Other Misc comments from 2014 Special 301 submissions.

National Association of Manufacturers (NAM)

India denies patent protection for inventions that would otherwise meet internationally accepted criteria. Since 2012, patents for at least 16 products have been invalidated, denied or revoked for various reasons. For example, under TRIPS, patents must be granted for inventions that are new, involve an inventive step and are capable of industrial application. But India’s patent law creates an impermissible fourth “enhanced efficacy” test. On that basis, India denied patents last year for an anticancer therapy that is already patented in 40 other countries around the world.

US-China Business Council

Full submission here.

Inventor remuneration. Further revise the draft Regulations on Service Invention in close consultation with all stakeholders, including foreign businesses, to address concerns, including provisions that would override existing investor-employer agreements, that inappropropriately extend remuneration to cover “know-how” or trade secrets, and that set standards limiting the ability of inventors and companies to openly negotiate appropriate remuneration.

The Intellectual Property Owners Association (IPO)

Full submission here.

. . . the Indian Government not yet passed the National Innovation Act,11 which would have been a positive step towards providing a more robust IPR environment. The Innovation Act would include a range of measures to promote innovation (including an annual “Science and Technology Plan” and provisions to aid public/private partnerships, promote innovation financing and establish special innovation zones). It would also codify rules on the protection of confidential information. Because protection to date relies on common law principles, the scope of protection is often unpredictable. . . .

Third Party Access to Essential Facilities in India . . . Section 5.1(vi) of the Competition Policy contains a blanket requirement for dominant infrastructure and IPR owners to grant third party access to “essential facilities” on “agreed reasonable and nondiscriminatory terms,” without providing more specifics about the situations in which this requirement may or may not be justified.. Experts have heavily criticized blanket application of an “essential facilities” doctrine to IPR owners, and such application has been severely curtailed around the world. A broad international consensus exists that the unconditional, unilateral refusal to license a technology rarely raises competition concerns. In addition, the decision not to license a technology is considered to be the most fundamental right conveyed under the IP rights laws – namely, the right to exclude.

. . .

China’s State Intellectual Property Office has been developing a new administrative Regulation intended to increase employer payments for “service inventions” that are created during an inventor’s employment, apparently in the belief it will increase innovation. The draft Regulation, if passed, will negatively affect the ability of companies to determine how best to incentivize innovation by its own employees and will increase legal and financial risks of conducting R&D in China. For example, under the second paragraph of Article 19, any agreement or policy reasonably implemented by an employer regarding inventor remuneration could be subject to repeated challenge as somehow “limiting” an inventor’s rights and could be retroactively supplanted by SIPO’s onerous default rules.

Peter Pitts, CMPI

Price isn’t the problem, and patents don’t prevent access in developing countries. In fact, few of the approximately 400 drugs on the World Health Organization’s model essential drug list have ever been patented in the world’s poorest countries.