Patent extensions: some academic perspectives?

The John Marshall Review of Intellectual Property Law (RIPL) has now published issue one, volume 10 (you can view it here). In the first of its four lead articles, Verne Luckow and Steven Balsarotti write about their empirical study on patent applicants seeking longer patent term adjustments (PTAs).  This study concludes that an understanding calculations behind patent term extensions is the key to the development of licensing and ownership strategies for patented technologies. While this article deals with US extensions relating to delays in grant caused by USPTO bureaucracy, not to European-style SPC extensions, one of the authors' findings will interest readers of this weblog because it indicates judicial attitudes towards the pharma sector as well as signalling originating pharma's intentions with regard to its proprietary technology:

"... Despite the intent of Congress to compensate applicants for delays in prosecution in an industry-independent manner, applicants seeking reconsideration of a patent term adjustment in Federal District Court are highly-biased toward institutions seeking patents on pharmaceutical and related biotechnology inventions. Unlike patent term extensions, which are sought in a six-month period prior to regulatory approval and sale of a pharmaceutical product, and often long after a patent has issued claiming the product, court cases identifying patents needing longer PTAs provide early notice to the public, including investors and competitors, of technologies considered to have particular value to the applicant. ...".

Professor Reichman

The SPC Blog has learned that, this Monday, the distingushed US academic Professor Jerome H. Reichman (Duke University School of Law, Durham, North Carolina), gave a lecture at CEIPI in Strasbourg on "Patents and Public Health: Legal, Economic and Public Policy Aspects of Access to Medicines". If any reader of this was present, can he or she let us know whether this lecture covered the public health and policy aspects of patent term extension, so that we can contact Professor Reichman if necessary and ask for a copy of what he said?

Date for the 2011 SPC Blog's seminar: when is best for you?

The SPC Blog is looking forward to running its third seminar this coming Spring, kindly hosted by the London office of Olswang LLP. There's a poll at the top of this weblog's side bar, so you can click the range of dates that suits you best. Do please let us know your preference!

Details of the conference programme will be available in due course.

Positive opinions on PIPs

Since 2008, the European Medicines Agency (EMA) has reported twenty positive opinions on compliance with a Paediatric Investigation Plan (PIP). The opinions are an important step towards obtaining the compliance statement required for obtaining an SPC extension.

Martijn de Lange (Netherlands Patent Office) has compiled information on the opinions from the EMA site with information on the status of corresponding Dutch SPCs, if any, from the Dutch Patents Registry and kindly shares it with us below.

2008: 5 positive opinions issued

1. Caspofungin

EU market authorization for Cancidas from Merck Sharp & Dohme Inc.

Dutch SPC nr. 300076, basic patent EP 620232 to Merck Sharp & Dohme Corp.

Last day of protection: 2017.04.23

This includes the 6 months extension that was granted

2. Ribavirin

EU market authorization for Rebetol from Schering-Plough Europe

SPC application nr.300083 based on EP 643970 to ICN Pharmaceuticals rejected in 2004

3. Peginterferon alfa-2b

(based on EMEA-000384-PIP01-08)

EU market authorization for ViraferonPeg from Schering-Plough Europe

Dutch SPC nr. 300127, basic patent EP 809996 to F. Hoffmann-La Roche AG

Last day of protection: 2017.06.19

SPC extension not yet requested

4. Peginterferon alfa-2b

(based on EMEA-000071-PIP01-07)

EU market authorization for PegIntron/ViraferonPeg from Schering-Plough Europe

Dutch SPC nr. 300127, basic patent EP 809996 to F. Hoffmann-La Roche AG

Last day of protection: 2017.06.19

SPC extension not yet requested

5. Zoledronic acid

EU market authorization for Zometa from Novartis Europharm Limited

Dutch SPC nr. 300058, basic patent EP 275821 to Novartis AG

Last day of protection: 2013.05.15

This includes the 6 months extension that was granted

Dutch SPC nr. 300059, basic patent EP 258618 to Roche Diagnostics GmbH

Last day of protection: 2012.07.24

SPC extension not yet requested

2009: 8 positive opinions issued

6. Losartan

National market authorization for Cozaar from Merck Sharp & Dohme Inc.

