American Invents Act Strategies Highlighted at the IPCC Conference

Patently BIOtech

By David SaravitzAlston + Bird

Day 2 of the 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Spring Conference kicked off with a panel on the America Invents Act (AIA).  The panel focused on how practitioners and the U.S. Patent & Trademark Office (USPTO) are dealing with various provisions of this new patent act.

Mr. Ira Finkelstein, Senior Patent Counsel with Baxter Healthcare, led off the session initially discussing the first-inventor-to-file provision of the AIA (§ 3) which becomes effective on March 16, 2013, and the interplay of its one-year grace period for public disclosures by an inventor.  Mr. Finkelstein reminded the audience that in most foreign countries a pre-filing, public disclosure by the first inventor would be disqualifying prior art.  Thus, Mr. Finkelstein concluded that his strategy is: “Don’t rely on the grace period. File early, and file often!”

Mr. Finkelstein also discussed the best mode requirement of 35 U.S.C. § 112, first paragraph.  Mr. Finkelstein pointed out that § 112 still requires an applicant for a patent to disclose the best mode contemplated by the inventors and that he will continue to require his inventors to disclose the best mode in patent applications. According to Mr. Finkelstein, it is likely that this information will need to be in the disclosure anyway, to support claims to narrow, dependent claims.

Dr. Murray Spruill, Leader of the Alston & Bird’s Biotechnology, Chemical and Pharmaceutical Patents Group, took the podium next to discuss “Post-Grant Proceedings.”  Dr. Spruill pointed out that a defendant in an infringement lawsuit older than 1 year after the patent owner files a complaint alleging infringement of a patent needs to decide whether to bring an inter-partes challenge against the patent in USPTO before September 16, 2011 because the defendant would be barred from requesting the new inter partes review proceeding in such a circumstance.  Finally Dr. Spruill reviewed similarities and differences between the new post-grant review and inter partes review proceedings

The third and final speaker was Dr. Remy Yucel, Director, Central Reexamination Unit (CRU), U.S. Patent & Trademark Office.  Dr. Yucel indicated that since the inception of reexamination proceedings at the USPTO the number of reexamination filings per year has generally trended upward.  She indicated that, although there has been a sharp increase in number of reexamination filings per year since 2002, the CRU had reduced the time from filing to the issuance of a reexamination certificate from about 40 months in 2006 to about 22 months in 2011.

Regarding reexamination and the AIA, Dr. Yucel pointed to three key changes that would impact the CRU: the change in the standard for granting an inter partes reexamination (IPR) effective September 16, 2011; the transition from inter partes reexamination to inter partes review at PTAB effective September 16, 2012; and the commencement of supplemental examination on September 16, 2012.  Dr. Yucel indicated that the new, AIA-mandated “reasonable likelihood” standard for instituting an IPR does not require that the requester establish a prima facie case. And, unlike the prior standard of the “substantial new question,” the AIA-mandated standard does not require that a legal question be “new.”

Next, Dr. Yucel turned the focus to Supplement Examination.  Some of the proposed rules that she discussed provide that the request must be filed by owner of the entire right, title, and interest in the patent, that third party participation is prohibited, that the number of items of information is limited to 10 per request, and that an unlimited number of requests may be filed at any time.  Dr. Yucel also discussed proposed rule 610 which indicates that the request must include: a list of each item of information and its publication date; identification of each issue raised by each item of information; explanation for each identified issue; identification of how each item of information is relevant to each aspect of the patent to be examination and how each item of information raises each identified issue; a copy of each item of information; and a summary of each document over 50 pages in length.

Dr. Yucel discussed  the equitable conduct immunization of supplemental examination but later indicated that if Director learns of “material fraud” committed in connection with the patent subject to supplemental exam, the Director has authority to confidentially refer the matter to the Attorney General and may take other action pursuant to § 257(e).  She indicated that the Office regards “material fraud” to be narrower in scope than inequitable conduct as defined in Therasense.  77 Fed. Reg. at 3667.  Before concluding her presentation, Dr. Yucel discussed some additional non-AIA-related changes to streamline the reexamination practice before yielding the podium to permit the audience to ask her and her fellow panelists some questions.

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