Indian pharma industry, having got recognition and appreciation for its leadership role in generic pharmaceuticals, needs strong support from the government to move on to the New Drug Discovery Research phase. To this extent, the new initiatives of the government and the timing of the National IPR Policy announcements are welcome, said noted patent expert Dr Gopakumar G Nair.

In an email interaction with Pharmabiz, Dr Nair who is also chairman of IPR Committee, IDMA said that Creative India – Innovative India concept enshrined in the newly announced National IPR Policy is welcome.

Of late, Indian pharma is facing severe impact of NTB (Non-Tariff Barriers) and TBTs (Technical Barriers to Trade) though exclusions from private (treaty) arrangements and punitive negative actions on quality, GMP, regulatory inspections and issues thereof. The invisible but submerged link is for all to see. In this context also, the announcement of the IPR policy is a “peace keeping” effort from the government. The vision and mission statements are simply laudable and well-stated. It may, specifically be taken note of that “focus on enhancing access to healthcare” is of vital social, economic and technological importance, as stated in the new National IPR Policy, he said.

Among the objectives, the awareness creation objectives continue to be of importance. The “Creative India : Innovative India” is astoundingly well-appreciated. However, in all other great initiatives of the government of India, such as “Skill India”, “Digital India”, “Make in India”, “Swatch Bharat”, though well intentioned, the delivery to the needy is still very much falling short due to the “middlemen” (gobbling) up, all the moola. The fund and the money allotted is going into the pockets of the powerful middlemen. This should not happen in the IPR policy. The gap between intentions and achievements/performance must be reduced and should avoid middlemen in procedures, the noted patent expert cautioned.

As far as “Generation of IPRs” are concerned India is far falling short. Due to increasing costs and more adversely increasing delays are putting off the inventors and applicants, leading to fewer filings.

Balancing of interest of right owners with larger public interest is very much welcome. It is heartening to note that the IPR Policy assures “India shall remain committed to the Doha Declaration on TRIPs Agreement and Public Health.” The revamping of IPR office administration is already happening, streamlining and making it cost effective and user-friendly is welcome initiatives. Considering all IPRs under one roof and formation of CIPAM (Cell for IPR Promotion and Management) is welcome, he added.

India has been far behind in commercialisation of IPRs or licensing of IPRs. CSIR which is one of the prolific patent filing entity in India, has been commercialising or licensing only 1 to 2 per cent of its IPRs.

Intellectual Property Appellate Board (IPAB) had shown promise initially in deciding on IPR disputes. However, over the years, IPAB has slowed down or come to standstill. Adjudication of IPR disputes through alternate dispute resolution mechanism is welcome. Commercial Courts can succeed only if adequately qualified judges in good numbers are available.

The “deadlock” over “Patent Agent examination” not being held for last few years, consequent to not appealing the Chennai High Court judgement is worth removing to improve Human Capital Development. Measures to improve this scenario are welcome. The IPR Policy should not face the fate of other policies in implementation. Even though the government announces “public and private sector institutions and other stakeholders, including state governments, will also be involved in the implementation process”, the “middlemen” appointed monopolistically corner all powers and financial gains depriving the genuine volunteers and beneficiaries. This scenario should not repeat in IPR Policy implementation, Dr Nair opined.

The government deserves compliment in IPR initiatives already. Many country experts are already complimenting India for digitalising the Patent, Trademarks, Design data and transparency of information available online from the “official website” of Indian IPR office. It is being commented that the Indian Patent & Trademark Official site (www.ipindia.nic.in) is getting good or closer to USPTO. Moves in this direction are welcome.

The government of India has already taken positive and constructive steps to alleviate the miseries and sufferings of the patenting community by minimising or eliminating the irritants road blocks and hurdles for researchers in natural products, herbals and biotechnology, by bringing the implementation of the Biodiversity Act more inventor-friendly and patentee-friendly. This will go a long way in making “Make in India” and “Research in India”, as success.

The Indian pharmaceutical industry welcomes the new “National IPR Policy”. As stated therein, it is hoped that implementation and procedural steps, will fully honour the flexibilities incorporated in the Indian Patent Act, 1970 and the assurances of affordable access, declared consequent to hard bargain, through the Doha Declaration for support to public health and nutrition, Dr Nair concluded.