US Biotechnology Innovation Organization CEO Jim Greenwood told Indian Prime Minister Narendra Modi this week if he follows western practices on intellectual property protection, his country would see a “tidal wave” of biotech industry investment.
“If your government joins the global community on IP rights, your industry will see a tidal wave of biotech investment and expansion right here in Gujarat,” he said. “Because with India’s remarkable STEM workforce and low R&D costs, the potential to innovate here is virtually limitless.” [STEM refers to science, technology, engineering and math]
Saying the United States also struggles with the “moral dilemma of making cutting-edge medicines more affordable without stifling innovation,” he argued that India should move beyond striving only to be the world’s top generics producer.
“[T]he question I’ll leave you with today is this: Will India embrace its tremendous potential to innovate, or be content to merely imitate?” he said.
Greenwood gave the speech in Gujarat on 11 January which BIO entitled, “India Can’t Become a True Global Biotech Leader Until It Protects Its Innovators’ Work.”
Greenwood also said, “The Indian government must create a more attractive climate for biotechnology investment, so innovators can access the capital they need to research and commercialize their products.”
He took credit for helping create the biosimilars in the US by lobbying in Washington: “We had a robust internal debate about how biologics should be treated under American law. Some of our member companies didn’t want to sanction any generic competition. But I strongly disagreed with this approach. I told them we have a moral responsibility to create a pathway to get affordable biologics to patients in need.”
He lavishly praised Indian ingenuity and business acumen in the US and India, and pointed to policymakers as needing to understand the innovators’ perspective. He said Modi had taken some “encouraging steps” such as not using compulsory licensing, but pushed him to do more: “[T]here’s much more work to do – to allow patenting of new products and to enforce companies’ IP rights.”
Greenwood took a familiar jab at India’s Section 3(d) law that requires patents to be granted only for true innovations rather than “evergreening” modifications of existing medicines. “Laws like India’s section 3D deny patents for modern, improved medicines,” he said.
He added, “[H]ere’s the sober reality: There is only so much Gujarat or any state government can do to attract biotech investment in a country with loose IP laws and strict price controls on many biotech products. That’s going to be a tough sell to potential biotech investors.”
“Biopharmaceutical companies spend billions of dollars to research, develop and secure government approvals for new treatments. These billions come from just two sources: investors and sales revenue from existing treatments,” he said. “Basic economics tell us that to attract sufficient investment, an industry’s returns must be commensurate with its risks. The biopharmaceutical industry is among the most hazardous sectors for investment. Our projects – and our companies – have a 90-percent failure rate.”
“Therefore,” said Greenwood, “investors require a strong return when they do finance a success. Their confidence in our industry’s ability to deliver healthy profits for a small number of winners fuels the entire system.”
And this is a good time to change strategies, he said, as many new breakthroughs may be coming. “I do believe we are on the cusp of revolutionary advances that will enable us to use gene editing, immunotherapies, cell therapies and other techniques to dramatically accelerate our progress toward our vision of a world without disease, hunger or pollution,” he said.
Greenwood highlighted innovation in the US and the thoroughness of lobbyists in Washington, saying: “American companies produce 57 percent of the world’s new medicines. Our innovators have discovered and commercialized more pharmaceuticals than the rest of the world combined. We miss few opportunities to remind our elected officials that biotech innovation is just as dependent on good policy as it is on good science.”