FDA Lawyers Blog

Charles Raubicheck, head of our firm's FDA practice, will chair a panel and deliver an address at the "U.S. & Brazil Conference: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation," to be held on September 10-11, 2012 in Sao Paolo, Brazil.

The conference, sponsored by The Food and Drug Law Institute ("FDLI"), will bring together representatives of companies, venture capital firms, government agencies, law firms and other groups involved in the drug, device and food industries. They will engage in high-level discussions about respective commercial, trade, legal and other aspects of doing business in this country and Brazil, the world's 6th largest economy.

Mr. Raubicheck's panel will focus on the interplay between regulatory and intellectual property issues pertinent to pharmaceuticals. His presentation is entitled "NDAs, ANDAs, FDA's Orange Book, and Patent Term Extensions."

by Brian Malkin

On January 23, The Wall Street Journal published a debate whether innovation would be sparked in the pharmaceutical industry by a further form of patent term extension. While it is clear that patent protection is key for innovators to protect their blockbuster products from generic competition, it is not so clear whether extending patent protection for this class of products drives or hinders innovation.

Josh Bloom, Director of Chemical and Pharmaceutical Sciences at the American Council on Science and Health, a health-care education and advocacy group based in New York, took the position that the pharmaceutical industry needs more and longer patent term protection to help support basic research and development that produces needed breakthrough products. According to Bloom, there are "far fewer" scientists engaged in pharmaceutical research than there were 10 years ago, in part because longer development times have translated to less time left on patents following new product approvals. Bloom describes this as an approaching "financial crisis" or "patent cliff" where a series of patents will soon expire for some of the most profitable innovator drugs, translating to lost profits on branded products approaching an estimated $160 billion in 2015.

Unlike the "steady stream of blockbuster drugs" in the 1990s, Bloom observes, newer products that treat more complicated diseases have required more clinical studies with more subjects, adding costs and extending development times. Extending the patents on current blockbusters would postpone the patent cliff and provide additional research time for more innovative products, Bloom speculates. Generic drugs, Bloom says, "contribute nothing to innovation. . . . [y]et they take up to 90% of sales away from the comparable brand-name drugs." But Bloom wants to discourage pharmaceutical companies from merely developing line extensions for current therapies and would propose that new products receive five year extensions, whereas patents for line extensions would only receive three years of extension.

by Howard E. Rosenberg, Ph.D.

Three more Supplementary Protection Certificate ("SPC") cases were decided by the Court of Justice of the European Union ("CJEU") recently underlining and further enhancing the decisions in the two cases Georgetown and Medeva, which we previously reported on here.

In Case C 630/10, the University of Queensland owned three patents but had been unable to get any SPCs at the United Kingdom's Patent Office. The UK Patent Office rejected all the SPC applications submitted, either because: (1) the combination of active ingredients in question were not claimed in the patents concerned or (2) the Marketing Authorizations ("MAs") provided in support of the SPC applications related to medicinal products containing other active ingredients that were not claimed in any of those patents, even though the applications related to individual active ingredients that were claimed in the patents concerned. The patents related to methods of production of papillomavirus-like particles ("VLPs") of the Human papillomavirus ("HPV") Type 6 ("HPV 6") and Type 11 ("HPV 11"), the VLPs per se and vaccines produced from or comprising VLPs.

As in Medeva, the first set of questions were answered by first restating that Article 3(a) of the regulation precludes the grant of an SPC relating to active ingredients that are not specified in the wording of the claims of the basic patent (Medeva, paragraph 25). Next, the CJEU stated that Article 3(a) of Regulation No. 469/2009 must be interpreted to preclude the competent industrial property office of a Member State from granting a SPC relating to active ingredients that are not identified in the wording of the claims of the basic patent relied on in support of the SPC application.

by Howard E. Rosenberg, Ph.D.

These cases concerned attempts at obtaining Supplementary Protection Certificates ("SPCs") for multi-component vaccines. Health Authorities prefer to administer several vaccines combined rather than to have them administered separately. The Medeva case (C-322/10) involved a vaccine comprising multiple active ingredients of which only two were the subject of a combination patent. As a consequence an SPC for this multi-component vaccine was refused, because the patent did not claim the additional active ingredients. SPC protection for a combination of the two active ingredients of the multi-component vaccine that were claimed in the patent was also refused in the United Kingdom, because the marketing authorization ("MA") was granted not for a medicinal product containing the combination of these two active ingredients only, but for the multi-component vaccine comprising other active ingredients.

