China - patent term extensions allowable soon?

There have been reports (here and here) of rumors that China will start allowing patent term extensions for pharmaceutical patents.  Does any SPC Blog reader have more information on this exciting development?  If so, please leave a comment below or email us here. 

Update on IL PTE practice: Notification date of MA to be used in calculating PTE duration

Liad Whatstein of Liad Whatstein & Co. brings news of a recent decision of the Israeli Patent Office regarding the calculation of the duration of Israeli patent term extensions (PTEs).  Liad represented Novartis in the IL PTE petition for secukinumab (Cosentyx®).  He writes:

The Israel PTO recently accepted that for the purpose of calculating the duration of IL PTEs the EMA MA notification date shall be taken into account. This development changes the practice of the IL PTO and comes only a few months after the IL Patents Commissioner held that the EMA MA grant date should be used.

The Israeli PTE system is unique and is based on a series of linkages to the expiry dates and extension periods of the US PTE and SPCs granted in any of the EU-5 countries (United Kingdom, Italy, France, Spain and Germany). In addition, the Israeli PTE must end no later than 14 years from the earliest date in which a regulatory approval was obtained in either the Unites States or the EU-5 countries.

In the matter of IL PTE petition for Apixaban (Eliquis®) published on September 16th, 2015, the IL Patents Commissioner held that for the purpose of calculating the duration of IL PTEs the EMA MA grant date rather than the EMA MA notification date will be used. As a consequence, the PTE for Apixaban (Eliquis®) will expire in Israel two days earlier than would have been the case if the EMA MA notification date started the 14 year count. The IL Commissioner justified his decision by referring to the lack of uniformity between different European Patent Offices on this issue (i.e., whether the EMA grant date or the EMA notification date should be used to calculate the duration of SPCs under Article 13 of Regulation No 469/2009). However, the IL Commissioner was not apprised of the opinion of the ECJ advocate general (AG) in Seattle Genetics which was published prior to the decision in the Apixaban case. If the IL Commissioner had been apprised of the opinion of the AG, the Commissioner would have likely reached a different result.

In any event, after the CJEU published its binding decision in Seattle Genetics (case C-471/14) on October 6th, 2015, it was only a matter of time until the IL PTO would be called to reevaluate its position. In the matter of IL PTE petition for secukinumab (Cosentyx®), the IL PTO examiner initially calculated the IL PTE period based on the EMA grant date which was 4 days earlier than the notification date. The patentee argued that once the CJEU issued a final decision, which is applicable in all of the EU-5 Countries (among others), holding that the calculation of the duration of supplementary protection should be based on the EMA MA notification date – the IL PTO is bound to follow the CJEU determination. The IL PTO reevaluated its position and decided to follow the CJEU ruling, effectively canceling the IL Commissioner’ decision in the matter of IL PTE petition for Apixaban (Eliquis®).

Many thanks to Liad for sharing the news with us!

Supreme Court affirms IP High Court's relaxation of the PTE system in Japan

Earlier this month The SPC Blog was delighted to host "Patent term extension in Japan: a guest post", here, by Dr Seigen Tsukuda (Ohno & Partners, Japan).  Here's a sequel, bringing some fresh news.

This is a quick notice that, on 17 November 2015, the Supreme Court rendered a decision rejecting the JPO's appeal against Intellectual Property High Court (IPHC) Grand Panel decision issued in May 2014. As a general principle, the Supreme Court decision can be outlined thuss:

In order to reject an application for a patent term extension (PTE) based on a prior authorization, in view of category and subject of patented invention(s) for which the application is submitted, a prior authorization and a new authorization shall be compared in terms of elements examined for authorization, such elements being relevant to substantial identity as a pharmaceutical product, and it must be established that the prior authorization encompasses the new authorization in terms of an authorization for production and sales of a pharmaceutical product.