Dutch SPC nr. 950009, basic patent EP 253310 to E.I. du Pont de Nemours and Company

Last day of protection: 2010.03.01

This includes the 6 months extension that was granted

7.Anastrozole

National market authorization for Arimidex from AstraZeneca AB

Dutch SPC nr. 970012, basic patent EP 296749 to AstraZeneca UK Limited

Last day of protection: 2011.02.10

This includes the 6 months extension that was granted

8.Abatacept

EU market authorization for Orencia from Bristol-Myers Squibb Pharma

Dutch SPC nr.300303, basic patent EP 606217 to Bristol-Myers Squibb Company

Last day of protection: 2017.12.15

This includes the 6 months extension that was granted

9.Colesevelam

EU market authorization for Foster/Kantos/Inuvair from Genzyme Europe

Dutch SPC nr. 300159, basic patent EP 764174 to Genzyme Corp.

SPC extension not yet requested

10. Valsartan

National market authorization for Diovan from Novartis Europharm Limited

Dutch SPC nr. 970001, basic patent EP 443983 to Novartis AG

Last day of protection: 2011.05.12

Request for SPC extension currently (30.09.10) pending

11. Purified diphtheria toxoid / Purified tetanus toxoid / Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)] / Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett) / Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)

EU market authorization for Pediacel from Sanofi Pasteur MSD

Dutch SPC nr.300443, basic patent EP 835663 to GlaxoSmithKline Biologicals S.A

Last day of protection: 2015.10.01

SPC extension not yet requested

SPC applications nrs. 300403 and 300404 based on EP 1666057 and 300185, 300187 and 300188 based on EP 747058 all to Medeva are currently pending in view of ECJ C-332/10

12. Leucine / potassium acetate / cysteine / glutamic acid / praline / alanine / glycine / histidine / isoleucine / magnesium acetate tetrahydrate / olive oil, refined / methionine/ ornithine hcl / phenylalanine / tryptophan / valine/ taurine / tyrosine / sodium chloride / arginine / calcium chloride dihydrate / aspartic acid / serine / threonine / sodium glycerophosphate, hydrated / soya-bean oil, refined / lysine monohydrate / glucose monohydrate

Market authorization for ? from Baxter World Trade SA/NV

No Dutch SPC

13. Atorvastatin

National market authorization for Sortis, Lipitor, Tahor, Xarator, Zarator, Liprimar, Totalip, Torvast, Cardyl from Pfizer

Dutch SPC nr. 970034, basic patent EP 247633 to Warner-Lambert Company

Last day of protection: 2011.11.06

SPC extension not yet requested

2010: 7 positive opinions issued

14. Montelukast

National market authorization for Singulair from Merck Sharp & Dohme Ltd.

Dutch SPC nr. 990009, basic patent EP 480717 to Merck Frosst Canada Ltd.

Last day of protection: 2012.08.24

SPC extension not yet requested

15. Latanoprost

National market authorization for Xalatan from Pfizer Global Research & Development

Dutch SPC nr. 970039, basic patent EP 364417 to Pharmacia Aktiebolag

Last day of protection: 2011.07.17

SPC extension not yet requested

16. Human papillomavirus1 Type 6 L1 protein / human papillomavirus1 Type 11 L1 protein / human papillomavirus1 Type 16 L1 protein / human papillomavirus1 Type 18 L1 protein

EU market authorization for Gardasil from Sanofi Pasteur MSD

Dutch SPC nr. 300318, basic patent EP 647140 to Georgetown University

Last day of protection: 2018.06.23

Dutch SPC nr. 300264, basic patent EP 1015561 to Medimmune

Last day of protection: 2021.09.19

Dutch SPC nr. 300269, basic patent EP 1165126 to Merck & Co

Last day of protection: 2021.09.19

In all three cases SPC extension not yet requested

17. Nomegestrol acetate / 17 beta-estradiol

Market authorization for ? from Organon N.V.

