Judicial development post 2005 amendment of Patent Act, 1970 [sec 3(d)]

There has been massive development in field of pharma post 2005 amendment of the Patent Act, 1970. The important cases thus are explained below. 

NOVARTIS AG DRUG GLIVEC CASE

Figure 2 Timeline for the landmark judgement on Sec 3(d).

Facts- 

Novartis, a swiss drug firm filed an application for seeking patent in Chennai Indian Patent office in 1998 under TRIPS agreement. The drug, ‘Glivec’ for treatment of Chronic Myeloid Leukaemia and Gastrointestinal Stromal Tumours, patented under 35 countries was rejected under the non-amended sec 5 however post 2005 amendment, sec 5 was repealed. Upon applied again, it was rejected on the grounds of novelty and non-obviousness. Sec 3(d) was invoked and it was decided that because of non-existence of therapeutic efficacy over Zimmermann patent, it cannot be patented. Novartis then challenged the constitutionality of sec 3(d) stands violative of TRIPS agreement as well as Article 14 of Indian Constitution. Post dismissal of this appeal, Novartis filled SLP in SC of India in 2009. 

Issues-

There were several issues raised however we concern ourselves with the meaning of efficacy u/s 3(d) and whether the increase of bioavailability is increase in therapeutic efficacy. 

Arguments-

The main argument of ex-Soliciter General of India, Gopal Subramaniam for Novartis was the fact that Zimmerman does not constitute as prior art as the composition of both the medicines vary. Alongside this was claimed that the beta crystalline form used in imatinib DOES increase the efficacy to pass the test u/s 3(d). The fact that imatinib was suitable for oral form was result of technologically advanced invention leading to an INVENTION. 

Judgements-

It was decided by 2 judge bench of SC that ‘Efficacy’ u/s 3(d) meant ‘Therapeutic Efficacy’ and no other property than this form of efficacy is important in case of pharmaceuticals. Thus, court rejected the appeal of Novartis. The reasoning given by court was that the courts want to prevent the evergreening of patented products thus providing relief to those who cannot afford it. the fact that India is a developing nation and it has been known for the cheaper drugs speaks again the monopolising the pharma market. 

Analysis- 

This attracts negative connotation to the interpretation of sec 3(d) for it appears to be encouraging restraint on incremental inventions. Contradictory to the court’s judgement, evergreening rather promotes monopolisation as it promotes high price of drugs. While we know that patents are to promote innovation via incentivising, the forum of patent can thus be utilised for promotion of innovations in healthcare. The definition of efficacy for aforementioned motives shall hence include development in bioavailability, heat stability, low side effects, more shelf time, safety etc. this step would also promote research and development sector of healthcare. 

F. HOFFMAN LA ROCHE V CIPLA

Facts-

Roche claimed Cipla infringed patent 774 in Delhi High Court. The court dismissed Roche’s claim in support of public interest by not prohibiting Cipla (Indian Manufacturer) from continuing the patent and production. It then appealed the Division Bench which upheld High Court’s decision for the court felt that Roche was unable to build a strong suit of infringement. The case heard as SLP was rejected as well lading to return of Roche back to single judge foe the trial of main relief. Roche could not prove that Cipla infringed IN774 thus the appeal in division bench.  

Arguments and judgement-

Cipla’s defence against Roche’s claim was that Roche’s patent was invalid as erlotinib is a derivative of quinazolin and did not involve any inventive steps. The complete specification disclosed did not specify the method of invention precisely. Roche’s drugs are approximately 4 times costly than Cipla’s and as the drug is a ‘life saving drug’, the interest of public shall be kept in mind. It also claimed that important information has been hidden by Roche as the medicine is made with mixture of polymorphs which is not quite useful in pharma. 

Roche invoked sec 3(d) stating that it does not allow derivatives of known substance. However, it was decided that Roche has applied for the patent of polymorph B which was earlier denied by Indian Patent office as against sec 3 (d). Court also held public interest above all. Here where a life saving drug is in question, court decided to dismiss Roche’s appeal as Cipla provided better and cheaper drug. 

Aishwarya Says:

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