On Monday, a DB of the DHC allowed Zydus to manufacture and market a biosimilar of the drug Nivolumab, marketed as Opdivo. The DB order is well-reasoned, providing a clear demarcation between infringement analysis and biosimilarity. Nivolumab, which is at the centre of the controversy, is an anti-cancer medication which increases the ability of the immune system to kill cancer cells.(here) I have previously explain how this drug works here. The EMA website states that Opdivo has “has been shown to benefit patients with certain advanced cancers…(and) effective in preventing the cancer from coming back after surgery in patients with melanoma, oesophageal cancer, cancers at the junction of the oesophagus and the stomach, and urothelial cancer.”
Being a life-saving drug, this is a heartening news for cancer patients in India. Currently, as per this report, Nivolumab can cost more than Rs. 1 Lakh per vial for treatment. Depending on the duration of treatment, the costs can run into several lakhs. (dosage requirement) Now, as per Zydus’s submissions, the biosimilar version would be at least 70% cheaper. So, all in all, this is a positive outcome.
Last I heard, the order has been appealed to the SC. If the readers have come across any such news, please link it in the comment section.
Biosimilarity does not mean Infringement!
A major reason for overturning the SB’s order was absence of claim-mapping i.e. mapping the infringing product against the claims of the patent application. As I wrote in my post, the Judge chose to dispense with the requirement of claim mapping to decide infringement. Since it was a quia timet application and Defendant’s product was not available for mapping, it relied on the proof of biosimilarity to decide infringement.
Back then, I had criticized this approach and written- “similar biologic only needs to be of comparable quality to the reference biologic in terms of identity, purity and potency.” That alone, however, does not prove that the biosimilar falls within the claims of the patent. I had also pointed out how this could lead to an ‘backdoor’ entry for patent linkage.
Hearteningly, the DB rejected the SB’s approach. It noted- “The issue of whether a biosimilar product can, on that basis alone, be said to be infringing of the reference biologic, appears to us to be extremely thorny. If the impugned judgment is accepted, every biosimilar product would, on that basis alone, infringe the patent claimed by the reference biologic.”
The DB, therefore, completely rejects the notion that the mere proof of biosimilarity is conclusive evidence of infringement. Rather, it says that “mapping of the product to the granted claim in the patent becomes indispensable.”
Mapping does not only mean claim-to-product mapping. It could mean any method which proves that the Defendant is dealing in a product falling within the patented claims.
To me, this is a welcome holding for future litigations involving life-saving biologic drugs.
How do you prove Infringement?
Although the decision is welcome, it leaves a larger question hanging- how exactly do biologic innovators prove infringement if claim-to-product mapping is not possible. This question has loomed large in another case- Hoffman v. Zydus (here).
In that case, Hoffman has been unable to secure an injunction against Zydus from manufacturing a biosimilar of Pertuzumab. Since the injunction application was filed even before the biosimilar’s launch, Zydus’s product was not available for mapping.
However, in that case, the Court never allowed the Defendant to launch. As a result, the fear of market erosion from launch of biosimilar never took place. The monetary interests of the biologic innovator, thus, stood protected.
The DB order, however, puts biologic innovators in a bind- If it files a quia timet injunction before the launch, it doesn’t have a product to map and prove infringement. Following the dictum in Para 26.5.8, if the biologic is life-saving, the Court will allow the launch of the biosimilar since there is no conclusive proof of infringement.
Where does that leave biologic innovator companies?
One approach could be to wait for the launch of the biosimilar and map the product against their claims to prove infringement. Even the court acknowledges that public interest will take a backseat if infringement has been made out through product-to-claim mapping. (26.5.6). However, this approach risks market erosion to some extent. Quia timet injunctions protect precisely against this risk of substantial market harm.
So what else can be done?
High Court of Delhi Rules Governing Patent Suits, 2022, to prove infringement, requires precise claim versus product chart mapping that compares each element of the claim and the manner in which Defendant’s product/process infringes the claims. In Novartis v. Zydus, the DHC, however, had held that it was not strict requirement.
In the present case also, the Court emphasised that other methods of mapping could also be used to prove infringement. It doubted whether doctrine of equivalents could be applied in cases relating to pharmaceuticals. It doesn’t give an answer as to what these other methods could be.
Where does this lead to?
Without an effective way to secure quia timet injunction, biologic innovators face a real risk of market harm by losing out to biosimilars. They will have to come up with a way to prove infringement before the launch of the product. Reddy and Thakur had pointed here how biologic companies leverage the inadequate legal framework for approval of biosimilars to “ cloud the credibility of these biosimilars.” As a result, even beyond the expiry of patent term, doctors would be hesitant to prescribe biosimilars, churning in revenue for the original biologic.
Would it use the same strategy here? We will have to wait and see. For now, the table are, albeit slowly, turning.
Bolar Exemption
Readers of the blog might remembers the huge controversy which had erupted after the SB order, claiming that the scope of 107A was being whittled down. However, there was no discussion on that in the present order.
There could be two reasons for that. One, Zydus maybe did not raise this issue in appeal. From the order, no such arguments seem to have been made. Two, Wander v. Antox limit the appellate bench’s power to overturn the finding unless either the discretion has been exercised arbitrarily or it ignored settled law. This severely limits the DB’s discretion to give a contrary finding on the issue.
