Tag Archives: pharma

Choosing Territories for the National Phase of an International Patent Application for Biotech/Pharma Inventions

This article discusses preliminary thoughts on how to choose which territories to proceed in at the national phase stage of the application.  This advice is in general appropriate for biotech/pharma inventions and is based on our experience of working with early stage biotech/pharma companies.

We believe the relevant criteria to be:

–          expected market size

–          expectations of potential buyers

–          cost of proceeding in the relevant territory

–          importance of the patent case to the company

Market Size and Expectations of Potential Buyers

For national phasing people often classify territories into groups of decreasing importance along the following lines:

Group 1: US, Europe, Japan

Group 2: Australia, Canada, China, India

Group 3: Brazil, Russia, South Korea, South Africa

Group 4: Singapore, Mexico, Israel.

We would also place Hong Kong in Group 4, but protection there can be achieved via registration of a European (the UK designation) or a Chinese case.

The above groups reflect perceived market importance to companies in the biotech/pharma sector.  For an early stage company it would not be common to proceed in other territories, although sometimes there are commercial reasons to do so.  In general early stage companies proceed in Europe and the US, and give serious consideration to all of the Group 1 and 2 countries.  Many companies would only proceed in Groups 3 and 4 where there were clear commercial reasons to do so.

Egypt, Indonesia, Vietnam and Malaysia could be seen as a possible Group 5, though it would be unusual for early stage biotech/pharma companies to proceed in any of these territories.

Cost of National Phasing and Importance of the Case

National phasing can be an expensive procedure, especially in countries that require a translation.  Clearly after national phasing there are continuing subsequent costs.  Clearly the decision as to how many territories to proceed in will depend on the resources available to the company as well as the perceived importance of the case.

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Interesting New Developments

1. On 26 July 2012 the USPTO published proposed guidelines for the first-to-file changes.  As expected there are provisions for an inventor disclosure to preclude (negate) third party disclosures (which has been described as a ‘first-to-publish’ system).  According to IPWatchdog the inventor and third party disclosures have to be identical, without any trivial variations.  Thus broader or narrower disclosures would presumably not be precluded.  This seems to severely curtail use of inventor disclosures to protect againt third party disclosures.

2. A new G decision, G1/10, has issued from the Enlarged Board of the EPO.  It is reported and available at the K’s Law blogsite.  The decision concerns whether a patent can be corrected based on Rule 140 EPC.  The Enlarged Board decided that it could not.

3. epi Information 2/12 (June 12) reports a meeting between the epi Biotech Committe and the EPO. One of the areas discussed was pharmacogenomics and claims to treatment of patients with a specified marker (such as an SNP or particular methylation profile). The EPO said that often such claims can lack novelty as at least one patient with the specified marker will have been treated even if the prior art does not explicitly say so.  If EPO Examiners adopt that position on novelty it will clearly make it more difficult to obtain patents in the field of personalised medicine where the contribution is identification of the patient group to be treated.  IPKat has written about this.

4. On 8 August 2012 the Big Red Biotech blog reported on the innovation crisis in pharma. Quoting from recent articles in the topic it claimed much more is spent on marketing (25% of revenues) than discovering new molecules (1.3%).  In addition pharma was alleged to have been focusing on development of me-too drugs, minor variations of existing drugs, rather than genuinely innovative therapies.

5. The SPC Blog reported publication of the CJEU decision on Case C-130/11 Neurim Pharmaceuticals.  The CJEU decided that existence of an existing marketing authorisation in the EU for the active ingredient did not  preclude an SPC for a different application of the same product for which marketing authorisation has been granted.  This went against the existing view on the issue.

6. The Federal Circuit came to the same judgment in the Myriad case of deeming claims to isolated human genes to be patentable after being asked by the Supreme Court to look at the issue again in view of Mayo v Prometheus.  Link to the Burrill Report article about it is here.

7. On 31 August 2012 the Federal Circuit issued an en banc decision on Akamai Technologies v Limelight Networks and McKesson Technologies Epic Systems concerning establishing of infringement when no single party performs all of the steps of the method claim.  The Court found that direct infringement required a party to perform all of the steps of the claim. However inducement of infringement could occur even where no one party performs every step of the claim.  This clearly has implications in the drafting of patent claims. It has already been noted that it is relevant to personalised medicine where diagnostic and therapy steps may be performed by different parties (see PharmaPatents).

8.  In the Federal Circuit judgment Santarus v Par Pharmaceutical the Court stated that ‘Negative claims limitations are adequately supported when the specification describes a reason to exclude the relevant information’. This raises the question of whether the Written Description requirement for negative limitations is stricter than for positive limitations (see IPWatchdog).

9.  The new supplemental examination is effective as of 16 September 2012. It allows a patentee to seek a review of a patent based on newly submitted information.  That can lead to the USPTO ordering reexamination. PatentlyO discuses how this may inoculate against failing to disclose prior art references during examination or even filing false data.