Understanding IP Law:Four Key Biotech Case Studies March 2025
Biotechnology's Legal Landscape: Who is Leading The Charge
By reading this article, individuals and companies can make informed decisions about their legal intellectual property strategies and investments in biotechnologies and medical devices.
Companies like AstraZeneca lead the charge in protecting intellectual property, innovation, and following their strategies is a great way to understand the nuances of intellectual property law, particularly for startups, small and large business owners alike, and entrepreneurs who wish to safeguard their creations and investments. This article delves into the complexities of the latest legal intellectual property strategies, offering insights to help businesses and investors make informed decisions
Case Study 1:AstraZeneca and the Forxiga Diabetes Drug [March 2025]
The High Court's decision on AstraZeneca's patent protections will determine the extent of generic competition in the diabetes treatment market and could influence future patent strategies in the pharmaceutical industry.
1. Background
Beginning invalidity proceedings, on 10 March 2025, generic drugmakers asked the High Court to remove patent protections for AstraZeneca's $1 billion Type 2 diabetes drug, Forxiga, as pharmaceutical competitors hope to pave the way for their competitive drugs.
2. Potential Outcomes:
- If the court revokes AstraZeneca's patent, it could allow generic manufacturers to produce lower-cost alternatives, thereby increasing market competition and reducing drug prices.
- Conversely, if the patent is upheld, it may strengthen the company's market exclusivity, limiting the availability of generics.
3. Legal Authority Sources:
- The principle of "patent validity" is guided by statutory frameworks such as U.S. Patent Law 35 U.S.C. § 101, which defines patentable subject matter, and § 102, which addresses conditions for patent validity. In the UK, S1 of the Patents Act 1977 defines what constitutes a patentable invention, while S2-4A outline the conditions for validity; S60 deals with infringement; and S74 states when a patent’s validity may be put in issue.
4. Examples of Successful Medical Patent Challenges:
In 2009, Teva Pharmaceuticals filed an ANDA to market a generic EpiPen in collaboration with Antares Pharma Inc, a maker of injection systems; Pfizer and King sued them for infringing US Patent 7,449,012 that was due to expire in 2025; Pfizer, Mylan, and Teva settled in April 2012 in a deal that allowed Teva to start selling the device in mid-2015, pending FDA approval.
Additionally, the Humira patent expirations in 2023 have allowed multiple biosimilars to enter the market, which lowers costs and increases availability for patients, showcasing the impact of patent validity on market access.
In summary, the outcome of AstraZeneca's patent protections for Forxiga will significantly affect healthcare costs, market competition, and the strategies of pharmaceutical companies concerning their intellectual property rights.
Case Study 2:10x Genomics DNA Analysis Patent Clashes [March 2025]
Overview of Patent Infringement Issues
10x Genomics is involved in numerous legal actions regarding potential patent infringement related to DNA analysis, which may impact their operations and intellectual property strategies for the entire bioscience industry.
1.Background
10x Genomics has been involved in patent litigation with several different parties, including Parse Biosciences and NanoString Technologies Inc., regarding the issue of validity of certain patent claims relating to DNA analysis in various US Courts and at the European Patent Office.
Detailed Insights into Patent Challenges
2. Understanding Patent Infringement: The situation highlights the complexities of patent law, especially in rapidly advancing fields like biosciences. Companies must navigate existing patents to avoid infringement, as seen with 10x Genomics.
3. Legal Authority References: According to the European Patent Convention (EPC), particularly Article 52, highlights the criteria for patentability including novelty and inventive step, which is crucial in determining whether a company infringes on existing patents.
4. Notable Historical Legal Cases in Bioscience: A past notable example in the biotech sector similar to the challenges faced by 10x Genomics now is in the case of Amgen Inc. v. Sanofi, in which the US Supreme Court affirmed a Federal Circuit decision invalidating Amgen's patents for lack of enablement. This case specifically concerned broad claims to a class of monoclonal antibodies that reduce LDL cholesterol. Amgen successfully enforced its patents, significantly impacting Sanofi's product development.
5. Actionable Insights:
For Companies: Regularly conduct patent searches and freedom-to-operate analyses to mitigate infringement risks.
For Investors: Monitor legal disputes as they can affect company stock valuations and market positions.
By understanding these elements, individuals and companies can make informed decisions about their legal strategies and investments in biotechnologies.
