Published 11/12/2021 by CIONCA IP TEAM (SE)
Teva Pharmaceuticals and its related firms (“The Petitioners” or “Teva”) are the owners of a patent on a manufacturing method for a drug known as Copaxone, used for treating multiple sclerosis (the “drug”).
Sandoz Inc. and other firms (“The Respondents”) submitted Abbreviated New Drug Applications (ANDAs) on the drug. The application was brought before the Food and Drug Administration (FDA) to produce and market generic versions of Copaxone.
On getting to know about the Respondents’ application, Teva sued the Respondents for patent infringement. Teva relied on two claims before the District Court.
At the District Court, Teva’s claims centered on using different molecular weight methods to distinguish between polymer samples. However, the District Court failed to distinguish between the different methods. Instead, it held that the claims were not indefinite, as argued by the Respondents. Hence, it held that the patent claims were sufficiently definite and valid, amounting to patent infringement by the Respondents.
Dissatisfied, the Respondents appealed to the United States Court of Appeals ( the “Federal Circuit”). The Federal Circuit found the molecule weight term indefinite and the patent invalid. In arriving at its decision, the Federal Circuit reviewed all aspects of the claim construction issue de novo, including the determination of subsidiary facts.
Teva sought further review before the Supreme Court. One of the issues for determination at the Supreme Court was whether a District Court’s finding of fact on a patent claim could be reviewed de novo for the first time as done by the Federal Circuit.
In a majority opinion of 7-2 led by Justice Breyer, it was held that a federal appellate court could only overturn the lower court’s finding of fact if it is clearly erroneous. The Supreme Court majority relied on the Federal Rule of Civil Procedure 52(a)(6).
It was further held that the construction of a patent claim is essentially a factual determination. Thus, it should be governed by well-established standards as laid down in the Federal Rule of Civil Procedure. The Supreme Court also found that the Federal Circuit did not accept Teva expert’s explanation while reviewing de novo. Thus, it also failed to see whether the District Court’s decision was clearly erroneous.
On this note, the Supreme Court remanded the case back to the Federal Circuit with an order that the Federal Circuit should apply the correct legal standards. It also ordered that the proper legal measures be used to determine whether the claims were definite or otherwise.
In the leading dissenting opinion, the Supreme Court held that patent construction claims were a question of law. Thus, the Federal Rule of Procedure was not the controlling standard. Instead, the rule of procedure applied only to questions of fact. As a result, he held that the Federal Circuit was right to have used the de novo standard of review.
Justice Thomas, who wrote the leading dissenting opinion, explained further that a District Court’s determination was factual if it dealt with the historical fact of the case. It was legal if it had applicable rules.
As in this case, patent construction claims should be considered a question of law.
Disclaimer: The views and opinions expressed throughout this blog are the views and opinions of the individual author(s) and/or contributor(s) and do not necessarily reflect the views and opinions of our firm, CIONCA IP Law. P.C.
CIONCA IP TEAM (SE)1/14/2022 4:52:22 PM
Fees and more Fees?
CIONCA IP TEAM (SE)12/17/2021 4:51:21 PM
Royalty or Lowborn
CIONCA IP TEAM (SE)12/10/2021 5:06:54 PM
Short-Range Wireless Networks
CIONCA IP TEAM (SE)12/3/2021 4:58:39 PM
TIGHT or TITE
CIONCA IP TEAM (SE)11/19/2021 4:57:10 PM
TAG Your It!
CIONCA IP TEAM (SE)11/12/2021 4:56:57 PM
CIONCA IP TEAM (SE)11/5/2021 4:40:14 PM
CIONCA IP TEAM (SE)10/29/2021 4:49:28 PM
CIONCA IP TEAM (SE)10/22/2021 4:10:03 PM
Free Speech and Trademarks
CIONCA IP TEAM (SE)10/15/2021 4:55:32 PM
DNA of Patents
CIONCA IP TEAM (SE)10/8/2021 5:02:03 PM
CIONCA IP TEAM (SE)10/1/2021 4:58:25 PM
Take a seat and read about seats
CIONCA IP TEAM (SE)9/24/2021 5:15:50 PM
Let's take a ride on the Segway!
CIONCA IP TEAM (SE)9/17/2021 4:57:53 PM
An Apple off the Apple Tree
CIONCA IP TEAM (SE)9/10/2021 4:59:08 PM
VROOM VROOM VROOM
CIONCA IP TEAM (SE)9/3/2021 4:56:24 PM
On Copyrights of Annotations.