No Dutch SPC

18. Esomeprazole

National market authorization for Nexium from AstraZeneca AB

Dutch SPC nr. 300027, basic patent EP 124495 to Aktiebolaget Hässle

Last day of protection: 2009.02.27

So SPC expired before extension could be filed

19. Midazolam

Market authorization for ? from ViroPharma SPRL

Dutch SPC application nr. 980040 based on NL 193145 withdrawn in 1999

20. Nevirapine

EU market authorization for Viramune from Boehringer Ingelheim International GmbH

Dutch SPC nr. 990022, basic patent EP 429987 to Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim Pharma GmbH

Last day of protection: 2012.12.22

SPC extension not yet requested

Thanks Martijn!

New UK Office Manual changes affect SPCs

A number of changes have just been incorporated into the October 2010 version of the UK Intellectual Property Office's Manual of Patent Practice. Among other changes, SPC sections SPM3.02.1, SPM3.02.3 have been amended in light of Yeda Research and Development Company Ltd v Comptroller General of Patents and the Court of Justice reference in Medeva's SPC Applications and Georgetown University, Loyola University of Chicago, and University of Rochester’s SPC Applications.

You can read the current version of the SPC section here. A line in the left-hand margin highlights text which you won't find in the earlier January 2010 version.

Even more about HPV vaccines and SPCs

Just in case you're not immune to issues around SPCs for HPV vaccines, here's the latest juicy case (BL O/335/10) that was decided before the UK Intellectual Property Office (IPO):

The University of Queensland and CSL Limited filed 8 SPC applications at the IPO: 6 different applications to single Human Papilloma Virus (HPV) L1 protein virus-like particles (VLPs) (2 applications for HPV 16, 2 applications for HPV 18, 1 application for HPV11 and 1 application for HPV6), 1 application for a product comprising HPV16 and HPV18 L1 protein LPV, and 1 application for a product comprising HPV6, HPV11, HPV16 and HPV18 L1 protein LPVs. The applications were based on basic patents EP 0595935, EP 1298211 and EP 1359156. The marketing authorisations for Cervarix and Gardasil/Silgard were used to support the applications.

The issues raised here are similar to those in the Medeva and Georgetown et al. cases and concern the interpretation of Articles 3(a) and 3(b) of the Regulation. The IPO therefore proposed to defer further consideration of the applications until the outcome of the references to the Court of Justice of the European Union (CJEU) in relation to the Medeva and Georgetown cases. The applicant however requested a decision to be issued based on the papers on file so that, if the IPO were to refuse the applications, the decision could be appealed and a further referral to the CJEU could be made and considered at the same time as the other HPV-related cases.

The hearing officer, Dr. L. Cullen, found that the 6 SPC applications directed to single HPV L1 protein VLPs did not meet the requirement of Article 3(b) of the Regulation because neither of the MAs cited was a valid authorisation to place any of the single HPV L1 protein VLP products on the market as a medicinal product. Each MA related to a combination of active ingredients rather than a single active ingredient.

Moreover, the HPV combination applications did not meet the requirement of Article 3(a) of the Regulation because the basic patents did not protect combination HPV L1 protein VLP products, but only related a method for preparing single HPV L1 protein VLPs, HPV L1 protein VLPs made by this method and vaccines prepared from HPV L1 protein VLPs made by this method. Nothing in the patents suggested that the single HPV products could be used in combination with each other.

The applications were rejected in accordance with Article 10(4) after the application was provided with an opportunity to correct the irregularities of the application.

The complete decision is available here.

Circadin appeal now published in the RPC

Back in May The SPC Blog reported briefly that Mr Justice Arnold (Patents Court, England and Wales) dismissed an appeal against the Intellectual Property Office's refusal to grant a supplementary protection certificate for Circadin.

