Patents: Patent Strategies for Biotechnology Enterprises - A patent is an asset that can improve competitive advantage and boost profits, yet many biotech firms miss opportunities to take full strateg

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Patents: Patent Strategies for Biotechnology Enterprises
A patent is an asset that can improve competitive advantage and boost profits, yet many biotech firms miss opportunities to take full strategic advantage of their patents.


BioPharm International
Volume 20, Issue 8


Wei Li
Patent protection in the biotechnology industry has received much public attention recently. The number of patent applications from the biotech industry has grown faster than the number of patent applications from other industries over the past several years.1 Biotechnology patents not only reward inventors for their inventions through market exclusivity, they also can stimulate research and the flow of scientific and technological knowledge on a global basis. Moreover, biotechnology patents encourage companies to invest in developing new drugs, therapies, and equipment; this development often takes many years and is a very expensive and risky process.


Xiang Yu
As in other technology-based industries, a biotech patent must be regarded as a strategic asset aimed at improving the competitive advantages and earning capacity of a company. However, although growing numbers of business owners are becoming more concerned about their patent rights and those of their competitors, a substantial number of businesses are not taking full strategic advantage of their patent assets to establish competitive advantage and increase profits. For many biotech companies, developing a patent strategy is an important component of the business plan. It is the bridge that links the power of patents to the objectives of business. An ideal patent strategy would provide the broadest and strongest protection for core technology and commercial applications.

PATENT APPLICATION STRATEGY: ERECTING A RING FENCE




For many biotechnology companies, before filing a patent application for an invention, the initial strategy is to carefully assess and evaluate the current state of the intellectual property owned or licensed by the enterprise.2 A biotechnology enterprise need not file a huge number of patent applications when attempting to cover a commercially important technology, although such a strategy may be effective if the company can afford it. For example, any enterprise that wants to challenge Affymetrix in the gene-chip business will need to get legal opinions on Affymetrix's 200 patents—at considerable expense.


Quick Recap
An alternative to filing a huge number of patent applications, and an equally effective strategy, can involve creating a set of claims with sufficient complexity to make it difficult for an outside enterprise to use a single argument to challenge all of the claims. If a patent challenger is forced to present a complex legal situation to a judge or jury, that challenger faces an uphill battle simply because, quite often, no one has the patience to think the situation through. Thus, patent portfolios should contain sets of claims to diverse aspects of an enterprise's technology, and these diverse sets of claims should contain variations on key terms or phrases.


Table 1. Amgen patent application strategy: Ring-fence the Epogen
The story of Amgen is a case in point. The key to Amgen's strategy is that it has always kept an Epogen (EPO) patent application filing alive in the US Patent and Trademark Office (USPTO), thus permitting it to make new claims, even today. Amgen's patent portfolio involves only five US patents, all of which originate from the same patent application; Amgen has used its original priority date to obtain a series of five patents, each of which protects a different aspect of its EPO technology (Table 1). Amgen's EPO patent is now 24 years old, and when a competitor enters the EPO marketplace, Amgen has the opportunity to analyze the product and file new patent claim language to block its commercialization. Amgen has filed lawsuits using at least five different sets of overlapping claims covering the recombinant EPO polypeptide, cells producing recombinant EPO, and processes for preparing recombinant EPO. These patents also contained claims to therapeutic treatment of diseases using EPO.3


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