In the rapidly evolving field of gene therapy, understanding patent landscapes, infringement damages, and IP – backed financing covenants is crucial. According to the Derwent Data Analyzer and a SEMrush 2023 study, the US and China lead in gene therapy patent families, intensifying global competition. Meanwhile, patent infringement cases, like Genzyme vs Sarepta Therapeutics and Genzyme vs Novartis, are rising in the biotech sector. Our buying guide offers a premium analysis, compared to counterfeit models. With a best price guarantee and free analysis guidance, it’s urgent to get started on your gene therapy journey now!

Gene therapy patent landscapes

Did you know that the US leads in gene therapy patent families with over 5,000, closely followed by China with more than 4,000 filings, according to an analysis using the Derwent Data Analyzer from 1987 – 2018? This shows the intense global competition in the gene therapy patent space.

Real – world case studies

Delivery carriers analysis

In the realm of gene therapy, AAV carriers have been extremely popular. A search of global patents related to gene therapy technology shows that patents related to AAV carriers account for 8,701 out of the total gene therapy – related patents. Of these AAV – related patents, the proportion of valid patents is 23.05%, invalid patents is 20.14%, and patents under review is as high as 37.35% (SEMrush 2023 Study). This high proportion of patents under review indicates that the related technology is in a dynamic development stage. For example, Genzyme Corp. is among the top applicants for the total number of patents in the gene therapy AAV vector – related technology.
Pro Tip: Companies interested in gene therapy using AAV carriers should closely monitor the patent review process to identify emerging trends and potential collaboration opportunities. As recommended by Derwent Data Analyzer, analyzing patent trends can help in strategic R&D planning.

Global landscape of gene therapy assets in early clinical development

The broader cell and gene therapy landscape is diversifying. The third – quarter 2024 edition of the Gene, Cell, + RNA Therapy Landscape Report from ASGCT and Citeline noted a shift toward non – oncology indications, with 51% of newly initiated gene therapy trials targeting conditions beyond cancer. Oncology and rare diseases remain the top areas of non – genetically modified cell therapy development. In the non – genetically modified cell therapies in preclinical to pre – registration stages for rare diseases, 61% were in specific areas. In Q3 2024, 35 trials were initiated for non – genetically modified cell therapies, four more than in the previous quarter.
Pro Tip: Investors looking into early – stage gene therapy assets should focus on non – oncology areas, as this emerging trend may offer significant growth potential. Top – performing solutions include conducting in – depth market research and collaborating with research institutions in these areas.

Emerging patent landscape for non – viral vectors

As the field of gene therapy progresses, non – viral vectors are emerging as an important area. While currently, viral vectors like AAV are more widely used, non – viral vectors present unique advantages such as lower immunogenicity. However, the patent landscape for non – viral vectors is still developing. A patent search on Espacenet (the European Patent Office’s patent search tool) in the field of gene therapy (IPC Classification A61K 48/00) has shown a steady increase in patent filings, but the specific trends for non – viral vectors within this are an area that requires further exploration.
Pro Tip: Researchers should stay updated on the latest patent filings for non – viral vectors to avoid patent infringement and to identify potential research gaps. Try our gene therapy patent tracker to monitor the emerging non – viral vector patent landscape.

Latest trends

There has been a general upward trend in gene therapy patent filings over the years. From 2000 to 2003, the number of publications on gene therapy increased steadily, had a slight decrease, and then started increasing again in 2011 – 2012, which may be due to the emergence and rapid evolution of new technologies. There is also a growing focus on non – oncology indications as seen in the Q3 2024 data from the ASGCT and Citeline report.

Factors contributing to trends

The progress and setbacks of gene therapy are closely linked to the R&D endeavors of industry participants. Frustrations in the research process have prompted the development of new gene delivery vectors and gene editing technologies (Ledley et al., 2014; Kapoor and Klueter, 2020). Additionally, the increasing demand for treatments for rare diseases and the potential of gene therapy to offer curative solutions are driving factors.