The decision applied the above principle to the present facts as follows:

In the context of product patents directed to ingredients of pharmaceutical products, "elements examined for authorization relevant to substantial identicalness as a pharmaceutical product" are components, quantity, administration, dosage amount, effect and efficacy. Administration and dosage amount of the previously authorized pharmaceutical product are 

"... intravenous drip infusion of 5mg/kg (body weight) per dose or 10mg/kg (body weight) per dose ... administration interval is 2-week or longer ...", 

while those of the newly authorized pharmaceutical product are 

"... intravenous drip infusion of 7.5mg/kg (body weight) per dose ... administration interval is 3-week or longer ...". 

Further, production and sales of the subject pharmaceutical product for a combination therapy of XELOX therapy and bevacizumab therapy newly became available by such new authorization. Based on the facts described above, it is not established that the prior authorization encompasses the new authorization in terms of an authorization for production and sales of a pharmaceutical product. Therefore, the decision of appeal board of the JPO is not legitimate, and the IPHC Grand Panel decision is approved.

As can be seen from the above, it seems that the Supreme Court accepted almost the whole framework of the IPHC Grand Panel decision establishing that a PTE may be allowed based on any substantially new authorization, so long as the subject patent covers the newly authorized pharmaceutical product.

Upon the Supreme Court decision, the JPO announced on 18 November 2015 that the JPO starts revising its PTE examination guidelines and stops examinations for PTEs until a publication of the revised guidelines. It is expected that under the revised guidelines, applications for PTE shall be more easily allowed. Further, while the Supreme Court decision is silent, as IPHC Grand Panel decision mentioned in obiter dictum, scope of an extended patent may become narrower than previously expected. It is therefore recommended that, whenever a new pharmaceutical product is authorized in Japan, an application for a PTE shall be considered for any patent covering the new pharmaceutical product

In this respect it should be noted that, when a patentee wishes to obtain a PTE, if an authorization is not delivered by 6 months and one day before the expiration date of a subject patent, a provisional application must be submitted by that day, i.e. 6 months and one day before the expiration date (Patent Act Article 67-2-2, paragraph 1), otherwise a non-provisional application must be submitted within three months from the delivery of an authorization (Patent Act Article 67-2, paragraph 2 and Implementing Regulation of Patent Act Article 3).

Further, in our previous post, it was mentioned that 

"If the patentee may wish to obtain a PTE corresponding to a dependent claim in the future, it is recommended to file a divisional application to establish a patent specifically directed to the invention of the dependent claim, describing the invention as an independent claim". 

Under the new examination guidelines, PTE may become available without filing such divisional applications.

Patent term extension in Japan: a guest post

Here's a guest post from Dr Seigen Tsukuda (Ohno & Partners, Japan, right) on patent term extensions in that important jurisdiction.  Our thanks go both to Dr Tsukuda and to Darren Smyth (EIP)) for procuring it on our behalf and giving it the benefit of his editorial scrutiny. 

  Introduction            

  Patent systems differ from nation to nation, and the practice relating to patent term extension (PTE) shows an extreme example of such variation.  The Japanese PTE system is quite distinct from those of Europe and United States.  Significant features of the present Japanese PTE procedure are as follows.

(1) Although it is required that an authorized pharmaceutical product falls within the scope of a claim of the patent, it is NOT required that the claim recites (specifies) any active ingredient.  Thus, patents relating to drug delivery systems (DDS), for example, can be extended in principle.  

(2) Multiple extensions are available for a single patent (but the term of extension may not exceed 5 years). 

(3) Multiple patents belonging to the same patentee can be extended based on a single authorization.  

  The idiosyncrasy of the Japanese system has increased even further recently.  In order to elucidate the current situation, let us look briefly into the Patent Act provisions and the history of Japanese PTE practice.  

