For both medical devices and pharmaceuticals ('health products'), for small and medium size companies (SMEs), a Defensive IP portfolio should have an array of IP protection, which can include utility patents, design patents, utility models, trademarks and trade secrets. The defensive IP portfolio is the SME's most effective tool for securing its business plane, since it can prevent competitors from penetrating its market niche by, for example, turning a competitor's use of the SME's technology into unlawful infringement of the technology, and by forcefully intercepting the competitor's marketing efforts. In other words, a defensive IP portfolio inwardly secures a health products SME's own business plane and its technological territory.
An offensive IP portfolio, on the other hand, outwardly targets the competitor's business planes, by preventing present and future commercial activity by both the SME's competitors and their strategic partners. A combination of defensive and offensive IP portfolios can catalyze R&D collaborations and fruitful commercial interactions between the SME and its business environment. Therefore, a combined portfolio including both offensive and defensive IP should be employed, especially in med-tech innovating territories such as USA, Germany, and Israel. In the lecture, medical device-originated and pharma-based case studies will be discussed and a handy list of "to do" hints will be shown.
In health products, an SME's business plans are strongly affected by, and can be determined by, CE and FDA regulation. The relationship between CE/FDA regulation and defensive and offensive IP portfolios will be further elaborated and underlined.
Eyal Bressler, Dr. Eyal Bressler & Associates, Patent Attorneys