Original preparation

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An original preparation is an approved drug that enables a certain drug to be used for therapeutic purposes on humans or animals for the first time. All dosage forms of the active ingredient are counted among the original preparations .

description

The development and marketing of original drugs is the basis of the business model of the research-based pharmaceutical industry . The business model is based on the limited-time exclusivity of the rights of use granted by patent protection . After the protection period has expired, other pharmaceutical companies can bring drugs with identical active ingredients ( generics ) onto the market.

In addition to new types of active ingredients that can represent significant advances in medicine, numerous analog preparations , including me-too preparations, are developed and sold as original preparations , as they can obtain independent patent protection due to a modified molecular structure compared to existing active ingredients. However, the changes in the molecular structure do not necessarily result in an advantage for the drug user.

Property rights

Patent protection

In most countries, the maximum protection period for a patent is 20 years, starting from the date of filing the application. Newly developed drugs are initially mostly protected by product patents or substance patents. During the protection period, the medicinal substance may only be manufactured, distributed and used with the consent of the patent holder.

In addition, application and process patents allow longer protection of original preparations. So z. B. the most economical way to manufacture a certain drug, be relocated a long time after the substance patent expires. Application patents, on the other hand, protect against the marketing of generic drugs for specific therapeutic or diagnostic purposes. An application patent only restricts the marketing possibilities of the manufacturer of a generic, but not the prescription by a doctor or use by a patient.

Substance patents for pharmaceuticals can be extended because the economic use of such patents is often limited by the long development time: often ten years or more pass before a patented substance becomes a component of an approved pharmaceutical. In the European Union (EU), Switzerland and Liechtenstein there is the possibility of obtaining a supplementary protection certificate for a product covered by a patent if more than five years have passed between patent application and approval.

As an economic incentive for the development of a medicinal substance for use in diseases of children and adolescents, the term of protection for such a product can be extended by a further six months. If a manufacturer a drug for orphan develop could take a two-year extension of the protection period.

Protection of the approval documents

Regardless of the length of the patent term, the knowledge of the original manufacturer (e.g. study results) gathered in the course of development is protected in the EU for ten years from the date of approval of a novel medicinal substance. Only after this period has expired, which can be extended to 11 years under certain circumstances, the authorities can issue authorizations for generics.

economic aspects

The temporary unique position for original preparations often leads to high prices for new drugs. They often only decrease towards the end of the patent term and thus immediately before the generic competition enters the market. The manufacturers of generic drugs have much lower development costs than the manufacturers of original drugs. With the entry of the generics on the market, the market share of the original preparation can decline very sharply within a short period of time. After the patent expiry of the active ingredient finasteride , the market share of the original preparation Proscar fell to 80 percent one month after the market launch of the first generic in April 2007, after three months to 50 percent and after twelve months to 20 percent.

Examples of original preparations

The drug aspirin , with the active ingredient acetylsalicylic acid (ASA), was brought onto the market by Bayer AG as an original preparation at the beginning of the 20th century . A large number of generic drugs containing the active ingredient ASA were brought onto the market by other manufacturers with different trade names or with direct reference to the active ingredient name after the Bayer AG's protection rights were lost. In the English-speaking world, the trademark aspirin is now used synonymously for the active ingredient itself.

The patent for the active ingredient Sildenafil (original product Viagra ) from Pfizer expired in 2013. Until then, only Pfizer was allowed to sell sildenafil as an active ingredient or to issue licenses to other companies. All pharmaceuticals on the market at the time that contained sildenafil and did not come from Pfizer were illegal in countries with existing patent protection, even if their manufacture was supposed to have taken place in countries without patent protection.

Individual evidence

  1. ↑ a b M. Huber and GA Kullak-Ublick: Generics - what should you watch out for when converting? (PDF file; 157 kB) In: TMJ 3, 2008, pp. 23–26.
  2. ↑ T. Drabinski et al. a .: Price formation of drugs in international comparison. Verlag Springer, 2008, ISBN 3-540-79887-0 , p. 117. Restricted preview in the Google book search
  3. ↑ The direct individual preparation of drugs in pharmacies on the basis of a doctor's prescription is mostly permitted and limits the effect of the patent; see §11 PatG-DE, No. 2.
  4. ↑ see PatG-CH Art. 140 a to m.
  5. ↑ Liechtenstein is an EEA member and the possibility of obtaining property rights certificates is subject to EEA first authorizations, which, however, raises the question of the relevance of the first authorization (also for Liechtenstein) by Swissmedic due to the customs treaty with Switzerland; The ECJ C-207/03 and C-252/03 gave its answer to this, whereupon, through an additional agreement between Switzerland and Liechtenstein, Swissmedic authorizations usually only take effect after one year in Liechtenstein.
  6. ^ A b Dagmar Fischer, Jörg Breitenbach (ed.): The pharmaceutical industry: insight, perspective, perspectives. Springer, Heidelberg 2009, ISBN 978-3-827-42129-6 limited preview in the Google book search.
  7. ↑ Directive 2001/83 / EC (Community Code on Medicinal Products for Human Use) , Article 10.
  8. ↑ Original manufacturers assert themselves in the competition with biosimilars. Bionity.com, dated April 30, 2009.

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