Today, we will talk about creating an Intellectual Property (IP) portfolio in light of the Mayo and Myriad Supreme Court cases. In the past, companies were able to patent inventions that involved relatively isolated natural processes or products, often focusing on naturally occurring phenomena or substances. However, the Mayo and Myriad decisions marked a shift in how patent eligibility is determined, particularly for biotech and life sciences inventions. Many innovations that were once considered patentable are now deemed ineligible, as the Court made it clear that patents cannot be granted for abstract ideas, laws of nature, or natural products unless they involve something more than what is naturally occurring.

The Mayo and Myriad rulings emphasize that just isolating a natural substance or applying a law of nature to a process is not enough to secure patent protection. These decisions have significantly affected how companies approach the creation of an IP portfolio, particularly in the life sciences and biotechnology sectors. With this context in mind, building an effective IP strategy today requires careful consideration of patent eligibility and an understanding of the legal landscape shaped by these key rulings.

What is an IP Portfolio?

An IP portfolio is a collection of intellectual property assets owned by an individual or company, which could include patents, trademarks, copyrights, and trade secrets. A well-developed portfolio serves to protect a company’s innovations, creates opportunities for licensing, and strengthens its competitive advantage. The process of developing an IP portfolio involves identifying valuable assets, determining which ones are eligible for protection, and ensuring they align with the business’s goals.

For biotech and technology companies, this typically involves securing patents to protect novel inventions, compositions, methods, and technologies. However, with the evolving nature of patent eligibility, particularly after the Mayo and Myriad decisions, it is essential to ensure that innovations meet the legal criteria for patentability.

Building a Strong IP Portfolio

When crafting an IP portfolio, a company should consider a mix of patents, trademarks, copyrights, and trade secrets to protect all aspects of its business. The portfolio should be designed not only to prevent infringement but also to maximize the business value of the company’s IP.

1. Patent Strategy

Patents are crucial for protecting inventions and discoveries. For an IP portfolio to be effective, it must include patent filings that cover key innovations. For life sciences companies, this might involve securing patents for novel compounds, diagnostic methods, or new uses of existing products. However, after Mayo and Myriad, companies must be mindful of the two-prong test to determine whether their inventions involve a law of nature and if the claims add something more than just the natural phenomenon.

2. Trademark Protection

Trademarks are vital for protecting brand names, logos, and slogans. They distinguish a company’s products or services from those of others in the marketplace. Unlike patents, trademarks offer indefinite protection, as long as they are in use and properly maintained. A strong trademark portfolio can significantly enhance the value of a business by building brand recognition and consumer trust.

3. Copyrights

Copyright protection is essential for original works of authorship, such as software code, written content, and artistic works. This type of protection prevents others from reproducing, distributing, or publicly displaying the copyrighted work without permission. Companies in creative industries should ensure they register copyrights for key works that form part of their business model.

4. Trade Secrets

Trade secrets offer a unique form of protection for proprietary information, processes, formulas, and techniques that give a company a competitive advantage. Unlike patents, trade secrets do not require public disclosure and can last indefinitely, as long as the information remains confidential. Trade secrets are especially important for companies that rely on internal knowledge or confidential business strategies to stay ahead in the market.

The Impact of Mayo and Myriad on Patent Eligibility

Both Mayo and Myriad cases involved challenges to the eligibility of certain biotech inventions for patent protection. These decisions set important precedents for patent law, particularly concerning naturally occurring products, laws of nature, and abstract ideas. Understanding these rulings is essential for building a patent portfolio that can withstand legal scrutiny.

Mayo Collaborative Services v. Prometheus Laboratories, Inc.

In Mayo, the Supreme Court established a two-prong test to determine whether an invention is patent-eligible under Section 101 of the Patent Act. The Court ruled that a method for diagnosing medical conditions based on naturally occurring correlations was patent-ineligible because it only involved a natural law and conventional steps. The Court emphasized that inventions that are merely based on laws of nature are not eligible for patent protection unless they add something inventive beyond the natural law.

The Mayo test includes:

1. Step 1: Is the claim directed to a law of nature? The Court first asks whether the claim concerns a law of nature, which could include natural correlations, phenomena, or substances that exist in nature.
2. Step 2: Does the claim add something significantly more? Even if the invention is based on a law of nature, it may still be eligible for a patent if it involves an inventive concept that adds something more than the natural law itself. This could involve novel applications or methods that are not routine or conventional.