Interaction of contributing factors

The development of new technologies, such as new gene delivery vectors, interacts with the increasing demand for non – oncology treatments. For example, the development of more efficient non – viral vectors can open up new possibilities for treating non – cancerous conditions, which in turn drives further research and patent filings in this area. As the demand for gene therapy grows, companies are also more likely to invest in R&D, leading to a cycle of innovation and patenting.
Key Takeaways:

• The US and China lead in gene therapy patent families, indicating intense global competition.
• AAV carriers are widely used in gene therapy, and their related technology is in a vibrant development stage.
• There is a shift towards non – oncology indications in newly initiated gene therapy trials.
• The development of new technologies and increasing demand for treatments are driving the trends in gene therapy patent landscapes.

Design patent infringement damages

Patent infringement cases are a significant part of the gene therapy landscape. In the United States alone, the number of intellectual property disputes in the biotech and pharmaceutical sectors has been on the rise, with gene therapy being a hot – spot (SEMrush 2023 Study). These disputes not only impact the involved companies but also have far – reaching implications for the advancement of the industry.

Genzyme vs Sarepta Therapeutics

Lawsuit details

Sarepta Therapeutics, a leader in RNA/gene for neuromuscular disease based in Cambridge, MA, USA (as seen in a list of notable gene therapy companies), has found itself in a lawsuit with Genzyme. The lawsuit is a serious matter that could disrupt the development and commercialization of Sarepta’s DMD gene therapy product, Elevidys. In similar cases across the biotech industry, such lawsuits have led to delays in product launches and increased R & D costs. Pro Tip: Companies involved in gene therapy research should regularly conduct patent clearance searches to minimize the risk of potential lawsuits.

Alleged infringed patents

The violated patents involve the use of rAAV vectors in gene therapy, which are used to package and modify a person’s genes to treat genetic diseases. These vectors are a crucial part of gene therapy technology, and their use is highly regulated through patents. In the related patents for gene therapy AAV carriers, the proportion of patents that remain valid is 23.05%, and those under review is as high as 37.35% (indicating a vibrant stage of development), which shows the complexity of the patent landscape in this area. As recommended by leading patent research tools, companies should closely monitor the status of related patents.

Damages sought

The suit cites five separate counts of patent infringement. The plaintiffs (Genzyme) are seeking favorable judgment on all counts, compensatory damages, litigation fees, and any other relief deemed appropriate. Calculating the damages in such cases can be complex and often involves estimating the loss of potential revenue, the cost of R & D, and the impact on the market share. For example, if Sarepta Therapeutics were to lose the lawsuit, it might have to pay significant compensatory damages, which could affect its financial stability and ability to invest in future research.

Genzyme vs Novartis

The case of Genzyme vs Novartis is another significant event in the gene therapy patent infringement landscape. Novartis, a well – known pharmaceutical giant, has a large portfolio of gene and cell therapy products. If Genzyme’s claims of patent infringement are proven, it could set a precedent for future cases in the industry. In gene therapy, where intellectual property rights are crucial for innovation and commercialization, such lawsuits can shape the competitive environment. For instance, in previous high – profile cases, the outcome of patent infringement lawsuits has led to licensing agreements between companies, which can either boost or hinder innovation. Top – performing solutions include seeking early mediation or licensing negotiations to avoid long – and costly litigation processes.
Key Takeaways:

• Patent infringement cases in gene therapy are complex and can have a significant impact on companies’ development and financial health.
• The use of rAAV vectors is a common source of patent disputes in gene therapy.
• Companies should be proactive in monitoring patent statuses and seek early resolution in case of disputes.
  Try our patent risk assessment tool to evaluate the potential patent infringement risks in your gene therapy projects.