The judge's decision has now been reported in full, together with a helpful headnote, in volume 127, issue 9, of the Reports of Patent, Design and Trade Mark Cases (RPC), published by Oxford University Press on behalf of the Intellectual Property Office.

Vaccines causing trouble once more....

Here we go again, another question on Article 3(b) referred to the CJEU, this time via Georgetown University (and others) - with yet another vaccine patent (referral here).

The question referred is the same as question 6 in the Medeva vaccine reference (reported here) on Article 3(b).

Specifically:

Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC which is the first marketing authorisation that places the single active ingredient or combination of active ingredients on the market?

Chastened that IPKAT posted this information before us, the SPC blog raises a weekend glass to that team!

SPC search in Denmark and Switzerland: a reader asks ...

One of our readers, head of IPM in an Indian pharma company, has written to ask for some advice:

"I want to know the I would like to know how to search the SPC details in Denmark and Switzerland. I have been trying for a long time but couldn't reach the right URL. Can you please help me in this regard?"

If anyone has some helpful hints, can he or she please post them as a comment below this blogpost?

New Swedish PRV search service includes SPCs

PRV, the Swedish Patent and Registration Office, has announced a new online service. The Swedish Patent Database is a free search service which covers Swedish patents. Requiring no login, the database covers not just Swedish patents and published patent applications but also European patents validated in Sweden, EP applications published under §88 of the Swedish Patents Act, granted EP patents whwhich designate Sweden (these are searchable in the database for six months from the EPO’s grant date), Supplementary Protection Certificates and their extensions.

The database, which is updated every night, offers access to searchable full text for all patent documents, as well as bibliographic data, information about classification, status, fees and registration, and links to File Inspection. The website adds:

"A Supplementary protection certificate search makes it possible to search through applications for supplementary protection certificate as well as granted SPC’s and extension of SPCs".

Court of Justice says "no" to Kirin Amgen, "yes" to Member States' transitional discretion

The Court of Justice handed down its ruling this morning in Case C‑66/09, Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biuras, Amgen Europe BV, a reference for a preliminary ruling from the Lietuvos Aukščiausiasis Teismas (Lithuania) dating back to 10 February 2009.

What was this about? In short, Kirin Amgen owned a 1994 European patent for Aranesp, which was extended to Lithuania. In June 2001 Kirin Amgen obtained a Community marketing authorisation and then lodged an application for an SPC with the Lietuvos Respublikos valstybinis patentų biuras (the Lithuanian Patent Office), accompanying the application with its Community marketing authorisation. The SPC having been refused initially and on several appeals, Kirin Amgen maintained that the fact that it held a Community marketing authorisation was sufficient to obtain an SPC in Lithuania: it did not exceed the six-month period for lodging its application, because that period had to be calculated from 1 May 2004, the date upon which the Republic of Lithuania acceded to the European Union. The Lietuvos Aukščiausiasis Teismas (Supreme Court of Lithuania) stayed the proceedings before it and asked the Court of Justice for a preliminary ruling on the following questions:

‘(1) Is the date, referred to in Article 19(2) of Regulation No 1768/92, upon which that regulation enters into force to be understood for [the Republic of] Lithuania as the date of its accession to the European Union?

(2) Should the answer to the first question be in the affirmative, what is the relationship between Article 19 and Article 7 of Regulation No 1768/92 when calculating the six-month period and which of those articles is it necessary to apply in a case?

(3) Did an authorisation to place a product on the market in the European Community enter into force unconditionally in the Republic of Lithuania from the date of its accession to the European Union?

(4) Should the answer to the third question be in the affirmative, can the entry into force of the authorisation to place the product on the market be equated to its grant for the purposes of Article 3(b) of Regulation No 1768/92?’

