Posts in International

South Africa currently faces a stark choice between protecting and incentivizing innovation and stymying life-saving therapeutic breakthroughs. Policymakers must choose between shoring up the protections that encourage the development of medicines that enhance and extend life, or sabotaging innovation through the weakening of the patent system. South Africa is purported to have the highest number of people living with HIV in the world, people who have the most to gain from breakthrough therapies. Innovative medicines have contributed to the 85 percent decline in the death rate from HIV/AIDS since 1995. The benefits of future medicines will become a reality only if these medicines are incentivized and developed. Strong, effective IP protection is essential to that process.

I prophesy that the best we can hope for is a Bilski-esque vague instruction (wherein our top court opined that some business methods are patentable, citing the machine or transformation test as one viable test, without pointing to other valid tests and without enlightening the confused public.) The Court is once again likely to limit software patentability in some arcane way that harms job creation and stifles economic growth. The bright side is that the Court’s failure to protect our largest growth industries may help spur the legislative branch into further action. A decade of intermittent patent reforms has created a permanent cadre of patent lobbyists very willing to focus their considerable efforts and talents on a new patent issue. It would be advantageous to the patent system if that attention were productively channeled to specifically include our emerging technologies in our patent statutes, and to legislate patent eligibility in a manner that treats 101 as the broad filter it was intended to be, while employing the other patent statutes, such as 112 and 103, to correctly provide the narrower filters.

The Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the Office for Harmonization in the Internal Market(Trademarks and Designs) (OHIM), the State Administration for Industry and Commerce (SAIC) and the United States Patent and Trademark Office (USPTO), (hereinafter referred to as the “Partners”) held the 2013 TM5 Annual Meeting in Seoul, Republic of Korea on 5-6 December 2013.

If this is a conspiracy to bring down Gurry it is one that includes a bipartisan group of highly experienced and very well respected Members of Congress. Having become a political watcher of sorts, it seems almost laughable to believe there is a conspiracy at play. The United States Congress cannot agree on anything any more, so when long serving, distinguished Members from both sides of the aisle uniformly agree and seek action and answers from the Obama Administration I take notice. Bipartisanship seems to so rarely happen any more, so when Members of Congress set aside party politics and unite there has to be at least some legitimate reason for careful scrutiny.

A source with knowledge close to the situation has also told me that “there will be other shoes to drop; the DNA episode is not the last.” To the outside world Gurry is affable, knowledgeable and a perfect ambassador of the benefits of intellectual property. Internally, however, he hides things and fosters conflict so that he can rise to the moment and come to the rescue. Indeed, aside from the various scandals WIPO appears to be an extremely dysfunctional workplace, which can only hinder the mission.

Francis Gurry, the Director General of the World Intellectual Property Organization (WIPO), finds himself in a precarious position this week as news has surfaced about a bizarre and presumably illegal acquisition of DNA samples from WIPO employees. Gurry has already been under pressure from Member States because he has been unable to pass a budget for WIPO, which many attribute to being uncomfortable with the cozy relationship seen between Gurry and Russian President Vladimir Putin. Gurry signed a deal to set up a WIPO office in Moscow, which reportedly has rubbed at least some Member States the wrong way.

Innovation provides new therapies and breakthrough treatments that extend and enhance life. The scientific and financial resources required for these advances are an investment worth making and an important precedent for global health. Patents encourage those innovations, making cutting-edge treatments a reality. Patents give innovation life. Current efforts to amend existing intellectual property legislation to “fix” the patent system will only undermine the incentives that encourage innovation. All innovation, both breakthrough discoveries and incremental improvements, is valuable and should be protected and rewarded. India, Brazil, South Africa and other emerging economies should take note. Their proposed changes, aimed at weakening intellectual property rights protections, are misguided and potentially very damaging to public health.

Employers often spend considerable resources recruiting, hiring and training key talent, only to face potential disaster when those trusted employees quit to join a competitor, often taking sensitive files on their way out the door. Even if they don’t act in bad faith, departing employees carry critical, confidential information inside their heads, which can’t be deleted. Fortunately, various remedies may be available for the former employer, from confidentiality and non-competition agreements, to lawsuits for actual or threatened misappropriation of trade secrets and the doctrine of inevitable disclosure. But there’s a conflict. Employers have a legitimate interest in preventing misappropriation of trade secrets, while employees have a legitimate interest in utilizing knowledge and skills gained through work experience and working for employers of their choosing.

