Some very notable developments for those watching rare-disease litigation in India. On 24th March, in F Hoffman v. Natco, the Delhi High Court refused to grant an interim injunction against Natco from manufacturing a generic version of Risdiplam. While that was a temporary cause of celebration for patients, we have heard from readers that this morning the Division Bench, in an appeal, has ordered a status quo till the next hearing- (FAO(OS) COMM 43/2025). Natco also appears to have given an undertaking to not launch the generic product till the next date of hearing viz. 2nd April, 2025. It is difficult to be clear without the order, which has not been uploaded as of the time of writing this.
At the heart of the dispute is a drug called ‘Risdiplam’ which is the only available drug in India to treat Spinal Muscular Atrophy, a rare genetic disorder. (here) The cost of the drug can range from 72 Lakhs to 1.86 crores per year (here) making it unaffordable for most, if not all, SMA patients. In an earlier post, Prof Saha argues that the government could procure Risdiplam at a significantly lower cost if manufactured locally. Roche’s patent for Risdiplam is currently due to expire in 2035 i.e. 10 years from now. SMA, thus, is a high-cost drug with severely limited accessibility.
To get a background on the dispute, please see Sabeeh’s excellent roundup of the issue.
Infringement, Invalidity and Injunction
Natco wanted to manufacture the generic version of Risdiplam. It had also applied for a process patent to manufacture Risdiplam. Roche, in response, filed an infringement suit and sought a permanent injunction u/s. 108. One of the defences against infringement is the revocation of the patent via counter-claim, on the grounds mentioned u/s. 64. Natco chose to argue that the suit patent was invalid on the grounds, among others, of (i) anticipation and (ii) obviousness.
On anticipation, Natco argued that Risdiplam was already disclosed in genus patent US ‘955 and stood anticipated. Roche, on the other hand, argued that Risdiplam was not ‘specifically claimed’ in the genus patent although it was covered.
The debate on ‘coverage-disclosure’ is not new. Last year, in Natco v. Novartis, DB of the DHC had said that “there cannot be dichotomy between coverage or claim on one hand and the disclosure on the other.” The Court said that it is not required that a substance is specifically claimed for it to be disclosed. Even if it is not specifically disclosed but obvious to a PSITA, it would stand disclosed. Disclosure, thus, can be explicit or implicit.
To decide who is a PSITA, the Judge used the ‘person in the know’ (PITK) test (AstraZeneca v Intas, DHC 2021) since both genus and species patents had the same inventors. As I wrote here, the standard of PITK shifts the onus from the challenger to the patentee to decide anticipation. The reversal of the onus balances the huge information asymmetry existing in such cases between the inventor and the challenger. (explained in the linked post)
To decide anticipation, the Court relied on statements made by Roche in infringement suits against generic companies for manufacturing Risdiplam.
For instance, in the US, Natco was planning to launch Risdiplam in the market. There, Roche claimed that Natco was infringing the genus patent US’955. On the other hand, when Natco planned to launch a generic version of Risdiplam, Roche argued that Natco was infringing the species patent US’754.
Roche was taking different positions in different jurisdictions on the same product. Roche’s position that the generic version of Risdiplam infringed US’955 amounted to an admission that Risdiplam was disclosed in the genus patent. Patent claims define the scope of the invention for which protection is claimed. If Roche is saying that Natco has infringed the genus patent, then there is no question that Risdiplam was claimed in the genus patent. To argue later that Risdiplam was not disclosed but covered in the genus patent is not acceptable. One cannot have it both ways!
Relying on the above, the Court concludes that PITK could easily anticipate Risdiplam from the genus patent. Roche’s argument that statements made in a foreign jurisdiction cannot be relied upon was rejected since this was on an application for an interim injunction. (Para 57)
A reminder of the Importance of Disclosure
The court’s reliance on Roche’s statements during the prosecution of application in foreign jurisdiction raises an important point- disclosure of corresponding foreign application u/s. 8. As I wrote here, this provision ensures the disclosure of crucial information relating to the invention and keeps a check on the conduct of the Appellant. Patent Amendment Rules, however, do away with this requirement. The case again brings out the importance of this provision.
On Obviousness
On obviousness, the Court notes in Para 68 that the only difference between suit patent and compound 809 (genus patent) is the replacement of CH group by Nitrogen in the former:
Thus, it would be obvious to PITK to replace CH with N since both the elements are bioisoteres i.e. same number of electrons. Further, given that Nitrogen is a dominant component in 809, a PITK would be easily motivated to replace the CH with N in 809 to get Risdiplam.
As a result, the Court was convinced that prima facie, the suit patent was vulnerable to revocation.
Public Interest Factor
Typically, for interim injunction, the Court has to examine three factors- (i) prima facie case; (ii) irreparable loss; and (iii) balance of convenience. However, in cases involving critical lifesaving drugs, the Court also has to consider another factor- ‘public health.’
In this blog, we have discussed cases where the Court has failed to consider the public interest factor in deciding cases involving critical lifesaving drugs. (here, here, here and here)
Fortunately, in this case, the Court gets this right. The Court notes that- “availability (of the drug) to the public at large at very economical and competitive prices is a material factor.” To reiterate, Risdiplam is the only drug available in India for SMA patients. The Court acknowledges that “costs involved for the drug… are much larger, as compared to the aid provided under the aforesaid National Policy for Rare Diseases.” Noting that Defendant could bring price reduction to the drug in its entirety, the Court concludes that the balance of convenience lies in the favour of Defendant.
Way Forward
The SC, last month, had said that the central government should negotiate with Roche to get concessional rates for SMA patients. The Court, in this case, considers foremost the impact on the availability of the drug for the general public. No doubt, the judgement is a step towards increasing the accessibility and affordability of Risdiplam.
As noted here, the judgement “is expected to bring down the prices of the said drug by 90%.” Purva Mittal, one of the intervenors (and SMA patient), also hoped that the “judgement will pave the way for affordable access for SMA patients.”Seba P.A., another intervenor who was suffering from SMA, said “I believe that the court’s decision will provide relief to SMA patients in our country.”
However, the battle is far from over after Roche has preferred to appeal the matter. Seba P.A., another intervenor who was suffering from SMA, had argued that
Orphan drugs are nearly impossible to manufacture without government assistance. 63 rare diseases are included in the National Policy for Rare Diseases. But how many of them are accessible? An annual dose of Trientine used to treat Wilson’s disease costs Rs 1.6 crore. Eliglustat drug for Gaucher’s disease is priced at Rs 1.8 crore annually. (here) How do we solve this inaccessibility, which is more acute for rare diseases?
The Indian Organisation for Rare Diseases suggests that the only viable solution is to domestically manufacture these drugs which would significantly reduce the prices. Even then, it is a hassle to get the regulatory nod from the DCGI or get access to the patient database to understand the demand. India needs to act on this quickly. One cannot rely on Courts always to provide access to lifesaving drugs whose job is to enforce the Patent. The Indian government needs to act and act now.