and copyrights. He regularly assists companies in relation to crucial technology issues. He also helps organizations or individuals to develop patent portfolio management strategies for exciting new inventions and processes. Abhishek has past work experience with reputed firms like SaiKrishna and Associates Advocates, L.S. Davar and Co., Masilamani Law Partners, and Ripple IP Services (NCR).