Clients eager to commercialise their invention and those aware of the risks of prior publication often ask about practical steps to maintain confidentiality during commercial discussions. A discussion about confidentiality agreements (NDAs) often ensues. It’s worth taking a closer look at the law of novelty. Particular circumstances surrounding the disclosure, can demonstrate that no prior publication has occurred.

Novelty Redux

Patents are invalid as lacking novelty when the invention has been published, by document or use, before the priority date. In either case, information from the alleged prior disclosure must be shown to have been publicly available before the priority date.

Often, the question of public availability is easily decided. For example, publication of an invention in a publicly accessible patent document or a technical paper before the priority date destroys novelty. Use of an invention by public demonstration, for example requesting public involvement, would similarly destroy novelty.

A Safe Place for Disclosure?

Other circumstances can point to a confidential disclosure. Such a case was recently considered by the Australian Patent Office in deciding the opposition Rozenberg & Co v Velin-Pharma AS [2017] APO 61 (5 December 2017). This case concerned a method for extracting microRNAs (“miRNAs”) from serum through an attractively simple sequence of steps. Serum is a fraction of mammalian blood and miRNAs are important because of their potential benefits in treating diseases of the immune system such as cancer.

Velin-Pharma, the Opponent, argued that claims to the method for extracting miRNAs from serum were not novel due to prior use of the method in private laboratory settings. Two prior use scenarios were considered:

  1. collection of blood samples and extraction of miRNAs in a medical laboratory (CBCT), CBCT being the laboratory arm of a leading cancer treatment centre; and
  2. use of miRNA samples by W, a veterinarian, in a veterinary practice.

For scenario 1, the Hearing Officer had to decide whether the extraction, described in evidence as an exception from standard procedure, made the information publicly available and novelty destroying.

The Hearing Officer thought it reasonable to consider that collection of blood samples from a patient and extraction of miRNA compositions would be done in a private area of CBCT and therefore not done in public. As the laboratory was private, members of the public would not be free to enter or receive information about activities there. Handling of the blood samples would also involve CBCT employees not free, in the context of medical procedures, to make use of information about sample collection and processing. The position was even stronger as the activity was an exception to standard protocols.

In summary, scenario 1 did not deprive the claims of novelty.

Scenario 2 was similarly dealt with. Use of the miRNA samples was done in W’s capacity as a veterinarian in a private practice with information similarly not available for dissemination to the public.

Take Outs

Novelty may not be destroyed through disclosure in a private and confidential setting. Medical and veterinarian practices and laboratories – with their known ethical standards – made it easier for the Hearing Officer to decide that novelty was not destroyed though a question still remains about which public is relevant.

More broadly, Rozenberg is an example of a longstanding doctrine that confidentiality can be inferred from circumstances. There may well be other circumstances and other safe places to disclose an invention before filing a patent application.

We think it better not to take chances if possible for at least the following reasons. All the circumstances of the disclosure need to be taken into account. There may be circumstances that point toward public disclosure. Commercial, rather than research activity is another problematic circumstance. Secret commercial use is also invalidating in Australia though there is a grace period exception now. If considering a prior disclosure, do seek advice.