Cholesterol: It's All About The Numbers, Even The Patents

Grace Teoh discusses a dispute on a patent for cholesterol medication.

Dave Barry, a Pulitzer Prize-winning American author and columnist, was quoted as saying, "It is a scientific fact that your body will not absorb cholesterol if you take it from another person's plate". On 3 April 2014, the New Straits Times reported in the article "More than a third of Malaysians suffer from high cholesterol" that over one-third of Malaysians suffer from high cholesterol due to unhealthy lifestyles.

Lovers of nasi lemak in Malaysia with high cholesterol levels requiring treatment may now have access to cheaper generic drugs, as a result of the Malaysian High Court's recent decision in Winthrop Pharmaceuticals (Malaysia) Sdn Bhd v AstraZeneca UK Ltd (KLHC CS No. D-22IP-57-10/2011)("Suit 57") to invalidate a particular patent.

CHEM 101, PHARMA 301

One of the treatments for hypercholesterolemia, or colloquially known as high cholesterol, is the use of drugs containing the cholesterol-lowering agent known as statins. Statins reduce the level of low-density lipoprotein (LDL) cholesterol (also known as "bad cholesterol") in the blood by inhibiting the production of it in the liver. One of these statins is "rosuvastatin". Drugs containing rosuvastatin may be administered in various forms, including via injections and orally.

AstraZeneca UK Limited ("AstraZeneca") was the registered proprietor of Malaysian Patent No. MY-136382-A ("Patent 382") for a particular oral dosage form of rosuvastatin; specifically, a drug composition containing 5 to 10 mg of rosuvastatin (or 5.2 to 10.4 mg of rosuvastatin calcium)("Claimed Dosage Range") to be administered to patients orally once daily. Put simply, the patent allowed AstraZeneca to monopolise the right to manufacture and market medicine capsules containing any amount between 5 and 10 mg of rosuvastatin in Malaysia.

AstraZeneca had applied to register the equivalents of Patent 382 in various jurisdictions, including the United Kingdom, Europe, and Australia. The validity of these patent applications or registrations has been attacked by various generic pharmaceutical companies. In AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99, a five-member panel sitting in the Federal Court of Australia held that the Australian Patent No. 769897 (the equivalent of Patent 382) was invalid.

In Suit 57, Winthrop Pharmaceuticals (Malaysia) Sdn Bhd ("Winthrop"), the Malaysian arm of Sanofi's generic pharmaceuticals business, filed an action in court against AstraZeneca, seeking, inter alia, a declaration that the patent was invalid, whether as-filed or as-amended. Winthrop challenged Patent 382 on several grounds: invalid claim to priority dates, lack of novelty...