This year, the streaming platform NETFLIX released the miniseries “Empire of Pain”. The dramatic work delves into the devastating opioid epidemic in the United States, centering its narrative on the tense legal process faced by Purdue Pharma, the US pharmaceutical company that introduced and popularized OxyContin in the 1990s.

The miniseries exposes the greed of Richard Sackler, the president of the pharmaceutical company, determined to surpass MS Contin, a morphine-based drug primarily for patients with severe diagnoses, such as cancer. The patent for MS Contin was held by Purdue Pharma, but its prescription was limited due to its striking side effects, including addiction.

Driven by this ambition, Richard Sackler spearheaded the creation of OxyContin, made from oxycodone. Proving to be more potent than morphine and deeply affecting the central nervous system, providing prolonged pain relief, this potency brought a dark consequence: an intense addiction in patients.

Throughout the episodes, we follow Edie Flowers, a lawyer who, in partnership with the US prosecution, files a lawsuit against Purdue Pharma. Her challenge is to understand how OxyContin came to be excessively prescribed by American doctors, while the persuasive tactics of Purdue Pharma in encouraging health professionals not only to prescribe the drug but also to increase doses are exposed.

Parallel to the main plot, we are introduced to the paths of Glen and Shannon, both affected by OxyContin, but from different perspectives. While Glen deals with the direct repercussions of the drug in his life, Shannon faces issues related to morality, ethics, and guilt.

The false idea propagated that OxyContin was a harmless and less aggressive drug than MS Contin demonstrates the insensitivity of the pharmaceutical company towards potential harm to its patients. Furthermore, it raises questions about how the registration was approved by the FDA (Federal Drug Administration), the US agency responsible for controlling food, drugs, cosmetics, etc., despite its previous inconsistencies and objections.

Comprising six captivating episodes, the miniseries makes a point of emphasizing that, although part of its narrative, characters, and dialogues are fictional, the testimonies of the real victims’ families of OxyContin are genuine. Shockingly, it is estimated that OxyContin is related to overdose deaths of about 300,000 people in the United States, and to date, no member of the Sackler family has been criminally charged.

Regarding patent aspects in the pharmaceutical industry, we clarify that there are 3 necessary steps to protect a drug in Brazil:

  • Authorization from ANVISA (National Health Surveillance Agency)
  • Patent Registration
  • Trademark Registration

ANVISA is the Brazilian government authority responsible for authorizing the sale and import of drugs in the country. In addition, its mission is to ensure the safety, efficacy, and quality of health-related products and services. To achieve this goal, the agency conducts deep analyses of clinical data, studies, research, and technical information, ensuring that drugs are not only safe but also effective for their purposes.

When discussing drug patents, the procedure is like other inventions. This registration grants the inventor the exclusive right to exploit their creation. In Brazil, the invention patent is valid for 20 years from the application date and cannot be extended.

In the first episode of the miniseries Empire of Pain, an emerging concern is the financial impact on Purdue Pharma after the expiry of MS Contin. This loss of exclusivity is conceptually different from the so-called “patent breach”.

In this context, the Brazilian term Patent Breach (Quebra de patente) is often used to describe the end of the exclusivity period. However, different from the concern in the series, a patent breach refers to the compulsory license of the patent, i.e., when the Government suspends the inventor’s right even before the end of the 20 years.

Thus, the inventor or titleholder company ceases to be the only one with permission to produce and sell drugs or other inventions. Other companies gain the right to manufacture and sell but must pay royalties to the holder.

The circumstances under which compulsory licensing can be established are detailed in Art. 71 of the Industrial Property Law (IPL) and include situations like national emergencies, public health crises, the absence of patent exploitation, practices that harm competition, etc.

To conclude, it is worth mentioning that the commercial name of a drug can be registered as a trademark before BPTO (The Brazilian Patent and Trademark Office), under class 05, in nominative, composite, or three-dimensional forms.

Would you like to know more about patent or trademark registration? Contact our experts by email or WhatsApp.

https://www.gov.br/pt-br/servicos/obter-registro-de-medicamentos-genericos-similares-novos-e-inovadores
https://www.planalto.gov.br/ccivil_03/leis/l9279.htm

Autor

  • Brenda Ozaki

    Brenda integra o escritório desde 2020 e atua na área internacional, auxiliando na gestão de portfólio de marcas no exterior.

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