The Georgetown case (C-422/10), was similar but had only one active ingredient, i.e., the basic patent claims an antigen of a vaccine, whereas the marketing authorization is for a multi-antigen vaccine, including additional antigens beyond the claimed ones. The cases were combined initially at the Court of Justice of the European Union ("CJEU") and were joined for the purposes of the oral procedure and the judgment, but the court decided that in view of the factual differences between the situations at issue in the main proceedings the cases were disjoined for the purposes of the judgment. In both cases the court felt that for a "product" covered, as a medicinal product by a MA, the essence of the SPC Regulation did not in itself rule out the possibility that the MA may cover other active ingredients contained in such a medicinal product and that in accordance with Article 4 of Regulation an SPC was intended to protect the "product" covered by the MA, not the medicinal product as such.

Thus the court's decision: Article 3(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the SPC for medicinal products must be interpreted as meaning that, provided the other requirements laid down in Article 3 are also met, that provision does not preclude the competent industrial property office of a Member State from granting a SPC for an active ingredient specified in the wording of the claims of the basic patent relied on, where the medicinal product for which the marketing authorization is submitted in support of the SPC application contains not only that active ingredient but also other active ingredients.

by Howard E. Rosenberg, Ph.D.

Case C-195/09 Synthon v Merz Pharma
Case C‑427/09 Generics [UK] v Synaptech

On July 28, the Court of Justice of the European Union ("CJEU") handed down decisions on two cases. The first between Synthon and Merz concerning the medicinal product, memantine and a second similar issue concerning galantamine. The CJEU followed the Attorney General's opinions and decided that the Supplementary Protection Certificate ("SPC") for both memantine and galantamine were invalid.

Memantine had been on the market in Germany (and approved in Luxembourg) without going through the now currently accepted safety and efficacy testing as required by the European Union ("EU") Directive 65/65. However a new marketing authorization was submitted for a second medical use and approved. This new authorization contained the safety and efficacy data required by the Directive. Subsequently the original product was withdrawn, the new product launched and an SPC applied for based on this new authorization.

The High Court of Justice (England and Wales) had doubts as to both the scope of Regulation No 1768/92 and the definition of 'first authorisation to place ... on the market in the Community', within the meaning of Articles 13 and 19 of that regulation, and referred questions to the Court of Justice for a preliminary ruling:

(1) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], is an authorisation a "first authorisation to place ... on the market in the Community" if it is granted in pursuance of a national law which is compliant with [Directive 65/65], or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that directive?

(2) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], does the expression "first authorisation to place ... on the market in the Community" include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with [Directive 65/65]?

(3) Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in [Directive 65/65] within the scope of [Regulation No 1768/92] as defined by Article 2?

(4) If not, is an SPC granted in respect of such a product invalid?

by Howard E. Rosenberg, Ph.D.

Guidance has now been provided by the Court of Justice of the European Union ("CJEU") on the first of the two European Supplementary Protection Certificates ("SPC") issues, which we discussed here.

Advocate General Mengozzi delivered his Opinion on the two closely related cases concerning the scope of Article 2 of Council Regulation (EC) No 1768/92 (the "SPC Regulation") and the types of marketing authorization, which could be considered to be "the first authorisation to place the product on the market in the Community" for the purposes of the SPC Regulation.
The opinions concerning memantine (C-195/09) and galantamine (Case C-427/09) can be found by inserting the case number here.

Both drugs had been marketed for many years in one or more member states prior to the later filing of dossiers, which included the full regulatory details and studies that are required under the European Economic Community Directive 65/65/EEC. Galantamine had been on sale in Europe as a medicine for more than 40 years. There were national marketing authorizations as Nivalin® in Austria (1960s) and West Germany (1978). Nivalin® continued to be marketed until its license was withdrawn once the 65/65/EEC compliant registration for Reminyl® was approved. Memantine was on the market in Germany before September 1976 (Akatinol®) and also authorized in Luxembourg. These licences were withdrawn, also, once a 65/65/EEC compliant registration for Ebixa® was obtained.

FLH's Scientific Advisor Howard E. Rosenberg, Ph.D will present on "Recent developments on SPCs" covering "The medicinal product - Review of relevant case law" at the 7th European Generic Medicines Association ("EGA") Legal Affairs Forum in Brussels, Belgium. Subtopics include "The medicinal product defined", "Where/when is the first MA (Marketing Authorisation) - problems with EU (European Union) enlargement", and "Combination products / Vaccines and adjuvants". The Forum will be held at the Renaissance Brussels Hotel. Event details may be found here.

by Howard E. Rosenberg, Ph.D.