Looking forward to an intermediate and longer-term horizon, Gurry explained that Member States should seize the moment to work toward establishing a legal global digital marketplace to replace. He explained that fears about such a global marketplace should not bog down the effort because there is already a global digital marketplace in effect, but that the one currently in existence is one that is an illegal marketplace that does not respect the rights of creators.

The friction between Pooley and Gurry has been something of an open secret. While not widely reported, as far as I can tell Wegner is accurate when he says this Congressional letter touches on a point of friction. I have heard at various times about the cool relationship between the two, and I have been told that Pooley unsuccessfully objected to WIPO’s sale of computers to North Korea.

Last week, police detained three employees of Taiwanese smartphone-maker HTC, raided their homes and offices and seized their computers and cellphones to search for evidence, as HTC is accusing them of stealing sensitive technology to sell to HTC’s competitors. The three men – a vice president of product design, director of R&D, and senior designer – are accused of stealing secrets relating to HTC’s Sense 6.0 smartphones, which are scheduled for launch later this year. The accused purportedly formed design companies in Taiwan and China and began speaking with Chinese phone-makers about selling them the stolen secrets. They are also accused of defrauding HTC out of more than US$300,000, by use of forged documents, apparently to raise capital for their new venture.

As many following India IP issues are well-aware, in 2012 India issued the 1st compulsory license (CL) to Natco for Bayer’s anti-cancer drug Nexavar. The granting of this CL was further upheld by the Intellectual Property Appellate Board in Spring 2013, leading to great concern and condemnation in the international IP community, especially by those in the Pharma field. Also in Spring 2013, BDR Pharmaceuticals, Ltd. filed the 2nd Indian application for a CL (still pending) for Dasatinib, Bristol Meyers Squibb’s blockbuster anti-cancer drug. Thus it appears to be the beginning of a trend for Indian pharma companies to request CLs, and I believe that this trend will continue and likely increase.

In a recent article in the New England Journal of Medicine, Amy Kapczynski argues that the Supreme Court of India’s strict interpretation of the country’s new patent law provides a model to be followed by other countries. Kapczynski applauds this “Patent Law 2.0” and argues that it will enhance access to medicines and may improve pharmaceutical innovation. Unfortunately she is wrong on both counts. Section 3(d) of the Indian Patent Act forbids the patenting of new forms of known drugs unless the new form significantly enhances efficacy and yields therapeutic benefits. Accordingly, much of the incremental innovation that is done on existing treatments will no longer be patentable under the so-called Patent Law 2.0. These are not issues considered by Kapczynski. Astonishingly, she interprets the impact of this law as follows, “Provisions like Section 3(d) can help reverse this effect [prioritizing incremental innovation over breakthrough drug discovery] and encourage companies to undertake the riskier and more expensive research that is required to generate breakthrough drugs.” Her analysis is strikingly naïve. It is laughable to think that weaker intellectual property rights (IPR) protection will incentivize innovative pharmaceutical firms to expend more resources and take on greater risk.

Newly implemented policies, compulsory licensing practices, and recent court decisions have heightened concern about IPR in India. Congressmen Erik Paulsen and John Larson expressed their worries with India’s intellectual property violations in a letter written to President Obama. Over 170 members of Congress, consisting of a bi-partisan support, signed the letter. During their speeches at the GIPC, the Congressmen emphasized that this bi-partisan support demonstrates the grave concern of IPR in India and the importance of persuading India to comply with global practices. The Congressmen sent the letter just prior to a visit to India by Secretary of State, John Kerry.

As in the U.S., when drafting claims in China, one must describe the invention sufficiently to enable a person skilled in the art to make and use the claimed invention. For software patents, a flow chart and explanation should be included, along with drawings and description of associated hardware. Portions of the source code may be included for reference. Software claims may be drafted as either method or apparatus claims. However, Justin Shi, patent attorney at Sony Mobile Communications in Beijing, warns that apparatus claims may be deemed invalid if they are phrased only in means-plus-function language and fail to describe the apparatus or its embodiments.