Patents & Licensing

How the companies perform

The companies divide into four groups. There are three clear leaders, with very close scores for the leading pair. These are followed by six above-average performers. Across all 20 companies, the wide spread of scores reflects companies’ diverse approaches to responsible IP-management, as well as the varying quality and transparency of these approaches.

Patents & Licensing remains a comparatively low-performing area on average, yet with improvement in three key dimensions. Firstly, more companies commit publicly to not filing for or enforcing patents in subsets of low- or middle-income countries (now 13 companies in total, with at least two more to follow). Across all 20 companies, there is greater willingness to engage in non-exclusive voluntary licensing. Looking at those companies that do engage, the use of licensing has deepened, with some evidence of innovation. Some companies, however, remain conservative. Thirdly, three companies have addressed patent transparency for the first time. In other areas, industry performance remains static. Companies generally remain conservative in their positions on the Doha Declaration on the TRIPS agreement and public health (exceptions are AstraZeneca, GSK and Merck KGaA). There is evidence of continued lobbying for tougher IP protection in countries in scope.

Leaders deliver breadth, depth, clarity and innovation

The same three companies lead as in 2014. All three have pulled ahead from the pack, with Gilead and GSK extending their lead over Bristol-Myers Squibb. Gilead and GSK lead for different reasons. Gilead’s approach to voluntary licensing represents best practice. It has licensed all its on-patent products for diseases in scope, often before market approval, making them available for manufacture by third parties. This includes multiple hepatitis C products, definitively demonstrating that licensing is suitable for non-HIV/AIDS products. Gilead is the only company to have reached voluntary licensing terms outside the Medicines Patent Pool that are comparable (e.g., in terms of their transparency and geographic breadth) with the pro-access terms negotiated via the Pool.

GSK is a strong performer in licensing, which it uses for HIV/AIDS products. Its licensing approach for dolutegravir (Tivicay®) has a wide geographic reach. It permits the supply of Tivicay® to countries outside the licensed territory, including in countries of manufacture or supply, whether or not the relevant patent is in force there. GSK clearly states where it will not file for or enforce patents, and commits to disclosing patent statuses in the future. It pledges to consider voluntary licensing for its entire portfolio in all lower-middle-income countries (LMICs).

Bristol-Myers Squibb is third, with a strong, consistent performance in licensing. It was the first company to license a product for hepatitis C (daclatasvir (Daklinza®)). Tivicay® and Daklinza® are available for licensing to multiple manufacturers through the Medicines Patent Pool.

Diverse approaches to IP-management

The next six companies are clustered, yet they take different pro-access approaches to IP-management. Merck & Co., Inc. (4th) uses non-exclusive voluntary licensing, albeit on narrower terms than the leaders. It has newly licensed paediatric formulations of the anti-retroviral (ARV) raltegravir (Isentress®) through the Medicines Patent Pool. AstraZeneca (5th) and Merck KGaA (6th) do not yet engage in licensing, but AstraZeneca pledges not to file for new patents, and Merck KGaA pledges not to file for new patents or to enforce existing patents. Both pledges apply to a comparatively broad range of countries. Both publish the status of patents held in countries in scope. Both acknowledge aspects of countries’ right to determine the grounds for compulsory licences. They are both open to engaging in licensing in the future, with AstraZeneca specifying precisely where and for which product categories it would consider voluntary licensing terms. Merck KGaA is held back by a negative judgement during the period of analysis relating to anti-competitive behaviour in Brazil.

Johnson & Johnson follows in 7th. Although it has not engaged in licensing to the same degree as the leaders, this is counter-balanced by the breadth of its non-assert declaration: it has expanded its promise not to enforce its patents on ARV darunavir (Prezista®) to 128 countries. Boehringer Ingelheim (8th), has the widest geographic scope of any non-assert declaration made: it promises not to enforce its patent on the extended-release formulation of nevirapine (Viramune XR®) in any low- or middle-income country (LICs, MICs), totalling 135 countries. AbbVie (9th) has newly licensed both paediatric and adult formulations of the ARVs ritonavir and lopinavir (Aluvia®) to multiple manufacturers. It falls back for the comparatively low transparency of its approach to filing for and enforcing patents.

Ranks 10 to 14 are occupied by companies that have either not yet licensed or have comparatively limited licensing activity, but have stated where they plan to file for or exercise IP rights (Eisai, Novartis, Roche, Novo Nordisk and Astellas, in that order). Eisai’s commitment is the broadest: it has a commitment to not enforcing patents in least developed countries (LDCs), LICs and low human development countries (LHDCs). Astellas, Novo Nordisk and Roche all commit to not filing for or enforcing patents in LDCs and LICs, with Roche also applying this commitment to its ARVs in sub-Saharan Africa. Novartis commits to not enforcing patents in LDCs, and agrees to offer licensing for supply to those countries. For Astellas, Eisai and Novo Nordisk these all represent new public commitments. Astellas, Novartis and Roche are willing to consider licensing. Novo Nordisk has now published the status of its patents worldwide, but is held back by a negative judgement during the period of analysis relating to anti-competitive behaviour.

The laggards: some static, with others set to rise

Among the final six companies, most lag because they have not improved, while Eli Lilly and Pfizer fall back due to settlements or judgements concerning anti-competitive behaviour. Daiichi Sankyo, Bayer, Pfizer, Sanofi and Takeda all lack transparency, with no public statement about how they plan to file for or enforce patents, no public commitment to licensing and no transparency around patent statuses. Bayer, Sanofi and Takeda, however, have stated (to the Index) that they will not file for and/or enforce patents in specific groups of countries: Bayer will not file in LDCs, Takeda will not file or enforce in sub-Saharan Africa, except South Africa; Sanofi will not file or enforce in LDCs and LICs. Takeda has also indicated to the Index that it is willing to consider licensing. Eli Lilly is the only lagging company to make a public commitment to not filing for or enforcing patents (specifically, in LDCs). Pfizer is the only lagging company to engage in licensing (via joint venture ViiV Healthcare).

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