A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Thursday 28 August 2008

A recent review of the scene in Europe -- and especially France

Alice de Pastors (Cabinet Alice de Pastors) has kindly prepared for this blog a shortened version of her firm's SPC-News 22 -- which was circulated in May of this year -- regarding medicinal SPCs in Europe. Alice writes:

* What is the situation in May 2008?

Supplementary Protection Certificates in Europe are governed
– in the 27 EU countries, Norway and Iceland by EEC Regulation 1768/92, amended by Regulation 1901/2006 of 12 December 2006 relating to medicinal products for paediatric use
– in Switzerland by National law of 3 February 1995.

* Medicinal Product SPCs in Europe from 1991 to 2007

About 10,925 SPC applications for medicinal products regulated by EEC Regulation 1768/92 or National laws were filed in European countries from January 1991 to December 2007, and published up to the end of March 2008. The graph below shows, for each country, the number of SPCs filed from 1991 to 2007, according to their status.

1991-2007 SPCs

M1 = SPC applications
M2 = granted SPCs in force
M3 = granted SPCs not yet in force
M4 = expired, lapsed, invalid SPCs
M5 = rejected or withdrawn SPC applications

The situation differs from one country to another due to the importance of the markets and/or to the applicable laws and/or to the date of entry in force of the EU Regulation:
– fewer than 20 SPCs in force in Bulgaria, Estonia, Lithuania, Malta, Poland, Romania, Slovakia, Czech Republic, Iceland, Slovenia, Hungary, Latvia, Cyprus
– fewer than 100 SPCs in force in Greece, Portugal, Spain, Norway, Finland, Ireland, Denmark
– fewer than 150 SPCs in force in The Netherlands, Germany, Austria, Luxembourg, Switzerland, Sweden, Belgium, UK
– more than 150 SPCs in force in France and Italy.
The graph below shows the number of SPCs filed from 1991 to 2007, according to ATC code (first level) of the products and to the SPC status.

* Medicinal Product SPCs in Europe in 2007

1,245 SPCs filed in 2007 were published at the end of March 2008. The graph below shows the number of SPCs for each country.

Medicinal Product SPCs filed in 2007

The EU SPC Regulation entered in force in Bulgaria and Romania on 1 January 2007. 87 SPCs were filed in 2007 and published in Romania and 23 SPCs in Bulgaria.

Which medicinal products?

The 1,245 SPCs filed in 2007 and published at the end of March 2008 cover about 170 different products (active ingredients, combinations of active ingredients, or formulations).

► Of these 1245 SPCs, about 38% relate to influenza or papillomavirus vaccines, 9% to glucose lowering agents, 6.6% to immunosuppressive agents and 6.3% to veterinary products.
► We noted 33 products, for which at least 10 SPCs were lodged.

Recent French decisions affecting SPCs

Decisions relating to Chiron EP0181150 and EP0318216 patents

Four decisions of Cour de cassation (3/04/2007)

These decisions confirmed the decisions of the Cour d'appel de Paris rejecting Chiron's appeal against the refusal by the French Patent Office of four SPC applications (01C0023, 01C0024, 01C0025, 01C0026) because these applications related to products neither used for treating or preventing disease, nor administered with a view to making a medical diagnosis but to test reactants for in vitro diagnosis.

Decision affecting Triflucan® drugs

Cour de cassation (3/04/2007)

In this decision the Cour de cassation set aside the Cour d'appel de Paris judgment of 12 October 2005 without ordering a new trial; the Cour de cassation considered that National SPC 92C0372 was invalid because the product had already been the subject of the certificate 92C0371.

Decisions affecting Fosamax® and/or Fosavance® drugs

Two decisions of TGI Paris relate to French SPC 96C0032 referring to French patent FR2525223:

TGI Paris (15/02/2008) MSD Somerset Ltd/Teva Classics, Teva Santé
TGI Paris (15/02/2008) Arrow Generiques, EG Labo, Ratiopharm / MSD Somerset Ltd
In these decisions the Court revoked, for lack of inventive step, the claims relating to pharmaceutical compositions suitable for the treatment of urolithiasis and inhibiting the bone reabsorption comprising a biphosphonic acid, and specifically 4-amino-1-hydroxybutan-1,1 biphosphonic acid. If these decisions are confirmed, SPC 960032 will no longer protect Fosamax® and/or Fosavance® drugs (these decisions are open to appeal).

Decision affecting aceclofenac

TGI Paris (22/02/2008) S.A. Laboratorios Almirall, S.A.S. Almirall/Merck Generiques, S.A.S. Qualimed, S.A.S. Pharm’Depo, Merck Farma y Quimica.

In this decision the Court revoked French SPC 98C0017, referring to EP0119332, due to the fact that the SPC was filed by a person other than the owner of the patent at the filing date. In fact Prodes filed SPC 98C0017 in 1998, but Prodes was no longer the owner after 25 January 1985, when the patent was transferred to Prodesfarma SA.