  Relevant provisions of Japanese Patent Act            

  Article 67 paragraph 2 provides conditions for PTE, mentioning "Where there is a period during which the patented invention is unable to be worked because ... disposition [authorization] ... is necessary to obtain for the working of the patented invention, the duration of the patent right may be extended ..., by a period not exceeding 5 years."            

  Art 68-2 provides effects of PTE, i.e. "Where the duration of a patent right is extended ..., such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the disposition [authorization] ... which constituted the reason for the registration of extension (where the specific usage of the product is prescribed by the disposition [authorization], the product used for that usage)." [Japanese Patent Act]

  PTE examination practice at JPO until 2011            

  Conventionally, the JPO assumed that "product" and "usage" recited in Article 68-2 should be interpreted as "active ingredient(s)" and "effect and efficacy" respectively.  Based on this assumption, the JPO further interpreted Article 67 paragraph 2 as meaning that a PTE can only be based on an authorization that is "new" in terms of a combination of "active ingredient(s)" and "effect and efficacy".  For example, let us assume a case where an authorization is obtained for a pharmaceutical product using a new DDS technology, and the DDS technology is protected by a patent.  In this case, according to the JPO practice, the patent could NOT be extended so long as there is a previous authorization corresponding to a pharmaceutical product whose active ingredient, effect and efficacy are the same for those of the newly authorized pharmaceutical product.  It is not relevant whether the previously authorized pharmaceutical product falls within or outside the claims of the subject patent (situation was similar to MIT case [C-431/04]).            

  According to Article 67 paragraph 2, a PTE may be allowed "when there is a period during which the patented invention is unable to be worked".  Under the Japanese Pharmaceutical Affairs Act, it is not permitted to market a pharmaceutical product of new formulation or new dosage until a new corresponding authorization is obtained, even if a previously authorized pharmaceutical product contained the same active ingredient and was authorized for the same effect and efficacy.  It could thus be argued that there is "a period during which the patented invention is unable to be worked".  Accordingly, since late 1990s, new-drug developers have been struggling in courts arguing that the above JPO's practice is not legitimate.  

  Supreme Court decision in April 2011            

  Finally, on 28 April 2011, the Supreme Court gave a decision determining that the above JPO practice is not legitimate [H21(Gyo-hi)326: Takeda v Commissioner of Patents].  According to the decision, an application for a PTE cannot be rejected based on a previous authorization if a pharmaceutical product authorized by the previous authorization does not fall within the scope of any of the claims of the subject patent for which PTE is applied.  The decision opened a door for PTE of a patent protecting a new formulation, such as DDS drugs. [H21(Gyo-hi)326] 

  Revised examination guidelines in December 2011            

  Forced by the Supreme Court decision, the JPO revised its examination guidelines for PTE in December 2011.  The revised guidelines are fairly complicated, but could be summarized as follows.  An application for a PTE based on a new authorization for a new pharmaceutical product cannot be rejected if an old pharmaceutical product authorized by a previous authorization falls outside the scope of all of the claims of the subject patent.  On the other hand, if the old pharmaceutical product falls within the scope of a broadest claim of the subject patent, the application for PTE must be rejected so long as the old and new pharmaceutical products do not differ in term of the elements described in the broadest claim of the subject patent.            

  For example, assume a case in which a new pharmaceutical product is a new formulation including active ingredient A and excipient polymers B and C2, where the old pharmaceutical product was a formulation including active ingredient A and excipient polymers B and C1.  In this case, a PTE will not be allowed if an independent claim of the subject patent simply recites active ingredient A, or a combination of active ingredient A and excipient polymer B.  On the other hand, a PTE may be allowed if the independent claim of the subject patent recites a combination of active ingredient A and excipient C (C1 and C2 are examples of C).            

