Published 28/01/2016 by Marin
by Marin Cionca and Iris Kim
In June 2015, Amgen challenged two patents (US Patent Nos. 8,916,157 and 8,916,158) owned by AbbVie Biotechnology Ltd., related to the drug Humira. The challenge was on the grounds that the reformulations of the biologic described in these patents are not significantly different from that of the prior art. The Patent Trial and Appeal Board (PTAB or The Board) has denied both of Amgen’s requests for inter partes review, in Amgen Inc. v. AbbVie Biotechnology Ltd. case numbers IPR2015-01514 and IPR2015-01517.
AbbVie asserted to the Board that preparing stable liquid aqueous formulations of antibodies at the recited concentrations may lead to unpredictable results. A claim is unpatentable as being obvious if “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made” (35 U.S.C. 103(a)) to one of ordinary skill in the art. Absolute predictability is not a requirement for obviousness, but “some articulated reasoning with rational underpinning to support the legal conclusion of obviousness” should be present (KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
In case IPR2015-01517, Amgen had submitted an argument that an article, Wang, provided guidance for formulating stable liquid aqueous antibodies at the concentration recited in the patents. However, AbbVie asserted that the Wang article demonstrates unpredictability in this art of formulating proteins as well, stating “[v]ery often, proteins have to be evaluated individually and stabilized on a trial-and-error basis.” “Although the Wang article indeed provides general guidance, the Wang article also underscores the unpredictability of the undertaking” (PTAB, IPR2015-01517).
Further examples of references that provide general guidance were provided. Amgen argued using Salfeld and Heavnerm stating that “because both focus on anti-TNF alpha antibodies, both focus on IgG antibodies, and both teach how to formulate these antibodies” a skilled artisan “would have had reason to combine Salfeld and Heavner” (PTAB, IPR2015-01517). AbbVie’s response was that Salfeld provides guidance “merely as a general approach” and Heavner only provides “bulk recitations” and “offers no guidance at all on how to actually select from this massive number of possible combinations” (PTAB, IPR2015-01517).
Given these arguments, the Board found that Amgen was not persuasive in their argument that a “skilled person would have had a reasonable expectation of success in applying the formulations commercially available and taught in the literature to D2E7,” D2E7 being the antibody described in the ‘158 patent (PTAB, IPR2015-01517). The Board concluded “that Amgen has not established a reasonable likelihood of prevailing with respect to its challenge,” (PTAB, IPR2015-01517). Similar arguments were presented in case IPR2015-01514, and both requests for inter partes review were denied in January 2016, demonstrating that, even with guidance, unpredictability may still be a factor in certain fields.
Marin11/18/2015 6:11:11 PM
PTAB Decisions Give Examples of Patent Eligible Subject Matter
Marin11/18/2015 6:15:40 PM
Covered Business Method Claims Are Not Required to Particularly Target Financial Industry
Marin11/18/2015 7:31:35 PM
When Is a Thesis Prior Art?
Marin11/19/2015 2:13:05 PM
An Innovator’s Dilemma: Design or Utility Patent?
Marin1/28/2016 9:10:56 PM
How Unpredictability Can Affect Obviousness Challenges
Marin1/28/2016 9:15:16 PM
The Patent Trial and Appeal Board Designates Two Decisions as Precedential
M. Cionca and I. Kim2/4/2016 5:55:16 PM
Software Inventions Are Still Patentable!
Marin Cionca2/16/2016 6:34:53 PM
In IPRs, patentees have to show that substitute patent claims are patentable
I. Kim PhD2/26/2016 8:47:51 PM
The U.S. Supreme Court Will Review Claim Construction Standards and Institution Decision Reviewability.
Iris Kim, PhD3/25/2016 8:34:14 PM
Challenging a Claim’s Validity with Different Standards of Claim Construction
Marin Cionca5/17/2016 8:57:23 PM
Patent Claims Rejection Based on Inherency
Iris Kim, PhD6/1/2016 7:04:50 PM
The Patent Trial and Appeal Board Designates Five More Decisions as Precedential
Marin Cionca9/6/2016 9:26:12 PM
Patent Case Law: New Example of Software as Patentable Subject Matter
Marin Cionca9/15/2016 9:47:39 PM
Patent Law Alert: Federal Circuit Opens Door for More Software Patents
Marin Cionca2/21/2017 12:30:52 AM
Software Patent Law Update: Federal Circuit Finds Graphical User Interface Patentable
Marin Cionca4/25/2017 9:48:49 PM
Monetization of Patents: How to Make Money with Patents
CIONCA - Staff6/15/2017 5:32:14 PM
Patent Law: Challenging the Patent Claim Definiteness Requirement
CIONCA - Staff6/28/2017 8:26:07 PM
Patent Law: Conditions Precedent May Expose Method Claim to Broad Interpretation During Prosecution
CIONCA - Staff8/9/2017 5:39:58 PM
Patent Case Study: The Novelty Of An “Invention” Is NOT Enough To Make It Patentable
CIONCA Staff8/20/2017 3:16:11 PM
CIONCA on Patents: Think Twice Before Suing for Patent Infringement and Fight Back when Unreasonably Sued
staff9/15/2017 9:33:30 PM
staff9/27/2017 5:00:12 PM
Claim Indefiniteness During Patent Pre-Issuance: Define Your Invention, Not Just Your Audience
staff9/27/2017 5:12:07 PM
CIONCA - Patent and Trademark Law Attorney
Staff9/28/2017 7:27:22 PM
Staff11/3/2017 4:20:04 PM
An Introduction to Provisional Patent Applications
11/10/2017 6:47:44 PM
An Introduction to Design Patent Applications
11/17/2017 1:24:20 PM
An Introduction to Patent Searches
12/1/2017 8:01:27 PM
An Introduction to Patent Cooperation Treaty Applications
12/26/2017 6:04:25 PM
CIONCA Sets Foot in San Francisco
1/2/2018 7:47:09 PM
The Lanham Act: Disparagement Provision Violates the First Amendment
CIONCA Team1/17/2018 8:12:06 PM
A Fork in the Road: Production or Protection?
CIONCA Team2/16/2018 4:07:48 PM
Fashion and Intellectual Property
3/8/2018 1:25:46 PM
Proceed with Caution: Consider Carefully when Narrowing Claims for Allowance
3/20/2018 12:50:05 PM
Andrei Iancu - New Director of the USPTO
CIONCA Staff4/13/2018 9:10:04 PM
It Take Two to Tango: Knowles v. Iancu, a Standing Dispute in a PTAB Decision
CIONCA Staff4/20/2018 5:25:25 PM
USPTO Changes Examination Procedure Pertaining to Subject Matter Eligibility in View of Berkheimer v. HP, Inc.
5/4/2018 7:37:51 PM
The Hague System for Protection of International Designs
CIONCA IP5/17/2018 9:54:58 PM
Marin Cionca Presents at OCIPLA May 2018 Luncheon
Marin Cionca, Esq.
Registered Patent Attorney
USPTO Reg. No. 63899
About our IP law firm: We are an Orange County, CA based boutique intellectual property firm with a focus on patent and trademark application, prosecution and opinion services, offering its IP services primarily at flat fee rates. We serve local OC clients, as well as clients throughout US and international clients.
We’d love to hear from you…we just need a little info
about your plans to take over the world!
P.S…Feel free to call us! (800)985-9198
Thank you for your message. We will respond within 24-72 hours. Thank you.