Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants. Today, we count down stories #15 to #12, and then throughout the week, we will work our way towards the top three stories of 2012. As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look. As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.
15. USPTO Continues Efforts to Cut Application Backlog and Pendency
In November, the U.S. Patent and Trademark Office released its Performance and Accountability Report for Fiscal Year (FY) 2012, which indicated that the Office had met all of its annual performance targets. For one of those targets -- average total pendency -- the Office not only hit its target by achieving a 32.4-month pendency (versus the target of 34.7 months), but it surpassed the average pendency achieved in each of the three previous fiscal years. The Office also noted that despite an increase in application filings (565,566 in FY 2012 versus 537,171 in FY 2011), the number of applications awaiting action dropped from 690,967 in FY 2011 to 633,812 in FY 2012 (the fourth consecutive year that the number of applications awaiting action had dropped) and the total number of pending applications decreased from 1,168,928 in FY 2011 to 1,157,147 in FY 2012. However, despite the improving numbers, the Office has continued to seek ways in which to cut the application backlog and application pendency. One issue on which the Office has focused its attention recently is the rising number of Requests for Continued Examination (RCEs). Earlier this month, the Office published a notice in the Federal Register (77 Fed. Reg. 72830) seeking public feedback on RCE practice. The notice, which indicated that the Office has a backlog of more than 90,000 applications that have not been examined since an RCE was filed, described some of the Office's efforts to reduce the RCE backlog, including the Quick Path Information Disclosure Statement (QPIDS) pilot program and the After Final Consideration Pilot (AFCP). Not surprisingly, the notice does not discuss the Office's efforts to decrease RCE filings by raising the cost of filing a first RCE to $1,200 (from the current fee of $930), and further raise the cost of filing subsequent RCEs to $1,700, a proposal that the Patent Public Advisory Committee (PPAC) has called "illogical." Comments to the Office's notice can be submitted until February 4, 2013 (see link below for information regarding the submission of comments).
For information regarding this and other related topics, please see:
• "USPTO Seeks Public Feedback on RCE Practice," December 13, 2012
• "USPTO News Briefs," June 21, 2012
• "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program," May 10, 2012
• "USPTO to Assess After Final Consideration Pilot Program," April 5, 2012
14. USPTO and Applicants Deal with Intersection of Patent and Copyright Law
In January, the Office of the General Counsel for the U.S. Patent and Trademark Office issued a memorandum in response to several inquiries the Office had received concerning copyright infringement and the use of non-patent literature (NPL) in the examination process. In that memo, USPTO General Counsel Bernard Knight, Jr. deemed the following practices to be protected by the doctrine of fair use: (1) the Office's practice of making copies of copyrighted NPL and providing such copies to an applicant in the course of patent examination; (2) the Office's practice of providing certified copies of entire file histories, including copyrighted NPL, to members of the public for a fee; and (3) the copying of copyrighted NPL by patent applicants and their attorneys and the submission of those copies to the USPTO pursuant to the USPTO's disclosure requirements. The memo was timely given separate lawsuits brought by a publishing company against two law firms in February. (Because one of the firms is McDonnell Boehnen Hulbert & Berghoff LLP, where the Patent Docs authors and contributors work, Patent Docs has not provided any coverage of these cases. However, former MBHB attorney Dennis Crouch has covered the cases on his Patently-O weblog; see here and here, for example.)
For information regarding this and other related topics, please see:
• "USPTO Issues Memo on Use of Non-Patent Literature During Examination," January 23, 2012
13. Congress Works to "Correct and Improve" Leahy-Smith America Invents Act
On November 30, Rep. Lamar Smith (R-TX) introduced a bill (H.R. 6621) entitled "To correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code." Demonstrating that you cannot judge a bill by its title, the legislation contained provisions having nothing to do with any of the AIA's provisions, including one that would have effectively eliminated patent rights for the ~200 pending U.S. patent applications having a filing date prior to June 7, 1995 (when legislation enabling the provisions to the Uruguay Rounds of the General Agreement on Tariffs and Trade (GATT) were enacted). This section, however, was replaced with a provision requiring a report to Congress on the status of pre-GATT applications before the House passed the bill by a 308-89 vote, and even that changed section was replaced with a clerical amendment in the Senate version of the bill. Following passage of the further amended bill by the Senate, the bill stalled back at the House when Rep. Bobby Scott (D-VA) objected to a vote on the grounds that a quorum was not present.
For information regarding this and other related topics, please see:
• "The Status Quo Reigns in Senate's Version of H.R. 6621," December 30, 2012
• "Congressional Corrections Regarding H.R. 6621," December 20, 2012
• "Congressional Misunderstandings (Apparently) Motivate H.R. 6621," December 20, 2012
• "The Plot Thickens around H.R. 6621," December 18, 2012
• "Pre-GATT Patent Applications Threatened by Lamar Smith's H.R. 6621," December 6, 2012
12. Federal Circuit Defines Presumption of Enablement for Prior Publications
On July 27, the Federal Circuit issued a decision in In re Antor Corp. that increased the burden on proving patentability created by prior art references for patent applicants and patentees by defining a presumption of enablement not only for prior patents and published patent applications but also for all prior printed publications, regardless of source of provenance. The Antor decision is likely to have important implications for practitioners attempting to provide patent protection for biotechnology-based inventions. This is because the inventiveness of biotechnology inventions is often assessed in view of prior art produced by university researchers, and it is a feature of some of this art that portions therein are reserved for what can most kindly be called discussions of possible future implications and applications of a scientific result (or unkindly, unsupported flights of fancy). However, the presence of such language in scientific references such as journal articles not expressly provides a much more robust source of prior art, insofar as anything said in a prior art printed publication now falls expressly within the presumption that it is enabled. While in many cases this will not pose an insurmountable challenge, it can be expected at the very least to increase the difficulties and cost of obtaining patents, and to open up a host of new prior art for use in invalidity defenses.
For information regarding this and other related topics, please see:
• "In re Antor Media Corp. (Fed. Cir. 2012)," August 20, 2012
Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.