  There remained a question of whether such revised guidelines (to refuse a PTE if the independent claim only recites active ingredient A, or a combination of active ingredient A and excipient polymer B) are in accordance with Article 67 paragraph 2, because marketing of the new pharmaceutical product (A+B+C2) is not allowed under authorization for the old pharmaceutical product (A+B+C1).  It may be possible to argue that "there is a period during which the patented invention is unable to be worked" in respect of the pharmaceutical product (A+B+C2) until a new authorization is obtained for the new pharmaceutical product (A+B+C2), even though the patented invention was able to be worked in respect of the old pharmaceutical product (A+B+C1).  New-drug developers again fought in courts questioning whether JPO's revised practice is legitimate or not. [Revised Guidelines]  

  Intellectual Property High Court (IPHC) Grand Panel decision in May 2014         

  On 30 May 2014, the Grand Panel of IPHC rendered a decision determining that the revised examination guidelines are not legitimate [2013(Gyo-Ke)10195: Genentech v Commissioner of Patents].  According to the decision, if an authorization is new in terms of a combination of components (not only active ingredients), quantity, administration, dosage amount, effect and efficacy, the application for a PTE shall not be refused based on a prior authorization.  This means that a PTE may be allowed based on any substantially new authorization, so long as the subject patent covers the newly authorized pharmaceutical product.            

  The decision also mentioned in obiter dictum that, during the extended period, the patent will cover only a drug within both the scope of claim of the patent and the scope of the authorized pharmaceutical product in respect of “components (not only active ingredients), administration, dosage amount, effect and efficacy”, and equivalents or substantially identical products thereof.  Since the PTE system was established in 1988 in Japan, there has been no legal precedent determined in ratio decidendi what is the claim scope of an extended patent. [2013(Gyo-Ke)10195] 

  Practical suggestions            

  As mentioned above, under the current examination guidelines, a PTE is allowed on a patent-by-patent basis, and examination will be performed based on the broadest claim of a patent.  In a case where a prior authorized pharmaceutical product falls within the broadest claim and there is a reason for rejection with respect to the broadest claim, a PTE is not allowed even if the old pharmaceutical product falls outside a narrower dependent claim (and the new pharmaceutical product falls within the dependent claim).  However, if a divisional application including the dependent claim is filed to separate the claim from the independent broadest claim of the parent, and a secondary patent is obtained, a PTE may be allowed for such secondary patent under the current examination guidelines, based on the authorization for the new pharmaceutical product.  If the patentee may wish to obtain a PTE corresponding to a dependent claim in the future, it is recommended to file a divisional application to establish a patent specifically directed to the invention of the dependent claim, describing the invention as an independent claim.         

  It should also be kept in mind that the current examination guidelines have been disapproved by the Grand Panel decision and the situation is quite unstable.  The JPO appealed against the Grand Panel decision, and the case is still pending at the Supreme Court.  It is expected that a decision will be given within a few years.  The JPO's practice has not substantially been changed since December 2011, but it is quite possible the guidelines will be revised again after a new Supreme Court decision.  If the Supreme Court affirms the Grand Panel decision, then a PTE will become more easily allowed, but the scope of protection provided by an extended patent will become more restricted.  In 2011, the Supreme Court decision stopped all PTE examination at the JPO until the examination guidelines were revised and fixed.  It is therefore recommended that, whenever a new pharmaceutical product is authorized in Japan, an application for a PTE shall be considered for any patent covering the new pharmaceutical product, even if the PTE might appear unallowable based on the present guidelines. 

Ezetimibe in Israel: a recent ruling on retroactive effect

There's a recent blogpost on Michael Factor's IP Factor weblog, "Israel Patent Office Shortens Patent term Extension for Ezetimibe", which provides a detailed analysis of Re 110956 Association of Israel Industrialists v Schering and Mercke, decided by Asa Kling on 18 September 2014. This ruling deals with, among other things, the retroactive effect of Israeli legislation on patent term.

