Patent term extensions (PTEs) are available in many countries and can be used to extend patent life to compensate patent holders for the time lost waiting for regulatory approval of a new drug.
Currently, PTEs are not available in China. However, it’s positive to note that PTE provisions have recently been passed into legislation in China through the fourth amendment of the Patent Law, which will take effect on June 1, 2021.
A number of issues around the proposed PTE program remain pending or unresolved but will be addressed by the amended Rules for the Implementation of the Patent Law (‘the Rules’). The amended Rules will be further explored once they are released.
Article 42 of the fourth amended Patent Law covers extensions, and is translated as follows:
42. ……. In order to compensate for reductions in patent term arising from regulatory review and approval of a new drug in China, the Patent Administration Department of the State Council, at the request of the patentee, may extend the term of an invention patent related to the new drug which has received regulatory approval. The term extension is no more than five years, and the total remaining term from the regulatory approval should not exceed 14 years.
The draft Rules suggest the extension is available for a drug product, a method for preparing the drug or a medical use of the drug. It also indicates that the new drug covers three types of drugs: chemical drugs, biological products and Chinese medicine.
Notably, the draft Rules clarify that the new drug-related invention patent refers to a patent related to the active ingredient of the new drug that receives regulatory approval for the first time by the Drug Supervision and Administration Department of the State Council.
However, we think there is a need for further clarification on the scope of the active ingredient, particularly on whether the term active ingredient refers to the active moiety and its salt, ester or crystal forms on a broad construction, or whether it is limited to the active moiety itself on a narrow construction.
Timing for Filing a Request for PTE
According to Article 42 set out above, the patentee cannot file a request for PTE before a new drug containing the active ingredient receives regulatory approval in China.
The draft Rules prescribe that the patentee must file a request for PTE with the Patent Administration Department of the State Council within three months from the date the new drug receives regulatory approval.
Furthermore, a request for PTE will need to be filed at least six months prior to the patent expiration date. With the amended Patent Law in China coming into force on June 1, it seems likely that certain pharmaceutical patents will miss the time limit for filing a request for PTE if the patent expires before December 1, 2021. No retrospective remedy is available.
Needless to say, it is essential for the patentees to monitor these time limits if considering a request for PTE.
Request for PTE Requirements
According to the draft Rules, applicants should satisfy the following requirements when filing a request for PTE:
- In the case that there is more than one patent related to a new drug, a request for PTE may be filed for only one eligible patent;
- In the case that a patent covers multiple drug products, the patent term may be extended on the basis of only one drug product;
- A patent term extension has never been applied to the patent; and
- The remaining term of the patent must not be less than six months.
We don’t believe these requirements prevent the patentee from filing another request for PTE based on a different patent (for example, a patent that claims different subject matter such as a preparation method and a medical use), in case a request for PTE based on one eligible patent (for example, a patent that claims a drug product) fails, but this needs confirmation.
It is also unclear if the regulatory review and approval period for a crystal form of the active ingredient can serve as a basis for a PTE, wherein an earlier product containing an amorphous form of the active ingredient previously received regulatory approval.
The second requirement arises when more than one drug product becomes subject to regulatory review and approval. Clarification is required on whether the one drug product that serves as a basis for a PTE request is meant to be the first one that receives regulatory approval.
Calculation of the Extension Term
According to the draft Rules, the extension term is equal to the period between the filing date of the patent and the date on which a new drug receives regulatory approval, reduced by five years.
Limited Protection Scope During the Extension Term
Compared to full protection afforded during the standard patent term, a more limited protection will be available during the extension term. Protection will be limited to only the new drug that receives regulatory approval and its approved indications (see Rule 85 item 6 of the draft Rules).
In response to the newly-introduced patent term extension program, a patent linkage system will be concurrently established in China. Given the huge potential market in China, it is critical for innovator and generic pharmaceutical companies to be prepared for these changes.
Madderns will endeavour to produce further explanatory articles in this series following this introduction, to ensure we can help provide a full picture of the changes which lie ahead.
Read More ›
We are looking for two new people to join our team:
Read More ›
- IP Administrator – for more information see our advertisement on SEEK
- Receptionist/Office Facilities Support – for more information see our advertisement on SEEK
Does your domain name end with a “com.au” or “net.au” or “org.au” and “asn.au” and you are a foreign entity that uses an Australian Trade Mark to support that domain registration? If so, you may not be able to renew or apply for a domain if it doesn’t exactly match a trade mark you own.
These new rules will apply from12 April 2021. Yes – that’s less than two months from now.
If you are a foreign entity and your trade mark is a word and that same word is the domain name to which “.com.au” or any of the other top-level domains is added, then all is OK. However, if the trade mark is not the same, you should check the rules below. If the trade mark and the domain name are the same, you do not need to do anything at this time.
However, you need to be aware that the changes coming into force will apply the next time you want to register or renew a “.com.au” or “.net.au” domain incorporating your new trade mark. They also apply if you intend to transfer a domain to your entity upon the purchase of a domain name and the corresponding trade mark.
For those with similar domain names to either the trade mark you have applied for, or an existing registered trade mark, then the following information is very important to know.