Last October the Italian Antitrust Authority ("Italy") commenced a procedure against Pfizer Italia Srl and Pfizer Health AB ("Pfizer Italy") for abuse of Pfizer Italy's dominant position with respect to the drug Xalatan® (latanoprost). Pfizer Italia Srl and Pfizer Health AB, are the holders of the Italian marketing authorizations ("MAs") on the product.

Italy was concerned that Pfizer Italy had pursued strategies to artificially prolong a patent for the purpose of preventing or delaying the entry into the market of generic versions of Xalatan®. This procedure was following a complaint filed by Ratiopharm, which seems understandable in light of the recent Enquiry on the Pharmaceutical Sector concluded in 2009 by the European Commission ("EC"). The procedure should be completed on October 15, 2011.

According to the submitted documentation, Pfizer Italy requested and obtained an extension of its patent, by filing an application for a divisional patent, which was followed by an application for a supplementary protection certificate ('SPC") aimed at extending patent protection up to 2011. The divisional patent for which the SPC was granted, however, was recently revoked by the European Patent Office ("EPO") in Munich.

Italy recently announced that it has extended the investigations to Pfizer Inc. ("Pfizer U.S.") based on the information it had collected from Pfizer Italy. Apparently, Italy found documentation "showing that the initiatives relating to the application for divisional patent EP '168 at the EPO in 2002 and the SPC application at the Italian Patent and Trademark Office in 2009, aimed at realigning the expiry of the rights in Italy with the expiry of the rights in the other European countries (from September 2009 to July 2011), were centrally coordinated and managed by the US company Pfizer Inc., either directly or through other European subsidiaries". Hence Pfizer U.S. is also now a party to the proceedings and will need to furnish all requested information to Italy and, presumably, will be subject to the decision made by the Italian Antitrust Authority.

FLH's Scientific Advisor Howard E. Rosenberg, Ph.D. will present on "International IP Developments" covering subtopics "Topical IP (intellectual property) cases", "EU (European Union), patents and SPCs" and "Review of other jurisdictions around the world" at the World Generics Medicines Congress Europe 2011 in London, United Kingdom. The Congress will be held at The Hilton London Paddington. Event details may be found here.

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will speak on a key topic essential to patent life cycle longevity--patent term extension on January 27. Mr. Malkin will provide insight that he learned while running FDA's patent term extension program during a greater part of the 1990s. The program is designed to offer practical solutions and in-depth instruction for attorneys servicing the pharmaceutical, biotechnology, and medical device industries to help optimize the length of their patents.

ACI is pleased to offer a discount of $200 to FDA Lawyers Blog readers. Please visit here for further details. For a copy of the conference brochure, see here.

ACI Patent Term Adjustment and Patent Term Extension Conference 2011

ACI, the creator of Maximizing Pharmaceutical Patent Life Cycles and Paragraph IV Disputes (April 2011) is pleased to present its inaugural advanced forum on the "ins and outs" of Patent Term Adjustment and Patent Term Extensions.

We have surveyed our life sciences audience and heard their overwhelming requests for a conference on these very complicated and challenging applications. In response, we have assembled a faculty of the most experienced patent professionals who will show you how to navigate these processes - step-by-step. They will help you:

• MASTER the essentials of PTA from questions of eligibility, calculation, application preparation and redress
• DECIPHER the mysteries of A, B and C-delays
• LEARN to solve the A and B-delay overlap dilemma and B-delay National Stage queries vis-à-vis Wyeth v. Dudas and Japan Tobacco
• AVOID applicant delays and circumvent "failure to engage" findings by the PTO
• NAVIGATE the complexities of PTE in terms of substance and procedure
• COMPREHEND how the key challenges in Wyeth Holdings, Photcure, Lupin and Angiomax will affect PTE determinations in the future
• APPRECIATE how second generation patents and regulatory exclusivities factor into patent term extensions
• EXAMINE the significance of Supplemental Protection Certificates (SPCs) in patent term restoration in the EU

Come to this conference and learn everything that you wanted to know about PTA and PTE and more.

ACI is pleased to offer a discount of $200 to FDA Lawyers Blog readers. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or logging on to here.

by Howard E. Rosenberg, Ph.D.

This year, 2011, may provide some useful guidance (or even a decision or two) in a couple of key Court of Justice of the European Union ("CJEU") cases regarding European Supplementary Protection Certificates (SPCs)--Europe's version of patent term restoration in the U.S. One case concerns the type of marketing authorization that enable a product to qualify for an SPC and the other case is about the meaning of the term "product" being protected by a basic patent in force.

