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Biotech News 11 May 2007

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Allens Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.


Grace periods in patent law

In brief: Patent Attorney and Lawyer Dr Rob Silberstein provides an overview of the grace period provisions under the patent laws of Australia and of various overseas jurisdictions and discusses a range of related patents issues.

Introduction

As a general tenet of patent law, in order to be patentable, an invention must be novel and must involve an inventive step, among meeting various other requirements. The issue of novelty is addressed by reference to the 'prior art', namely publications and/or public uses or disclosures that have been made before the relevant filing date of a patent application. In order to properly preserve novelty of an invention, it is advisable to keep the invention confidential, at least until a patent application has been filed.

Maintaining an invention in confidence before filing a patent application is not always a simple or practicable undertaking. For example, many scientists subscribe to the well-known adage 'publish or perish', as it can be very important to publish the findings of their research as soon as possible. Alternatively, another related party (such as a colleague or associate) may disclose an invention, even though not authorised to do so by the inventor or prospective patent applicant.

Some jurisdictions have sought to address these and other circumstances of prior disclosure of an invention by creating specific exceptions to the novelty requirement for patentability. A grace period, which requires a patent application to be filed within a prescribed period following the first disclosure of the invention, is an example of such an exception.

Some, but not all, jurisdictions provide a grace period to preserve the novelty of an invention. As will be seen, different jurisdictions approach the relevant issues in different ways, whether with respect to the period prescribed or to the circumstances that permit the grace period to be invoked. There are various tips and tricks of which to be aware when managing the best approach to the grace period (and other) exceptions, and these are discussed in this article. However, to minimise the inherent dangers of prior disclosure, Allens Arthur Robinson recommends that best practice is always to file a patent application to an invention before the details are disclosed in any way, shape or form. 

Currency of information

Patent laws are regularly amended and changed. Often, attempts are made by one jurisdiction to bring its patent laws into alignment with the patent laws of one or more other jurisdictions. However, there is frequently a lack of uniformity and timing when comparing changes in the laws in one jurisdiction to changes in another. The question of harmonisation of patent laws has been, and will continue to be, a hotly debated topic among patent applicants, practitioners and other interested parties.

When considering the appropriate patent filing and/or prosecution strategies, it is imperative to bear in mind the currency and reliability of the information at hand. This is particularly true when dealing with provisions that are deadline-specific, such as, for example, provisions relating to the operation of a grace period imposing a deadline by which a patent application must be filed. This article provides information on grace periods and related issues from a wide range of jurisdictions. The information on which it is based was compiled between October 2006 and January 2007. 

Overview of issues relating to patent law grace periods

The operation of a grace period is often dependent on, or affected by, a number of factors. These include:

  • the prescribed duration of the grace period;
  • the nature and type of disclosure that was made in relation to the invention;
  • the novelty threshold operating in the relevant jurisdiction;
  • the type of intellectual property right for which registration is being sought; and
  • the member status of the jurisdiction in question to a recognised patent region or treaty, for example, the Patent Co-operation Treaty (PCT).

In some circumstances, other issues may also play a role in determining the operation of the grace period.

Prescribed duration of grace period

Some jurisdictions provide a broadly operating grace period, without significant limitations in relation to specific circumstances that must be satisfied before the grace period can be invoked.

Australia, the United States, Canada, Mexico, Brazil, the Philippines, Ghana and Ukraine are examples of such jurisdictions, providing a period of 12 months in which to file a patent application following the initial disclosure or publication of the invention. South Korea and Russia also provide a similarly broadly operating grace period, providing a period of six months in which to file a patent application following the initial disclosure or publication of the invention.

At the other end of the spectrum, Europe, New Zealand, South Africa, Zimbabwe and Zambia make no provision for a grace period. We also understand that there is no provision for a grace period in India or Mongolia.

In the section that follows, we discuss issues surrounding the nature and type of disclosures which may or may not be problematic for the purposes of proper operation of a grace period.

We point out that there are a range of jurisdictions that provide a grace period on limited grounds, thereby falling somewhere in the spectrum between those that provide broadly operating grace periods and those that provide no grace period. Argentina and Tanzania are examples of two jurisdictions that provide a 12-month grace period, provided certain limited circumstances have occurred. Chile, Indonesia, China, Japan, Vietnam and, it would appear, the Republic of Kazakhstan are examples of jurisdictions that allow a six-month grace period, provided certain limited circumstances have occurred.

Nature and type of disclosure

The nature and type of disclosure can be significant to the operation of a grace period and the specific limitations imposed upon it. The nature and type of the disclosure may also be of importance with regard to the novelty threshold applied in the particular jurisdiction, irrespective of whether that jurisdiction provides a grace period.

