Can a prior art reference that does not contain a teaching sufficient enough to allow it to be used in an obviousness combination nevertheless be used as a background reference for evidence of motivation to combine? ...more
On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more
10/20/2016
/ Biosimilars ,
Biotechnology ,
Celltrion ,
Food and Drug Administration (FDA) ,
Obviousness ,
Patent Expiration ,
Patent Infringement ,
Patent Invalidity ,
Patents ,
Pfizer ,
Pharmaceutical Industry
Have you ever mixed up the obviousness determinations of "motivation to combine" and "reasonable expectation of success"? If so, you are apparently not alone -- the Federal Circuit recently faulted the Patent Trial and...more
Back in January 2002, when this author was near the beginning of his patent law career, the Federal Circuit handed down the In re Sang-Su Lee case. Among other things, this case provided patent practitioners with support for...more
Do you want the good news or the bad news first? Well, the good news is that the Federal Circuit has begun reversing PTAB decisions on the merits for IPR proceedings. To be fair, in the Microsoft case, the Federal Circuit...more
One of the first IPR petitions ever filed, IPR2012-0006, was related to biotechnology -- specifically DNA sequencing. Illumina, Inc. filed that petition, and two others, IPR2012-00007 and IPR2013-00011, against patents owned...more
Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more
The press has been all too eager to decry the so-called "broken" U.S. patent system and the alleged "scourge" of non-practicing entities (NPEs). However, few if any articles attempt to provide an even-handed analysis of...more
12/19/2014
/ CLS Bank v Alice Corp ,
Covered Business Method Patents ,
Nautilus Inc. v. Biosig Instruments ,
Non-Practicing Entities ,
Obviousness ,
Octane Fitness v. ICON ,
Patent Litigation ,
Patent Reform ,
Patent Trial and Appeal Board ,
Patent Trolls ,
Patents ,
SCOTUS ,
Software
Just what does it take to amend your claims during an IPR proceeding before the PTAB? Of course, the America Invents Act ("AIA") specifically provides that Patent Owners may file one motion to amend the claims. AIA, §...more
When does a prior art disclosure of a concentration range of a medicament render obvious the use of a species that falls within that range, when that same use was also known in the prior art? After all, common sense should...more
12/18/2013
/ Drug Approvals ,
Generic Drugs ,
Hatch-Waxman ,
Inventions ,
Obviousness ,
Patent Applications ,
Patent-Eligible Subject Matter ,
Patentability Search ,
Patents ,
Pharmaceutical Industry ,
Presumption of Validity ,
Prior Art
A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This...more
7/30/2013
/ Abbreviated New Drug Application (ANDA) ,
Enablement Inquiries ,
Indefiniteness ,
Infringement ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Teva Pharmaceuticals
When is a combination of two separate treatments for a particular disease obvious-to-try, such that it is rendered obvious for the purposes of patentability? The Supreme Court answered this question in KSR Int'l Co. v....more