Indonesia Should Preserve Protections against Unworthy Biopharmaceutical Patents and Revise its Proposed Patent Law Amendments to Secure the Right to Health (original) (raw)

Prof. Emeritus Brook K. Baker, Northeastern U. School of Law

Sept. 30, 2024

With little opportunity for consultation and input from civil society and other interested parties, the Government of Indonesia is considering wide-ranging amendments to its Patent Law 13 of 2016, some which will extend patent monopolies and enrich multinational drug companies at the expense of the government, patients, and other payers. Although some of proposed changes might be beneficial, others clearly are not. Having consulted with the government on the 2016 amendments, I am particularly concerned about proposed amendments that would make it easier for biopharmaceutical patentholders to be granted additional 20-year patent protections for so-called secondary or evergreening patents that are either routinely discovered or are based on tweaks to known medical substances that offer little or no therapeutic benefit.

Indonesia’s current patent law wisely chooses to exclude secondary patent protection for “new uses of existing and/or known products” (Art. 4(f)(1)) and “a new form of an existing compound that does not generate significantly enhanced efficacy and contains different relevant known chemical structures from compound” (Art. 4(f)(2). Although these descriptions may sound arcane, they are easily explained.

Patents should only be granted for inventions that are novel (new), truly inventive, and capable of industrial application. Time-consuming and expensive scientific research and development that produces a new active ingredient that has practical medical application and benefit is the prototype of a patentable invention. However, when such a patent is granted, it is already on the basis of some medical usefulness and the inventor is granted a 20-year right to exclude competition by others – what in many instances amounts to a monopoly. Such a patent allows the patentholder to maximize profits and charge whatever the market will bear (especially what the richer, private sector part of the market).

But we know that many medicines may have one or more “use” – that a medicine can be used to treat several different diseases. These new uses are regularly and routinely researched by biopharmaceutical companies because new authorized uses will expand sales and increase profits. Moreover, “new use” investigations typically are far less expensive and time-consuming because the active ingredient is already known to be safe. The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement), which imposes certain norms on Indonesia, does not require Indonesia or any other country to grant patents for new therapeutic uses. In fact, it explicitly states that WTO Members can exclude “therapeutic methods for the treatment of humans” from patent eligibility (TRIPS Art. 27(3)(a).)

Moreover, drug companies frequently “game” the patent system to delay R&D on new uses so that they can file a new use application late in the 20-year patent term on the existing compound so they can get a new 20-year term of patent protection. Perversely, this not only extends the period of monopoly control and high prices, it also disincentivizes companies from conducting R&D earlier on important new uses, which they would otherwise do if they wanted to maximize profits during the initial 20-year patent term. By adopting a no new-use rule in 2016, Indonesia jointed India and a few other countries in rejecting industry’s demands for evergreening protections. Indonesia’s decision had no negative impacts on ongoing R&D undertaken by major multinationals and instead can save the health system millions of dollars because of earlier entry by generic and biosimilar manufacturers.

A well-known example of a medicine with multiple uses is AbbVie’s Humira (generic name adalimumab), which treats eleven indications, including rheumatoid arthritis, juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, hidradenitis suppurativa, uvetis, and plague psoriasis. AbbVie filed 311 patent applications on Humira in the U.S., 165 of which were granted, included multiple new use patents. New use and other secondary patents added 19+ years to AbbVie’s monopoly term. Humira is the best-selling drug in history, with global sales of 208billionbetween2002and2022,208 billion between 2002 and 2022, 208billionbetween2002and2022,114 billions of which were earned during its post-2016 evergreening period.

Indonesia also wisely chose to exclude new patents on new forms (minor variations) of the chemical structures of known medical compounds if those variation do not generate significantly enhanced therapeutic benefits. It is almost always in the interest of biopharmaceutic companies to continue to “optimize” their compounds through well-known explorations of salts, esters, and other substitutions/variations. A famous example of a compound-variation medicine that gained new, highly profitable patent exclusivity in many countries, but not all, is Novartis’s cancer medicines Glivec. This medicine was based on a minor variation of a base compound, imatinib. The Supreme Court of India, applying the identical non-patentability rule, held that the selection of the beta crystalline form of imatinib, which showed no significantly enhanced effectiveness was not patentable. Again, this provision prevents new or longer patent term protections for routine and trivial modifications and ultimately saves public and private health spending.

One last flaw in the proposed patentability criteria amendments is introduction of an ambiguous provision concerning “method, system, and use” patents (Proposed Art. 19(1)(c)). Not only are such patent undefined, but their inclusion introduces unneeded ambiguity about the patentability of “business method” patents and medical/therapeutic use patents, otherwise excluded from patent protection. To reiterate, the TRIPS Agreement does not require coverage of such patents.

There are other flaws in the proposed amendments and some useful changes that could be further improved. Indonesia should slow down its patent reform process and take onboard critical analyses that will preserve and strengthen its ability to safeguard its population against the risk of unnecessary and counter-productive patent protections. In particular, it should preserve existing provisions that prevent pernicious evergreening of patent monopolies on medicines.