Introduction

Patent law typically provides protections for people who invent or discover new processes. However, the Court makes exceptions to this rule by providing exceptions for those who try and patent "laws of nature." One court case involving Mayo Collaborative Services v. Prometheus Laboratories, Inc. explores the limits of patentable inventions and processes and has severe implications for pending and future Federal Circuit cases. Let's discuss what happened in this case.

Discussion

The Mayo Foundation for Medical Education and Research, affiliated with a nonprofit academic medical center called the Mayo Clinic, operates a for-profit testing lab called Mayo Collaborative Services.

At the testing lab, Mayo Collaborative Services bought medical tests from Prometheus Laboratories, Inc. to help improve patient outcomes will administering medications.

Essentially, the treatment of autoimmune diseases requires the use of thiopurine drugs. Yet, there's a challenge with administering thiopurines. Every individual's body metabolizes this class of drugs differently. Therefore, safe, and effective administration of thiopurines requires doctors to run diagnostic tests to ensure patients are prescribed the correct dose. Too high of a dose leads to adverse side effects, while too low and the thiopurines become ineffective at treating disease.

Scientists at the Hospital Sainte-Justine in Montreal were the first to discover the threshold of efficacy while treating some autoimmune diseases by testing a patient's blood. After making this discovery, these scientists filed a patent on methods that use the threshold level to determine the correct dosage for patients.

Prometheus Laboratories, a corporation owned by Nestlé, creates diagnostic testing kits and operates a testing lab to obtain information about a patient that helps diagnose and treat disease. They were the party to license two patents from the Hospital Sainte-Justine to build tests that help doctors discover the correct medication dosage.

Mayo Collaborative Services used diagnostic kits from Prometheus Laboratories until 2004. Afterward, Mayo created its diagnostic equipment, which it planned to operate within its testing lab, while also selling it to other medical centers. After announcing that Mayo would produce and sell their diagnostic kits to identify the proper dosage of thiopurines for fighting autoimmune disease, Prometheus sued Mayo for patent infringement.

The case went to District Court, the Federal Circuit Court twice, and finally, the Supreme Court. The District Court found that to use the test required three steps:

  1. A doctor must administer a thiopurine-containing drug to a patient.
  2. The medical professional performs a test to determine the metabolite levels in the patient's blood.
  3. From testing, the doctor determines whether there should be a change in the dosage of the thiopurine medications.

During the case, the third point became a point of dispute between both parties. Although Prometheus felt that the whole process was patentable, the Court decided otherwise, believing that the inventors were observing the relationship of a natural process rather than creating a new process itself. Therefore, Prometheus held patents to a "law of nature," which shouldn't be patent-eligible.

In the higher courts, there was much back and forth between both corporations about the earlier rulings. However, in 2012, there was a unanimous decision from the Supreme Court that supported the initial findings of the District Court. The Justice argued that companies could not patent a product that identifies the connection between naturally produced chemicals within the body and the efficacy of a medication.

Conclusion

This ruling brought support and opposition to the Supreme Court by those in the biotech industry, law schools, and medical associations. After one day of the verdict, the United States Patent and Trademark Office issued a memorandum that explained how to determine whether new patents were valid per the Supreme Court ruling. 

Source: https://www.supremecourt.gov/opinions/11pdf/10-1150.pdf

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. 

PATENT and IP Law Blog

  • CIONCA IP TEAM (SE)9/17/2021 4:57:53 PM

    An Apple off the Apple Tree

    More
  • CIONCA IP TEAM (SE)9/10/2021 4:59:08 PM

    VROOM VROOM VROOM

    More
  • CIONCA IP TEAM (SE)9/3/2021 4:56:24 PM

    On Copyrights of Annotations.

    More
  • CIONCA IP TEAM (SE)8/27/2021 4:55:40 PM

    Rejecting Trademark Contracts

    More
  • CIONCA IP TEAM (SE)8/20/2021 4:42:46 PM

    It's a Bratz Girl, in a Barbie World (Pt. 2)

