In an increasingly competitive landscape, pharmaceutical companies are finding creative ways to protect their patents. Most of the time, patents are the only things that protect a company from direct competition. If a drug is successful but still protected under a patent, other companies prepare their chemical synthesis manufacturing capabilities to be able to take advantage of expiring patents as soon as they become available. There is a time limit on patents; however, if drug companies construct patents around a manufacturing process in just the right way, it does not become economically feasibility for competing companies to enter the market.
AbbVie’s treatment for inflammatory diseases, Humira, has been the bestselling drug of all-time. The drug has been made for 15 years. Normally at this moment, competitive drug makers would be ramping up manufacturing to roll out alternative generic drugs. The chemical synthesis was not the challenge. The challenge was finding a way around more than 100 process patents that AbbVie had methodically been granted (Koons, 2017). Another example of a patent conglomerate is Johnson and Johnson’s Remicade.
Despite the patent fortress that AbbVie has created, Amgen is trying to create a generic version of Humira. AbbVie is suing to block Amgen’s efforts (Koons, 2017). This is the first time this type of case has been tried in US Courts. Regardless of the case decision, the fact is: more patents, does not guarantee protection. Congress will consider the amount of time drugs should have exclusivity, while AbbVie will contend that the numerous patents are the only things it has to protect all of its innovation and investment.
In addition to the sheer number of patents, drug manufacturers are transferring patent rights to Indian Tribes in attempts to prolong their patents. Allergan is paying almost $14 million to “partner” with the Saint Regis Mohawk Tribe in upstate New York to claim sovereign immunity in order to dismiss a patent challenge for their drug Restasis® (Thomas, 2017; Wolfe & Erman, 2017). In return, the tribe rents the patents back and receives $15 million annually so long as the patents remain active. Some legislative critics believe that these types of sovereignty deals could undermine the essence of why these challenges in the patent office occur: to overturn invalid patents. Likewise, Mylan looks poorly upon Allergan for conducting such an undermining move of transferring patent ownership to claim sovereignty (Wolfe & Erman, 2017).
References
Koons, C. (2017). Guarding Big Pharma’s Crown Jewel. Scribd. Retrieved 28 January 2018, from https://www.scribd.com/article/358290333/Guarding-Big-Pharma-S-Crown-Jewel
Thomas, K. (2017). How to Protect a Drug Patent? Give It to a Native American Tribe. Nytimes.com. Retrieved 28 January 2018, from https://www.nytimes.com/2017/09/08/health/allergan-patent-tribe.html
Wolfe, J., & Erman, M. (2017). Mylan says Allergan misusing tribal sovereignty in patent dispute. Reuters. Retrieved 28 January 2018, from https://www.reuters.com/article/legal-us-allergan-patents-mylan/mylan-says-allergan-misusing-tribal-sovereignty-in-patent-dispute-idUSKCN1BN2XH