Israel's Amendment No. 11 now imminent

From Liad Whatstein (Shlomo Cohen & Co) comes news of Amendment No. 11 of the Israeli Patents Act which, Liad tells us, is expected to be enacted shortly --as soon as next week, unless there is an unexpected delay.  The Amendment introduces several important revisions in the Israeli Patent Term Extension (PTE) system. Here's the firm's overview, from which the following is extracted for your interest:

The unique Israeli PTE system is based on “external” linkages to PTEs or SPCs granted in 21 “Recognized Countries” (US, EU-15 (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom), Australia, Iceland, Japan, Norway, and Switzerland). 

Eligibility to PTE and the calculation of the PTE period is based on multiple linkages: 

* The extension will be equal to the shortest extension granted to a Reference Patent in any of the Recognized Countries; 

* The PTE will expire no later than the first expiry date of a PTE of a Reference Patent in any of the Recognized Countries; 

* The extension must end no later than 14 years from the earliest date in which a regulatory approval was obtained in any of the Recognized Countries. 

* PTE in Israel will only be available if PTE/SPC was granted in the US and in at least one EU-15 country;

The result of these multiple linkages is that in most cases the de-facto extension period does not exceed two to three years. 

Amendment No. 11 of the Patents Act is the result of a bilateral agreement between Israel and the US. It has recently been approved by the Knesset (Israeli Parliament) Judiciary Committee and will be enacted shortly. 

Amendment No. 11 reduces the number of Recognized Countries to include only the US and the top five European markets (UK, France, Germany, Spain and Italy). It remains to be seen whether this reduction in the number of Recognized Countries will meaningfully extend in average Israeli PTEs.

Unfortunately, Amendment No. 11 also includes several provisions which further curtail the scope of PTE protection under Israeli law:

* An Israeli PTE will automatically expire when a Reference Patent is revoked or a PTE/SPC of a Reference Patent is revoked or withdrawn in any of the Recognized Countries; 

* If the basic term of the patent is about to expire and US/EU PTEs/SPCs have not yet been granted (i.e. no eligibility for PTE under the linkage mechanism), interim PTE orders will no longer be available; 

* Extensions of the deadline for filing the PTE petition (90 days after the date of regulatory approval in Israel) will not be granted; 

* Only one extension will be allowed during prosecution of the PTE petition; 

* A PTE petition must now be filed within 90 days of regulatory approval in Israel also if the patent application is still pending (previously, the deadline to file a PTE petition was extended until 90 days after patent grant); applicants will have a 90 days grace period from the date of the Amendment to file PTE petitions for pending patent applications. 

The pdf can also be downloaded here.

Thanks so much, Liad!

patent term extension in Macau: even more information

If anyone ever doubted that The SPC Blog was a useful tool for finding out about jurisdictions in which a person has little or no personal involvement or experience, the answers received in response to a reader's question concerning Macau must surely go some way towards dispelling those doubts.  First we received this response; now we have been sent even more information by our ever-helpful friend Alice de Pastors, which we are delighted to reproduce here:

A few SPC data are available on the website of Macau Patent Office.For instance
- SPC 5 for linezolid has an expiry date 18/08/2021 (7 years from the patent term)- SPC 8 for atorvastatin has an expiry date 05/10/2017 (10 years from the first MA date).Below please find an extract from the Macau Patent Office database.


SPC data from Macau Patent Office No. of Complementary Certificate for the Protection of Medicines and Phyto-pharmaceutical Products F/5Applicant / Holder 法瑪西雅厄普約翰美國公司 PHARMACIA & UPJOHN COMPANY LLC
Address
Address 美國密執安 7000 Portage Road, Kalamazoo, MI 49001, USA
Invention Patent No. / Extension Invention Patent No. J/65 - 16/08/1994 Invention Patent No. / Extension Invention Patent No. J/65 - 16/08/1994Title of Patent (Chinese / Portuguese Version Only) 取代的噁嗪和噻嗪噁唑烷酮抗微生物劑。 Date of Application 23/06/2008
Date of Ruling 05/02/2009
Protecção de certificado complementar de protecção para medicamentos e produtos fito-farmacêuticos  05/02/2009                         9/2009              II  04/03/2009 
Product Identification Zyvox (Linezolid)
No. of the First Authorization to Place the Product on the Local Market 600459
Date of the First Authorization to Place the Product on the Local Market 25/01/2002Valid Until 16/08/2021 7 years from the patent termStatus Foi emitido