    More
  • CIONCA IP TEAM (SE)8/13/2021 4:57:49 PM

    Personalized Medication

    More
  • CIONCA IP TEAM (SE)8/6/2021 4:39:04 PM

    It's a Bratz Girl, in a Barbie World

    More
  • CIONCA IP TEAM (SE)7/31/2021 3:21:56 AM

    Ice Cream, You Scream

    More
  • CIONCA IP TEAM (SE)7/23/2021 4:12:50 PM

    Cereal Killer

    More
  • CIONCA IP TEAM (SE)7/16/2021 5:00:45 PM

    Buy me a ring, darling

    More
  • CIONCA IP TEAM (SE)7/7/2021 2:52:33 PM

    Offensiveness vs Free Speech in Trademark Law

    More
  • CIONCA IP TEAM (SE)6/25/2021 4:45:12 PM

    Woof Woof - Trademark Law

    More
  • CIONCA IP TEAM (SE)6/18/2021 5:29:44 PM

    Forum Selection 101

    More
  • CIONCA IP TEAM (SE)6/11/2021 4:23:58 PM

    Willful v Innocent

    More
  • CIONCA IP TEAM (SE)5/17/2021 2:38:30 PM

    Thryv, Inc. v. Click-To-Call Technologies, LP

    More
  • CIONCA IP TEAM (SE)4/23/2021 5:34:02 PM

    Oracle Patent Problems

    More
  • CIONCA IP TEAM (SE)4/5/2021 5:38:23 PM

    Blockchain and the Expanding US Patent Landscape

    More
  • CIONCA IP TEAM (MC)3/24/2021 2:19:11 PM

    Invention and Art Analogy

    More
  • CIONCA IP TEAM (BR)1/19/2021 4:57:54 PM

    QuikTrip West, Inc. v. Weigel Stores, Inc.

    More
  • CIONCA IP TEAM (AP)12/7/2020 4:06:28 PM

    St Jude Medical LLC v Snyders Heart Valve LLC

    More
  • CIONCA IP TEAM (SE)12/1/2020 5:07:58 PM

    Allen v. Cooper, Governor of North Carolina

    More
  • 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

    More
  • CIONCA IP TEAM (SG)10/6/2020 2:42:35 PM

    Apple, Inc., v. Voip-Pal.com, Inc.: Sanction Orders and Obviousness

    More
  • CIONCA IP Team (SE)9/16/2020 4:21:45 PM

    CIONCA IP Launches New Online Patent Website

    More
  • CIONCA IP Team9/15/2020 5:11:49 PM

    Comparing Apples to Apples: TTAB on In re Horizon Group USA, Inc.

    More
  • CIONCA IP Team9/3/2020 4:30:41 PM

    D2 Holdings v. House of Cards

    More
  • CIONCA IP Team8/31/2020 12:09:17 PM

    Blackbird Tech LLC, DBA Blackbird Technologies, v. Fitbit, Inc., Wahoo Fitness LLC: Obviousness

    More
  • CIONCA IP Team8/11/2020 11:56:24 AM

    Adidas AG v. Nike INC.

    More
  • CIONCA IP Team7/20/2020 7:40:21 PM

    Fitbit Inc. v. Valencell Inc.: Joint Parties in IPR Proceeding

    More
  • CIONCA IP Team7/14/2020 7:51:31 PM

    CIONCA IP Launches New Online Trademark Website

    More
  • CIONCA IP 5/19/2020 7:36:30 PM

    Uber Technologies, Inc. v. X One, Inc.: “Obvious to Try” Rationale

    More
  • Marin Cionca4/15/2020 4:41:43 PM

    The Day After COVID-19 Pandemic – Hope or Fear?

    More
  • CIONCA IP4/13/2020 9:33:36 PM

    Two of a Kind: TTAB on Shannon DeVivo v. Celeste Ortiz

    More
  • CIONCA IP3/16/2020 8:43:10 PM

    GS CleanTech Corporation v. Adkins Energy, LLC: Inequitable Conduct

    More
  • CIONCA IP3/10/2020 7:45:30 PM

    Koninklijke Philips N.V. v. Google LLC, Microsoft Corporation, Microsoft Mobile Inc.

    More
  • Marin Cionca2/9/2020 7:46:10 PM

    Analogous Prior Art or Not? A critical patent obviousness question

    More
  • CIONCA IP 1/15/2020 4:47:19 PM

    FOX Factory, Inc. v. SRAM, LLC: Presumption of Nexus

    More
  • CIONCA IP 1/9/2020 4:43:58 PM

    The Bigger Picture: TTAB’s Decision in In re James Haden, M.D., P.A.

    More
  • CIONCA IP 12/31/2019 4:29:41 PM

    The Chamberlain Group, INC. v. One World Technologies, INC.

    More
  • Marin Cionca12/9/2019 8:07:20 PM

    A “glove” approach to patent claim construction

    More
  • 11/15/2019 8:15:11 PM

    Liqwd, Inc. v. L’Oreal USA, Inc.: Objective Indicia and Copying

    More
  • CIONCA IP10/16/2019 1:28:13 PM

    To Use or Not to Use: The Statutory Period of Trademark Nonuse Prior to Presumed Abandonment

    More
  • CIONCA IP10/7/2019 5:44:50 PM

    A Decision in Henny Penny Corporation v. Frymaster LLC

    More
  • Marin Cionca9/27/2019 9:32:48 PM

    Can an Online Patent Attorney File My Patent?