In line with Article 11 of the Paris Convention for the Protection of Industrial Property (1883), several jurisdictions make provision to exclude a publication or disclosure that occurred at a recognised exhibition from impacting on the novelty of an invention claimed in a patent application in their jurisdiction.

Some jurisdictions make such provisions irrespective of whether they also make a grace period available. For example, Australian patent law provides a grace period of 12 months for a wide range of disclosures, but also provides an exception in respect of any publications or disclosures that may have taken place at an internationally recognised exhibition (provided that a patent application is filed within a prescribed period). Other jurisdictions, including Chile, Argentina, Indonesia, China, Japan, Vietnam and Tanzania, incorporate the 'recognised exhibition' limitation as one of the circumstances that must have occurred in order for the grace period provision to be invoked.

The grace period in Chile, China, Vietnam and Tanzania can also be invoked in circumstances where a third party disclosed or published the invention without authorisation before the applicant filed a patent application.

Disclosures or publications that involve testing, trialling or experimentation with the invention may also provide a basis for the operation of the grace period in Chile, Indonesia and Japan. As things currently stand, the Australian legislature has opted to make no express provisions directed to the impact on novelty of testing, trialling or experimentation with the invention. However, the prevailing view in Australia is that the use of an invention for testing or trialling purposes may, depending on the circumstances of disclosure or publication, provide a defence to anticipation of an invention claimed in an Australian patent application.

As mentioned above, the type of disclosure or publication can also be significant in relation to the threshold of novelty applied in a particular jurisdiction, irrespective of whether that jurisdiction provides a grace period. In the section that follows, we provide an overview of some of the novelty thresholds provided in various jurisdictions. A disclosure or publication of an invention can occur in written form in a publication or published document, or it can occur by way of public use. When considering the preservation or destruction of novelty, different thresholds apply in different jurisdictions with regard to the type or form of publication or disclosure.

For instance, when seeking to invoke the grace period provisions in China, apart from meeting the relevant limitations imposed on the operation of the grace period provisions, it is important to also bear in mind that the novelty threshold in China is 'relative novelty'. Accordingly, an invention claimed in a Chinese patent application will be novel if, before the date of filing of the patent application, no identical invention or utility model has been publicly disclosed in publications in China or abroad or has been publicly used or made known to the public by any other means in mainland China.

Another important type of disclosure or publication relevant to the possible operation of a grace period is that of commercialisation before a patent application has been filed. A general tenet of patent laws in most jurisdictions is that patent protection provides a limited monopoly term to exploit the invention, in exchange for the disclosure of the invention to the public. Any attempts to extend the patent term by, for example, commercialising the invention before a patent application has been filed, may be considered a de facto extension of the patent term. The operation of the grace period has not necessarily been tested in the courts of all jurisdictions and it is, therefore, not possible to provide a conclusive view on the impact or possible operation of the grace period in the event of commercialisation prior to filing a patent application. However, such prior commercialisation clearly raises great risk for prospective applicants and should be avoided.

Novelty thresholds

As the above example regarding patent law in China illustrates, the novelty threshold applied in a particular jurisdiction can have a significant impact on the operation of grace period provisions, and can additionally have an impact on the practical significance of a publication or disclosure, irrespective of whether a particular jurisdiction makes provision for a grace period.

Increasingly, jurisdictions that formerly applied a local novelty test are adopting the absolute novelty threshold. Zambia is an example of a jurisdiction that retains the 'local novelty' threshold. Local novelty means that any disclosure made outside the relevant jurisdiction will not impact on the novelty of the invention claimed in a patent application filed in that jurisdiction. Accordingly, any publication or disclosure of the invention outside Zambia will not affect the novelty of an invention claimed in a patent application later filed in Zambia.

Relative novelty, as discussed above with reference to the current patent law in China, may operate slightly differently in the jurisdictions to which it applies. A publication in a published document, as opposed to a use in a public forum, may have a different impact on the preservation or destruction of novelty in the relevant jurisdiction.

The absolute novelty threshold typically provides that any disclosure or publication of any kind anywhere in the world could be novelty-destroying to an invention claimed in a patent application filed after the disclosure, subject, of course, to the proper operation of grace period provisions, if available. Australia, the United States, Canada, Europe, New Zealand, Mexico, South Africa, Ghana, Tanzania, Zimbabwe and India are examples of jurisdictions in which the absolute novelty threshold applies.

Peru, which provides a 12-month grace period, has a threshold of regional novelty. The grace period will only operate under Peruvian law if the prior disclosure or publication was made in an Andean community country (ie Bolivia, Columbia, Ecuador and Peru).