No. of Complementary Certificate for the Protection of Medicines and Phyto-pharmaceutical Products     F/8Applicant / Holder WARNER-LAMBERT COMPANY LLC Address 235 East 42nd Street, New York, NY 10017, United States of America Invention Patent No. / Extension Invention Patent No.     J/64 - 08/07/1996Title of Patent (Chinese / Portuguese Version Only) 結晶〔R－（R*，R*）〕－2－（4－氟苯基）－β，δ－二羥基－5－（1－甲基乙基）－3－苯基－4－〔（苯氨基）羰基〕－1H－吡咯－1－庚酸半鈣鹽。Date of Application 13/11/2008
Date of Ruling 05/02/2009
Protecção de certificado complementar de protecção para medicamentos e produtos fito-farmacêuticos 05/02/2009        9/2009                         II                       04/03/2009
Product Identification Lipitor (Atorvastatin)
No. of the First Authorization to Place the Product on the Local Market    605193
Date of the First Authorization to Place the Product on the Local Market 05/10/1997Valid Until 05/10/2017 10 years from the first MAStatus Foi emitido 

Patent term extension in Macau: an answer

In swift response to today's earlier post seeking information on patent term extension in Macau, a kind reader has submitted the following information which this weblog gratefully posts:

"Section III, Articles 125 to 128 of Decree-Law Nº 97/99/M of 13 December 1999 provides for Complementary Protection Certificates (CPCs) in Macao. The Macao CPC law is a vestige of Macao having been a Portuguese colony, since Portugal had provided for CPCs even before other European countries enacted their Supplementary Protection Certificate (SPC) laws.

Patents pertaining to medicines and “phyto-pharmaceutical products” (i.e., plant extracts) are eligible for a CPC. Veterinary drugs may be included within the scope of “medicines” -- but the statute does not expressly mention them.

The CPC application cannot be filed until six months from the original (unextended) expiration date. It is recommended that the application be filed on the first possible day, since the legal effect of a patent’s expiration during the pendency of a CPC application is not known. There is no specific provision in the law for interim extensions comparable to that under the U.S. law.

The statute does not describe any limitation on the scope of the CPC.

The maximum duration of a CPC is 7 years. However, the statute does not provide any formula for calculating the duration in individual cases".

Meaning of 'product' in US patent extensions

"An ‘active ingredient’ of a drug must be present when the drug is administered" is the title of a Current Intelligence note by Bart A. Gerstenblith (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC) on the US decision in PhotoCure ASA v Kappos, 603 F.3d 1372 (Fed. Cir. 2010). This District Court, Eastern District of Virginia, decision concerns the interpretation of the patent term extension provisions of the Drug Price Competition and Patent Term Restoration Act 1984 (the ‘Hatch-Waxman Act’).  It considers the term ‘product’ in 35 USC §156(a), explaining that it means the active ingredient that is present in a drug when administered, not necessarily the ‘active moiety’ of the drug.

This note has been published on the Advance Access service of the Journal of Intellectual Property Law & Practice (JIPLP), but has been made fully available to all on the jiplp weblog here.

US Court of Appeals Decides Enantiomer Patent Term Extension Case

We don't usually report on US issues, but Jeffrey S. Boone, Vice President, Intellectual Property, for Covidien (Hazelwood, Missouri, US) has kindly sent us this update on patent term extensions in the US.