    More
  • CIONCA Team Member9/4/2019 7:20:46 PM

    Guangdong Alison Hi-Tech Co. v. International Trade Commission: Objective Boundaries

    More
  • CIONCA Team Member8/19/2019 7:46:17 PM

    In re Yarnell Ice Cream, LLC: Trademark Descriptiveness and Acquired Distinction

    More
  • CIONCA Team Member8/5/2019 2:29:33 PM

    Is Speculation Enough Evidence for an Appeal?: General Electric Company v. United Technologies Corporation

    More
  • CIONCA Team Member7/5/2019 2:22:42 PM

    In re: Global IP Holdings LLC: Broadening Claims Through Reissue Applications

    More
  • 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.

    More
  • Marin Cionca6/11/2019 8:43:17 PM

    Can I Successfully License My Invention?

    More
  • CIONCA Team Member5/20/2019 8:25:57 PM

    PTAB Designates Cases as Precedential

    More
  • CIONCA Team Member5/7/2019 7:13:41 PM

    The Federal Circuit Defines a Technological Invention

    More
  • Marin Cionca4/17/2019 3:48:33 PM

    What Qualifies as Proper Use in Commerce Claim in a USPTO Trademark Application?

    More
  • CIONCA Team Member4/3/2019 7:25:37 PM

    The Patent Trial and Appeal Board (PTAB) Designates Three Decisions Precedential

    More
  • CIONCA Team Member3/21/2019 3:49:43 PM

    Defining Inherency: A Decision in Personal Web Technologies, LLC v. Apple, Inc.

    More
  • Marin Cionca3/1/2019 9:36:50 PM

    USPTO Director Andrei Iancu Visits Orange County!

    More
  • CIONCA Team Member2/19/2019 7:12:46 PM

    Revised Guidance by USPTO on Patent Subject Matter Eligibility and Examining Computer-Implemented Functional Claims

    More
  • CIONCA Team Member2/5/2019 7:22:27 PM

    TiVo Puts Tivoli on Pause: TTAB’s Decision in TiVo Brands LLC v. Tivoli, LLC

    More
  • Marin Cionca1/23/2019 9:45:30 PM

    Patent Law Alert: All Sales of the Invention, Including Secret Sales May Invalidate a Patent

    More
  • CIONCA Team Member1/4/2019 4:12:21 PM

    In re: Tropp: New Matter in a Continuation Can Be Relevant to Written Description Requirement

    More
  • CIONCA Team Member12/18/2018 6:12:48 PM

    Schlafly v. The Saint Louis Brewery: The Registration of Merely a Surname

    More
  • Marin Cionca12/8/2018 8:35:06 PM

    IP Assets - Procurement, Enforcement, Monetization

    More
  • CIONCA Team Member11/19/2018 1:07:51 PM

    The Appeals Process

    More
  • CIONCA Team Member10/16/2018 6:50:31 PM

    A Double-Edged Sword: Benefit of Priority or Longer Patent Term

    More
  • Marin Cionca10/1/2018 7:42:12 PM

    Can I Register a Color as a Trademark or Service Mark?

    More
  • CIONCA Team Member9/17/2018 4:33:20 PM

    Trademarks and Likelihood of Confusion: Federal Circuit’s Decision in In re: Detroit Athletic Co.

    More
  • Staff8/31/2018 7:26:58 PM

    Patent Claim Interpretation By Federal Circuit's on Facebook's Contiguous Image Layout

    More
  • Staff8/16/2018 4:24:01 PM

    Correcting or Changing a Patent After Issue Through the Central Reexamination Unit

    More
  • Marin Cionca7/31/2018 6:50:05 PM

    My patent expired? Can I still sue for patent infringement?

    More
  • 7/3/2018 7:44:33 PM

    Impax Laboratories Inc. v Lannett Holdings Inc. on Claim Invalidation

    More
  • CIONCA IP5/17/2018 9:54:58 PM

    Marin Cionca Presents at OCIPLA May 2018 Luncheon

    More
  • 5/4/2018 7:37:51 PM

    The Hague System for Protection of International Designs

    More
  • CIONCA Staff4/20/2018 5:25:25 PM

    USPTO Changes Examination Procedure Pertaining to Subject Matter Eligibility in View of Berkheimer v. HP, Inc.

