On March 4, 2014, the U.S. Patent and Trademark Office (“USPTO”) issued a memorandum to the Patent Examining Corps with guidance for determining the patent eligibility of claims relating to products of nature and laws of nature (“the Guidance”) in view of the U.S. Supreme Court decisions in Assoc. for Molecular Pathology v. Myriad Genetics (“Myriad”) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Prometheus”). While the Guidance does not have the force or effect of law, it will have a significant impact on the prosecution of pending U.S. applications having claims falling within its scope. And that scope is extremely broad.
The question of patent eligibility touches upon whether or not the claimed subject matter is something for which a patent can be granted. Although the language of the U.S. statute broadly defines the scope of this subject matter, the U.S. Supreme Court has, over the years, carved out three general exceptions: products of nature, laws of nature, and abstract ideas. The Guidance deals with the first two of these, products of nature and laws of nature. We can expect a further memo dealing with abstract ideas following the Supreme Court decision in CLS Bank later this year.
Last March, the USPTO experienced an enormous spike in the typical number of application filings per week, as numerous US provisional and non-provisional patent applications were filed in advance of the March 16, 2013 effective date for the “First to File” provisions of the America Invents Act (AIA).
Thus, a large number of provisional applications are due for conversion in the coming days. As you are preparing your applications for conversion and/or foreign filing, there are few things to keep in mind to make sure your filings go smoothly:
- Anticipate that there will be a serious strain on the electronic filing systems at the USPTO and be prepared for unexpected delays and outages. Alerts about the current status of the electronic filing systems of the USPTO can be found at:
- Have an emergency plan in place in case you cannot file electronically. Ensure everyone on your staff is familiar with alternative means for filing US nonprovisional and PCT applications. Locate your closest Post Office and have additional supplies ready for paper filing, if necessary.
- Arrange to have multiple methods available to pay all necessary filing fees:
- If you have a Deposit Account, be sure to replenish it as often as possible to ensure sufficient funds are available for your daily filings
- If you are using a credit card to pay for filings, check that your available balance can accommodate all filings
Recently, the Federal Circuit issued a decision in Novartis v. Lee (2013-1160, Fed. Cir., Jan. 15, 2014) which alters Patent Term Adjustment (PTA) calculations for patents where a Request for Continued Examination (RCE) was filed during prosecution.
In the Novartis decision, the Federal Circuit agreed with the USPTO that the filing of an RCE tolls the running of the three year B-delay clock regardless of whether the RCE was filed before or after the 3 year date. Thus, the Federal Circuit concluded that once an RCE is filed, no B-Delay is available for any time in continued examination. (See Novartis at page 13).
The Federal Circuit also held that, for cases where an RCE was filed during prosecution, applicants could be entitled to B-Delay for the time period between allowance and issuance. The USPTO currently excludes all time following the filing of an RCE from the B-Delay calculation. However, in the Novartis decision, the Federal Circuit held that the time from allowance to issuance does not fall under the exclusion set forth in 35 U.S.C. 154(b)(1)(B)(i). Thus, according to the Federal Circuit, the “examination” referred to in the 35 U.S.C. 154(b)(1)(B)(i) exclusion presumptively ends at allowance, unless prosecution on the merits resumes following receipt of a Notice of Allowance. (See Novartis at pages 15-16).
Because RCEs are filed in many cases, the Novartis decision could potentially impact a large number of patents. The USPTO has not yet indicated when it will change its procedure for calculating B-delay in cases where an RCE has been filed or whether the decision will be applied retroactively.
We recommend reviewing all patents that have issued recently where an RCE was filed to determine whether they may be entitled to additional PTA days in view of this decision.
In October 2013, we reported that the EPO had removed the time limits for filing divisonal applications. An outstanding detail at that time was the level of the fees that would be levied for filing second or any subsequent generation divisional applications. Those fees, which are payable in addition to the filing fee, have now been announced:
- Additional fee for a divisonal application of second generation – €210
- Additional fee for a divisonal application of third generation – €420
- Additional fee for a divisonal application of fourth generation – €630
- Additional fee for a divisonal application of fifth or any subsequent generation – €840
It seems unlikely that these fees will put applicants off since they already have to pay retrospective renewal fees for divisional applications, which will often swamp the new fees. It would nevertheless be worthwile taking care to file new divisional applications based on the oldest generation earlier application that is still pending to minimise the fees due. The new fees will be payable from 1 April 2014.
The Patent Prosecution Highway (PPH) gives applicants the opportunity to accelerate the examination of their patent applications in multiple countries once they have received a favourable report in one country. This is useful to inventors and businesses because it allows foreign patents to be granted sooner, and by having IP offices make use of the work products of other offices also yields cost savings and other efficiencies to the benefit of all stakeholders. In January 2014, further improvements to the system will be launched in the form of the Global Patent Prosecution Highway (GPPH).
