[This post is authored by SpicyIP Intern Tejaswini Kaushal with inputs and comments from Swaraj and Praharsh. Tejaswini is a 3rd-year B.A. LL.B. (Hons.) student at Dr. Ram Manohar Lohiya National Law University, Lucknow. She is keenly interested in Intellectual Property Law, Technology Law, and Corporate Law].

Recently, the Print reported that Novartis and Eli Lilly have voiced their opposition to the idea of compulsory licensing (“CL”) for breast cancer medications, Ribociclib and Abemaciclib. In an affidavit filed before the Kerala High Court in the ongoing hearings pertaining to the availability of the drug (XXX v. Union of India) (previously discussed on the blog here and here) these pharmaceutical giants have argued that their sales have remained strong despite the pricing of these drugs in response to an ongoing hearing before the Kerala High Court. The petition seeks CLs for their HER2-negative breast cancer drugs, a move that would enable the production of more affordable generic versions. While attending the recent TWN webinar titled “Breaking Patent Barriers: Struggle to Access Breast Cancer Medicines in India” (notification here), on the background and implications of the case XXX v. Union of India, several thoughts and questions arose in my mind, and I will try to lay them out in this post. In particular, the post analyzes whether the argument for granting a CL in India is realistically the solution for this problem and highlights why there is a need for a more pragmatic approach towards this crisis.

Comprehending the Key Facts

The plaintiffs who were a couple with a monthly pension of INR 74,400. In July 2021, the wife was diagnosed with metastatic HR+/HER2- Breast Cancer, for which she was prescribed Ribociclib (INR 58,140 per month), Letrozole (INR 1027.75 per month), and Zoledronic Acid (INR 4,313 per month). Additionally, she incurred INR 5,000 in expenses related to cardiac issues, which totaled their monthly expenditure to INR 68,480. In January 2022, she appealed for government support for affordable drug production. By June 2022, she filed a case in Kerala’s High Court but passed away in September 2022. The court took suo motu action and began inquiry about other drugs like Eli Lilly’s Abemaciclib and appointed Maitreyi Sachidananda Hegde as an amicus curiae. These affidavits were filed consequent to the March 2023 order where the court made Novartis and Eli Lilly parties to the present matter, and the relief sought included free treatment, local drug production, and access to breast cancer data, alongside a grant of CL under Sections 92 or 100 of the Indian Patent Act, 1970.

While the government refused to grant a CL on the grounds that breast cancer is not a matter of ‘national’ or ‘extreme’ urgency, it acknowledged the effectiveness of Ribociclib for breast cancer treatment, and thus the present post will take into considerations the relevant figures pertaining to Ribociclib. Presently it is protected via a Patent ( No. 283133, Application No. 9406/DELNP/2008), titled “Pyrrolopyrimidine Compounds and Their Uses”). The term of the patent is set to expire in 2027. The matter of CL grant remains a pivotal matter of discussion since these drugs remain costly. An interesting pricing strategy that is being followed is that patients bear all expenses for the first nine months before potential free support from pharmaceutical companies, as Mr. Gopa Kumar (Senior Researcher and Legal Advisor, Third World Network) asserted during the aforementioned webinar.

Investigating Form 27 Discrepancies in Drug Patent Working Declarations

One crucial aspect of this analysis revolves around the Form 27 disclosures made by the company for the drug, which goes by the brand name Kryxana. However, before we get to the specific filings, it is pertinent to note that there is a potential difference in how “value” and “cost” are being interpreted in the Form. This contention has been previously detailed here, and this case shows how this difference in interpretation can lead to some serious discrepancies in understanding how exactly the patent has been ‘worked.’ In the July 2022 order, a month’s supply of a Ribociclib was said to cost INR 58,140. Novartis stated that the recommended dose of Ribociclib is 600 mg (3 x 200 mg film-coated tablets) taken orally once daily for 21 consecutive days, followed by 7 days off treatment. As previously discussed here, an online search verified that a strip with 21 tablets of 200 grams each was priced at INR 20,700, implying a monthly drug cost of INR 62,100 for 63 pills, closely matching the mentioned amount in the court’s order.

However, it isn’t quite clear how and if the Form 27 disclosures tell the same story. 

The 2017-18 Form says that the patent was not worked in that year. (The patent was granted on May 5, 2017.) 

