November 1, 2010 (Vol. 30, No. 19)

Substantive Harmonization Is More Likely than a Single Universal Structure

The biotechnology industry is both patent-dependent and increasingly global, yet, there is no such thing as a “global patent.” Instead, patents are national rights, granted and enforced according to the laws of a particular country. These laws vary, both with respect to procedure and substance. 

The result? Considerable confusion, time, and expense for patent applicants and a growing demand for change, both from within the biotechnology industry and from other sectors also burdened by the complexity of the national system.

In 2009, Horacio Gutierrez, deputy general counsel for Microsoft, created an online stir by publicly calling for the creation of a “world patent.” Gutierrez’ world patent would “be derived from a single patent application, examined and prosecuted by a single examining authority, and litigated before a single judicial body.” 

Could a truly global patent system ever come to pass? And if it did, would it solve the problems of the current system? Or, is there another alternative—something short of a world patent—that might still satisfy the needs of biotechnology companies and others struggling with the current system?

In fact, while patents are territorial, there are already global aspects to the current system. Most were established under international treaties in response to past frustrations not unlike Gutierrez’. The Paris Convention for the Protection of Industrial Property—the world’s first intellectual property treaty—arose from practical necessity. In 1873, the Austria-Hungarian Empire invited other countries to Vienna for an exhibition of inventions. Attendance was light, in part because foreign exhibitors believed their inventions would not receive legal protection.

Rebecca Kaufman

This led to a series of events culminating in the Paris Convention, which provided inventors who were nationals of one member country the right to national treatment in other member countries, as well as a right of priority (i.e., the right to have a filing date in the home country recognized as a filing date in another member country). Today, more than 170 countries are members of the Paris Convention.

Decades later, the Patent Cooperation Treaty (PCT) was born from the recognition that incredible efficiencies remained for those interested in pursuing multinational patent rights. The PCT’s principal objective was to provide a simple and inexpensive way to initiate the patent process globally—by filing a single initial patent application. The PCT also provided for a preliminary search and examination of the application.

The World Intellectual Property Organization’s (WIPO) Patent Law Treaty (PLT)—concluded in 2000—harmonizes certain additional procedures, reducing or eliminating formalities and the potential loss of rights among its members.

But procedural improvements can only help so much. No patent can issue directly from a PCT application. Instead, the PCT really works to delay the inevitable, while hopefully providing more information to the applicant about likely prospects before entering the costly national phase, where the applicant still becomes subject to the laws of the particular nation. 

There have been some successes in substantive patent harmonization under the current national system. Substantive harmonization would provide, in theory, for a similar course of prosecution (and outcome) on a global basis. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), concluded in 1996, established the requirement that member countries provide patent protection for any type of invention, as well as a uniform patent term (20 years from the earliest filing date). Yet, TRIPS leaves some of the most important substantive decisions up to the member countries.

Overall, substantive patent harmonization has been slow going. The WIPO is almost a decade into efforts to spearhead substantive patent law harmonization through the proposed Substantive Patent Law Treaty (SPLT). The debate remains focused on what substantive issue should be considered and in what order of priority. Developing nations generally oppose substantive harmonization out of concern that it may negatively impact public health by limiting access to medicines.

In theory, the more radical proposal put forth by Microsoft’s Gutierrez would fully streamline procedural and substantive issues by adopting a single set of rules, administered by a single granting and enforcement body.

But how would it be implemented and at what cost? A system of this type would result in a loss of sovereign authority, which has been a roadblock to substantive harmonization. There are examples in which nations have ceded control to international tribunals in the past, most notably the International Criminal Court (ICC), which carries out prosecutions for genocide, war crimes, and crimes against humanity. Apart from the divergent subject matter, however, even the ICC defers to a member nation with jurisdiction and the ability to properly prosecute the case.

While the buzz surrounding a global patent system continues, the more likely result is the continued push for substantive patent harmonization. As the SPLT slowly moves forward, the practical problem of the massive patent backlog is prompting some national patent offices to work more closely together on patient examination.

The Patent Prosecution Highway (PPH) was created in the form of a series of bilateral agreements that permit member patent offices to take advantage of work sharing. When at least one claim has been found allowable in the office where the application was first filed, accelerated examination of corresponding claims can be requested in a second office.

The U.S. currently has PPH agreements with Europe, Japan, and several other countries. Collectively, efforts of this type are producing a more harmonized and efficient system with a solid base of support that, while less radical than a truly global system, will ultimately benefit patent applicants.

Rich Miller

Rebecca Kaufman ([email protected]) is a partner, and Rich Miller([email protected]) is an associate in King & Spalding’s Intellectual Property Group.

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