MVS Filewrapper® Blog: FDA Releases First "Purple Book" for Biosimilar Products

The Biosimilars Act (BSA) was passed into law on March 23, 2010 with the goal of encouraging the market entry of generic products, similar to the system that exists for generic drugs under the Hatch-Waxman Act.  The BSA sets forth an abbreviated approval pathway for biologics through a regulatory demonstration of biosimilarity (i.e. interchangeability).

 

More than 4 years after the BSA went into effect, the FDA has released its "Purple Book" listing biological products, including any biosimilar and interchangeable biological products licensed by FDA.  The Purple Book is intended to serve a similar function to the "Orange Book" that lists drug products with therapeutic equivalence evaluations that have been approved by the FDA.  The release of the Purple Book follows closely behind the filing of the first two applications for approval of biosimilar products.

 

For more information about the BSA, see the June 2014 issue of MVS Briefs, available here. 

More information on the "Purple Book"—including current lists of licensed biological products— is available from the FDA website here.

 

 

 

 

 

MVS Filewrapper® Blog: USPTO Glossary Pilot Program

The USPTO has instituted a new program, the Glossary Pilot Program, which began June 2, 2014. The program will allow applicants for computer-related inventions to petition to make special entry into the Glossary Pilot Program with the filing of an application. Applications accepted into this pilot program will receive expedited processing and be placed on an examiner’s special docket prior to the first office action, with special status up to the issuance of the first Office action.

This program is set to run for six (6) moths through December 31, 2014, but may be cut off once the USPTO accepts 200 grantable petitions.  The program is intended to encourage the use of a glossary that provides clear definitions for some terms used in the claims in order to help the reader understand the disclosed invention with a higher level of clarity.

In order to qualify for the Glossary Pilot Program, all of the conditions set forth in the Federal Register Notice, must be met. Specifically:

(1)   The application must be an original, non-reissue, non-provisional utility application that does not claim benefit of a prior filed non-provisional U.S. application, unless the application is a continuation-in-part application filed for the purposes of providing a glossary.

(2)   The application and petition must use Form PTO/SB/436 and must be filed after June 2, 2014 and before the pilot deadline expires.

(3)   The claimed invention must be classified in one of the Art Areas related to computer-related and business method inventions, including those involving Computer Architecture Software and Information Security (Technology Center 2100); Computer Networks, Multiplex, Cable and Cryptography/Security (Technology Center 2400); Communications (Technology Center 2600); and Transportation, Electronic Commerce, Construction, Agriculture, Licensing and Review (Technology Center 3600).  The complete list of qualifying Art Areas is available here.

(4)   The glossary must be placed at the beginning of the detailed description portion of the original specification of the application, identified with a heading, and presented on filing of the application. Definitions for key terminology found in the claims, terms with special definitions, abbreviations, relative terms, terms of degree and functional terminology should be provided, but cannot rely on other parts of the application for completeness, cannot consist of what the term does not mean, cannot be open-ended, cannot consist solely of examples and synonyms, and cannot be disavowed elsewhere in the specifications.

(5)   Filing must be done via EFS-Web.

(6)   The application must contain at least one claim, but no more than four independent claims, and no more than 30 claims total.

 

Status of the petition will be available via Private PAIR. If a dismissal decision is received, the applicant can file a petition if it is believed that the dismissal is not proper. Also, any preliminary amendment filed after the application has entered the pilot program but before the issuance of the first Office Action will be entered unless the amendment causes the application to be non-compliant with the requirements of the program. More information can be found at the USPTO's website.

MVS Filewrapper® Blog: USPTO Proposes Rule Changes for International Design Applications

The U.S. Patent and Trademark Office is seeking comments on it proposed rules for implementing the provisions of Title I of the Patent Law Treaties Implementation Act of 2012.  The law is the implementing legislation for the 1999 Geneva Act of the Hague Agreement Concerning the International Registration of Industrial Designs (“the Hague Agreement”).  The rules proposed rule changes under the law will allow applicants to file a single international design application; U.S. applicants will be able to file a single application, potentially seeking protection of an industrial design in more than 40 territories.

Under the proposed rules, international design applications could be filed by U.S. applicants in the USPTO as an office of indirect filing, meaning that the USPTO would transmit the international design application to the International Bureau of the World Intellectual Property Organization (“WIPO”).  The International Bureau would review the application for compliance with the applicable formal requirements under the Hague Agreement. Where these requirements have been met, the International Bureau would register the industrial design in the International Register and, subsequently, publish the international registration and send a copy of the publication to each designated office. Since international registration would only occur after the International Bureau finds that the application conforms to the applicable formal requirements, examination before the Office would generally be limited to substantive matters.

According to the USPTO proposal, the “major changes to U.S. practice in title I of the PLTIA pertain to: (1) Standardizing formal requirements for international design applications; (2) establishing the USPTO as an office through which international design applications may be filed; (3) providing a right of priority with respect to international design applications; (4) treating an international design application that designates the United States as having the same effect from its filing date as that of a national design application; (5) providing provisional rights for published international design applications that designate the United States; (6) setting the patent term for design patents issuing from both national design applications under chapter 16 and international design applications designating the United States to 15 years from the date of patent grant; (7) providing for examination by the Office of international design applications that designate the United States; and (8) permitting an applicant's failure to act within prescribed time limits in an international design application to be excused as to the United States under certain conditions.”

Additional information, including the specific proposed rules and information on how to submit comments, is available here.

Failure to disclose patents to SSO results in unenforceabilty against products using standard

In a recent decision, the Federal Circuit affirmed-in-part a district court decision that a patentee had breached a duty to disclose relevant video-compression technology patents while participating in a joint video team standards-setting organization (SSO).  The Federal Circuit, however, reversed in part the district court decision finding the patents unenforceable against the world, instead holding the patents should only be held unenforceable against products embodying the applicable video standard.

The court affirmed the district court's finding that the case was exceptional and awarding attorney fees to the defendant.  The plaintiff had concealed the existence of tens of thousands of relevant documents throughout discovery, with their existence not revealed until near the end of trial (we previously blogged about the district court's decision awarding fees here).  The Federal Circuit held this litigation misconduct was sufficient to support the exceptional case finding even absent the failure to disclose the patents to the SSO.

More on Qualcomm Inc. v. Broadcom Corp. after the jump.

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