Here are discussions of several life sciences utility patents owned by companies and universities.
Presented by Melak Alemu (Virginia Tech)
Here is a video presentation by Melak, which offers a more detailed discussion of the patented technology for the DUSA Illuminator.
DUSA’s patent for an Illuminator for Photodynamic Therapy
DUSA is a pharmaceutical company that creates and manufactures dermatology products and technologies.
DUSA’s Illuminator uses Blue light to treat symptoms of actinic keratosis and other harmful skin conditions. By patenting its Illuminator DUSA will obtain a monopoly on use of this technology, which it may also license to other manufacturers.
Before DUSA was granted its patent (image above) it demonstrated the technology met three basic requirements for patentability: useful, novel, and non-obvious. The technology is useful because it ameliorates certain unhealthy skin conditions affecting millions of individuals. It is novel because the technology was not previously publicly known or accessible. And this technology is non-obvious because it is not a technology that could be considered readily apparent within the pharmaceutical/medical device industries.
DUSA likely chose patent instead of trade secret protection because it wants the public to be aware of (and purchase) this technology. This awareness and access to the technology, however, involves the risk that a competitor might reverse engineer the technology and legally manufacture and sell a similar product. By obtaining a patent, DUSA is guaranteed a 20 year monopoly on its Illuminator, regardless of the ability of a competitor to reverse engineer the innovative technology it embodies.
Presented by Miles Cook, Harvey Mudd College (Claremont Colleges)
CRISPR Cas9 (Gene editing technology)
Here is a video presentation by Miles, which offers a more detailed discussion of the patented technology for CRISPR Cas9 and the patent ownership dispute it generated.
CRISPR-Cas9 is a genetic editing technique that allows scientists to easily modify DNA sequences. The biological components that CRISPR-Cas9 relies upon have been studied since 1987, but it was not until 2012 that they were specifically used for DNA modification. From an intellectual property perspective, this non-obvious application of CRISPR-Cas9 for a particularly new and useful purpose is a great example of a patentable process. However, CRISPR-Cas9 has become the center of an ongoing battle involving an infringement claim by UC Berkeley and the University of Vienna, against the Broad Institute, which is affiliated with Harvard and MIT.
The conflict began in 2012 when Jennifer Doudna’s lab at the University of California Berkeley and Emmanuelle Charpentier’s team at the University of Vienna utilized CRISPR-Cas9 technology to modify DNA isolated in a test tube. The two labs then filed for a patent on this new process together. However, in 2013, Fen Zhang of Broad Institute used CRISPR-Cas9 to modify DNA in eukaryotic cells, not isolated sequences in a test tube. Broad Institute then filed for patent protection on their specific process but paid for a priority or expedited review. Therefore, in 2014 the USPTO granted Broad Institute their patent for CRISPR-Cas9 technology while UC Berkeley and the University of Vienna were still waiting for a decision on their earlier-filed application.
UC Berkeley and the University of Vienna then filed an appeal stating that Broad’s patent application was too similar to their filing, but this appeal was rejected by the USPTO on the basis of the different mediums the labs worked in. In 2018, UC Berkeley and the University of Vienna took legal action again and filed suit in the US Court of Appeals for the Federal Circuit, but this court also sided with Broad Institute. However, in 2019, the USPTO finally granted UC Berkeley and the University of Vienna patents for CRISPR-Cas9 use but only in prokaryotic cells. Broad Institute still holds the patent for CRISPR-Cas9 use in eukaryotic cells today.
One may wonder why UC Berkeley fought such a long and expensive legal battle, but the financial incentives of the CRISPR-Cas9 patents make it clear. Holding the patents for CRISPR-Cas9 use could be extremely profitable for the owner due to its applicability in so many different fields from agriculture to medicine. But, as the two groups argued, other labs looking to avoid the CRISPR-Cas9 monopoly developed new CRISPR techniques such as CRISPR-Cas 12, 13, X, and Y, making CRISPR-Cas9 less desirable. Patents not only protect innovation but help push it along. Hopefully, this example provides greater insight into some of the legal processes of intellectual property through an ongoing and controversial patent dispute.
Presented by Yiyi Zhang, University of California, Santa Barbara
Apeel’s Edible Protective Coating for Produce
Apeel Sciences is a biotechnology company established by UCSB students.
Its patented technology is the formula for a plant-derived powder consisting of lipids and glycerolipids which, when mixed and applied with water, prolongs the shelf life of fresh produce. This product is distributed to growers and suppliers to be applied post-harvest so the produce will remain fresh for longer periods through shipment, and on retailers and consumers’ shelves. Here is a promotional video from Apeel, which demonstrates the efficacy of its product.
Apeel’s technology alleviates the significant problem we now face of food waste, and reduces the amount of plastic packaging required for selling produce, as well as harmful greenhouse gas emissions from food in landfills.
Apeel’s technology satisfies the prerequisites for patent protection because is useful; it is not merely an idea, but a product that has been proven to work as Apeel has claimed. It is novel in that it is not based on previously known knowledge. It is also non-obvious because the formula for the compound could not be said to be apparent to others working in this life sciences field. Its technology is not a trade secret because Apeel has disclosed to the public that its product is plant-derived, and it is possible for competitors to reverse-engineer its compound. Accordingly, Apeel chose to protect their formula with a patent.