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
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.
Aug 1, 2007 By:
Wei Li, Xiang Yu BioPharm International
Volume 20,
Issue 8
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