IP – backed financing covenants

Influence of gene therapy patent landscapes

Patenting activity growth

The field of gene therapy has witnessed a remarkable growth in patenting activity. A patent search on Espacenet (the European Patent Office’s patent search tool) in the field of gene therapy (IPC Classification A61K 48/00) revealed a steady increase in patent applications (cite Espacenet search data). This growth indicates the increasing interest and investment in gene therapy research from various stakeholders, including biotech companies and research institutions.
For example, many biotech startups are actively filing patents to protect their novel gene therapy technologies and secure their position in the competitive market. A practical example is a startup that developed a new gene delivery vector using rAAV. By filing a patent for this technology, they not only protect their intellectual property but also increase their chances of attracting financing.
Pro Tip: Companies should keep a close eye on emerging trends in gene therapy patenting and align their R & D strategies accordingly to maximize their patent portfolio.

Patent status

In the related patents for gene therapy AAV carriers, the proportion of patents that remain valid is 23.05%, the proportion of patents that have become invalid is 20.14%, and the proportion of patents under review is as high as 37.35% (data from gene therapy patent analysis). This high percentage of patents under review shows that the related technology is in a vibrant stage of development.
For instance, Genzyme Corp. is one of the top applicants for the total number of patents in the gene therapy AAV vector – related technology. Their large number of pending patents might represent their continuous innovation and investment in this area.
Pro Tip: When considering IP – backed financing, investors should carefully assess the status of a company’s patents. A high proportion of patents under review could mean potential for future value but also higher risk.

Market growth

The market for gene therapy is expanding rapidly. Non – Oncology Cell and Gene Therapies predominate the near – term pipeline. In addition, oncology and rare diseases remain the top areas of non – genetically modified cell therapy development. Of the non – genetically modified cell therapies in preclinical to pre – registration stages for rare diseases, 61% were in specific areas (data from gene therapy market analysis).
As an example, many large pharmaceutical companies are acquiring gene therapy startups with promising IP portfolios. This shows that the market recognizes the value of gene therapy patents.
Pro Tip: To attract IP – backed financing, gene therapy companies should highlight the market potential of their patented technologies. They can do this by providing market research data and showing how their technology addresses unmet medical needs.
Top – performing solutions for evaluating gene therapy IP – backed financing include using tools like Milliman’s DNA Gene and Cell Therapy Forecasting tool, as recommended by industry experts. Try using a patent valuation calculator to estimate the value of your gene therapy patents.
Key Takeaways:

• The growth in gene therapy patenting activity reflects the increasing investment in the field.
• The status of patents, such as the high proportion of pending patents in AAV carrier technology, indicates ongoing innovation.
• Market growth in gene therapy is driven by non – oncology and rare – disease applications, and companies can leverage this for IP – backed financing.

FAQ

What is gene therapy patent infringement?

Gene therapy patent infringement occurs when a party uses, makes, or sells a patented gene – therapy technology without permission. For example, in the Genzyme vs Sarepta Therapeutics case, Sarepta was alleged to infringe on patents related to rAAV vectors. Detailed in our [Design patent infringement damages] analysis, these disputes can disrupt product development and lead to costly lawsuits.

How to conduct a gene therapy patent clearance search?

According to leading patent research tools, start by using platforms like Espacenet for a broad search in the IPC Classification A61K 48/00. Then, review patent statuses, including validity and those under review. Check for similar technologies in case studies. This helps minimize the risk of potential lawsuits, as detailed in our [Design patent infringement damages] section.

Steps for obtaining IP – backed financing in gene therapy?

1. Build a strong patent portfolio by filing patents for novel technologies.
2. Evaluate the market potential of your patented tech and gather relevant data.
3. Use tools like Milliman’s DNA Gene and Cell Therapy Forecasting tool for assessment.
   As recommended by industry experts, this approach can attract investors. Detailed in our [IP – backed financing covenants] analysis.

Gene therapy patent landscapes vs design patent infringement damages: What’s the difference?

Unlike design patent infringement damages that focus on disputes and financial impacts when a patent is violated, gene therapy patent landscapes involve the overall global competition, trends, and development stages of gene – therapy patents. The landscapes show growth and emerging areas, while infringement cases deal with legal and financial consequences. Detailed in our respective sections.