Case Study 3:Salts Healthcare Ltd v Pelican Healthcare Ltd EWHC 1539 (Pat) [2025],
1. Background of the Case
Salts Healthcare accused Pelican Healthcare of infringing their UK patent (GB2569212) for an ostomy appliance, specifically the ModaVi bag. "Stoma bags" are pouches that collect waste from a stoma (an opening in the abdomen) created during surgery. "Pelican" is a brand that offers a range of stoma care products, including bags and accessories. Salts cases was that Stoma bags infringed on their products. In a March 2025 decision, Salts claims were rejected and Pelican was permitted to continue selling its version of the stoma bag.
2. What Can Be Learned?
Patent claims, especially those involving medical devices such as stoma bags, can be contested and upheld in courts, allowing certain manufacturers to continue their operations despite infringement claims.
3. Key Outcomes from the Case:
The case showcases how a medical device maker successfully defended its right to sell a product despite a rival’s patent infringement claims. It underscores the importance of establishing strong patent validity or non-infringement arguments.
4. Legal Principles Involved:
The validity of patent claims can hinge on several factors, including:
Novelty: Was the invention new at the time of filing?
Non-obviousness: Does the invention produce unexpected results or significantly improve prior art?
Enablement: Can someone skilled in the field sufficiently understand and replicate the claims?
5. Conclusion:
Businesses involved in patent disputes can take valuable lessons from this case regarding the defence strategies they may employ and the importance of having robust intellectual property protections. Furthermore, engaging in pre-litigation patent analysis can inform companies on the viability of their claims and help avoid costly litigation.
Case Study 4:Well Lead Medical Co Ltd v CJ Medical Ltd [2025] EWHC 492 (IPEC) (07 March 2025)
Overview of the Patent Dispute
This IPEC case concerns European Patent No. 3 760 143 B1, which pertains to a device designed to remove stone fragments, specifically kidney stones and gallstones, which have historically caused problems for patients. The invention focuses on improving endoscopic lithotripsy, a method that uses energy to break stones into fragments and employs suction through a sheath inserted into the urinary tract to remove these fragments. The patent is held by Well Lead, who accuses CJ Medical of infringing on it by marketing similar products. CJ Medical contests the infringement claim and argued that the patent is invalid. The Court found in favour of CJ Medical.
What can be learned?
Patent claims can be contested in court because of a failure to provide sufficient evidence of infringement, which can result in a loss of rights to enforce the patent.
1. Outcome of the Case: In this situation, Chinese Medical Co. was unsuccessful in its patent infringement claim against a British competitor. Simply holding a patent does not guarantee its enforcement, especially if the evidence of infringement is lacking.
2. Important Legal Sources and Insights: Under the UK Patents Act 1977, a patent holder must demonstrate that the alleged infringement involves utilising the patented invention. In Huawei Technologies Co. Ltd v. ZTE Corp. and ZTE Deutschland GmbH (Case C-170/13) concerns an alleged infringement of a patent that is essential to a standard established by a standardisation body (a "standard-essential patent" or "SEP"). The European Court set out some guidance on the principles to consider when seeking injunctive relief for patent infringement.
3. Actionable Insights:
- Before pursuing a patent infringement claim, ensure you have robust evidence to support your allegations.
- Companies should assess competitors' products thoroughly to identify potential overlaps with patented technology.
- Seek the assistance of a specialised in intellectual property lawyer to evaluate the strength of patent claims before proceeding with litigation.
Conclusion: Leveraging IP Strategies for Innovation
In conclusion, understanding and implementing effective legal intellectual property strategies is paramount for individuals and companies in the biotechnology and medical devices sectors. By taking a proactive approach to IP management, leveraging international protections, and learning from industry leaders like AstraZeneca, businesses can secure their innovations and make informed investment decisions.
Protect Your Innovations
After reading this article, you have the tools to better understand intellectual property law and protect your important ideas. Use IP to safeguard your creations and help your business grow in the competitive fields of biotechnology and medical devices. In a world where new ideas set you apart, managing your IP well is essential for lasting growth and staying ahead of your competition.
Useful Links
Navigating Critical AI Patents
Patent Registration Service Page
Patent Infringement Service Page
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For a quotation, please contact us at (020) 7305-7491 or peter@pailsolicitors.co.uk. We would be delighted to assist you. Mr Peter Adediran is the owner and principal solicitor at PAIL® Solicitors. Subscribe to our newsletter to get blog post updates and other information about the firm straight to your inbox.
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Disclaimer
We provide cases and statutes as general information because contracts should be flexible to adapt to legal changes. Our articles on media and IP agreements serve as starting points for readers to brainstorm ideas. They are not a substitute for professional legal advice. Each contract is unique; even good templates need adaptations for specific situations. One party typically presents a contract based on industry standards and in-house policies. Replacing the contract may be difficult, but you can negotiate important clauses and agree on amendments.