The FDA recently issued Guidelines on Product Recall of health products, placing overall responsibility of conducting product recalls with the Market Authorization Holder (MAH). In particular, MAHs are responsible for providing an appropriate product recall strategy and implementing the same. The Guidelines also created a Product Recall Committee whose principal functions are to review "triggers" for product recall, issue recall resolutions and monitor recall implementation.
Here are some of the salient points of the amended rules on Inter Partes Proceedings.
1. The period to file a notice of opposition and answer has been extended from 90 days to 120 days, restoring the original period under the previous Inter Partes rules.
2. For opposition documents executed abroad, authentication may be secured after filing of the opposition case provided that the execution of the opposition documents is prior to such filing and that proof of authentication is submitted prior to the issuance of default order or conduct of preliminary conference. Notably, there appears to be no similar provision in respect of authentication of answers. Thus, it apppears that authentication of answers must still be done before their filing.
2. The Hearing/Adjudication Officers is now authorized to issue and sign decisions and final orders. Previously, this authority was reserved only to the Director of Bureau of Legal Affairs and the Committee of Three (in petitions to cancel patents).
3. The decisions or final orders in Inter Partes cases must now be issued within 60 days from the date the case is deemed submitted for resolution.
4. The appeal to decisions or final orders issued by Hearing/Adjudication Officers must be filed with the Director of the Bureau of Legal Affairs prior to the appeal with the Director General of the IPO. This adds another layer to the appeals process.
The Intellectual Property Office has released the amendments to the Implementing Rules and Regulations on Inter Partes Proceedings (IPOPHL Memorandum Circular No. 16-007). The amendments took effect on 29 July 2016.