CIONCA IP TEAM (SE)8/27/2021 4:55:40 PM
Rejecting Trademark Contracts
CIONCA IP TEAM (SE)8/20/2021 4:42:46 PM
It's a Bratz Girl, in a Barbie World (Pt. 2)
CIONCA IP TEAM (SE)8/13/2021 4:57:49 PM
CIONCA IP TEAM (SE)8/6/2021 4:39:04 PM
It's a Bratz Girl, in a Barbie World
CIONCA IP TEAM (SE)7/31/2021 3:21:56 AM
Ice Cream, You Scream
CIONCA IP TEAM (SE)7/23/2021 4:12:50 PM
CIONCA IP TEAM (SE)7/16/2021 5:00:45 PM
Buy me a ring, darling
CIONCA IP TEAM (SE)7/7/2021 2:52:33 PM
Offensiveness vs Free Speech in Trademark Law
CIONCA IP TEAM (SE)6/25/2021 4:45:12 PM
Woof Woof - Trademark Law
CIONCA IP TEAM (SE)6/18/2021 5:29:44 PM
Forum Selection 101
CIONCA IP TEAM (SE)6/11/2021 4:23:58 PM
Willful v Innocent
CIONCA IP TEAM (SE)5/17/2021 2:38:30 PM
Thryv, Inc. v. Click-To-Call Technologies, LP
CIONCA IP TEAM (SE)4/23/2021 5:34:02 PM
Oracle Patent Problems
CIONCA IP TEAM (SE)4/5/2021 5:38:23 PM
Blockchain and the Expanding US Patent Landscape
CIONCA IP TEAM (MC)3/24/2021 2:19:11 PM
Invention and Art Analogy
CIONCA IP TEAM (BR)1/19/2021 4:57:54 PM
QuikTrip West, Inc. v. Weigel Stores, Inc.
CIONCA IP TEAM (AP)12/7/2020 4:06:28 PM
St Jude Medical LLC v Snyders Heart Valve LLC
CIONCA IP TEAM (SE)12/1/2020 5:07:58 PM
Allen v. Cooper, Governor of North Carolina
CIONCA IP TEAM (JM)10/8/2020 2:57:24 PM
Royal Crown Company Inc., Dr. Pepper/Seven Up Inc., v The Coca-Cola Company
CIONCA IP TEAM (SG)10/6/2020 2:42:35 PM
Apple, Inc., v. Voip-Pal.com, Inc.: Sanction Orders and Obviousness
CIONCA IP Team (SE)9/16/2020 4:21:45 PM
CIONCA IP Launches New Online Patent Website
CIONCA IP Team9/15/2020 5:11:49 PM
Comparing Apples to Apples: TTAB on In re Horizon Group USA, Inc.
CIONCA IP Team9/3/2020 4:30:41 PM
D2 Holdings v. House of Cards
CIONCA IP Team8/31/2020 12:09:17 PM
Blackbird Tech LLC, DBA Blackbird Technologies, v. Fitbit, Inc., Wahoo Fitness LLC: Obviousness
CIONCA IP Team8/11/2020 11:56:24 AM
Adidas AG v. Nike INC.
CIONCA IP Team7/20/2020 7:40:21 PM
Fitbit Inc. v. Valencell Inc.: Joint Parties in IPR Proceeding
CIONCA IP Team7/14/2020 7:51:31 PM
CIONCA IP Launches New Online Trademark Website
CIONCA IP 5/19/2020 7:36:30 PM
Uber Technologies, Inc. v. X One, Inc.: “Obvious to Try” Rationale
Marin Cionca4/15/2020 4:41:43 PM
The Day After COVID-19 Pandemic – Hope or Fear?
CIONCA IP4/13/2020 9:33:36 PM
Two of a Kind: TTAB on Shannon DeVivo v. Celeste Ortiz
CIONCA IP3/16/2020 8:43:10 PM
GS CleanTech Corporation v. Adkins Energy, LLC: Inequitable Conduct
CIONCA IP3/10/2020 7:45:30 PM
Koninklijke Philips N.V. v. Google LLC, Microsoft Corporation, Microsoft Mobile Inc.
Marin Cionca2/9/2020 7:46:10 PM
Analogous Prior Art or Not? A critical patent obviousness question
CIONCA IP 1/15/2020 4:47:19 PM
FOX Factory, Inc. v. SRAM, LLC: Presumption of Nexus
CIONCA IP 1/9/2020 4:43:58 PM
The Bigger Picture: TTAB’s Decision in In re James Haden, M.D., P.A.