The 2018-19 Form reports quantum (No of units) as 8299, and value at INR 127,009,834, and only states that the working was done through importation from Switzerland. It also says that no licenses were given out. If we look solely at the quantum, it’s unclear whether these are 8299 ‘strips’ of 200mg tablets, or 8299 units of 200mg tablets. If we assume the latter, and also if we assume a patient needs 63 tablets per month, for 12 months in the year, then 8299 tablets only account for ~11 patients. If we assume the former (with 21 tablets in a strip and a patient consumes 3 strips per month), then this accounts for 231 patients. Neither is a very impressive number. 

The 2019-20 Form mentions 24,859 units with a value of INR 371,838,664. Here, if we assume 24,859 tablets of 200mg, then this serves approximately (24,859/63/12) = 33 patients. If we assume 24,859 strips of the tablet, then this serves approximately 693 patients. 

The 2020-21 Form format was changed by the 2020 patent rules. Nonetheless, Novartis filled it in the same manner. Quantum 38,910 units, and value of INR 489,466,100. If the quantum is for no. of tablets, then that serves ~51 patients. If the quantum is for the no. of strips, then that serves 1071 patients. 

The 2021-22 Form mentions 57,254 units with a value of INR 648,947,385. If the quantum is for no. of tablets, then that serves ~ 76 patients. If the quantum is for the no. of strips, then it serves 1507 patients.

The 2022-23 Form mentions 94,189 units with a value of INR 886,157,495. If the quantum is for no. of tablets then that serves ~ 125 patients. If the quantum is for the no. of strips, then it serves 2616 patients. 

Needless to mention, without any disclosure of the method of ‘working’ (ie, regular sales, free samples, patient assistance programmes, etc), the “values” don’t give us much useful information. However, clearly the quantum of worked items is much lower than the 2,38,908 number of afflicted patients in the country. (Gentle reminder here, that there are now proposals to ensure that even these worked numbers are not required to be disclosed).

This raises the question as to what is considered fulfilling the reasonable requirements of the public. 

Examining the Remedies Provided by the Patent Act

The Indian Patent Act does permit the government to intervene and sideline patent exclusivities in a time of need. Looking at the relevant provisions on the patent levers (discussed in detail below) one can see that the power to exercise such levers is discretion subject to fulfillment of the relevant requisites. 

One mechanism for granting a CL is under Section 84 of the Indian Patent Act, 1970. This mechanism allows the government to grant licenses for producing affordable generic medicines if any of the following grounds are fulfilled:

1. The patented invention is not worked in India.
2. The patented invention is not available at a reasonably affordable price.
3. The reasonable requirements of the public are not met.

The first condition technically does not default since the patent has been worked in India since 2018 (as reflected in the above-discussed Form 27s). Though, clearly, it is not being worked anywhere close to the requirement of the drug. 

Moving on, the questions of reasonably affordable prices and reasonable requirements of the public are not as black and white. While the high cost of the drug is worrisome, as argued by Mathews here, the price of Rs. 58,140 per dose, by itself, doesn’t automatically indicate unreasonableness. It can be argued that several factors including production costs and research and development expenses must be considered while considering whether a drug is priced resonably or not. However, to understand this the focus should be on what is affordable for an Indian patient. As reported by Print, the companies have claimed relatively lower prices compared to elsewhere in the world (for instance, approximately $6,064-$15,162 per month in the United States (INR 505,281.89 – 1263,371.38 with the exchange rate as of 09 October 2023)  and  witnessing of increasing sales, thus suggesting there are no issues with the accessibility of the drug. However, a relook at the average income of an Indian citizen combined with low average savings, as highlighted in the previous section, is warranted here. It becomes difficult for the average Indian citizen to be able to afford this drug even at this supposedly low price.

Moving on to the third ground regarding reasonable requirements being fulfilled. In its affidavit Noravtis revealed that Ribociclib sales in India have shown significant growth. In 2018, the drug generated Rs 12.7 crore in revenue from 8,000 units sold, its first year on the market. Subsequently, sales increased each year: reaching Rs 37.18 crore with 24,859 units in 2019, Rs 48.15 crore with 33,191 units in 2020, Rs 59.90 crore with 39,968 units in 2021, and finally, Rs 83.67 crore with 53,061 units in 2022. The affidavit also stated that the drug benefited approximately:

2018: 267 patients
2019: 829 patients
2020: 1,106 patients
2021: 1,332 patients
2022: 1,769 patients
(As can be seen these slightly vary from our calculations as taken from their Form 27 demonstrated earlier). 