The first case is actually the combination of two cases (galantamine in Generics [UK] Ltd. v. Synaptech and memantine in Synthon v. Merz), where each drug was marketed for many years in one or more member states prior to the later filing of dossiers which included the full regulatory details and studies that are required by the European Economic Community Directive 65/65/EEC. These subsequent EU-wide authorizations were compliant with 65/65/EEC, and SPCs were obtained based on the new 65/65/EEC authorizations. The combined case before the CJEU raises questions to clarify what constitutes an acceptable marketing authorization (i.e., approval under a national law or only under 65/65) and/or whether products marketed for the first time in the EEC without going through the administrative procedure Directive 65/65 actually fall within the scope of SPC law at all.

The second case concerns the availability of SPCs for Medeva's multi-disease vaccines. The UK has generally rejected applications for SPCs where the applications have been based upon a marketing authorization for a product containing a combination of active ingredients, but where the basic patent has explicitly claimed only one of the components. Recently, the UK court has acknowledged that there may be some doubt as to whether the words "protected by a basic patent in force" in Article 3(a) of the SPC Regulation (EC 469/2009) requires a "direct protection" test (the active ingredients of the authorized product must be both disclosed and claimed in the basic patent) or just an "infringement" type test (does the patent claim at least one of the authorized products and thus a third party would infringe that claim).

The Medeva case, referred to the CJEU, specifically asks what is meant in Article 3(a) of the SPC Regulation by "the product is protected by a basic patent in force" and what criteria should be used in deciding it. It also includes an Article 3(b) question as to whether an SPC is available for an approved medicinal product containing a single active ingredient or combination of active ingredients together with one or more other active ingredients which is the first marketing authorization that places the single active ingredient or combination of active ingredients on the market.

If you are interested in SPCs or patent term extension in the U.S., FDA Lawyers Blog's own Brian J. Malkin will be speaking at an inaugural American Conference Institute event focusing on patent term adjustments, patent term extension, and SPCs later this month. For more information and an FDA Lawyers Blog reader discount, see here and here.

ACI Patent Term Adjustment and Patent Term Extension Conference 2011

ACI is pleased to announce its inaugural advanced forum on the "ins and outs" of Patent Term Adjustment and Patent Term Extensions. This conference will take place at the Downtown Conference Center in New York City on January 26-27, 2011. ACI has designed this conference on the "ins and outs" of Patent Term Adjustment and Patent Term Extensions to give you the winning edge on preventing drug patent losses related to these PTO and FDA procedures.

Brian J. Malkin will be on a panel with Mary Till from the PTO addressing the topic of Laying the Groundwork for Patent Term Restoration. The conference will help you:

• MASTER the essentials of PTA from questions of eligibility , calculation, application preparation and redress

• DECIPHER the mysteries of A, B and C-delays

• LEARN to solve the A and B-delay overlap dilemma and B-delay National Stage queries vis-à-vis Wyeth v. Dudas and Japan Tobacco

• AVOID applicant delays and circumvent "failure to engage" findings by the PTO

• NAVIGATE the complexities of PTE in terms of substance and procedure

• COMPREHEND how the key challenges in Wyeth Holdings, Photcure, Lupin and Angiomax will affect PTE determinations in the future

• APPRECIATE how second generation patents and regulatory exclusivities factor into patent term extensions

• EXAMINE the significance of Supplemental Protection Certificates (SPCs) in patent term restoration in the EU

ACI is pleased to offer a discount of $200 to FDA Lawyers Blog readers. Please visit here for further details.

FLH's Scientific Advisor Howard E. Rosenberg, Ph.D will present on Supplementary Protection Certificate (SPC) cases: Generics (UK) Ltd. v. Synaptech and Synthon v. Merz Pharma at the Royal Society of Chemistry Law Group, Seminar on Recent Chemistry Case Law - Patents. The Seminar will be held at the Royal Society of Chemistry, Burlington House, Picadilly, London. Event details may be found here.

by Howard E. Rosenberg, Ph.D.

The Italian Government, after having carried out a thorough revision of the current regulations, has amended the Italian IP Code ("IPC"). The new IPC was issued on August 13, 2010 and entered in force on September 2, 2010.

Italy's prior national Supplementary Protection Certificate ("SPC") law enacted before the European Union (EU) SPC law, included clause Art. 61(5) IPC. This clause provided that it "allowed" applicants to file a Marketing Authorization (MA) application, e.g., generic or hybrid applicaitons, up to one year before the expiry of the SPC--implying that an earlier filing would infringe the SPC and, by analogy, also the patent.

Recent case law in Italy had concluded, however, that the simple filing of a market authorization does not constitute evidence of an infringing activity (Court of Milan June 11, 2009, Eli Lilly v. Synthon and others). This decision complies with the Article 10(6) of the Directive 2004/27/EC of the EU.