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From Scurvy to Modern Medicine

Dr. Tobias Popp
Patent Attorney, Licensed Pharmacist, Dr. rer. nat., M.Sc.
Munich
Dr. Karin Grau Kuntz
Lawyer, LL.M.
Munich

The Evolution of Clinical Trials and the Role of Patent Protection and Supplementary Protection Certificates (SPC)

Transoceanic journeys during the Age of Exploration were not just perilous but also a testament to the bravery and resilience of sailors. Besides navigating with inaccurate charts and rudimentary aids, they also had to battle a mysterious disease named scurvy, which became the plague of the sea. According to Kenneth John Carpenter, a nutrition scientist who wrote about the history of scurvy, in the 18th century, the disease became a crucial issue for the British Navy, causing more deaths than enemy action.

Despite their best efforts, the scientific understanding of the 18th century proved inadequate to combat scurvy. Sailors, who were often the victims of this disease, would have been relieved to know how to cure or prevent scurvy, which is linked to a deficiency in dietary vitamin C. 

During the Age of Exploration, diet on ships was major contributor to scurvy. The typical provisions on long voyages consisted of items like salted meat, cheese, dried grains, and ale. These were chosen for their long shelf life and resistance to spoilage. Unfortunately, fresh fruits and vegetables, rich in vitamin C, were not commonly stored or consumed during lengthy sea journeys due to their quick spoilage.

Although the connection between scurvy and vitamin C deficiency was first scientifically established in the 20th century, some empirical knowledge of scurvy prevention using citrus fruits emerged by the late 18th century through the work of the British Royal Naval surgeon, James Lind.

By 1747, he had become a surgeon of HMS Salisbury in the Channel Fleet, and observing the large number of sailors suffering from scurvy, he decided to investigate possible cures for the disease. He selected twelve sailors suffering from scurvy and divided them into six pairs. Each pair was treated with different popular remedies, including cider, vitriol elixir, vinegar, a preparation of garlic and mustard, two oranges and one lemon, and a mixture of nutmeg.  

The pair who received the two oranges and the lemon exhibited remarkable and swift enhancement within a short span. The disparity in outcomes was striking compared to the other treatments. Lind concluded that something in citrus fruits was extraordinarily effective in curing the disease.

Lind's systematic approach to treating scurvy through controlled experiments changed professional and political opinions among naval authorities in favor of lemon juice and underscored the importance of evidence-based medicine. Systematic evaluation is the foundation for contemporary clinical trials, which are now integral to developing new medical treatments. In today's pharmaceutical landscape, clinical trials are meticulously designed to ensure the safety and efficacy of new drugs before they reach the market. This rigorous scientific validation process is closely linked to the realm of patent protection and Supplementary Protection Certificates (SPCs) in the European Union, because each SPC require a marketing authorization and a patent. Patents and SPCs are valuable tools for the innovative pharmaceutical industry and can be used to prevent competitors from exploiting the benefits of new active ingredients, the new treatment of indications with known active ingredients etc. These tools enable the innovative pharmaceutical industry to make a return on their costly and risky investments into pharmaceutical research. Investments into new medicinal products are also protected by other tools such as data and market exclusivity, but the term of patents and SPCs usually exceeds the term of protection by data and market exclusivity. In other words, building a patent portfolio is key for success of any innovative pharmaceutical company.