United States Patent 5,229,137: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,229,137, issued to Brigham and Women’s Hospital, Inc., is a significant patent that has been at the center of several legal battles, particularly in the pharmaceutical industry. This patent covers a method for treating heartburn using a combination of H2-blockers and antacids. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, titled "Method for treating episodic heartburn," was granted for a method that combines the immediate relief provided by antacids with the sustained relief offered by H2-blockers. This combination was innovative at the time, as it addressed both the immediate and long-term needs of heartburn sufferers[1][2][5].
Claims of the Patent
The patent claims revolve around the co-administration of these two types of drugs. Here are the key aspects of the claims:
- Combination Therapy: The patent claims a method of treating heartburn by administering both an H2-blocker and an antacid.
- Immediate and Sustained Relief: The combination is designed to provide immediate relief from antacids and sustained relief from H2-blockers.
- Specific Ingredients: The patent specifies the use of famotidine as the H2-blocker and calcium carbonate or magnesium hydroxide as the antacid[1][2][5].
Patent Scope and Breadth
The scope of the patent is defined by its claims, which are critical in determining what is protected and what is not. Here are some key points:
- Independent Claim Length and Count: Research suggests that patent scope can be measured by metrics such as independent claim length and count. However, in this case, the focus is more on the specific combination and its effects rather than the length or count of claims[3].
- Innovation Over Prior Art: The patent's innovation lies in combining two known ingredients to achieve a new and useful result—immediate and sustained relief from heartburn. This combination was not obvious from the prior art, which only used these ingredients separately[1][4].
Patent Landscape and Litigation
The patent has been involved in several significant legal cases, which have shaped its validity and enforcement.
Brigham & Women’s Hospital, Inc. v. Perrigo Company
- Infringement and Validity: In this case, Brigham & Women’s Hospital, Inc. alleged that Perrigo Company’s generic version of Pepcid Complete infringed their patent. The jury initially found the patent valid and infringed, but the district court later overturned this verdict, stating that no reasonable jury could have found infringement based on the evidence presented[1][2].
- Immediate Relief Requirement: A crucial element of the patent was the requirement for "immediate relief" after administration. The court found that Brigham failed to prove that Perrigo’s generic product did not meet this criterion, leading to the dismissal of the infringement claim[1].
Licensing and FDA Listing
- Exclusive Licensing: Johnson & Johnson exclusively licensed the patent and listed it in the FDA's Orange Book. However, when Perrigo filed its generic ANDA (Abbreviated New Drug Application), Johnson & Johnson chose not to file suit on this patent, leading to its removal from the Orange Book listing[1].
Sovereign Immunity and Patent Eligibility
While not directly related to this specific patent, the broader patent landscape includes discussions on sovereign immunity and patent eligibility, which can impact similar patents.
- Sovereign Immunity: In cases like University of Florida Research Foundation, Inc. v. General Electric Company, the issue of sovereign immunity under the 11th Amendment has been raised. This can affect how state universities' patents are challenged and enforced[1].
- Patent Eligibility: The eligibility of patents, especially those related to data synthesis and other abstract ideas, has been a topic of debate. Patents like U.S. Patent No. 7,062,251 have been found ineligible as a matter of law due to their abstract nature[1].
Industry Impact and Commercial Success
The commercial success of the patented method has been significant, as evidenced by the market performance of Pepcid Complete.
- Market Dominance: The combination therapy has become a standard treatment for episodic heartburn, reflecting the commercial success and long-felt but unmet need addressed by the patent[1][5].
- Litigation Costs: The extensive litigation surrounding this patent highlights the costs associated with defending and challenging patents. These costs can be a barrier to innovation and can diminish the incentives for further research and development[3].
Key Takeaways
- Innovative Combination: The patent protects a method that combines H2-blockers and antacids for treating heartburn, providing both immediate and sustained relief.
- Litigation Challenges: The patent has faced significant legal challenges, including issues with proving infringement and the requirement for "immediate relief."
- Commercial Success: Despite legal challenges, the patented method has achieved commercial success and addressed a long-felt need in the market.
- Patent Landscape: The broader patent landscape includes considerations of sovereign immunity, patent eligibility, and the costs associated with litigation.
FAQs
What is the main claim of U.S. Patent 5,229,137?
The main claim is for a method of treating episodic heartburn by co-administering an H2-blocker and an antacid.
What are the key ingredients specified in the patent?
The patent specifies the use of famotidine as the H2-blocker and calcium carbonate or magnesium hydroxide as the antacid.
Why was the jury verdict in Brigham & Women’s Hospital, Inc. v. Perrigo Company overturned?
The district court overturned the verdict because Brigham failed to present sufficient evidence of direct infringement, particularly regarding the "immediate relief" requirement.
How has the patent impacted the market?
The patented method has become a standard treatment for episodic heartburn, reflecting its commercial success and addressing a long-felt but unmet need.
What are some broader implications of this patent in the patent landscape?
The patent highlights issues such as sovereign immunity, patent eligibility, and the costs associated with litigation, all of which can impact the incentives for innovation.
Sources
- Patently-O: "February | 2019 - Patently-O"
- Fish: "Massachusetts Patent Litigation Wrap Up - August 2019"
- Hoover Institution: "Patent Claims and Patent Scope"
- Casetext: "McNeil-PPC, Inc. v. Perrigo Company"
- Finnegan: "Only Having the Pieces of a Jigsaw Puzzle Isn't Enough - They Have to Be Assembled Together"
