Since Novartis v. UOI (2013), a growing litany of cases relating to genus-species patent have been decided by various HCs of the country. Post Novartis, a consistent (and contentious) issue has been whether a later species patent stood disclosed and, thus, priorly claimed in the prior genus patent u/s. 64(1)(a). However, the recent decision of the DHC in FMC Corporation v. Natco raises the inverse issue- does a prior species patent anticipate a later genus patent u/s. 64(1)(a)? This question, in my research, has not been previously decided by Indian Courts.
Facts
Unlike previous genus-species dispute, the present case did not relate to pharmaceuticals patents. Rather, it involved a patent over a method of preparing ‘N-Phenylpyrazole-1-carboxamides’ (IN 298645), used to manufacture insecticides. Claim 12 of suit patent covered a compound of Formula 3 used as an intermediary during the manufacturing process.
FMC alleged that Natco used the compound of Formula 3 as an intermediary to manufacture ‘Cyantraniliprole.’ Natco, admitting to use of the alleged compound, thus, infringed IN’645 and FMC sought an interim injunction.
Natco, on the other hand, argued that IN’645 was invalid for ‘prior claiming’ and ‘lack of novelty’. It claimed that the suit patent was a genus of prior art IN 269104, which disclosed three compounds covered under Claim 12. The prior speciespatent covered the compounds under Claim 12. Thus, suit patent stood priorly claimed u/s. 64(1)(a).
Determining Genus-Species relationship
FMC, to counter invalidity, argued that the suit patent and IN’104 did not share a genus-species relationship. The two patents shared a distinct lineage, differing scope and purpose, and no enabling teaching to make the other.
When can it be said that two compounds share a genus-species relationship?
The Guidelines For Examination of Patent Applications in the Field of Pharmaceuticals, a genus encompasses a group of closely related compounds which share a common chemical structure (or backbone). Further, the structure consists of functionally equivalent compounds in one or more place. (refer here for meaning of functionally equivalent) Inevitably, the species which can be extrapolated from the genus inevitably share a common part of the chemical structure. (EPO Guidelines)
Does the suit patent share a common chemical structure with IN’104?
Figure 1: Comparison of the structure of IN’104 (left) and Suit Patent (Right)
The Court, based on the above comparison, noted-
- both the structures have a common benzene ring having common molecules at position 1 and 2, i.e., C(O)NH and NH2.
- both (prior art and suit patent) claim compounds of 2-Aminobenzamide, meaning, they have a common core structure, and thus share a significant structural element.
Thus, relying on the above laid down principles, the Court concluded that the suit patent and IN’104 share a genus-species relationship.
However, the Court did not discuss whether, apart from the commonality of structure, the prior art consisted of functionally equivalent compounds. Does this break the link between genus or species relationship? Having a limited understanding of chemistry, I leave this question for the readers.
Killing Reference: “Disclosure” of Prior Species and Prior Claiming
In a 1971 paper, Goldberg called the “disclosure of a single species in a reference” (or prior art) as the ‘Killer Reference.’ Why? The existence of a single species in the prior art invalidates the genus for lack of novelty or anticipation. American case laws- In re Gosteli and In re Slayter– have stated “a generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.”
In the present case, the Defendant argued invalidity for prior claiming u/s. 64(1)(a). It was argued that IN’104 disclosed three compounds encompassed in claim 12 of the suit patent-
Adarsh Ramanujan, in ‘Ramanujan’s Patent Law’, highlights three approaches taken by DHC while deciding Prior claiming-
- Re-monopolization Test– Astrazeneca I laid down that to determine prior claiming, the Court has to see whether the latter claim, on a fair construction, would re-monopolize that which is in prior claim, on its fair construction.
- Identical Claims– In Kudos, the Court held that a genus and species patent must have identical claims for the prior claiming objection to apply.
- Proof of Enablement– In FMC v. Best Crops, the Court held that for a successful prior claiming objection, the challenger must show that the genus patent enabled a POSITA to reach the covered species.
(i) and (iii) test, as Ramanujan argues, are distinct- (i) requires that every embodiment covered under the disputed claim is priorly claimed whereas (iii) requires the challenger to show that the covered claim was also disclosed or enabled to succeed in prior claiming. Thus, (iii) adds an additional burden of showing enablement.
In the present case, the Court, in Para 72, agrees that a species automatically anticipate a genus. Why? It notes:
“If a patent is granted over a specific claim…(a) broader genus, would necessarily encompass the earlier specific species within it…. leading to double patenting and re-monopolization of the specific species.”
The Court, thus, adopts the (i) approach to decide prior claiming in this case.
However, as Ramanujan notes, none of the above tests are binding and there is no single correct view on the subject.
The present dispute is unlike the ones before: here, the genus, allegedly, is priorly claimed in the species patent. The suit patent i.e. genus encompassed 40 compounds as per the Plaintiff. (Para 6.14) On the other hand, the species (IN’104) encompassed only three compounds. (Para 7.11) Admittedly, there was an overlap of three compounds. (Para 7.22)
Should the test re-monopolization be applicable here?
The Court, before applying this test, noted: “(if) there exists a species-genus relationship between the said two patents…(it) would lead to automatic anticipation of the genus by the species.” (emphasis added) (Para 67 & 72)
This is where I see potential for mischief: the Court, for some reason, has assumed that mere existence of a species patent would anticipate the genus. This assumption, to add, would be “automatic.”
For the below reasons, I disagree.
The U.S. cases cited by the Court to affirm this view hold- “a generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.”
Further, the Manual of Patent Office Practice and Procedure cited, too, observes that “a specific disclosure in the prior art takes away the novelty of a generic disclosure.”
The above detracts from the Court’s view of automatic anticipation. Rather, it requires that the prior species was ‘disclosed.’ Sec. 10 and Sec. 11 mentions that a claim must be fairly based on the matter disclosed in the specification. In other words, the claim must be supported by the description to enable a POSITA to make and use the invention. Only then, the invention stands disclosed. If not, it is not fairly based on the matter disclosed under the Act.
As a result, automatically assuming anticipation owing to mere existence of a species is erroneous and not supported by the cited authorities.
Although the Court notes, in Para 48, that a POSITA will be able to use the invention in IN’104, it is wrong to automatically assume anticipation of genus without assessing disclosure.
The Court, before applying the re-monopolization test, could have provided reasons as to why it deviated from the above authorities. Rather, it cited them with approval without realizing that it was, in fact, moving away from it. If it did follow them, then the (iii) would be applicable, not (i).
Novelty
Even on Novelty, there are reasons to disagree from the Court. To prove lack of novelty, all elements of a claimed invention must be disclosed in a prior art. (here) Further the prior art must enable a POSITA to reproduce the invention without undue experimentation. (Lava) The standard of novelty is not different for genus-species disputes.
Since genus, at times, encompasses millions of compounds, how does disclosure of a single species invalidate a genus for lack of novelty? The species does not enable a POSITA to reach each element encompassed in the genus.
Although a species discloses the significant structural element of the genus, that, by itself, is not sufficient to reach all compounds encompassed in a genus. Even a genus, to be valid, should enable the POSITA to reach other species with routine, not undue, experimentation.
In the present case, the species neither claimed all elements of the genus nor enabled a POSITA to make and use the genus. Novelty, thus, was not adequately addressed in the Judgement.
(A big thanks to an anonymous reader of the blog for their inputs. Also, Swaraj and Praharsh for their long and insightful discussion on the case)