Tuesday 26 August 2008

Court invokes "fairness in the administration of the patent system" in rejecting late challenge to patent extension

We are grateful to Antony Taubman (WIPO) for drawing our attention to a decision of the Federal Court of Australia last week, Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1283.

In short, what happened here was that Lilly held a patent in Australia for difluro nucleoside antivirals. In 2000 Lilly sought and the Commissioner of Patents granted an extension of term for a period of five years ending in March 2009, based on the registrations in the Australian Register of Therapeutic Goods (ARTG) of the commercial product Gemcitabine hydrochloride, approved for use in the treatment of cancer of the lung and pancreas.

Interpharma objected that there was a disconformity between the product registered in the ARTG and that described in Lilly's patent specification. Accordingly Interpharma sought (i) to have the Commissioner's decision to extend the patent set aside and removed from the patent register, (ii) revocation of the patent itself and (iii) damages for false representation under the Trade Practices Act 1974. Lilly cross-claimed for infringement.

Sundberg J dismissed Interpharma's application in its entirety. The claim based on a false representation under the Trade Practices Act 1974 had to fail because that Act only applied in respect of statements made to those with whom one has, or may have, dealings in the course of commerce; this was not the relationship between Lilly and the Commissioner. Interpharma also failed to establish that it was a "person aggrieved" under the Administrative Decisions (Judicial review) Act 1977 with locus standi to challenge the Commissioner's decision since, on the facts, it was not in a position to make the patented product itself. Interpharma's application was also fatally delayed, even if allowance was made for the fact that the company was not incorporated until two years after the decision to extend the patent was taken. The judge concluded, at paragraphs 39 to 40:

"39 Another relevant matter in relation to delay is that the term of a patent is not of interest only to the patentee. As Lilly points out, it is effectively a right in rem, and of significance to all in the patent area who might be interested in trading within or near the subject matter of the patent. For this reason, the Commissioner must publish in the Official Journal a notice that an extension application has been made and is open to public inspection. If an application for extension is accepted, the Commissioner must publish a notice to that effect in the Official Journal. Provision is made for opposition proceedings. If the Commissioner grants an extension, a notice of the grant must be published in the Official Journal. ...

40 I agree with Lilly that once the opposition period has expired and an extension is granted, the patentee and third parties are prima facie entitled to proceed on the basis of the extension. Admittedly, one must take into account that the applicant was not incorporated until nearly two years after the extension. Nevertheless, the public interest to which I have referred is relevant notwithstanding that. As a matter of fairness in the administration of the patent system, it would be extraordinary if extensions could be challenged some eight years after grant. Even taking into account the applicant’s date of incorporation, it would still be extraordinary that a challenge could be made six years after that".

Monday 25 August 2008

Literature on SPCs: a Google search and other things

While looking for literature on SPCs I thought I'd take a look at the Google Scholar facility. Reputedly Google Scholar is much appreciated by students writing their dissertations and theses, since they can supplement their own slender knowledge of a subject with the fruits of patient research of others (hence the Google Scholar motto "Stand on the shoulders of giants").

Keying in the search term "supplementary protection certificate" I received 312 hits. I had not expected a large number but I had certainly thought that there would be more than this, especially since these hits would include writings that deal with the economic and industrial aspects of SPCs as well as the legal. However, it seems that the database of published research on SPCs is primarily legal, since the addition of the search word "law" only reduces the total hits to 252.

Google Scholar offers to search for research papers and articles published in other EU languages too: its lists French, Portuguese, German and Spanish. Be that as it may, the bias is strongly in favour of English-language materials: for example, a search for "Certificat Complementaire de Protection" retrieved only six hits.

The SPC Blog is hoping to build up a bibliography of useful articles, papers and other materials on SPCs, so that anyone working in the subject -- or approaching it for the first time -- will be able to get to grips with it more easily. If any readers have strong recommendations that they would like to share, can they please email me here and let me know.

Wednesday 20 August 2008

New Zealand mulls new patent law -- but there's no room for patent extensions

The Patents Bill 2008 is currently under consideration in New Zealand (you can read a short note here or the full text of the Bill, together with the New Zealand Government's explanatory notes, here). A notable omission is any provision relating to supplementary protection certificates for pharmaceutical or agrochemical substances.

Right: Does New Zealand prioritise the interests of the farmer over that of the pharma ...?

This omission may seem surprising to some when it is borne in mind that "neighbouring" Australia (if any country can be regarded as a neighbour in those parts), which shares much the same legal traditions and business culture, enacted patent extension provisions for pharmaceutical substances in s.70 of its Patents Act 1990. Since New Zealand patent law seems to be treated to a major overhaul about once every 50 or so years, this may be a good time for the innovatory side of the industry to do some lobbying.