Today the Court ruled as follows:

"Articles 7 and 19a(e) of Council Regulation ... 1768/92 ..., as amended by the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic ..., must be interpreted as not allowing the holder of a valid basic patent in respect of a product to apply to the competent Lithuanian authorities, within six months of the date upon which the Republic of Lithuania acceded to the European Union, for the grant of a supplementary protection certificate where an authorisation to place that product on the market as a medicinal product was obtained more than six months before accession under Council Regulation ... 2309/93 ... laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, but the product did not obtain a marketing authorisation in Lithuania".

In its analysis of the legal position, the Court justified its position in the following terms:

"45 As regards the objective pursued by Regulation No 1768/92, it is admittedly true that the regulation establishes a uniform solution at European Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State and by providing, in particular, for a uniform duration of protection (see, by analogy, Case C-350/92 Spain v Council [1995] ECR I-1985, paragraph 34, and Hässle, paragraph 37). As is apparent from the sixth recital in its preamble, that regulation seeks thereby to prevent the heterogeneous development of national laws leading to disparities likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.

46 Nevertheless, certain Member States wished, in accordance with the 10th recital in the preamble to that regulation, to safeguard for a longer period the achievement of other legitimate objectives, concerning their public-health policies, and, in particular, ensure the financial stability of their health system by supporting the generic medicinal product manufacturing industry (see, to this effect, Hässle, paragraph 38).

47 In order to take account of those differences in assessment, Articles 19 and 19a of Regulation No 1768/92 contain different relevant dates as a transitional measure. The setting of those dates according to the Member State thus appears to be justified inasmuch as each of them shows the assessment made by each Member State in the light, in particular, of its health system, the organisation and financing of which vary from one Member State to the next (see, by analogy, Hässle, paragraphs 39 and 40).

48 It follows from the foregoing that the objective pursued by Regulation No 1768/92 of according uniform protection for a medicinal product throughout the European Union does not preclude transitional provisions, resulting from the accession negotiations, which may mean that it is not possible to apply for an SPC for certain medicinal products in certain Member States. This outcome, which may impede, even if only temporarily, that objective and the functioning of the internal market, is justified by the legitimate objectives concerning health policies, including, as the case may be, the financial stability of the health systems of the Member States (see, to this effect, Hässle, paragraph 46).

49 In the circumstances of the main proceedings, it would run counter to the outcome of the negotiations which led to the accession of the Republic of Lithuania to the European Union to accept that a holder of a Community marketing authorisation such as the holder in the main proceedings can rely on Article 7 of Regulation No 1768/92 to obtain an SPC in Lithuania. Article 19a(e) of that regulation provides for the possibility of applying to the competent Lithuanian authorities for grant of such an SPC only on the basis of a first marketing authorisation obtained in Lithuania before the accession of that State. As has been stated in paragraph 33 of the present judgment, that provision does not lay down any derogation concerning products which have been the subject of a Community marketing authorisation.

50 Furthermore, if the entry into force of a Community marketing authorisation in a new Member State could be equated to its grant there, every Community marketing authorisation would confer entitlement to the grant of an SPC if it were applied for within six months of the accession of such a Member State to the European Union, even if the date of grant of that marketing authorisation were prior to the dates for the obtaining of an authorisation that are referred to in the transitional provisions of Regulation No 1768/92. This would also run counter to the outcome of the accession negotiations.

51 To give an example concerning another Member State, it would be possible, if the grant of a marketing authorisation were equated to its entry into force, for the holder of a Community marketing authorisation obtained before 1 May 2004 to apply in the Czech Republic for an SPC until 30 November 2004, although Article 19a(a)(ii) of Regulation No 1768/92 provides for the lodging of such an application, so far as concerns that Member State, only within six months of the date on which the first marketing authorisation was obtained.

52 Consequently, the wording and the context of Articles 3(b), 7 and 19a(e) of Regulation No 1768/92 as well as the objective of the latter, and in particular the objective pursued by its transitional provisions, preclude the entry into force of the Community marketing authorisation from being equated to its grant within the meaning of Article 3(b)".