Generics in the Animal Health Industry: Threats and opportunities will provide
essential business information for managers in R&D-focused and generic companies
on patent and product registration law, marketing, new product development and
market dynamics. The report features:
An analysis of patent and product registration laws, allowing you to understand
the mechanics of patent law and the range of registration procedures in all the
major markets
An analysis of the market for generic animal health products by region and product
group, allowing you to identify the regions and sectors where generics are already
dominant, and where the growth will be achieved over the next decade
A review of the generic product issues facing animal health companies in the
US and the major EU markets, including the importance of parallel imports, distribution
routes and labelling requirements
A guide to the strategies used by R&D-based companies to defend off-patent
products
A review of how generics companies are improving the image of their industry
and using new product development and marketing strategies to compete with their
R&D-focused rivals
Ten case studies, discussing the techniques used by R&D-based companies to
defend their off-patent products; and the strategies used by generics companies
to improve their market share.
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Contents:
Chapter 1 Generics in the Animal Health Industry
Chapter 2 Patent Issues
Chapter 3 Registering a Generic Animal Health Product
Chapter 4 The World Market for Generic Animal Health Products
Chapter 5 Strategies for R&D-Based Companies
Chapter 6 Strategies for Generics Companies
Chapter 7 Case Studies
Chapter 8 Future Trends in the Animal Health Generics Industry
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This report defines generics in the animal health industry context as 'veterinary
products that have come off-patent, and can therefore be manufactured and marketed
by second parties'. The original developer of a product retains the brand name
rights, while generics manufacturers market their versions under new brand or
non-proprietary scientific names.
The most obvious legal mechanism involving generics - besides their registration
as medicinal products - is patent law. The viability of the pharmaceutical industry
as a whole is governed by the protection of its intellectual property. Without
this protection the industry as such would hardly progress. A patent for an invention
is granted by the government of the country where it has been applied for. It
gives the inventor the right for a pre-determined period to stop others from making,
using or selling the invention without the permission of the inventor. The scope
of protection provided by a patent is defined in the application at the time the
claims are made. The date on which the application is filed sets the time at which
the patent commences. International organisations such as the World Intellectual
Property Organisation, (WIPO), have campaigned for all countries to adopt a standard
patent protection period of 20 years in the effort to harmonise the patenting
procedures over the world and to create a global patent policy.
Over recent years, the patented life of pharmaceutical products has been eroded
by increased regulatory demands. In recognition of this, various countries have
introduced legislations that offer extended protection to certain products. In
the EU, the Supplementary Protection Certificate was introduced, allowing up to
five years of additional marketing exclusivity for the patent holder. In the US,
the so-called Hatch-Waxman legislation was introduced in 1984, enabling drug patents
to be extended by up to five years, if there had been delays during the review
phase of the patenting process. Japan followed the same route as the US, allowing
patent extension by up to five years, providing that obtaining approval was delayed
by at least two years.
The generic share of animal health sales in 2002 was estimated at 40% - ie $5.3
billion - of the total global sales of animal health products. Generic animal
health products are very prevalent in the developing regions of the world, such
as certain Latin American, African and Asian countries. In these regions, they
hold market shares of approximately 60%. Compared with that, generic products
in the developed regions, such as North America and the EU, only have a share
of below 30%.
This report reviews the structure of the generic animal health market and the
supplying industry. It then analyses the strategies that are available to R&D-based
companies and generics companies to defend and develop their market shares. For
the former these include defending the patent through extending the family of
patents or patenting related compounds; and developing the brand through marketing
and promotion, adding value to the product or price reductions. Generic companies
often compete largely on price but they can also focus on niche markets, develop
added-value bands, or compete on improved after-sales service or more efficient
distribution. The report features ten case studies that illustrate how both R&D-based
and generics companies have responded to changes in the marketplace as more animal
health products come off-patent.
The report concludes by predicting how the generic animal health industry will
develop over the next decade, as generics take an ever-greater share of the world
animal health market, companies in emerging markets challenge those in the west,
and distinctions blur between R&D-based on generic animal health companies.