"In the United States, the Court of Appeals for the Federal Circuit (CAFC) today (2010 May 10) issued its decision in the case of Ortho-McNeil Pharmaceutical, Inc. v Lupin Pharmaceutical, Inc. The court decided that the previous approval of a racemic mixture does not prevent a patent term extension for a single isomer of the racemic mixture.

US 4,382,892 claims ofloxacin, an antibiotic which is a racemic mixture of equal amounts of two stereoisomers (enantiomers). The patent was granted in 1983 and the US FDA approved the commercial marketing of ofloxacin (FLOXIN®) in 1990. In 1991 a subsequent patent, US 5,053,407, was granted for levofloxacin, one of the enantiomers in ofloxacin. In 1996 the FDA granted marketing approval for levofloxacin, which has been sold under the proprietary name LEVAQUIN®.

The plaintiff submitted an application for a Hatch-Waxman patent term extension for the ‘407 patent, which claims the single enantiomer. With full knowledge that the racemic mixture had been previously granted marketing approval, the FDA decided that the marketing approval of levofloxacin (the single enantiomer), was the “first” permitted commercial marketing or use of the “product”, as defined under 35 USC 156(f)(1). Thus, the FDA decision, which was consistent with several similar prior cases, was essentially that the racemic mixture and the single enantiomer were not the same “product”, as defined by the statute.

In litigation that resulted from the defendant’s filing of an ANDA (an application for a generic version of LEVAQUIN), the defendant, Lupin, argued that an enantiomer is half of its racemate, and thus the enantiomer was a component of the previously approved drug. However, the district court declared on 2009 April 30 that the patent term extension was valid.

Now, the court of appeals has affirmed the district court. The court quoted one of the witnesses who stated “in each and every instance in which it has considered the question, the FDA has described a racemate as a single active ingredient, distinct from its enantiomers, and each enantiomer as a single active ingredient distinct from the other and from the racemate”."

You can read the case here.

Australian Patent Office allows patent term extension for a drug delivery system for two or more active substances

The Australian Patent Office has recently handed down a case, N. V. Organon [2009] APO 8 (298 May 2009) which impacts the type of subject matter which is eligible for a patent term extension in Australia, particularly relating to formulations and delivery devices. The test for whether a product qualifies for a patent term extension now appears to be whether there is "integration" between the active ingredient and the other feature.

The Intellectual Property Laws Amendment Act (1998) amended the Australian Patents Act 1990 to provide, inter alia, for an extension of term for pharmaceutical patents. The scheme allows patentees to apply for an extension of term of up to 5 years for a standard patent that claims a pharmaceutical substance.

In order for a patent to be eligible for an extension, it must satisfy the criteria set out in section 70(2) of the Australian Patent Act:

• one or more pharmaceutical substances per se must be in substance disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification, or
• one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification.

Pharmaceutical substance in the Australian Act is defined in Schedule 1 as a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

• (a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or
• (b) action on an infectious agent, or on a toxin or other poison, in a human body;
  but does not include a substance that is solely for use in in vitro diagnosis or in in vitro testing.

In the case in question, the patentee applied for an extension of term of the patent based on its patent relating to a drug delivery system adapted to the slow release of particular steroidal mixtures such as for the purpose of contraception or hormone replacement therapy. A key aspect of the invention is that the steroidal mixture is contained in a thermoplastic polymer core over which is laid a permeable thermoplastic skin. It was considered whether the product as claimed in the patent was a pharmaceutical substance within the meaning of the Act and more particularly whether it was a substance for therapeutic use as provided in the definition given in Schedule 1.

The Commissioner held that

"the definition of a pharmaceutical substance encompasses a compound with a controlled spatial configuration if, as a whole, it can still be considered a “pharmaceutical substance”, but the combination of such a substance with what would reasonably be considered a separate physical device, layer or structure is excluded. It may be difficult to determine whether a particular feature of a product is correctly considered part of a “substance” rather than a separate physical integer but in the present case the steroidal components are mixed with and necessarily diffuse through the thermoplastic materials in the core and skin regions and as such the product as a whole exhibits a level of integration or interaction between the component parts that was considered more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.
Consequently the application to extend the term of the patent was allowed. "

In its decision, the Australian Patent Office followed a line of reasoning similar to that expressed by Advocate General Leger in the ECJ MIT case.

