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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...

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BioPharma Patents Quick Tips and News-Jan/Feb 2014

.................By: Leanne Rakers

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BioPharma 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...

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The 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...

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BioPharma 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...

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BioPharma 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....

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BioPharma 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...

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BioPharma 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...

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SCOTUS 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...

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Chemistry & 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

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BioPharma 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...

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Updated 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...

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FDA 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...

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