The patent wars
The drug patent laws all over the world are varied and the line which demarcates the approval or denial of patents is very thin and at times ambiguous too. This is mainly attributed to rapid advances in the field of drug development. The number of patent infringement law suits is increasing day by day, as the pharmaceutical companies try to figure out the loopholes in the patent law.
As discussed above, patent right to a drug is always not complete. A company may possess patent to the composition of the drug but a second company may utilize a novel method to synthesize the compound and acquire patent, called the process patent. And a third company may own a patent for the purification step of the compound. These many patents on a single drug moiety may jeopardize the persistence of the drug as a whole.1
Some patent issues can be sorted out by mutual consensus between two parties. For example, a small company with novel use patents for a biosimilar can tie up with the bigger innovator company which is synthesizing the drug, to develop and market the biosimilar for newer indications.2
Similarly, an investigator may discover a totally unrelated action of a marketed drug and opine that this distinct action can be used for a newer indication. This investigator may approach the company for further development and marketing of the drug or alternatively the investigator himself can apply for a patent for that use.3
There are also controversies surrounding the so called noncommercial, “pure” research, done by university-based non-profit researchers, which can be exempted from patent restrictions.4
Though the patent protection system encourages innovation and creativity, the rewards for innovation and creativity can be undermined by widespread theft associated with counterfeiting and trafficking of pirated drugs – the so-called fake-medicines.5
References
1. Biotechnology. In: Spilker. B. Guide to Drug Development – A Comprehensive Review
and Assessment. Philadelphia: Lippincott Williams & Wilkins; 2009.
2. Licensing activities and issues. In: Spilker. B. Guide to Drug Development – A
Comprehensive Review and Assessment. Philadelphia: Lippincott Williams & Wilkins; 2009.
3. Groups that influence protocol design. In: Spilker. B. Guide to Drug Development – A
Comprehensive Review and Assessment. Philadelphia: Lippincott Williams & Wilkins; 2009.
4. Patenting and commercialization of discoveries. In: Lo B. Ethical Issues in Clinical
Research: A Practical Guide. Philadelphia: Lippincott Williams & Wilkins; 2010.
5. Blackstone EA, Fuhr JP, Pociask S. The Health and Economic Effects of Counterfeit Drugs. Am Health Drug Benefits. 2014 Jun;7(4):216-24.