The Commission's view on paediatric extensions

Recently, the Commission sent the official records of the 3rd meeting of national SPC experts held on 26 September at the EMEA to national patent offices. This meeting was mainly devoted to the implementation of paediatric extensions. The records are particularly interesting to those who are involved with the administrative implementation of Regulation 1901/2006. Some national patent offices, such as the German PTO, have yet started a consultation procedure to discuss with representatives of industrial pharmaceutical associations administrative issues, such as the format of proofs.

As regards the contents of the records it is somewhat disappointing that, by and large, the Commission takes a rather formalistic approach, even when the wording of the provisions seems to be quite clear. This is especially true with respect to Article 36.3 of Regulation 1901/2006 and Article 8.1.d.ii of Regulation 1768/92. When the wording is somewhat ambiguous, as in Article 36.1 of Regulation 1901/2006 and Article 8.1.d.i of Regulation 1768/92, the result is the same. The Commission seems to apply the maxim "in dubio contra paediatric extension".

Consequently, this basic incentive will be devaluated. Of course, such tendencies of strict interpretation undermine the very aims of the Regulation 1901/2006. It remains to be seen if the national patent offices are able and willing to practise the relevant provisions in a more flexible way, e.g., by using the instrument of Article 10.3 of Regulation 1768/92.

Synergistic combinations of active ingredients doesn't save patent term extension in the US

The aroma of a recent patent term extensions decision by the US PTO has reached this side of the pond with the Patent Baristas report of AstraZeneca's attempt to obtain a patent term extension for Symbicort, an asthma drug comprised of a combination of the active ingredients formoterol fumarate dihydrate and budesonide:

AstraZeneca filed an application for a patent term extension (PTE) of the patent term of U.S. Patent No. 5,674,860 under 35 U.S.C. § 156 in the United States Patent and Trademark Office. They tried to get the extension based the time for FDA review under section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) of Symbicort®, having the active ingredients, formoterol fumarate dihydrate and budesonide. [n.b. both of these active ingredients were each approved for commercial marketing or use before the approval of Symbicort]

The Patent Office determined that the ‘860 patent was ineligible for patent term extension based upon the regulatory review period because (1) Symbicort does not constitute the first permitted commercial marketing or use of the product Symbicort (formoterol fumarate dihydrate and budesonide) under the provision of law under which such regulatory review period occurred, and (2) the PTE Application was not timely filed.

AstraZeneca had argued that, since Symbicort is a synergistic combination of formoterol fumarate dihydrate and budesonide, it should be considered as a single active ingredient for patent term extension purposes.

The Patent Office disagreed with the synergistic combination argument:

Applicant’s argument is incorrect. The synergistic effect of the active ingredients formoterol fumarate dihydrate and budesonide has no relevance in determining “first permitted commercial marketing or use of the product” as required by 35 U.S.C. § 156(a)(5)(A). The term “product” as used in 35 U.S.C. § 156 includes any new drug or antibiotic drug, “as a single entity or in combination with another active ingredient.” 35 U.S.C. § 156 (f)(2). Section 156(f)(2) says nothing about whether a combination is synergistic. See Arnold Partnership v Dudas, 362 F.3d 1338, 1343 (Fed. Cir. 2004) (”Moreover, this court doubts that synergistic effects are an appropriate distinction for term extension policies, particularly where the statutory language does not distinguish at all between synergistic and nonsynergistic combinations.”).

Read more here.

Although the corresponding SPC for Symbicort (SPC/GB02/033) was granted in the UK in 2003, the patent was revoked in appeal proceedings at the European Patent Office in 2007.