CIONCA IP 12/31/2019 4:29:41 PM
The Chamberlain Group, INC. v. One World Technologies, INC.
Marin Cionca12/9/2019 8:07:20 PM
A “glove” approach to patent claim construction
11/15/2019 8:15:11 PM
Liqwd, Inc. v. L’Oreal USA, Inc.: Objective Indicia and Copying
CIONCA IP10/16/2019 1:28:13 PM
To Use or Not to Use: The Statutory Period of Trademark Nonuse Prior to Presumed Abandonment
CIONCA IP10/7/2019 5:44:50 PM
A Decision in Henny Penny Corporation v. Frymaster LLC
Marin Cionca9/27/2019 9:32:48 PM
Can an Online Patent Attorney File My Patent?
CIONCA Team Member9/4/2019 7:20:46 PM
Guangdong Alison Hi-Tech Co. v. International Trade Commission: Objective Boundaries
CIONCA Team Member8/19/2019 7:46:17 PM
In re Yarnell Ice Cream, LLC: Trademark Descriptiveness and Acquired Distinction
CIONCA Team Member8/5/2019 2:29:33 PM
Is Speculation Enough Evidence for an Appeal?: General Electric Company v. United Technologies Corporation
CIONCA Team Member7/5/2019 2:22:42 PM
In re: Global IP Holdings LLC: Broadening Claims Through Reissue Applications
CIONCA Team Member6/27/2019 7:41:52 PM
Obviousness in a Single Prior Art Instance: Game and Technology Co., LTD., v. Activision Blizzard INC., Riot Games, INC.
Marin Cionca6/11/2019 8:43:17 PM
Can I Successfully License My Invention?
CIONCA Team Member5/20/2019 8:25:57 PM
PTAB Designates Cases as Precedential
CIONCA Team Member5/7/2019 7:13:41 PM
The Federal Circuit Defines a Technological Invention
Marin Cionca4/17/2019 3:48:33 PM
What Qualifies as Proper Use in Commerce Claim in a USPTO Trademark Application?
CIONCA Team Member4/3/2019 7:25:37 PM
The Patent Trial and Appeal Board (PTAB) Designates Three Decisions Precedential
CIONCA Team Member3/21/2019 3:49:43 PM
Defining Inherency: A Decision in Personal Web Technologies, LLC v. Apple, Inc.
Marin Cionca3/1/2019 9:36:50 PM
USPTO Director Andrei Iancu Visits Orange County!
CIONCA Team Member2/19/2019 7:12:46 PM
Revised Guidance by USPTO on Patent Subject Matter Eligibility and Examining Computer-Implemented Functional Claims
CIONCA Team Member2/5/2019 7:22:27 PM
TiVo Puts Tivoli on Pause: TTAB’s Decision in TiVo Brands LLC v. Tivoli, LLC
Marin Cionca1/23/2019 9:45:30 PM
Patent Law Alert: All Sales of the Invention, Including Secret Sales May Invalidate a Patent
CIONCA Team Member1/4/2019 4:12:21 PM
In re: Tropp: New Matter in a Continuation Can Be Relevant to Written Description Requirement
CIONCA Team Member12/18/2018 6:12:48 PM
Schlafly v. The Saint Louis Brewery: The Registration of Merely a Surname
Marin Cionca12/8/2018 8:35:06 PM
IP Assets - Procurement, Enforcement, Monetization
CIONCA Team Member11/19/2018 1:07:51 PM
The Appeals Process
CIONCA Team Member10/16/2018 6:50:31 PM
A Double-Edged Sword: Benefit of Priority or Longer Patent Term
Marin Cionca10/1/2018 7:42:12 PM
Can I Register a Color as a Trademark or Service Mark?
CIONCA Team Member9/17/2018 4:33:20 PM
Trademarks and Likelihood of Confusion: Federal Circuit’s Decision in In re: Detroit Athletic Co.
Staff8/31/2018 7:26:58 PM
Patent Claim Interpretation By Federal Circuit's on Facebook's Contiguous Image Layout
Staff8/16/2018 4:24:01 PM
Correcting or Changing a Patent After Issue Through the Central Reexamination Unit
Marin Cionca7/31/2018 6:50:05 PM
My patent expired? Can I still sue for patent infringement?
