Glaxo Receive Patent Term Extension but Warned to be Polite

patent term extension

The Glaxo Group LTD requested a patent term extension for IL 178152 titled “4-[HYDROXY(DIPHENYL)METHYL]-1-{2- [PHENYLMETHYL)OXY]ETHYL}-1- AZONIABICYCLO[2.2.2] OCTANE BROMIDE USEFUL FOR TREATING MUSCARINIC ACETYLCHOLINE RECEPTOR MEDIATED DISEASES, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT “.

The Application was filed on 27 April 2005 and was granted on 1 September 2011 and registered in the name of the Applicant. On 21 April 2015 the Applicant requested a Patent Term Extension based on the medication called ANORO ELLIPTA. According to the Ministry of Health, this medication includes two active ingredients: Vilanterol and Incruse Ellipta which includes the active ingredient Umeclidinium which was registered for sale on 8 February 2015.

The active ingredient Umeclidinium is the subject of claim 1 of the patent and the medication itself is claimed in claim 3.

An Affidavit from Mr Fowler, a Glaxo representative, was appended to the Extension request. This affirmed that Anoro Ellipta was the first medication registered for usage in Israel which included the active ingredient Umeclidinium.

The earliest approval for Anoro Ellipta was from the FDA in the United States and issued on 18 December 2013. Even now, the drug has not received a Patent Term Extension in the US, and the request for a Patent Term Extension in Israel is under Section 64 e(5) of the Israel Patent Law 1967 as currently amended.

The Patent Term Extension abroad that is the basis of the request in Israel is the Patent Term Extension Italy, which until the filing of the request for a Patent Term Extension was the only extension given by a recognized (Bolar) country. Since then, France and Spain have issued similar extensions.

In a letter from the Deputy Chief Examiner dated 19 May 2015, the Applicants were asked whether the combination of  Vilanterol and Umeclidinium in Anoro Ellipta creates a new active ingredient, since claim 1 claimed one active ingredient and claim 3 claimed the combination. In the same letter, the Deputy Chief Examiner noted that Vilanterol was already the subject of a patent term extension request and therefore the Application was not the first application as per Section 64(d)4.

In response and with a further Affidavit from Mr Fowler, the Applicant countered that on the basis of this being the first medical usage of Umeclidinium, the medication Umeclidinium deserved a patent term extension and this was the first time this active ingredient was registered. That Vilanterol had previously been registered was immaterial.

The Deputy Chief Examiner disagreed. and on 28 July 2015 ruled that this could not be considered the first usage under the Law, since the Applicant failed to show that the combination created a new medication. Furthermore, if a new medication is indeed created then the basic patent does not support this combination. She went on to affirm that in her opinion, the previous registration of Vilanterol rendered the combination of Vilanterol and Umeclidinium impossible to be considered as a first use and thus entitled to a Patent Term Extension.

The request was rejected and the Applicant appealed to the Commissioner, submitting a further affidavit, this time signed by Helen Quillin, the Deputy President of Glaxo and an employee thereof since 1993. the Affidavit affirmed that Anoro Ellipta is a ground breaking drug for the treatment of chronic lung blockage. The Applicant contends that the application for a patent term extension is legitimate. As far as the request relates to Umeclidinium as claimed in claim 1 of the ‘152 patent; the registration of this drug on 28 January 2015 was the first registration in Israel. Even if Umeclidinium combined with Vilanterol creates a new medication, it still fulfils the requirements of Section 64d(1) of the Law since bot the combination and Umeclidinium alone cannot be considered to have been registered earlier. It is noted that this is the first time that Applicant related to the question raided by the Deputy Chief Examiner.

The Question of the first registration of a drug combination has been related to a number of times by the patent office. What is required is that the registration in question is the first registration of the active ingredient.

Thus, for example, concerning Novartis AG 97219 (decision from 26/12/2005), the then Commissioner ruled that the term composition in section 64a is in the singular, and intends a single active ingredient. The then Commissioner stated that where a patent term extension is applied for on the basis of a patent for a combination of active ingredients and at least one of these had not benefited from prior Ministry of Health Approval, a patent term extension was possible. Furthermore, the District Court related to this in an appeal of the above case to the Tel Aviv District Court (1062/06 Novartis vs. Commissioner of Patents 26/2/2007) where it is stated that the term  חומר – material or matter implies the active ingredient and not the specific formulation, so long as the formulation is not more than the sum of its parts. Furthermore, in the Lundbeck decision concerning Cipralex, the isolated right hand molecule was not considered a new substance when compared to the  racemic mixture.  the court explained that the active ingredient may assume different forms, such as salts, and even if a drug is the first use of a particular form of the active ingredient, if the active ingredient has previously been registered in a different form, the second registration cannot be considered as the first registration of the active ingredient.

Based on the above, one can conclude that Anoro Ellipta is the first permitted usage of Umeclidinium and may be entitled to a drug term extension under Section 64d(3).

Vilanterol has been previously registered. As explained in 117459 Merck vs. Sharp and Dohme Corp. the previous registration of one active ingredient that is found in a new mediation that includes several active ingredients need not necessarily prevent the new medication from benefitting from a Patent Term Extension.

Anoro Ellipta,  like Umeclidinium, is entitled to a patent term extension and claim 3 which states: 

“3. A pharmaceutical composition according to claim 2, which further comprises one or more other therapeutic ingredients.”

does not detract from the fact that the composition contains Umeclidinium and is entitled to protection for that reason.

The Applicant does not consider that  Umeclidinium and Vilanterol form a new compound. This in Ms Quillin’s statement:

“The combination of these two active pharmaceutical ingredients does not create a new compound that differs from each of its components. In fact, each of these active ingredients is stored as a separate dry powder composition within the ELLIPTA™ inhaler of the ANORO™ ELLIPTA™ inhalation product.

The inhaler prevents the two ingredients from coming into contact with each other.

On the basis of the above analysis, the basic patent for ANORO™ ELLIPTA™  is extended by 965 days until 18 December 2027 and this decision will be published for opposition purposes in the forthcoming journal. The calculation is based on the Italian patent term extension and from the first published use in the US.

As an after-note, the Commissioner cautioned the Applicant for making disparaging comments about the Deputy Chief Examiner which should not have been made, and that a certain decorum is required when interacting with examiners.

COMMENT

I think the Deputy Chief Examiner was concerned that allowing a patent term extension for a combination of drugs or a cocktail could enable the unscrupulous to obtain an extension for a drug previously published by combining it with something new or at least not previously published.

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