Patent Attack

Until very recently, brand managers could rely on the timing of a patent expiration. Decisions about sales force allotment, marketing and promotion, manufacturing, and long-term product planning were made under predictable environments during launch and mid-lifecycle phases. Likewise, exit strategies could be created with predictable timing: removing sales and marketing support was the last step of the so-called "harvest" phase before the entry of generic competition.

But the dramatic rise in generics manufacturer challenges to brand patents has significantly complicated product management. Now, for many brands—whether they are blockbusters from large companies or small life-blood products for single-product companies—timing certainty has left the product management equation.

Once considered a "legal" problem by brand companies, the in-house legal staff could manage the patent challenge quietly and without interaction from the brand team. Now, many companies face generic challenges for a majority of their product portfolios and a large portion of their revenue. Paragraph IV challenges can no longer be considered a legal problem but instead have become a business and portfolio problem with profound implications. (See "Paragraph IV Primer,")

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