Association for Molecular Pathology v. Myriad Genetics, Inc.

The Myriad case further clarified the boundaries of patent eligibility for natural products. In this case, the Supreme Court ruled that naturally occurring DNA sequences, even when isolated from the body, are not patentable. The Court held that DNA sequences are products of nature, and isolating them does not change their fundamental nature. However, the Court allowed patents for complementary DNA (cDNA) because it is a synthetic product that is not naturally occurring.

The key takeaway from Myriad is that while natural substances cannot be patented, modified or synthetic versions may still be eligible for protection.

Patent-Ineligible Subject Matter

The Mayo and Myriad decisions clarified several categories of inventions that are patent-ineligible, particularly in the context of biotechnology:

1. Laws of Nature: Any natural principle, such as physical laws or biological processes, cannot be patented. For instance, a method for diagnosing a condition based solely on a natural correlation would not meet the eligibility requirements.
2. Abstract Ideas: Abstract concepts, such as mathematical formulas, algorithms, or methods that apply natural laws without additional inventive steps, are generally ineligible for patent protection.
3. Natural Phenomena: Products or substances that are naturally occurring, such as minerals, plants, or genes, are not patentable, even if they are isolated from their natural environment.
4. Products or Processes That Are Not Significantly Altered: If a product or process simply isolates or purifies a natural substance without adding any inventive step, it is likely to be considered patent-ineligible. For example, isolating a natural gene sequence without modification would not be patentable under Myriad.

Building an IP Portfolio in the Wake of Mayo and Myriad

Given the legal changes brought about by Mayo and Myriad, companies must carefully evaluate the eligibility of their innovations before filing for patents. The following strategies can help businesses build an effective and legally sound IP portfolio:

1. Innovate Beyond Natural Phenomena: Focus on innovations that go beyond mere natural discoveries. For example, rather than patenting a naturally occurring gene, a company could patent a method for editing that gene using CRISPR technology, which involves an inventive application of existing knowledge.
2. Ensure Novelty and Inventiveness: To meet the requirements for patent eligibility, ensure that the invention represents something more than a natural law or abstract idea. It should offer a novel and non-obvious application or transformation of the natural phenomenon.
3. Use Synthetic Biology: Rather than patenting natural materials, companies can focus on synthetic biology, which involves creating new products or methods that are not found in nature. For instance, synthetic DNA (cDNA) or engineered proteins are more likely to meet patent eligibility criteria.
4. Regularly Review and Update Your Portfolio: Given the shifting nature of patent eligibility, regularly review your portfolio to ensure that your patents remain valid and enforceable under current law. Work with IP professionals to stay informed about new developments and to adapt your strategy accordingly.

USPTO Guidance on Patent Eligibility

The U.S. Patent and Trademark Office (USPTO) has issued guidance to help examiners apply the Mayo and Myriad decisions when evaluating patent applications. The guidance focuses on the following key points:

1. The Mayo/Alice Two-Prong Test: Examiners use the Mayo two-prong test to assess whether a patent claim is directed to a law of nature or abstract idea and whether it adds something inventive beyond that natural law.
2. Exceptions to Patent Eligibility: The USPTO reiterates that laws of nature, natural phenomena, and abstract ideas are not patentable. However, inventions that involve significant transformation or inventive applications of these concepts can still qualify for patent protection.
3. Patents on Synthetic Biology: The USPTO has emphasized that synthetic products, such as cDNA, which are not naturally occurring, are patentable. Innovations that involve the manipulation of natural materials or processes in new and inventive ways may be eligible for patent protection.

Examples of IP Portfolios

To illustrate the importance of a well-rounded IP portfolio, here are examples of how companies might build their IP holdings:

1. Biotech Company Portfolio: A biotechnology company could secure patents for novel biotechnological processes, synthetic drugs, and diagnostic methods. The company might also protect its branding with trademarks and safeguard proprietary data with trade secrets.
2. Tech Startup Portfolio: A tech startup might focus on patents for new software algorithms, trademarks for its branding, and copyrights for its code. The company might also protect trade secrets relating to user data and algorithms to stay competitive.

In conclusion, building a strategic and legally sound IP portfolio is crucial for any business, particularly in the face of evolving patent eligibility standards. Understanding the impact of the Mayo and Myriad cases is essential for ensuring that your patents meet current legal criteria, and staying informed about USPTO guidance is key to adapting your strategy as needed. With careful planning and ongoing evaluation, businesses can protect their innovations and create lasting value from intellectual property.