As there is no publically available data on the number of patients suffering from HR+/HER2- Breast Cancer (as pointed out above), it seems impossible to say if the “reasonable requirements” of the public are fulfilled. It is also currently unclear how many patients there are who can afford but don’t have access to the drugs because of how few drugs are imported, and how many patients can’t afford the drug at that price, regardless. Though in a country like India, it can probably be safely assumed that there are a significant number in the latter category.  

As discussed previously, there is one company, MSN, listed as a local manufacturer for Ribociclib. However, a closer examination of the Form 27s reveals that all production still relies on imports, creating some ambiguity surrounding the current situation. Additionally, there is no clear information available regarding whether MSN has pursued a voluntary license for manufacturing. Provided that Section 84 specifically provides that only a generic pharmaceutical company has the locus standi to make (and subsequently fail) to obtain a voluntary license to trigger the applicability of the remaining portions (See Section 84(6)(ii) and (iii)). This requirement serves as a crucial trigger for the subsequent applicability of the provision, which fails here, rendering the provision somewhat redundant regardless of its applicability for Ribociclib.

It was also claimed that Palbociclib, a similar medication, is available at an affordable price. However, patients often do not have the choice to switch to generic alternatives as their treatment is prescribed based on medical necessity (for more on this, see here). Surely with the expiration of Pfizer’s patent for Palbociclib in India would have made generics available at a fraction of the cost. However, the patients are forced to bear the high costs of non-generic medications (like Ribociclib) if that’s what has been prescribed. Another factor of importance is that Ribociclib and Palbociclib are not perfect substitutes for each other. In various deterministic sensitivity analyses, Ribociclib outperformed Palbociclib in terms life-years gained and quality-adjusted life-years gained.

Another remedy provided by the Indian Patent Act is under Section 92 where the Central Government can grant a CL suo moto in cases of national emergency, extreme urgency, or public non-commercial use. While an effort for this was made and subsequently turned down by the Indian government, with the reason that its not a matter of “extreme” or “national” urgency.  The question then arises, what are the criteria to determine “extreme” or “national” urgency? Unfortunately, the law is silent on this and does not specify when exactly will any urgency be a “national” or an “extreme” one.  

Apart from these two levers, there are two more (albeit a little radical) safeguards within the Patents Act. First, under Section 100 whereby the government is empowered to authorize companies to use the patented invention for “the purposes of government” and make them available in the market in a non commercial basis and ; Second, under Section 102 read with Section 47 (4) whereby the government can acquire the patent and make the drugs available via state run hospital/ pharmacies.   

What Does the Past Tell Us? 

But realistically speaking, it seems like a distant dream that the government will resort to these remedies. Speaking about the chances of the government issuing such licenses or taking expropriatory measures like under Section 100- we have seen in the past how threats of unilateral sanctions like Special 301 Report, influence the policy on resorting to such measures. Plus, given that India is already negotiating bilateral trade agreement with developed counterparts like the UK and the EU, issuing such an order may have some serious repercussions there. Even if (hypothetically speaking) the government takes up such measures, then too there isn’t any surety that the road ahead will be seamless. First, there still exists a question on whether the court can direct the executive to issue a compulsory license? (though earlier this idea was explored before the Supreme Court with regard to Remdesivir, Tocilizumab and other drugs, no conclusive finding was issued by the court on these points.) Second,  despite being able to access the disclosure made before the Patent Office, there still exists a huge know-how gap against which no safeguard has been prescribed under any law and thus, any generic manufacturer manufacturing the drug using this compulsory license, would still have to overcome this know-how challenge. Furthermore, as evident from the ongoing litigation over Trastuzumab in the Delhi High Court, chances are the patentees may approach the court against such a move, not under Patent Act but rather challenging the approval granted by the drug regulator and may seek a stay, alleging “extended passing off”. All of this brings us back to square one and forces us to perhaps agree that Compulsory License is not the be all and end all solution to this problem of shortage of life savings drugs and rather its high time that the issue inaccessibility to essential life savings drugs be approached from a more holistic and pragmatic sense. 

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• Source: https://spicyip.com/2023/10/ribociclibs-compulsory-licensing-debate-in-india-what-does-the-numbers-and-the-past-tells-us.html