7/3/2018 7:44:33 PM
Impax Laboratories Inc. v Lannett Holdings Inc. on Claim Invalidation
CIONCA IP5/17/2018 9:54:58 PM
Marin Cionca Presents at OCIPLA May 2018 Luncheon
5/4/2018 7:37:51 PM
The Hague System for Protection of International Designs
CIONCA Staff4/20/2018 5:25:25 PM
USPTO Changes Examination Procedure Pertaining to Subject Matter Eligibility in View of Berkheimer v. HP, Inc.
CIONCA Staff4/13/2018 9:10:04 PM
It Take Two to Tango: Knowles v. Iancu, a Standing Dispute in a PTAB Decision
3/20/2018 12:50:05 PM
Andrei Iancu - New Director of the USPTO
3/8/2018 1:25:46 PM
Proceed with Caution: Consider Carefully when Narrowing Claims for Allowance
CIONCA Team2/16/2018 4:07:48 PM
Fashion and Intellectual Property
CIONCA Team1/17/2018 8:12:06 PM
A Fork in the Road: Production or Protection?
1/2/2018 7:47:09 PM
The Lanham Act: Disparagement Provision Violates the First Amendment
12/26/2017 6:04:25 PM
CIONCA Sets Foot in San Francisco
12/1/2017 8:01:27 PM
An Introduction to Patent Cooperation Treaty Applications
11/17/2017 1:24:20 PM
An Introduction to Patent Searches
11/10/2017 6:47:44 PM
An Introduction to Design Patent Applications
Staff11/3/2017 4:20:04 PM
An Introduction to Provisional Patent Applications
Staff9/28/2017 7:27:22 PM
staff9/27/2017 5:12:07 PM
CIONCA - Patent and Trademark Law Attorney
staff9/27/2017 5:00:12 PM
Claim Indefiniteness During Patent Pre-Issuance: Define Your Invention, Not Just Your Audience
staff9/15/2017 9:33:30 PM
CIONCA Staff8/20/2017 3:16:11 PM
CIONCA on Patents: Think Twice Before Suing for Patent Infringement and Fight Back when Unreasonably Sued
CIONCA - Staff8/9/2017 5:39:58 PM
Patent Case Study: The Novelty Of An “Invention” Is NOT Enough To Make It Patentable
CIONCA - Staff6/28/2017 8:26:07 PM
Patent Law: Conditions Precedent May Expose Method Claim to Broad Interpretation During Prosecution
CIONCA - Staff6/15/2017 5:32:14 PM
Patent Law: Challenging the Patent Claim Definiteness Requirement
Marin Cionca4/25/2017 9:48:49 PM
Monetization of Patents: How to Make Money with Patents
Marin Cionca2/21/2017 12:30:52 AM
Software Patent Law Update: Federal Circuit Finds Graphical User Interface Patentable
Marin Cionca9/15/2016 9:47:39 PM
Patent Law Alert: Federal Circuit Opens Door for More Software Patents
Marin Cionca9/6/2016 9:26:12 PM
Patent Case Law: New Example of Software as Patentable Subject Matter
Iris Kim, PhD6/1/2016 7:04:50 PM
The Patent Trial and Appeal Board Designates Five More Decisions as Precedential
Marin Cionca5/17/2016 8:57:23 PM
Patent Claims Rejection Based on Inherency
Iris Kim, PhD3/25/2016 8:34:14 PM
Challenging a Claim’s Validity with Different Standards of Claim Construction
I. Kim PhD2/26/2016 8:47:51 PM
The U.S. Supreme Court Will Review Claim Construction Standards and Institution Decision Reviewability.
Marin Cionca2/16/2016 6:34:53 PM
In IPRs, patentees have to show that substitute patent claims are patentable
M. Cionca and I. Kim2/4/2016 5:55:16 PM
Software Inventions Are Still Patentable!
Marin1/28/2016 9:15:16 PM
The Patent Trial and Appeal Board Designates Two Decisions as Precedential
Marin1/28/2016 9:10:56 PM
How Unpredictability Can Affect Obviousness Challenges
Marin11/19/2015 2:13:05 PM
An Innovator’s Dilemma: Design or Utility Patent?
Marin11/18/2015 7:31:35 PM
When Is a Thesis Prior Art?
Marin11/18/2015 6:15:40 PM
Covered Business Method Claims Are Not Required to Particularly Target Financial Industry
Marin11/18/2015 6:11:11 PM
PTAB Decisions Give Examples of Patent Eligible Subject Matter
Marin Cionca, Esq.
Registered Patent Attorney
USPTO Reg. No. 63899
About CIONCA® IP Law firm: We are an Orange County, CA based boutique intellectual property firm with a focus on patent and trademark application, prosecution, opinion, licensing and IP enforcement 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.