United States BioPharma Patents - Quick Tips and News - Nov/Dec 2013
A. Three Tips for Overcoming U.S. Obviousness Rejections - 1) Argue no PFO first: Always argue down existence of an Examiner-asserted presumption of prima facie obviousness (PFO), before going on to...
View ArticleBioPharma Patents Quick Tips and News - May/June 2014
QUICK TIPS - 35 U.S.C. 112 Tips: 1) Does your U.S. Examiner assert that not enough representative species are described in the specification? MPEP Section 2163 II.A.3(a)(ii) says that “(t)he written...
View ArticleThe December Sequel to the USPTO’s March Guidance
The much-anticipated subject-matter eligibility Guidance has finally been released by the U.S. Patent & Trademark Office (USPTO) for public inspection and comment. Although the new Guidance is...
View ArticleBioPharma Patents: Quick Tips & News - September 2015
For our BioPharma audience, you might be interested in Harness Dickey’s Quarterly BioPharma Newsletter, which reports on the impact of the Akamai v. Limelight, Suprema v. ITC, and Amgen v. Sandoz cases...
View ArticleBioPharma Patents: Quick Tips & News - January 2016
Subject matter eligibility and “laws of nature.” As reported in our July 2015 newsletter, the Federal Circuit invalidated claims to a method of diagnosing fetal abnormalities without amniocentesis....
View ArticleBioPharma Patents Quick Tips & News – July 2016
U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re...
View ArticleBioPharma Patents Quick Tips & News – October 2016
October 2016 BioPharma Newsletter — Halloween Edition - U.S. patent eligibility can be scary! Tips to avoid the Grim Reaper (a.k.a. the Examiner or a Judge) killing your claims: Bonus tip: This...
View ArticleSCOTUS to Weigh In on Two Biosimilar Patents, Provisions of the BPCIA in 2017
2017 is shaping up to be a big year for biosimilars and for the Biologics Price Competition and Innovation Act of 2009 (BPCIA) specifically. The Supreme Court is scheduled to hear oral arguments on...
View ArticleChemistry & Nanotechnology Developments to Watch in 2017
As cases and outcomes make their way into the news this year, we will be watching the following developments closely and sharing them with the IP community....By: Leanne Rakers
View ArticleBioPharma Patents Quick Tips & News – November 2017
Diagnostic Method Claims in the U.S. I. Let’s recap the last five years! Mayo (2012) = Supreme Court prohibits patents for diagnostic methods without “significantly more” (essentially, you must not...
View ArticleUpdated Examination Procedure For 101 Rejections Announced in USPTO...
Andrei Iancu, confirmed to lead the USPTO in February 2018, has made his views clear on the current state of subject matter eligibility under 35 U.S.C. § 101. At the U.S. Chamber of Commerce, he stated...
View ArticleFDA Implements Biosimilar Action Plan to Boost Biosimilar Competition
With the goal of boosting competition in the biosimilar market, the FDA has released a 9-page “Biosimilars Action Plan” (BAP). In introducing the BAP, FDA Commissioner Dr. Gottleib noted that...
View Article
More Pages to Explore .....