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The Impact of the First to File Statute on Life Sciences
The Leahy-Smith America Invents Act (AIA) is changing United States patent law. The reforms being implemented are similar to key jurisdictions all over the globe. On March 15, 2013, the first to file law went into effect, replacing the US’s first to invent standard and beginning the transformation of US patent filings. LMG Life Sciences Editor Phillip Bausk spoke with a few attorneys to see how the first to file system is already playing a significant role within the industry.
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nited States patent law was considered to be well behind the curve compared with patent law in most parts of the world. Recent patent reforms in the US are bringing the country up-to-date with trends and procedures that are commonplace in many other key markets. With the implementation of the first to file law, the US is taking the first big step towards major patent reform. For over 65 years, the US patent filing protocol recognized the first to invent as the proper patent holder, a stark difference from the first to file system used in other major markets in the IP industry. As the industry has become more global, it was clear that the United States needed to change certain aspects of its patent law to mimic Europe and Asia, two of the industry’s largest marketplaces. Other important IP hubs within the industry such as Brazil and parts of South America have also been first to file jurisdictions. “Intellectual property is such a vital part of the life sciences industry, which has long valued markets outside the US,” states Ropes & Gray partner David Halstead. “With the first to file system firmly established in most parts of the world, life science companies are better prepared to deal with this change in the US, even if the United States’ version isn’t a carbon copy of Europe’s or any other jurisdiction’s patent filing law.“ Halstead thinks that industry-related companies are well-equipped to deal with the first to file system because of their experience in other jurisdictions and are ready for the changes coming in the US. These adjustments to the law will both maintain and enhance the value of the US market in the global life sciences community. Marshall Gerstein & Borun partner David Gass believes, “The US continues to be an important market and the ability to get meaningful patent protection in a valu-
able market can be an important business consideration for life sciences companies. I think that companies familiar with 'first to file' from seeking protection in other jurisdictions were more prepared for the switch than inexperienced filers or US-only filers.” There are some nuances to the US’s first to file statute that differ from other parts of the world. Firms are quickly educating clients about both the similarities and the differences with regard to US, European, and Asian patent filing laws. “Most international companies are already very familiar with first to file provisions based, for example, on their experiences in Europe,” explains Gwilym Attwell, partner at Fish & Richardson. “We have been working with clients to develop strategies that will allow them to deal with the obstacles and opportunities they may face with the new first-inventor-to-file law in the United States.”As life sciences companies are becoming familiar with this new procedure, they are also going to become more comfortable with challenging their competitor’s patents. Another element of the AIA is the transition from reexamination proceedings to the new inter partes review and post-grant review methods. These procedures are more cost-effective than litigation, and while they do come with some risk, they provide good opposition opportunities for others investing in their own patent application. Even though these review forums have been in place since last September, they have yet to play a major role concerning life science patent filings and contestations. Frost Brown Todd partner Steven Goldstein believes, that the first inventor to file aspect of the AIA will modify the current approval and filing of patent applications. “As soon as a company gets to the point where they have technology of value, they are going to file a provisional
patent application covering what they know as of the provisional filing date. This will lead to a series of provisional applications that will be folded into a final patent application.” Goldstein thinks that over time, as parties become more comfortable with the review procedures, we will see these reviews become commonplace in the industry. He states, “Post-grant review and inter partes review are going to be a regular part of the practice. The law here is still not as clearly defined as in Europe or other countries, and once the procedures and estoppel effects become more clearly defined by court decisions, these procedures will be used more frequently and effectively.” Both international and domestic companies are familiarizing themselves with the new changes in US patent reform. It will take a great understanding of the new first to file system in place to help usher in a new era of US patent filings.
“With first to file going into effect, you now have a lot of interested parties, mainly life sciences companies, who are more prepared to be active in the US market.” Gass adds, “These companies are always conscious of filing first and this helps their prospects in the US marketplace.”
LMG LIFE SCIENCES 2013
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