Type of intellectual property right sought to be registered

While this article is intended to provide an overview of the operation of the grace period for patent rights in various jurisdictions, it is worth just touching on the novelty requirements and/or provision of grace periods in respect of other intellectual property rights.

In each jurisdiction, the novelty requirements and possible grace period provisions may well differ between design rights and patent rights. Design rights protect the visual features of an article or product, ie the features of shape, configuration, pattern or ornamentation. By contrast, patent rights typically seek to protect the functional aspects of an invention, ie the way an invention works, rather than the way it looks. The newness or novelty threshold for a design under Australian law is determined by reference to the prior art base for a design that consists of designs publicly used in Australia and designs published in a document within or outside Australia before the filing date of the design application. There are also other designs that form part of the prior art base under Australian design law, but they are not relevant to this discussion.

To borrow from the terminology of patent law, it could be said that a relative novelty threshold operates for Australian designs. As mentioned above, Australia provides relatively broadly operating grace period provisions for patents. However, no such grace period provisions apply for designs under Australian designs law.

In contrast, in Japan (for example), where the patent law grace period provisions are limited by a number of circumscribed circumstances, which may not be able to be satisfied even though the applicant has taken action within six months of the first disclosure of the invention, there are no such limitations under the country's design law. Accordingly, provided that the relevant threshold of newness or novelty under Japanese design law could be met by a particular design and that a Japanese design application is filed within six months of the first disclosure of the design, it may still be possible to obtain valid protection in Japan for that design.

National versus regional patent laws

Many of the jurisdictions that provide a grace period and are members of the PCT also recognise the international filing date of the PCT application as giving rise to the possible operation of the grace period in their jurisdiction. For example, provided a PCT application designating the United States is filed within 12 months of the first disclosure of the invention, that PCT application filing date will be recognised for the purposes of the operation of the grace period under US patent law if a US patent application enters the national phase from that PCT application within the prescribed time limit of 30 months from the earliest priority date.

It is also important to bear in mind that, in certain circumstances, a number of jurisdictions have effectively grouped themselves together under a common convention in order to give rise to intellectual property rights administered by that convention. The European Patent Convention and the Eurasian Patent Convention are two examples of conventions that link a group of jurisdictions, so as to give rise to the possibility for applicants to obtain intellectual property rights that are ultimately enforceable in all of the member jurisdictions that have signed and ratified the relevant convention.

As European patent law provides no grace period, for the purpose of illustrating the potential significance of regional patent rights with respect to the operation of grace periods, we make reference here to the Eurasian Patent Convention. A number of jurisdictions have become a party to the Eurasian Patent Convention. However, as at the end of December 2006, only the following jurisdictions had ratified the convention: the Russian Federation, the Republic of Kazakhstan, the Republic of Azerbaijan, the Kyrgyz Republic, the Republic of Moldova and the Republic of Armenia. The Eurasian Patent Convention provides a six-month grace period. The Eurasian region is a region that is a party to the PCT.

We provide here an example of the possible operation of the grace period with respect to obtaining an enforceable patent right in Russia. As mentioned above, Russia also provides a grace period of six months. In practical effect, provided a patent application has been filed in a member country within six months of the first disclosure of an invention (First Filed Patent Application), a PCT application (designating Eurasia) filed within 12 months of the filing date of the First Filed Patent Application will preserve the novelty of the invention in the Eurasian (regional phase) patent application, according to the grace period provided under the Eurasian Patent Convention. If granted, the Eurasian patent, when validated for Russia, would also preserve the novelty of the invention for the purposes of Russian patent law, despite the prior disclosure.

Conclusions: what this means for your patent filing and prosecution strategy

This article has set out to provide an overview of the way in which grace periods are dealt with in various jurisdictions and to provide several related issues for consideration. We emphasise once more that the preference should always be to file a patent application before any disclosure of the invention is made.

In the event of an inadvertent disclosure, steps should immediately be taken to ascertain the availability of a grace period in the jurisdiction/s of interest, with a view to determining what steps, if any, need to be taken to adequately and fully preserve any potential patent rights in relation to the invention.

The global position should always be considered, along with the fact that there is an extremely wide variety of ways in which the various jurisdictions that have decided to enact grace period provisions have elected to make those provisions available. It is essential that a filing and/or prosecution strategy is based on current and reliable information and that decisions be made bearing in mind the likely jurisdictions/regions of interest and the commercial interests of the rights owner.

Company news

In brief: Regular news from the biotech industry.


