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The Center for Biosimilars asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.  Venable Fitzpatrick partner Ha Kung Wong weighed in.

 

Ha Kung Wong, JD, partner at Venable
“Regarding developments this year, the most interesting from a legal perspective was the United States Supreme Court’s decision in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, on April 24, 2018, holding that the inter partes review (IPR) procedure does not violate Article 3 of the Constitution. Thus, IPRs are still a viable route for challenging a patent.

According to BiologicsHQ, all challenged claims are found unpatentable in 67% of IPR Final Written Decisions concerning biologic products. So you can understand how this is incredibly important to biosimilars companies, as it provides a significant route for challenging patents that may pose infringement concerns in advance of potentially engaging with the convoluted ‘patent dance’ detailed in the Biologics Price Competition and Innovation Act.

As for the future, one case that biologics and biosimilars companies should keep an eye on is Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc., case number 17-1229, currently before the United States Supreme Court, where the scope of the on-sale bar after the America Invents Act (AIA) is at issue.

The on-sale bar holds that sales of an invention that occur more than a year before a patent application is filed are prior art that can be used to invalidate a patent. Importantly, the on-sale bar is in play even if these sales are confidential and no details of the invention are disclosed. However, many believe that the AIA has narrowed the on-sale bar so that it is in play only when the public sales actually disclose the details of the invention. This decision will be particularly interesting since it not only concerns legal precedence, but also aspects of legislative history and intent of the AIA.

For biologics and biosimilar products, this decision can significantly impact how they conduct business, and when they seek patent protection for various aspects of their product. Will the Supreme Court put us in line with other countries by narrowing the on-sale bar, or will it stick with history?

We should find out soon, as the case was argued before the Supreme Court on December 4, 2018.”

 

Read the full article here.


Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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