3. Proposed Guidelines Promotes Patent Evergreening

Patent evergreening is a common strategy used by pharmaceutical patent holders to extend market exclusivity beyond the standard 20-year term by securing additional patents on minor modifications to existing medicines, such as new uses, formulations, dosages, or delivery methods. These follow-on, or “secondary,” patents typically provide little or no meaningful therapeutic benefit. Instead, they are primarily pursued by multinational pharmaceutical companies to prolong monopolies, delay generic entry, and sustain high prices to maximise profits. In Malaysia, the absence of sufficiently rigorous patent examination by MyIPO has enabled the widespread use of such practices, contributing to delayed generic competition and persistently elevated medicine prices. As mentioned above this is a challenge identified in the NIMP pharmaceutical sector plan.

An often-cited example of patent evergreening is the lopinavir and ritonavir combination (LPV/r), a second line treatment for HIV. In Malaysia, although no primary patents existed on lopinavir or ritonavir compounds, secondary product patents on crystalline polymorphs, heat-stable formulations enabled AbbVie the patent holder company to maintain a prolonged monopoly and charge high prices. As a result, Malaysia remained dependent on purchasing Kaletra, the originator’s brand-name version of LPV/r. In 2018, the cost of the originator product (200 mg/50 mg) was approximately RM 3,103 per patient per year (around US$735 at the time), while generic versions were available for less than US$300 per patient per year.

Similarly, in Malaysia, the compound patent targeting cancer drug nilotinib expired in July 2023, but the patent grant of a nilotinib method of treatment has extended the patent duration until November 2030. In contrast, in India, except for the compound patent, the rest of the patent claims were either rejected or withdrawn. Thus, in India, with generic competition the nilotinib tablets cost around RM3 per tablet, while prices in Malaysia are between RM55 to RM70 per tablet, i.e. more than 18 times the price in India.

The proposed Guidelines legitimise patent evergreening, i.e. an abuse of the patent system. Section 4.4 of the proposed Guidelines allows patent linkage for product patents claiming active pharmaceutical ingredients, formulations, polymorphs, salts, esters, dosage forms, dosing regimens and approved medical use indications. These types of patents are almost exactly the list of what patent scholars call “secondary patents” – patents that pharmaceutical companies file after filing the original compound patent, to extend their monopoly. Empirical research shows that these types of secondary patents add on an average 6 to 7 extra years of patent life beyond the original compound patent and are disproportionately filed for best-selling pharmaceutical products. Despite this, NPRA has sought to recognize such frivolous patents, for the purpose of patent linkage.

When such secondary patents are linked to the marketing approval process, as proposed in the Guidelines, they create significant barriers to generic entry—even where no actual patent infringement exists. For example, under Category 3, secondary patents listed by the originator (PRH NDP) can effectively extend the perceived patent expiry date on an ongoing basis. Under Category 4, these same patents can be used to trigger legal proceedings including frivolous legal action against generic companies, resulting in suspension of the regulatory process.

Moreover, the proposed Guidelines permit PRH NDP (originator companies) to continuously update and expand their patent lists as new patents are granted. By recognising and incorporating secondary patents into the patent linkage mechanism, and allowing their ongoing addition, NPRA is effectively encouraging patent evergreening practices and facilitating the use of legal actions to delay or block generic competition in Malaysia.

Fixed dose combinations (FDCs): A number of important products for treatment are FDCs. For e.g. FDC for antiretroviral (ARV) include dolutegravir/lamivudine (Dovato), dolutegravir/rilpivirine (Juluca) and bictagrevir/emtricitabine/TAF (Biktarvy). The clearest example is TLD (tenofovir/lamivudine/dolutegravir) which WHO has recommended as the preferred first-line regimen for adults and adolescents and MOH is planning to accelerate transition to TLD. Similarly, a large number of treatments for non-communicable diseases such as cardiovascular and diabetes are FDCs.

Patents on FDCs are usually considered to be frivolous as they are essentially combinations of known compounds and thus lacking in novelty and inventive step. And when such patents are challenged through advocacy or opposition proceedings, the patent holder may abandon the patents. For example, patents sought over rifapentine and isoniazid combinations (used to treat latent tuberculosis infection) were withdrawn globally by Sanofi, once patent oppositions were filed in India and in other countries. Another example is the combivir patent, a fixed-dose combination ARV medication used to treat HIV/AIDS. It contains two ARV medications, lamivudine and zidovudine, and was used together with other antiretrovirals. It was first introduced to the market in 1997 and marked a major breakthrough as the first fixed-dose combination therapy for people living with HIV. In Malaysia, combivir was patented and the cost of originator combivir was very high. By issuing a government use license in 2003, Malaysia accessed affordable generic versions and the average cost of treatment per patient per month dropped dramatically—from US$315 to US$58, a reduction of approximately 81%. Following global protests against GSK’s frivolous patents over combivir, the company eventually withdrew its patent claims for the combination worldwide, including in Malaysia.

The proposed Guidelines seems to extend to FDCs as the definition of “pharmaceutical products” speaks of “combination of substances” and Section 4.4 includes “formulation” product patents. Given that such patents are known to be used strategically by patent holders to extend their market exclusivity without corresponding therapeutic advances, their inclusion raises serious concerns about patent misuse to delay generic entry.

In sum, the scope of patents eligible for linkage is excessively broad, extending far beyond primary patents on new chemical entities (NCEs) to encompass a wide range of secondary patents. This approach effectively legitimises and entrenches patent evergreening, creating a clear pathway for patent holders to game the system. By allowing such patents to trigger regulatory barriers, the linkage mechanism becomes a tool to prolong market exclusivity, delay generic entry, and sustain high prices at the expense of patients, our public health system, and timely access to affordable medicines.