Archive for the ‘Non-U.S. Practice’ Category

UK Patent Applications On The Fast Track – Nothing Extra Payable

Tuesday, February 8th, 2011

Guest post from Paul Cole of Lucas & Co.

Claims searched, examined and approved for grant (subject to publication and possible third party comments) within six working days? Not only theoretically possible but actually achieved in an application filed earlier this year at the UK IP Office through our firm. And in contrast to the situation in the US, achieved at no additional cost to the applicant.

The UK IP Office offers three types of accelerated service:

  • Combined search and examination (CSE)
  • Accelerated search and/or examination
  • Early publication

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EMA Draft Guidelines For Biosimilar Antibodies Released

Wednesday, December 29th, 2010

From Dr. Stefan Danner

On November 18, 2010, the European Medicines Agency (EMA) released draft versions of two guidelines relating to the regulatory approval of monoclonal antibodies: the “Guideline on biological medicinal products containing monoclonal antibodies”1 and the “Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use”.2 Both guidelines are now subject to public consultation until May 31, 2011.

The former regulation for the approval of biosimilar monoclonal antibodies (mAb) was long-awaited by the pharmaceutical industry, as many basic patents for therapeutic mAb will expire within the next couple of years. The present guideline sets forth the non-clinical and clinical requirements for mAb-containing medicinal products claiming to be similar to another one already marketed (i.e., biosimilars) and complements several previous guidelines for biosimilar medicinal products, based on which 13 such products have been approved so far in Europe.

The second guideline on the immunogenicity assessment of mAb that was released by the EMA is applicable to all biological medicinal products containing mAbs, not just biosimilars.

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Newsflash! EPO announces that it does not require search results from priority applications filed at the USPTO, JPO and UKIPO

Monday, December 13th, 2010

From Marks & Clerk – This is a correction to the post of December 10th.

Late yesterday – December 9, 2010 – a decision of the President of the European Patent Office (EPO) was posted on the EPO website confirming that the search results from a priority application filed at the US Patent Office (USPTO), Japan Patent Office (JPO) or UK Intellectual Property Office (UKIPO) do not need to be filed by the applicant at the EPO to satisfy the requirements of new Rule 141(1). The Rule 141(1) requirement is automatically satisfied due to arrangements between the EPO and USPTO/JPO/UKIPO.

Under Rule 141(1), from January 1, 2011, the EPO requires the search results of a priority application to be filed at the EPO on filing of the EP application or “without delay” once the results become available. The EPO hoped to arrange automatic transfer of these documents with some patent offices so that the applicant would not need to file the documents themselves. Such an arrangement has been reached with the USPTO, JPO and UKIPO. This arrangement is effective from January 1, 2011 and so will apply to all EP applications filed under new Rule 141(1).

It is important to note that this arrangement only exists with the USPTO, JPO and UKIPO. If an EP application claims priority from one or more applications filed with an office other than the USPTO, JPO or UKIPO, the applicant will still need to file the documents under Rule 141(1). Even if a US IDS has been filed at the USPTO, it will still be necessary to file search results at the EPO if at least one of the priority applications was filed at an office other than the USPTO, JPO or UKIPO.

For the EP applications where we still need to file the search results from the priority application, we need to file the search report or exam report issued by the patent office handling the priority application. We cannot file a letter explaining the content of the search/examination report, the EPO requires the actual document issued by the patent office.

In addition to requiring the search results of the priority application, the EPO (under Rule 141(3)) can ask for prior art taken into consideration in national or regional patent proceedings and concerning an invention to which the European patent application relates. The above agreement between the EPO and USPTO/JPO/UKIPO does not affect this additional request for information. However, if this additional information is required, the EPO will send a communication setting a time limit for response.

Let’s Get Physical! Australian Patent Office Wrestles With Method Claims

Wednesday, November 17th, 2010

The Australian Patent Office appears to grappling with the requirement that a physical effect take place in order for a business method to be patentable.  This note sent by Bill Bennett of Pizzeys Patent and Trademark Attorneys raises interesting issues about the need for a “physical effect” as “the touchstone of patentability.”

The APO has issued a decision which has created uncertainty regarding the patentability of business methods.

Until recently, our advice to clients was that business methods were patentable in AU, provided that the claims were limited to execution of the business method in a computer environment.

The APO has now issued the Iowa Lottery decision in which the Deputy Commissioner of Patents concludes (at para 17) that:

I do not believe there is any authority in Australian law for the proposition that the mere identification of a physical effect is sufficient for patentability. (underlining added)

The decision can be viewed here: 
http://www.austlii.edu.au/au/cases/cth/APO/2010/25.html

The above reference to “physical effect” is a reference to the precedential decision of the Full Federal Court in the Grant case.  In 2006, the Full Federal Court concluded in the Grant case (at para 32) that:-

A physical effect in the sense of a concrete effect or phenomenon or manifestation or transformation is required. In NRDC, an artificial effect was physically created on the land. In Catuity and CCOM as in State Street and AT&T, there was a component that was physically affected or a change in state or information in a part of a machine. These can all be regarded as physical effects. (underlining added)

 

Thus, the Full Federal Court in Grant found that “physical effect” is the touchstone of patentability.  It is especially noteworthy that the Full Federal Court expressly referred with approval to cases where a business method was implemented in a computer environment such that performance of the method resulted in a “change of state or information” in a part of the computer.

We find it very difficult to reconcile the Deputy Commissioner’s statement in Iowa Lottery with the precedential statements of the Full Federal Court in Grant.  The apparent discord between the Deputy Commissioner’s view and legal precedent may ultimately only be clarified by further appeals to the Federal Court by patent applicants denied claims to business methods.

Until such time that the law is further clarified, our practical advice to applicants is to draft and claim inventions in the context of being a method of operating a computer (as opposed to being a business method which happens to be implemented in a computer).  Such description and claims should focus heavily on the changes in state or information which occur within the computer and should make these features central to the invention.  For cases which have already been filed in AU, we suggest re-drafting, within the limits of allowable amendments, to focus heavily on the changes in state or information that occur within the computer.