Biotech and the New USPTO Interim Guidance on Patent Subject Matter Eligibility

The new Guidelines are available here. A PDF version is available here. The associated ‘Nature-Based Products’ examples are available here.

The new Guidelines are slowly being analysed by US attorneys and subsequent posts will provide links to the best analyses. See below for posts with useful initial comments.

From the viewpoint of a European biotech patent attorney the Guidelines are important in determining what is patentable and what we need to show to support eligibility. Now it seems ‘isolated’ natural products are patentable provided the ‘markedly different’ test can be met. The markedly different test requires a new characteristic in terms of structure or function. That means new biological, pharmacological, chemical or physical properties, a new phenotype or new structure or form. Importantly, if that test is passed there is no need to proceed to the ‘significantly more’ test. Clearly this provides a lot of guidance as to the sort of data that may be needed to support patentability.

The ‘significantly more’ test requires improvements to a technology or field, applying the judicial exceptions (i.e. the law of nature, natural product, etc) by means of machine, affecting a transformation; or adding a specific limitation other than a well-known one, or a meaningful limitation linking to a particular technology or environment. Clearly this provides an idea of the sorts of limitations that claims will need to have to give eligibility.

However, our biggest concern at the moment is Mayo type of invention (Example 5 in the main Guidelines document).  The invention concerns a relationship between the concentration in the blood of a substance and the likelihood the drug will be ineffective or cause harmful side-effects. The Guidelines say that ‘the relationship is a natural consequence of the ways in which thiopurine compounds are metabolized in the body, even though human action is needed to trigger a manifestation of the relationship’. This leads to ineligibility. It is unclear to us what types of relationships could be the basis of eligible inventions, and what further limitations would have rendered the Mayo invention eligible. In particular this is of concern for diagnostic and personalised medicine inventions.

See IPWatchdog here for interesting initial comments on the ‘Alice’ aspects of the Guidelines.

See Managing IP’s comments here.

See PatentDocs here.

See Lexocology here.

Update: See PharmaPatents here.