The first PPH agreements were bilateral, allowing favourable examination reports in the office of first filing to be employed in a second office to short-circuit the examination process. Since 2006, 30 separate bilateral PPH arrangements have been implemented, resulting in a complex network of agreements that is sometimes called “The Spaghetti Bowl“. The problems with these early PPH agreements is that they required an applicant to have a positive examination report in his office of first filing before he could accelerate processing in the office of second filing, which was not always possible, especially if the first application was withdrawn in favour of an international application under the PCT, and there were disparate formalities requirements under different agreements, leading to even greater complexity. Subsequent developments were the PCT-PPH, allowing users to make use of a favourable international preliminary examination report in participating offices, and, most significantly, PPH 2.0 or “Mottainai” which allowed applicants to make use of any positive examination report – not just one from the office of first filing.
On 4 December 2013, the High Court of Australia handed down a decision confirming that methods of medical treatment can fall within the scope of patentable subject-matter.
It is interesting to note that this is the first time that the High Court of Australia has explicitly considered this question. Accordingly their consideration involved an extensive analysis of case law on what is excluded from being a manner of manufacture and hence excluded from patentability.
The conclusion is good news in the form of certainty for patent applicants and patentees in the healthcare sector.
While methods of medical treatment fall within the scope of patentable subject-matter in the United States, it remains the case that methods of medical treatment are not considered patentable subject-matter by the European Patent Office. Patent protection for such subject-matter in Europe should be sought via alternative claim types, such as first and second medical use claim formats.
Recent years have seen a surge in the number of investigations before the United States International Trade Commission (ITC), owing to the promise of speedy resolution combined with the leverage that accompanies the threat of an exclusion order. With the increased volume of investigations have come calls for the ITC to streamline the process of an investigation. In June 2013, the ITC announced one such effort, a pilot program for early adjudication of certain potentially-dispositive issues.
Specifically, for investigations in the program, the ITC will expedite initial determinations on threshold grounds, such as:
(A) domestic industry (19 U.S.C. § 1337(a)(3));
(B) importation (19 U.S.C. § 1337(a)(1)(A)); and
In so doing, the ITC seeks to save the parties the time and expense of full discovery and litigation of the investigation in its entirety where the case turns on such a dispositive issue.
The firm’s alert on the pilot program, International Trade Commission Takes Steps to Promote Early Adjudication of Dispositive Issues, provides a greater level of detail.
Written by Alison Haile
The European Patent Office (EPO) has announced rule changes that will provide applicants with the option to have additional searches carried out during the European regional phase of Euro-Patent Cooperation Treaty (PCT) applications.
In future, for any applications for which the EPO was not the International Searching Authority (ISA) and the supplementary European search report has not been drawn up by 1 November 2014, the EPO will issue an invitation to pay one or more additional search fees for the second and subsequent inventions identified by the examiner. An additional search report will then be drawn up for those inventions for which an additional fee has been paid and the applicant will be allowed to select the invention to be prosecuted within the application.
This is a significant improvement on the current situation, in which the search report is only drawn up in relation to the invention first mentioned in the claims and the applicant is forced into pursuing this invention or filing costly divisional applications if the subsequently mentioned inventions are of more interest. Applicants who have avoided using other ISAs, such as the United States Patent and Trademark Office (USPTO), for this reason may therefore now select the ISA of their choice without fear of restricting their future options in Europe. Continue Reading
Written by David Wraige
News broke last week that the European Patent Office’s (EPO) Administrative Council has decided to remove the time limits for filing divisional applications. As of 1 April 2014, applicants will be able to file divisional applications at any time whilst an application is pending at the EPO. Applicants need to be aware that this might change the way they choose to prosecute some of their applications – full details are in our advisory. There are still some details to be made available, which we will report in this blog when they are released.
Written by Peter Rands
In the wake of the Patent Box, the UK government continues to place IP at the centre of its plan to boost private-sector growth.
Earlier this month we got a sneak-peak at the findings of an independent report entitled ‘Banking on IP’, commissioned by the UK’s Intellectual Property Office (UK IPO), on ways to increase access to finance for IP-rich small to medium enterprises (SMEs). The Executive Summary was published in advance of the full report, and now a more detailed summary has been made available.
Broadly speaking, these summaries conclude that IP finance would benefit from a) an increased understanding of the value of IP, and b) more resources to mitigate risk associated with investing in IP. To achieve these objectives a number of recommendations are proposed, including:
- creating a toolkit to help SMEs, lenders and other financiers identify, understand and make more effective use of their IP
- developing templates and providing advice to help banks and others understand the cash flow and business value of IP
- supporting the development of more accessible and effective IP marketplaces
- increasing availability of insurance policies to guard against unforeseen events
This report highlights a very important relationship that needs attention if growth of IP-rich companies is to be expected and makes a number of pragmatic and well-reasoned points. Both the Business Secretary, Vince Cable, and the IP Minister, Lord Younger, have endorsed the Report’s recommendations, with Vince Cable being quoted as saying:
“Intellectual property is too important an asset to be undervalued by banks, who are the main source of finance.”
It will be interesting to read the full report once it is made available. In the meantime, the Executive Summary and a more detailed summary are already available.