Amgen announces results of trial that may dispel safety concerns of anaemia drug Aranesp

19 April – Amgen today announced the results of its '145 study' of 600 previously untreated patients with small-cell lung cancer receiving chemotherapy. The study demonstrated no statistically significant difference in risk of death between those patients who received Aranesp and those who received a placebo. The announcement may dispel some of the recent safety concerns over the drug. Last month, the Food and Drug Administration imposed strict warnings on the drug after evidence emerged that suggested it could make cancer worse, increase the risk for serious cardiovascular events or hasten death. Amgen's stock rose 4 per cent, to close at US$62.32 on the improved news.;

[Source: Company announcement]

Avexa honours over-allocation in rights issue

1 May – Australian biotech Avexa's recent rights issue has been over-allocated by 8.2 million shares. The company has determined to honour the allocation of the additional shares as a placement to shareholders on the same terms as the rights issue shares. The accommodation of the over-allocation would bring the total amount raised through the rights issue to A$64.5 million, before expenses. Following the capital raising, the company has cash reserves of approximately A$78 million. 

[Source: Company announcement]

Biotech revenues top US$70 billion

16 April – In 2006, the revenues of all publicly traded biotechnology companies exceeded US$70 billion for the first time, growing by 14 per cent in 2006 to US$73.4 billion. According to Ernst & Young's annual review, the sector's success is reflected in the record takeover premiums in M&A deals. In transactions worth more than US$500 million, the average premium paid was 60 per cent in 2006, which was more than double the average premium paid between 2003 to 2005.

[Source: http://www.reuters.com/article/health-SP/idUSL1534079120070416 ]

Dia-B Tech announce positive trial results

18 April – Melbourne -based biotech Dia-B Tech Ltd has announced positive progress of the phase one trial of its lead type 2 diabetes drug compound ISF402. Stage A of the phase one trial has been completed with the dosing of 32 healthy male volunteers. There were no clinical adverse events in the human subjects. Dia-B Tech is therefore proceeding immediately to Stage B of the phase one trial. Commenting on the progress, Dia-B Tech CEO Ken Smith noted that 'it is timely that the Coalition of Australian Governments, only last Friday, announced AU$200 million would be directed toward a new initiative on diabetes', a disease that Chairman and former Federal Health Minister Dr Michael Wooldridge highlighted 'is now a significant international health issue warranting a unanimous vote at the UN General Assembly in December 2006 which called for united global action'. Interim data is suggestive of a biological effect of ISF402 similar to that found in previously conducted animal trials. 

[Source: Company announcement]

GSK and Wellcome Trust to collaborate to fight drug resistant infections

30 April – GSK and the Wellcome Trust announced a collaboration to develop a new class of antibacterial to combat the rise of certain drug-resistant hospital infections. GSK has received a UK£4 million award from the Trust to accelerate the development of compounds for the treatment of gram-negative bacteria such as pseudomonas, klebsiella and acinetobacter. These are becoming increasingly resistant to available antibacterials and commonly cause hospital-acquired pneumonia and septic shock, particularly in patients in intensive care units. Without adequate therapy mortality is high, and recovery can be long and complicated. GSK will make a matching contribution.

[Source: Company announcement]

GSK announces FDA approval of impetigo ointment Altabax

12 April – GSK announced that the US Food and Drug Administration had approved Altabax, its antibacterial for the topical treatment of impetigo, a highly contagious infection of the top layers of the skin, most common in young children and infants. Altabax represents the first new class of antibacterials to be approved by the FDA in nearly two decades.

[Source: Company announcement]

Novartis expands oncology pipeline with AS1404

19 April – Novartis has entered an exclusive licensing agreement with Antisoma for the worldwide rights to AS1404, a small molecule vascular disrupting agent expected to begin Phase III trials in 2008 in patients with squamous non-small cell lung cancer. Contingent upon development and approval milestones, the financial terms of the agreement could reach US$780 million. Novartis reached this agreement following the presentation in November 2006 of positive Phase II results involving patients with non-small cell lung cancer that showed AS1404 extended median survival by five months when used in combination with a standard chemotherapy regimen of paclitaxel and carboplatin over chemotherapy alone. A response rate of 50 per cent in AS1404 patients has been shown. AS1404, given as a 20-minute infusion immediately following chemotherapy, is the first compound in this new class of compounds called vascular disrupting agents to report positive data from a randomized Phase II clinical trial. These compounds selectively disrupt established blood vessels in solid tumours, which rely on a network to survive and grow.

