An online resource for tracking gene patents

In a paper published in the journal Nature Biotechnology, researchers have stated that overworked patent offices are struggling to keep up with the rapid explosion in information and technology that genetic sequences represent, while the public at large is kept in the dark about gene patenting practices. It is hoped that a free online resource will bring some transparency to an otherwise opaque system.

In a ruling earlier this year, “the US Supreme Court held that naturally occurring sequences from human genomic DNA are not patentable subject matter”, the researchers, from Cambia and Queensland University of Technology (QUT), said. “Only certain complementary DNAs (cDNA), modified sequences and methods to use sequences are potentially patentable.”

But of those sequences which are patentable, “many patent offices have no way of tracking genetic sequences disclosed in patents and currently do not provide them in machine-searchable format”, said principal author and QUT academic Professor Osmat Jefferson.

“This likely means patents are being granted for genes that are not ‘newly discovered’ at all, because the patent offices have no way of really knowing.”

The team found that while major patent offices claimed to use sophisticated search tools and databases to access patent-disclosed sequences, those search mechanisms are not generally available to the public and may not be accessible to the dozens of patent offices in jurisdictions with limited budgets or emerging intellectual property protection. The study also found that the majority of over 2000 US patent claims did not actually claim the gene sequence itself, but rather its use for particular purposes.

“What is happening? Who’s doing the patenting? Why are they doing it? How much are they doing it? What rights are being granted? And how much is our society benefiting from these biological patent teachings?” Professor Jefferson asked.

The researchers say there is a “pressing need for precise analysis of patents that disclose and reference genetic sequences”. Furthermore, they state, “data sets, standards compliance and analytical tools must be improved - in particular, data sets and analytical tools must be made openly accessible - in order to provide a basis for effective decision-making and policy setting to support biological innovation”.

With this in mind, an international team led by Professor Jefferson is analysing biological patents for open-access web resource The Lens, run by Cambia in collaboration with QUT. The Lens’s PatSeq (Patent Sequence) database currently holds more than 120 million DNA sequences and 10 million protein sequences drawn from patent documents.

Using sequences extracted from millions of global patent documents, coupled with cutting-edge, web-based software, the toolkit provides the first open public insight into exactly who has sought patents over genes and proteins. It includes:

• a graphical tool to visualise the scope of patents overlaying the human genome;
• an analysing tool which allows detailed findings to the finest level to be correlated with the patent document;
• a search tool that allows anyone with a gene or protein sequence to find matches in the PatSeq database.

“Perhaps the toolkit’s most important feature is that all findings can be embedded and shared with anyone, anywhere at no cost, allowing researchers, policymakers and concerned citizens to explore the evidence underlying this practice,” Professor Jefferson said.

“The public - and indeed enterprise and policymakers - need to know the answers if we’re to have a transparent, fair and economically productive society.”