16 March 2014

Reining-In Amendments Under Australian Patent Law Reforms

AmendmentsAs regular readers will be aware, I have been working with CCH Australia to assist in updating the patents commentary in its Australian Industrial and Intellectual Property ‘loose-leaf’ service (which is also available as an online service).  Among other content, this service provides full text legislation and detailed commentary on copyright, designs, patents and trade marks.

The most recent update to the patents commentary includes coverage of reforms to provisions for amending patents and applications, which were introduced by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.  This article discusses some of these reforms, and the corresponding updates to the CCH commentary.

Background

Before the commencement on 15 April 2013 of the Raising the Bar Act, the Australian Patents Act 1990 included some of the most generous amendment provisions in the world.  In extreme cases it was possible, and indeed remains possible for those patent applications to which the former provisions continue to apply, to file a wholly inadequate patent specification, and to correct this defect by amendment up until at least the date of grant of the patent.

For patents and applications filed on or after 15 April 2013, and for pending applications for which a request for examination had not been filed prior to this date, this generosity has ceased to apply.  In common with most other major jurisdictions, it is no longer possible to make amendments which result in any new disclosure.

This change is something that applicants accustomed to being permitted to amend specifications to add additional supporting examples, or new experimental results, will now need to bear in mind.

Amendments under the former law

Section 102 of the Patents Act sets out the amendments that are not allowable under the Act. Formerly, s 102(1) specified that:

An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.

Notably, this provision is concerned only with what is claimed, measured against what is ‘in substance disclosed’ in the filed specification.

The authorities establish that the test for ‘in substance disclosed’ falls short of that for a full description, and disclosure of the best method of performing the invention, as required by s 40(2) prior to 15 April 2013.  In Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224 (which related to a patent covering the well-known drug Viagra) a full bench of the Federal Court of Australia confirmed that a filed specification could disclose a claimed invention ‘in substance’ without necessarily satisfying the requirements under s 40 for the invention to be described fully, including the best method known to the applicant, at the time of filing, for performing the invention.

The Full Court found that ‘complete specification’ meant the specification, including any amendments made subsequent to filing, and thus that any defects with respect to the s 40 requirements could be corrected by amendment, at least up until the date of grant of the patent: [390], [347].

Motivation for change

The provisions governing amendment prior to 15 April 2013 were considered to be problematic for at least two reasons.

First, they enabled an applicant to gain protection for an invention before meeting the obligation to provide the public with a complete disclosure.

Second, they created uncertainty in the period between publication of the patent specification and grant.  In particular, in the absence of full details of the invention, it is difficult to be certain about the activities that can be conducted without risk of infringing a patent that might ultimately be granted from the application.

In contrast, many other countries’ patent laws require the disclosure requirements to be met at filing, and do not allow the addition of any material that could not be directly derived from the information in the specification at filing.  This includes not allowing the addition of new material to address deficiencies in the level of description.

Amendments after Raising the Bar

Section 102(1) of the Patents Act now provides that:

An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in the following documents taken together:
(a) the complete specification as filed;
(b) other prescribed documents (if any).

Other documents are prescribed in regulation 10.2A of the Patents Regulations 1991, and include the abstract filed with the complete specification, and the contents of certain amendments and corrections permitted in limited circumstances under the Act and relevant provisions of the Patent Cooperation Treaty.  In the vast majority of cases, however, s 102(1) acts as a prohibition against any amendment that would add new matter to a specification beyond that which is present at filing.

As a result, amendments that may have been permissible under the former provisions, such as the addition of new examples or additional supporting experimental results that do not alter the scope of the patent claims, may no longer be allowed.

Who is impacted?

The changes to the provisions governing the allowability of amendments impact particularly on applicants, such as pharmaceutical companies, which may wish to file somewhat speculative applications with the intention of subsequently amending the specification to include supporting data confirming the original speculation.

Similar situations, in which the patent specification turns out to be deficient in some respect relative to the invention as ultimately claimed, may arise inadvertently.  In the past, such deficiencies might often have been corrected by amendment, whereas it is now likely that the deficiencies would be fatal to the patent.

Applications and patents originally filed prior to 15 April 2013, and for which a request for examination was made before that date, remain subject to the former amendment provisions. Patents and applications subject to both of the different amendment provisions will therefore continue to coexist for many years to come.

Updates to the CCH patents commentary

In view of the above changes, ¶54-000ff of the patents commentary in CCH’s Australian Industrial & Intellectual Property service has been reviewed and updated to reflect the new amendment provisions.

Other amendments to the commentary in light of last year’s Raising the Bar reforms and other recent developments are as follows:
  1. at ¶45-630, relating to treatment of human beings and the High Court case Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50;
  2. at ¶45-110, relating to regulation of the profession, including incorporated patent attorneys;
  3. at ¶52-600, ¶52-620, ¶52-640, ¶52-650 and ¶52-700, in relation to the restructuring of legislation relating to Convention and PCT applications;
  4. at ¶52-720, relating to continuation fees;
  5. at ¶52-520, relating to standard patents numbering system and principal steps;
  6. at ¶47-140, relating to ‘double patenting’;
  7. at ¶57-250, relating to lapsing of Australian patent applications; and
  8. at ¶62-020, relating to revocation for lack of entitlement.

Ongoing Maintenance of the Commentary

With these most recent amendments, the project to cover the Raising the Bar reforms is substantially complete, making the CCH commentary one of the most up-to-date resources available on Australian patent law.

Of course, the law is a moving target, with new court decisions and legislative changes clarifying and amending laws on a regular basis.  As with any legal commentary, there are areas of the CCH patents commentary that would benefit from being refreshed, and ongoing updates will be required to keep pace with developments in the law.  At present, I am continuing to work with CCH on the maintenance of the commentary.

No comments:

Post a Comment