[Source: Company announcement]

Overweight dog drug successfully completes first stages

2 May – Australian biotech Stirling Products has completed initial studies to collect data for a safe and effective dose of R-salbutamol to treat overweight animals. The trial was run over two stages in the United States. The first stage established an initial dose range that was considered safe to administer to dogs without any clinical side-effects. The second phase tested a high and low dose for efficacy in reducing the weight of overweight dogs. Results with R-salbutamol-treated dogs indicated in each of two separate cycles of treatment up to 2.77 per cent weight loss per week. Approximately 48 million (35 per cent) of the total population of dogs and cats in the United States are considered overweight or obese. In 2006, Americans spent an estimated US$38 billion on their pets, including US$9.3 billion on veterinary care.

[Source: Company announcement]

Pfizer and Bristol-Myers Squibb to collaborate to develop anticoagulant

26 April – Bristol-Myers Squibb and Pfizer have announced a worldwide collaboration to develop and commercialise apixaban, an anticoagulant discovered by Bristol-Myers Squibb being studied for the prevention and treatment of a range of venous and arterial thrombotic conditions. In a separate agreement, the companies will collaborate in a Pfizer discovery program with potential applications for the treatment of metabolic disorders, including obesity and diabetes. Phase III trials are currently investigating the potential use of apixaban in the prevention of venous thromboembolism, which includes deep vein thrombosis. Under the apixaban agreement, Pfizer will make an upfront payment of US$250 million to Bristol-Myers Squibb. Pfizer will fund 60 per cent of development costs and the two companies will share commercialisation expenses and profits/losses equally on a global basis.

[Source: Company announcement]

Sigma announces agreement with Arrow Group for generic pipeline expansion

12 April – Sigma Pharmaceuticals announced that it has reached an agreement with international generic company Arrow Group for an additional pipeline of generic drugs to consolidate its position as the leading generic player in the Australasian region. A minimum of 25 additional products, on top of the 60 drugs originally agreed under the merger 18 months ago, are to be delivered to Sigma within five years under the agreement. In consideration for this, the Sigma board has agreed to release Arrow Group from their Minimum Holding Obligations and voluntary escrow arrangements that were put in place at the time of the merger. If at least 70 products total are not delivered within five years, the royalty payable of all products will be reduced from 5 per cent to 4 per cent until 70 products are delivered. To date, 54 products have been registered and commercialised.

[Source: Company announcement]

Sigma opens new manufacturing facility in Victoria

3 May – Sigma Pharmaceuticals has announced the opening of a new AU$63 million manufacturing facility in Dandenong, Victoria. The facility development makes Sigma Australia's largest manufacturer of pharmaceutical products by volume. CEO Elmo de Alwis said the additional capacity would allow Sigma to increase manufacturing of over-the-counter and generic products from the Arrow group.

[Source: Company announcement]

BioTip: Patent and design rights

Some technologies may be protected by more than one form of intellectual property right. Medical devices, for example, are potentially suitable subject matter for patent and/or design protection. While patents protect the 'functional' aspects of the invention to which they are directed, registered designs protect the 'visual features' (eg shape, configuration, pattern or ornamentation) of the design to which they are directed. For a product that could easily be moulded and reproduced by third parties, it might be commercially valuable to consider additional design protection. Careful consideration should always be given to the types of intellectual property protection available for a given innovation, and to the appropriate filing strategy applied in order to obtain the appropriate protection.

Events

Information on the latest conferences

See conferences in: May | June | November

May

NEWSan Diego Bio-Pharma Conference 2007
Saturday, 19 May
San Diego, California, United States
Contact: Feng Tian

June

NEW International Pharmaceutical Regulatory and Compliance Congress
Wednesday, 6 June – Thursday 7, June
Brussels, Belgium
Contact: Paul Tunnecliff
http://www.internationalpharmacongress.com/

NEW International Intellectual Property Law and Pharmaceuticals
Monday, 25 June – Thursday 26 June
Macau

NEW Genomics in Business 2007
Sunday 17 June – Tuesday 19 June
Amsterdam, Netherlands

November

NEW Pharma Partnering Event - One-To-One License Meetings
12-13 November, 2007
Hilton Hotel, Barcelona (Spain)
http://www.pharmavenue.com/

NEW Asian Patent Attorneys Association (APPA) Annual Meeting
17-20 November, 2007
Adelaide Convention Centre, South Australia

As active members of APAA, we look forward to attending what promises to be a very enjoyable and rewarding conference and, of course, to meeting many of our clients and contacts there. If you are planning to attend this meeting, please do take the opportunity to come and visit us in our Sydney or Melbourne office while you are in Australia. Let us know by getting in touch with Trevor Davies, contact details set out below.

For further information, please contact:

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