Unveiling patenting strategies of therapeutics and vaccines: evergreening in the context of COVID-19 pandemic.

In the pharmaceutical sector, evergreening is considered a range of practices applied to extend monopoly protection on existing products. Filing several patent applications related to the same active pharmaceutical ingredient (API) is one of the most common manifestations of evergreening. During the COVID-19 pandemic, several health technologies were developed. This study aimed to analyze the extension of evergreening for selected health technologies for SARS-CoV-2 through patent filing strategies. Starting with the selection of three antivirals, one biological and two vaccines, a patent landscape was built based on public and private databases. Regarding these selected technologies, we analyzed some of the evergreening strategies used by different applicants, academic institutions or pharmaceutical companies and found a total of 29 applications (10 after the pandemic) for antivirals, 3 applications for a biological drug (1 after the pandemic), and 41 applications for vaccines (23 after the pandemic). Despite differences among the technologies, a common aspect found in all analyzed cases is the intense patent filing after the pandemic, aligned to the fact that those technologies were moving through the R&D process up to regulatory approval. The evergreening approach pursued has already been found in other diseases, with the risk of monopoly extension and also bringing legal uncertainty due to the lack of transparency of newer patent applications covering specific medical indications. Therefore, efforts to address evergreening should be pursued by countries, including the adoption of a public health approach to the patent examination of those technologies to prevent the granting of undeserved patents.

Treatment advocate tactics to expand access to antiviral therapy for HIV and viral hepatitis C in low- to high-income settings: making sure no one is left behind.

INTRODUCTION: Worldwide, 71 million people are infected with hepatitis C virus (HCV), which, without treatment, can lead to liver failure or hepatocellular carcinoma. HCV co-infection increases liver- and AIDS-related morbidity and mortality among HIV-positive people, despite ART. A 12-week course of HCV direct-acting antivirals (DAAs) usually cures HCV - regardless of HIV status. However, patents and high prices have created access barriers for people living with HCV, especially people who inject drugs (PWID). Inadequate access to and coverage of harm reduction interventions feed the co-epidemics of HIV and HCV; as a result, the highest prevalence of HCV is found among PWID, who face additional obstacles to treatment (including stigma, discrimination and other structural barriers). The HIV epidemic occurred during globalization of intellectual property rights, and highlighted the relationship between patents and the high prices that prevent access to medicines. Indian generic manufacturers produced affordable generic HIV treatment, enabling global scale-up. Unlike HIV, donors have yet to step forward to fund HCV programmes, although DAAs can be mass-produced at a low and sustainable cost. Unfortunately, although voluntary licensing agreements between originators and generic manufacturers enable low-income (and some lower-middle income countries) to buy generic versions of HIV and HCV medicines, most middle-income countries with large burdens of HCV infection and HIV/HCV co-infection are excluded from these agreements. Our commentary presents tactics from the HIV experience that treatment advocates can use to expand access to DAAs. DISCUSSION: A number of practical actions can help increase access to DAAs, including new research and development (R&D) paradigms; compassionate use, named-patient and early access programmes; use of TRIPS flexibilities such as compulsory licences and patent oppositions; and parallel importation via buyers' clubs. Together, these approaches can increase access to antiviral therapy for people living with HIV and viral hepatitis in low-, middle- and high-income settings. CONCLUSIONS: The HIV example provides helpful parallels for addressing challenges to expanding access to HCV DAAs. HCV treatment access - and harm reduction - should be massively scaled-up to meet the needs of PWID, and efforts should be made to tackle stigma and discrimination, and stop criminalization of drug use and possession.

Factors associated with HIV status disclosure to one's steady sexual partner in PLHIV in Morocco.

The objective of the present study was to determine the factors independently associated with disclosure of seropositivity to one's steady sexual partner in people living with HIV (PLHIV) who are recipients of services provided by Association de Lutte Contre le Sida, a Moroccan community-based organization (CBO) working on AIDS response. Between May and October 2011, 300 PLHIV were interviewed about their sociodemographic and economic characteristics, their sexual life and disclosure of their serostatus to their friends, family and to their steady sexual partner. A weighted logistic regression was used to study factors associated with serostatus disclosure to one's steady sexual partner. We restricted the analysis to people who declared they had a steady sexual partner (n = 124). Median age was 36 years old, 56 % were men and 62 % declared that they had disclosed their serostatus to their steady sexual partner. The following factors were independently associated with disclosure: living with one's steady sexual partner [OR 95 % CI: 9.85 (2.86-33.98)], having a higher living-standard index [2.06 (1.14-3.72)], regularly discussing HIV with friends [6.54 (1.07-39.77)] and CBO members [4.44 (1.27-15.53)], and having a higher social exclusion score [1.24 (1.07-1.44)]. Unemployment (as opposed to being a housewife) was negatively associated with disclosure [0.12 (0.02-0.87)]. Despite the potential positive effects for the prevention of HIV transmission and for adherence to HIV treatment, many PLHIV had not disclosed their serostatus to their steady sexual partner. Some factors shown here to be significantly associated with such disclosure will help in the development of future support interventions.

HIV, syphilis and sexual risk behaviours among men who have sex with men in Agadir and Marrakesh, Morocco.

OBJECTIVE: To collect baseline measurements of HIV and syphilis prevalence and sexual risk behaviours among men who have sex with men (MSM) in Agadir and Marrakech, Morocco, and provide strategic information to improve outreach programmes. METHODS AND DESIGN: Respondent-driven sampling was used to recruit men who reported having anal sex with another man in the last 6 months, aged 18 years and older and living in either Agadir or Marrakech for the past 6 months, regardless of nationality. Data were analysed with the multiplicity estimator using respondent-driven sampling analysis tool V.6.0. RESULTS: 323 MSM in Agadir and 346 in Marrakech were recruited into the survey. Most MSM in both cities reported being < 25 years, being unemployed, bisexual and in a couple with both a man and a woman. Most reported selling sex and having sex with women. HIV prevalence was 5.6% in Agadir and 2.8% in Marrakesh; syphilis was 7.0% in Agadir and 10.8% in Marrakesh. Among MSM who tested positive for HIV, 31.6% in Agadir and 56.4% in Marrakesh were co-infected with syphilis. CONCLUSIONS: HIV and syphilis findings coupled with high risk activities indicate the need for expanding programmes targeting MSM throughout Morocco. Selling sex and sex with women may be a strategy to cope with extreme stigma towards MSM. Criminalisation and discrimination of MSM in Morocco underscores the urgent need for long-term and sustainable risk reduction through legal reforms and promotion and protection of human rights.