An IPAB bench consisting of Chairman Manmohan Singh J. and the new technical member for Patents Dr. B.P. Singh has quashed the Controller of Patent’s decision that revoked Novartis’s patent on the anti-cancer drug Ceritinib. It held that while the compound was contained in a broader genus patent, it was not ‘disclosed’ therein, as it hadn’t been specifically identified. The 104-page order examines several issues regarding novelty and obviousness, the extent of coverage and disclosure, and timelines for filing of evidence.
Background
Novartis’s Ceritinib is an ALK inhibitor targeted at non-small lung cancer treatment. The compound was granted an Indian patent on 26th September 2016 (IN 276026). Natco had filed a post-grant opposition in 2017, and the patent was eventually revoked by an order dated 16th August 2019. In July 2020, this revocation was stayed on grounds of serious procedural lapses (discussed here).
In the present appeal against the Controller’s revocation, Novartis argued that the Controller completely disregarded the Opposition Board’s report which had recommended that the opposition be dismissed and the patent be allowed to stand. It also accused the Controller of violating principles of natural justice by selectively considering Natco’s additional evidence but rejecting the subsequent rebuttal evidence filed by Novartis. On merits, it insisted that the Controller had not applied the test of novelty to assess the patent, instead relying on hindsight analysis and cherry-picking of the compound’s constituents.
Fee Payment, Timelines and Additional Evidence
Before delving into the merits, the order tackled several procedural issues plaguing the post-grant opposition. Natco had paid an amount of ₹2,400 at the time of filing opposition on 26th September 2017, which is the amount payable by a natural person. As a legal entity it was required to pay ₹12,000. The balance was paid on 8th November 2017, after the statutorily permissible 1 year period for filing opposition had expired on 30th September 2017. Although this issue had not been raised, IPAB pointed to Section 142(2) of the Patent Act and held that the Controller’s order of 16th August 2019 being passed on a non-existent post-grant opposition was not maintainable ab initio.
The failure to adhere to timelines prescribed by the Patent Rules 2003 was also taken up. Like the stay order mentioned above, the present order criticised the fact that additional evidence was accepted long after the fixing of hearing on 25th September 2018, against the mandate of Rule 60. It further clarified that Rule 138 (Controller’s discretionary power to extend time periods) could not have been invoked in any circumstances as Rule 60 does not provide any timelines to begin with. The order also criticised the contradictory statements made in the revocation order where the Controller first states that no further evidence was considered (para 3), and then goes on to say that an ‘important document’ has been brought into its notice and has therefore been considered (para 6). IPAB was also of the view that the rebuttal evidence filed by Novartis ought to have been considered by the Controller as the Delhi High Court had intended the same in its order.
This reiteration of the significance of statutory timelines is much needed, seeing as there has been another recent case of Ibrutinib patent, where additional evidence was admitted several days after the fixing of hearing, at odds with Rule 60. Interestingly, in this case too, both IPAB and the Delhi High Court had reprimanded the Controller, with the former awarding a stay on the Controller’s revocation due to this reason (discussed here and here). This revocation has now been quashed as well.
What amounts to Disclosure?
Natco’s ground for opposition was that Ceritinib is covered in the markush structures of two earlier patents (IN 240560 and IN 232653) which reveal a broad genera of compounds that anticipate it. They argued that there is no technical advance that Ceritinib makes over these patents. Novartis had countered this, arguing that the generic disclosure of a chemical class did not take away the novelty of a specific compound within the class, unless the latter was ‘individualised’.
IPAB noted that all the documents relating to the earlier patents that were considered for post-grant revocation had already been scrutinized at the stage of pre-grant examination. The objection had been dropped as Novartis’ reply was deemed satisfactory. No additional facts had been brought forth. With that established, it looked into the Opposition Board’s report. The report had concluded that while a series of compounds had been described by way of a Markush Structure, none of the earlier patents exemplified compounds suggested the modifications required to obtain Ceritinib.
Novartis insisted that only identification, and clear and unmistakable directions (in the prior art) to do what the patentee claims to have invented would anticipate the claim, and in the absence of that, Ceritinib could not be said to have been ‘disclosed’ by IN ‘653 and IN ‘560. Natco refuted this, citing the judgment of Merrel Dow Pharmaceuticals v. HN Norton & Co., to suggest that there is no specific requirement in law that a compound must be disclosed by name, structure or formula in prior art. Scrutinizing the exact wording of Merrel, IPAB rejected Natco’s interpretation and sided with Novartis on requirement of specific identification (para 10).