    More
  • CIONCA Staff4/13/2018 9:10:04 PM

    It Take Two to Tango: Knowles v. Iancu, a Standing Dispute in a PTAB Decision

    More
  • 3/20/2018 12:50:05 PM

    Andrei Iancu - New Director of the USPTO

    More
  • 3/8/2018 1:25:46 PM

    Proceed with Caution: Consider Carefully when Narrowing Claims for Allowance

    More
  • CIONCA Team2/16/2018 4:07:48 PM

    Fashion and Intellectual Property

    More
  • CIONCA Team1/17/2018 8:12:06 PM

    A Fork in the Road: Production or Protection?

    More
  • 1/2/2018 7:47:09 PM

    The Lanham Act: Disparagement Provision Violates the First Amendment

    More
  • 12/26/2017 6:04:25 PM

    CIONCA Sets Foot in San Francisco

    More
  • 12/1/2017 8:01:27 PM

    An Introduction to Patent Cooperation Treaty Applications

    More
  • 11/17/2017 1:24:20 PM

    An Introduction to Patent Searches

    More
  • 11/10/2017 6:47:44 PM

    An Introduction to Design Patent Applications

    More
  • Staff11/3/2017 4:20:04 PM

    An Introduction to Provisional Patent Applications

    More
  • Staff9/28/2017 7:27:22 PM

    CIONCA

    More
  • staff9/27/2017 5:12:07 PM

    CIONCA - Patent and Trademark Law Attorney

    More
  • staff9/27/2017 5:00:12 PM

    Claim Indefiniteness During Patent Pre-Issuance: Define Your Invention, Not Just Your Audience

    More
  • staff9/15/2017 9:33:30 PM

    cionca

    More
  • CIONCA Staff8/20/2017 3:16:11 PM

    CIONCA on Patents: Think Twice Before Suing for Patent Infringement and Fight Back when Unreasonably Sued

    More
  • CIONCA - Staff8/9/2017 5:39:58 PM

    Patent Case Study: The Novelty Of An “Invention” Is NOT Enough To Make It Patentable

    More
  • CIONCA - Staff6/28/2017 8:26:07 PM

    Patent Law: Conditions Precedent May Expose Method Claim to Broad Interpretation During Prosecution

    More
  • CIONCA - Staff6/15/2017 5:32:14 PM

    Patent Law: Challenging the Patent Claim Definiteness Requirement

    More
  • Marin Cionca4/25/2017 9:48:49 PM

    Monetization of Patents: How to Make Money with Patents

    More
  • Marin Cionca2/21/2017 12:30:52 AM

    Software Patent Law Update: Federal Circuit Finds Graphical User Interface Patentable

    More
  • Marin Cionca9/15/2016 9:47:39 PM

    Patent Law Alert: Federal Circuit Opens Door for More Software Patents

    More
  • Marin Cionca9/6/2016 9:26:12 PM

    Patent Case Law: New Example of Software as Patentable Subject Matter

    More
  • Iris Kim, PhD6/1/2016 7:04:50 PM

    The Patent Trial and Appeal Board Designates Five More Decisions as Precedential

    More
  • Marin Cionca5/17/2016 8:57:23 PM

    Patent Claims Rejection Based on Inherency

    More
  • Iris Kim, PhD3/25/2016 8:34:14 PM

    Challenging a Claim’s Validity with Different Standards of Claim Construction

    More
  • I. Kim PhD2/26/2016 8:47:51 PM

    The U.S. Supreme Court Will Review Claim Construction Standards and Institution Decision Reviewability.

    More
  • Marin Cionca2/16/2016 6:34:53 PM

    In IPRs, patentees have to show that substitute patent claims are patentable

    More
  • M. Cionca and I. Kim2/4/2016 5:55:16 PM

    Software Inventions Are Still Patentable!

    More
  • Marin1/28/2016 9:15:16 PM

    The Patent Trial and Appeal Board Designates Two Decisions as Precedential

    More
  • Marin1/28/2016 9:10:56 PM

    How Unpredictability Can Affect Obviousness Challenges

    More
  • Marin11/19/2015 2:13:05 PM

    An Innovator’s Dilemma: Design or Utility Patent?

    More
  • Marin11/18/2015 7:31:35 PM

    When Is a Thesis Prior Art?

    More
  • Marin11/18/2015 6:15:40 PM

    Covered Business Method Claims Are Not Required to Particularly Target Financial Industry

    More
  • Marin11/18/2015 6:11:11 PM

    PTAB Decisions Give Examples of Patent Eligible Subject Matter

    More

Marin Cionca, Esq.

Registered Patent Attorney

USPTO Reg. No. 63899

VERIFY

CONTACT INFO

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.

HOME               

Let’s talk!

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