When the “.au” Domain Administration (auDA) changed the eligibility rules, it strengthened the Australian presence requirement hence the effect of this change on domains held by foreign entities. As for Australian businesses they are not affected since they meet the local presence test and their domains do not need to meet the exact match criteria. The new rules state that the domain name must be an exact match to the relevant trade mark and apply to:
- newly applied-for domains;
- to domains that are transferred to a new owner; and
- all domains that are being renewed after 12 April 2021.
So what is an exact match? This requirement is different from the old rule, which allowed the domain name to be ‘closely and substantially connected to your trade mark’.
The domain name MUST include all the words in the same order as they appear in the Australian Trade Mark or Trade Mark application. However, there are some exceptions:
- you can ignore the .com.au and other DNS identifiers;
- you can ignore punctuation marks in the trade mark, such as: ‘! And ‘ ;
- you can ignore joining terms such as ‘a’, ‘the’, ‘and’, ‘of’; and
- you can ignore ampersands ‘&’.
The new rules are tough, and if your domain is not an exact match, you need to do something soon or make sure you act before the next domain renewal date.
There are many possibilities when considering how to act:
- Change your domain name to ‘match’ your trade mark; or
- Change your trade mark to ‘match’ your domain name.
At least one of the new rules allows domain registrations to be owned by a related body corporate, as long as the related company meets the Australian presence requirement.
You can read more about the rules changes at .auDA.
All of the above options have several important implications. So the way forward may not be as simple as it seems. Please consider obtaining professional advice.
Read More ›
As many will be aware, Australia has a 2-tier patent system, providing for the more common Standard Patents (which provide protection for up to 20 years for inventions that are novel and inventive), and Innovation Patents (providing protection for up to 8 years for inventions that are novel and “innovative”).
The most significant difference between the two patent types is that the threshold for an invention being “innovative” is much lower than that for an invention being “inventive” and in practice, Innovation Patents can provide protection for inventions that are essentially only novel over the prior art, even if they may be obvious.
As well as being used to protect more incremental inventions (which may nevertheless be very commercially valuable), Innovation Patents have been used as a tool in patent enforcement because, since they cannot be invalidated for lack of inventiveness, they are very robust patents and can be difficult to invalidate. Indeed, they have been described as the “strongest patent in the world”.
After a review conducted by the Australian Government1, the decision was made to abolish the Innovation Patent system. This takes effect on 26 August 2021, from which date no new Innovation Patent applications can be filed. There is however, a quite generous transition phase, which still allows new Innovation Patent applications to be filed as divisional applications of a pending patent application, or converted from a pending patent application, provided that that pending patent application was filed before 26 August 2021. This means that the significant benefits of the Innovation Patent system can still be accessed for the next 8 years, until 26 August 2029, at which time all Innovation Patents will have expired.
This means that, should you wish to keep your options open to use the Innovation Patent System for the next 8 years, you must take certain steps to ensure that a Standard or Innovation Patent Application is filed before 26 August 2021. A number of different scenarios include:
a) pending Provisional Patent application in Australia: if you have a pending Australian Provisional Patent application whose 12-month period expires on or after 26 August 2021, you should consider filing an Australian Standard Patent application or Innovation Patent application before this date. The Provisional Patent application may still be used after that date as a priority basis for filing overseas patent applications before the expiry of the 12-month period as usual.
b) pending overseas patent application: If you have a first patent application filing for an invention in another country, and the 12-month period for claiming priority expires after 26 August 2021, you can consider filing an Australian Standard Patent application or an Innovation Patent application before this date.
c) invention in development: while filing a patent application too early is generally discouraged, and it may not be practical or in the best interests of your long-term protection strategy for an invention under development, consideration should be given to the potential value of keeping the option of obtaining an Innovation patent for your invention, or at least a part of your invention, by filing a Standard Patent application or Innovation Patent application before 26 August 2021.
So while the Innovation Patent system is soon coming to an end, early and appropriate planning can maximise your opportunities to still benefit from its many advantages for up to 8 years. If you would like to consider the options available to you, speak with your Patent Attorney soon.
Read More ›
Madderns is proud to have been included in the WTR 1000 list for 2021, recognising our team for outstanding work with iconic Australian names and in particular, the wine and fashion industries.
The WTR 1000 is the only standalone publication to recommend individual practitioners and their firms exclusively in the trademark field, shining a spotlight on the firms and individuals deemed outstanding in this critical area of practice.
Recognising Australia’s competitive IP landscape, Madderns has been cited for its expertise in prosecution and strategy.
WTR 1000 cited Madderns for catering to a “large client base of iconic Australian names with big export businesses”.
“The firm’s expertise in the wine industry is known and respected far and wide, while its reputation in the fashion industry continues to grow. The set is experienced in complex prosecution work and regularly represents rights holders in opposition and non-use cancellation proceedings domestically and globally. A specialised side offers filing and prosecution services in China too.”
Congratulations also to Louise Emmett, Megan Ryder and Craig Vinall for their individual professional mentions. Louise and Megan were recognised as being part of the specialist trademarks team assisting clients on prosecution matters, and Craig for juggling both patent and trademark matters.
For further information about the WTR 1000, click here https://www.worldtrademarkreview.com/directories/wtr1000/rankings/australia
Read More ›