Five years ago it was reported by NZ law firm Baldwin Son & Carey that "the Government Minister responsible ... says that the issue of extending the term of pharmaceutical patents will be investigated as part of the review of the Patents Act". Does any reader know what has happened since? Is there a matter of principle involved or is it felt that, since NZ has such a small domestic market, the availability of extension of the patent term for pharma substances is unlikely to play a major part in the investment decisions of pharmaceutical companies?

Thursday 14 August 2008

SPC legislation: past, present and future problems

In the recently-published issue of the Life Sciences Intellectual Property Review 2008 (LSIPR 2008), John Miles of Potter Clarkson LLP provides an overview of some resolved problems and also some unresolved issues regarding the interpretation of the SPC legislation.

Read the article here.
For the full contents of LSIPR 2008, click here.

Tuesday 12 August 2008

SPCs a "hot topic" for the BIA

The Annual BioScience Forum of the BioIndustry Association (BIA) takes place on 25 September 2008 in the lovely venue of One Great George Street, London SW1. According to the organisers this event
"combines a cutting-edge agenda with unrivalled networking opportunities. Parallel sessions will focus on

• Translational Medicine
• Intellectual Property Hot Topics
• Business Development Hot Topics
• Talent Management".
The SPC Blog understands that one of the "Intellectual Property Hot Topics" on the BIA's programme will be supplementary protection certificates, which is a good reason for readers of this blog to support this event.

STOP PRESS: Sophie Broster-James (BIA) has emailed to warn us that places at the Forum are limited and that early booking is recommended. You can read the details of the programme and book your place here.

Friday 8 August 2008

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.

Wednesday 6 August 2008

Concern about the future, but demand for extended term is far from unanimous

Via the Cambridge Network comes news of a survey carried out during April and May of this year for UK-based patent and trade mark attorneys Marks & Clerk. The survey, which underpins the findings of that firm's current annual biotechnology report, covered some 500 respondents in the biotech and pharma sectors in Europe, the US and Asia. It reveals (among many other things) that

* 72 per cent of respondents believe that future drug pipelines will become much harder to deliver unless the drug approval process is relaxed;

* extensions to the existing patent term are advocated by 73 per cent of respondents;

* 91 per cent consider the time it now takes for drugs to get through the system is eating into patent protection;

* 78 per cent believe the climate for enabling biotechnology innovation has deteriorated within the past year.

Factors identified as giving rise to concern are the growing caution of the US Food and Drug Administration in the granting of marketing approval for new drugs which, in turn, put added pressure on the patent life, and the likelihood that genuine innovation will take a back seat behind drug modification and late-stage development. In addition to the findings of the survey, the report also highlights key issues relating to IP law and policy. For a copy of the report email Jo Colton here.

One subject worthy of speculation and analysis is why the percentage of respondents who do not advocate an extension of the existing patent term stands at 27%. Is the divide between the pro- and anti-extension lobbies within the industry characterised by differences in national laws, industry sector, perceptions of the worth of new products in the corporate pipeline, job description ... or what?

Friday 1 August 2008

British court allows Gilead tenofovir appeal

Mr Justice Kitchen (Patents Court, England and Wales) gave his judgment yesterday in Gilead Sciences, Inc's appeal against the Comptroller's refusal of its tenofovir SPC application. The product in question was a combination therapy for HIV and the patent's claims were directed to a class of novel compounds, within which one of the compounds fell. That compound was also specifically disclosed and claimed. As well as compound claims, the patent had a claim directed to a pharmaceutical composition comprising the novel compound "together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients".

The Comptroller's refusal of the SPC application relied heavily on Takeda Chemical Industries Ltd's SPC Applications (No.3) [2004] RPC 1, [2003] EWHC 649 (Pat), where the Patents Court upheld a refusal of SPC applications on lansoprazole in combination with other named antibiotics. The judge held in Takeda that the patent did not protect the combination, but only the lansoprazole element of the combination.

The Comptroller in Gilead indicated that the specification of the patent should at least provide a clear pointer to the specific combination product. Kitchen J rejected this test, holding at para.33 that a clear test applicable to a product comprising a combination of active ingredients
"is to identify the active ingredients of the product which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent. It is those ingredients, and only those ingredients, which can be said to be protected within the meaning of the Regulation. So, in the case of a product consisting of a combination of ingredients A and B and a basic patent which claims A, it is only A which brings the combination within the scope of the monopoly. Hence it is A which is protected and not the combination of A and B. ... The product comprises two active ingredients... It falls within the scope of claims 1 and 25 only because of the presence of (one of those compounds). Hence, on the Takeda test, claims 1 and 25 do not protect the product within the meaning of the Regulation. However, claim 27 is directed to a composition comprising (the first compound) together with a carrier and optionally other active ingredients. The product falls within this claim too and it does so, in so far as the claim is directed to a combination, as result of the presence of both (compounds)."
The Comptroller has been granted leave to appeal.

Thanks to Helen Jones (Gill, Jennings & Every -- who acted the for appellant, instructing Charlotte May, 8 New Square) for supplying this information.