It’s been a busy summer. This brief note provides an update of the quickly-changing Compulsory License and Statement of Working situations in India. In some cases, companies may want to strategically-reconsider their current standard procedures, especially with respect to Statements of Working.
Compulsory License Denied for Trastuzumab
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.
On July 18, 2013, at the US Chamber of Commerce, the Global Intellectual Property Center (GIPC) hosted an event, “India: International Outlier on IP.” The two-part event began with Congressmen John Larson (D – CT) and Erik Paulsen (R – MN) giving keynote speeches about the concerning status of IP law in India. A panel discussion followed consisting of David Torstensson, Senior Consultant, Pugatch Consilium; Manisha Desai, PhD, Assistant General Patent Counsel, Eli Lilly; and Michael Schelsinger, Counsel, International Intellectual Property Alliance.
The GIPC previously released its International IP index, Measuring Momentum, on December 11, 2012. Pugatch Consilium ranked nations based upon intellectual property rights (IPR) to provide a global overview. Various factors included patent enforcement, fairness of compulsory licensing, copyright term of protection, and membership to international treaties. Not surprisingly, Brazil, Russia, India, and China (BRIC) comprised the bottom of the list. While most would expect China to be ranked last, India was ranked last overall and in almost all individual categories, including Foreign Direct Investment (FDI), Research and Development Spending, and Membership and Ratification of International Treaties. David Torstensson of Pugatch Consilium noted that while IPR in China are lacking, some legislation does in fact exist, which helped its ranking. Notably, India is the only country in the study that is not a signatory for any international IP treaties, such as the Patent Law Treaty (PLT) and World Intellectual Property Organization (WIPO) Internet Treaties.
In the United States, attorneys, judges and others have struggled for decades to determine when, if ever, computer programs or software should be eligible for patent protection. In the 1960’s the U.S. Patent Office declared that software could not be patented. Since then, a series of court decisions have rejected that view and established that one may definitely patent software in the U.S., although the exact requirements remain unclear and critics increasingly demand that it should not be patentable.
As a starting point, 35 U.S.C. §101 provides that any new and useful process, machine, manufacture, or composition of matter, or new and useful improvement thereof, is eligible for patent protection, subject to other requirements of the Patent Act (that is, §101 is just the threshold test for patentability). Congress has never stated any limitations to the patentable categories of §101 and case law has only recognized three categories of exceptions – subject matter that may not be patented: laws of nature, physical phenomena and abstract ideas. Computer software is often found to be ineligible on the ground that it comprises abstract ideas, but courts have struggled to provide a precise formula or definition for abstract ideas.
Trademarks are an important protection for any business, but nowhere in Canada is this as vital as in Québec, where failure to have a registered trade-mark may lead to notices and fines for business owners. These are precipitated, but not imposed, by the Office de la langue française (translated to: Office of the French Language), or OQLF, a public organization mandated to uphold the quality of the French language, and to ensure it become the “normal and everyday language of work, instruction, communication, commerce and business” in the province of Québec. Since the 2012 provincial election that saw a return to power for Québec’s leading sovereigntist party, the Parti Québecois, the OQLF has been implicated in a few high profile cases that have muddied the waters for businesses operating in Québec.
Most famously, in November 2012, major retailers such as Walmart, Gap and Best Buy, decided to take the organization to court after receiving notices and potential fines. Many major retailers have already made francization efforts: notably KFC to PFK (“Poulet frit Kentucky”) and Starbucks, who added “Cafe” before their brand name. The OQLF is looking for the other big retailers to follow suit, adding a French descriptive such as les magasins (“stores”) to their signs. Louise Marchand, former head of the OQLF, made the bold statement, “Displaying the name of the company in French is a show of respect for the law.”
Over 850 delegates from more than 100 countries are attending the three-day meeting from 24 to 26 April that is being chaired by the World Customs Organization (WCO) and hosted by Turkish Customs with the support of the Union of Chambers and Commodity Exchanges of Turkey.
United around a common goal to stop the trade in counterfeit and pirated products, the organizers and participants aim to share experiences and devise strategies to counteract this global phenomenon and the harm these goods can have on consumer health and safety, as well as intellectual property rights (IPR).
During a recent trip organized by AIPLA’s Special Committee on Intellectual Property Practice in Israel, I had the pleasure of meeting the enthusiastic and tireless Asa Kling, who is the Director of the Israel Patent Office and Commissioner of Patents, Trademarks & Designs. Since stepping into the role in 2011, he has focused on ensuring that Israel’s patent office matches Israel’s status as one of the world’s foremost technological innovators.
In 2012, the Israel Patent Office examined nearly 7,000 (6,800) new applications and reduced the time to first examination to less than 3 years (32.5 months). Leading American companies, such as Raytheon, Qualcomm, and Genentech, have signaled their faith in the importance of the Office by filing hundreds of patent applications in Israel within the last year. Additionally, since June 2012, the Israel Patent Office has become one of only sixteen active offices to operate as an International Searching Authority (ISA)/ International Searching and Preliminary Examination Authority (IPEA) for international Patent Cooperation Treaty (PCT) applications.
After the trip, I had the honor of asking Commissioner Kling a few questions over the phone. The transcript of our conversation is below, and is edited for length and clarity.
Northern Exposure focuses on Canada and Canadian intellectual property laws, cases and procedures. From time to time we will also publish a Canadian perspective on important issues relating to US and Global intellectual property. For more articles please visit Northern Exposure – Canadian IP.
After receiving Royal Assent on June 29, 2012, the provisions of Bill C-11 came into force on November 7, 2012. Titled the Copyright Modernization Act, it has garnered the nickname “Canada’s SOPA” by some media outlets , referring to the highly contentious Stop Online Piracy Act bill introduced in the US House of Representatives that led to both physical and digital protests. Yet despite such bold claims, the Canadian amendment to the copyright act is a largely innocuous piece of legislation that falls in line with its stated objectives.
Before delving into the major points of the bill and of its critics, it is important to note that an amendment has been a long time coming. The last one was in 1997. To put it into perspective: that was the year IBM’s Deep Blue defeated Garry Kasparov, and a good five years before any viable form of digital music became available for consumers. This means that for the better part of fifteen years, Canadians have been acting beyond the limitations of 20th century technological terminology. Instead, in the void of proper legislation, the Supreme Court of Canada has set the precedents, with five of the most recent rulings made in July 2012.
On February 19, 24 members of the 27 European Union signed a unified patent court agreement in Brussels, Belgium. Bulgaria is expected to sign once it completes internal administrative procedures, but because the single patent will only need to be in English, German or French, only the countries of Poland and Spain have so far refused to join in the effort.
What does this all mean?
Efficient patent protection in Europe is a cost-intensive procedure. Overall, the acquisition of patent protection in all 27 European Union (EU) member states, including the costs of litigation, costs around 36,000.00 EUR (approx. US $48,000) today to book. This compares to an average price of a U.S. patent of 1850.00 EUR (US $2,500).
In light of these high costs, efforts have been made over the last 30 years to make patents uniformly applicable. Although the agreement for a European patent was signed in 1975, it hasn’t been close to reality until recently.
How to Write a Patent Application is a must own for patent attorneys, patent agents and law students alike. A crucial hands-on resource that walks you through every aspect of preparing and filing a patent application, from working with an inventor to patent searches, preparing the patent application, drafting claims and more.
Without hesitation I recommend One Simple Idea and think it should be required reading for any motivated inventor. There is so much to like about the book and so much that I think author Stephen Key nails dead on accurate. The book is educational, information and inspirational. For the $14 cover price it is essential reading.
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