Looking into the expert affidavits submitted by the parties, IPAB took the view that listing the compound in question in the Orange book for Patent Term Extension (PTE) under US law does not amount to disclosure. It only means the compound is ‘read on’ or ‘encompassed’ in the structure of the broader genus patent under which it is listed. Requirements of PTE are different from those of novelty and inventiveness and ought not to be mixed up. As the former is inapplicable in India, it cannot have a bearing on the decision.
It then referred to the cardinal rule that any anticipatory disclosure must be contained within a single document, unless multiple documents are linked in a manner intended to be read as one. Lack of novelty cannot be established through a cumulative effect by forming a ‘mosaic of elements’ taken from several documents. It also found that one could not have worked Ceritinib naturally from the prior art except through ‘hindsight analysis’. This refers to the method of drawing a line from the solution to the problem with the benefit of hindsight, as opposed to working the solution from the problem. For this reason, IPAB agreed with the Opposition Board’s recommendation and held that the cumulative effect of unclear and ambiguous prior art could not be said to have anticipated the compound. The Controller should have considered the report and if he disagreed, he should have explained with reasons.
Notably, this view captures the essence of Rule 62(5) which requires Opposition Board’s recommendation to be considered and reasons to be provided. Previous decisions such as Supreme Court’s Cipla v. Union of India have laid great emphasis on this. The IPAB itself has stressed this in the Ibrutinib stay order discussed above.
Coverage v. Disclosure
It is stated in para 9.5 that Novartis cited AstraZeneca v. Emcure (AstraZeneca), a recent controversial decision where the Delhi High Court had accepted an argument asserting that coverage may be greater than disclosure. The court had interpreted Supreme Court’s decision in Novartis v. Union of India (Novartis) to hold that while the earlier genus patent in question covered the compound of Ticagrelor, it was only disclosed and marketed in the later species patent (discussed here).
Although the present order does not discuss how Novartis relied on AstraZeneca to build its case, IPAB has analysed the issue of the (false) dichotomy between coverage and disclosure by relying on Novartis, which held that ‘the coverage in a patent might go much beyond the disclosure thus seems to negate the fundamental rule underlying the grant of patents’. This complements the principle in Section 10(5) which requires claims to be clear, succinct and based on the matter disclosed in the specification in order to be patented. IPAB observed that since sufficiency of disclosure is a prerequisite for grant of patent, the question of whether a given claim sufficiently discloses all that it seeks to cover, relates to the patentability of that particular claim. Therefore, it is to be ascertained by the Controller while examining that patent, not raised in opposition to any subsequent patent which adequately describes and claims a specific subject matter (para 19.8). As the two earlier patents had been examined and granted, there was a natural presumption that there was no gap between coverage and disclosure that needed to be addressed.
It is important to note that unlike AstraZeneca, the patent in question here was the species patent. The primary inquiry did not focus on whether a compound could be covered in the earlier patents and disclosed in a later one, but on what amounted to disclosure. Once it was established that the earlier patents did not disclose (identify) the compound, a plain application of Novartis led to the natural conclusion that only the subject matter that disclosed it was covered (patentable).
IPAB’s take on the coverage-disclosure issue is a sound one, drawn from the fundamental economic principles behind patent law. The system of patenting awards a limited monopoly in exchange for complete disclosure of the invention. If a party were to claim that it ought to enjoy monopoly despite not disclosing the invention in the same patent, it would defeat the bargain. This view is reflected in Novartis. After the perplexing ruling in AstraZeneca, the Ceritinib interpretation helps clarify the law by emphasizing disclosure/enablement for the purpose of determining coverage.
why patent application status is not available at IPO
“It is important to note that unlike AstraZeneca, the patent in question here was the species patent. The primary inquiry did not focus on whether a compound could be covered in the earlier patents and disclosed in a later one, but on what amounted to disclosure. Once it was established that the earlier patents did not disclose (identify) the compound, a plain application of Novartis led to the natural conclusion that only the subject matter that disclosed it was covered (patentable)”???
If memory serves me right AstraZeneca v. Emcure was a case where the species was asserted, not the genus.
The author’s views on whether a subsequent ad interim stage order can differ from an interim judgment on the same issue, the same patent asserted by the same Plaintiffs??