New Delhi: Biotechnology products, often billed as the future of medicine, have emerged laggards in securing patent protection in India, as the numbers seeking protection surge and government authorities struggle to ascertain innovation in these products based on living organisms.
While such patent applications have crossed the 2,800 mark—a jump of more than 750 times—in the last five years, approvals are stuck at a low 122, according to the annual report from Office of Controller General of Patents.
India’s patent offices received 1,525 applications in 2005-06, the latest data available, up from two in 2001-02, but granted patent immunity to merely 51 products. The other categories scored much better with the patent office clearing 1,140 patents for chemicals from 5,810 applications, 457 for drugs out of 2,211 filings and more than 4,300 from 24,500 applications across all categories.
A change in India’s patent regime in 2005 is seen as the prime reason to have caused a sudden spurt in biotechnology patent filings. “Before that, 90% of biotech products were unpatentable,” said H. Subramanium, a New Delhi lawyer specializing in patents. The Indian Patent Act, in Section 3, provides for patents on micro-organisms that are not naturally occurring in nature and methods of treatment involving artificial introduction of a gene. The law, however, has kept gene therapy, tissue engineering, foetal tissue research, or cloning outside the purview of patentable products.
Experts offer a slew of other technological and commercial reasons on what is causing biotechnology to trail even though it is a subject of intensive research and investigation among drug makers, agriculture scientists and other specialists globally. “There are inherent complexities in biotech products that make them harder to examine than regular chemical-based drugs. The patent office, with lesser experience than their global counterparts in the field, is also more cautious,” said Subrata Ray, general manager of ratings agency Icra.
Biotechnology has always been a slippery ground for regulators in patent issues as these products are drawn from living organisms and have challenged the concept of when a naturally-occurring substance has been modified enough to earn a patent.
The intrinsic complexity of biotech products—they are made up of complex chain of proteins and bigger molecules as compared with simple, smaller drug molecules—is one reason impeding speedy disposal of their patent applications. “The authorities have to investigate thoroughly if there is any higher living organism beyond a micro-organism that is involved,” said Subramanium.
There are business strategies at play that experts say have increased the number of biotech patent filings. “Companies file for a patent very early on (to secure patent immunity and fend off competitors), but don’t request for an examination of their own patent applications,” said a senior official in the Office of Controller General of Patents and Designs. A patent filing in India grants the applicant up to five-and-a-half years of protection from a competing filing before the government decides to accept or reject the application.
An executive from Bharat Biotech International Ltd, a company that has received seven patents out of the 15 filed, said patent offices needed more staff to process biotech filings. “Even though the new patent law came into existence two-and-a-half years ago, it is only in the last one year or so that the patent office has started sprucing up its manpower and infrastructure to take on the increased number of biotech applications,” said Krishna M. Ella, chairman of the firm. “It will take a while before they catch up with the lag,” he said.
Another New Delhi pharma firm that has 400 drug and biotech patents filed and 150 procured, admitted that a lot of companies in this field go bust if a couple of their products fail. “One might file a patent and then find a superior technology and product, in which case it is best not to pursue the earlier patent,” the company executive said.
The Patent Cooperation Treaty that allows for unified filing of a patent across several countries, is another reason that a lot of applications end up being filed even though they are sure to fall by the side, given the definition of patentability in India.