Protecting intellectual property and managing product liability in pharmaceutical manufacturing

Risk Avoidance Plan:

IP, intellectual property development and limitation, and product liability

For a company such as World-Wide which is dependent on unique ideas to thrive, protecting its intellectual property concerns is essential. Although trademarks and branding are less critical for pharmaceuticals and medical devices from a marketing standpoint, there is always a risk of counterfeiting, particularly in the developing world, as well as questions of other manufacturers capitalizing upon its research and development to generate innovative products (Meiners, Ringleb, & Edwards, 2015, p. 241). For drug manufacturers that have a limited patent on new drugs, it is critical to make a profit as long as possible before other companies are allowed to produce generic versions. Intellectual property also is linked to product liability concerns given that counterfeit products are often dangerous; they are often produced with inferior ingredients or parts to make them less expensive. "Guidelines are necessary for all types of IP within an organization. A full leadership team must be aware of and promote these policies, procedures and records. There should also be systems in place for managing IP with employees and among third-party supply chain companies," and the IP team should be constantly monitoring all potential areas of security 'leakage' along the supply chain spanning from computer systems which store critical data; to the construction of contracts; to employees and third party organizations with which World-Wide does business (Pressman 2013).

A pharmaceutical and medical technology company can only remain competitive through the constant cultivation of new products. "Over the last three years major pharmaceutical companies have lost tens of billions of dollars to smaller companies for one primary reason: the patent cliff -- a series of patent expirations of important prescription drugs" (Ahmed 2014). Careful planning is required to ensure that World-Wide does not have a series of patent expirations without a subsequent rise in new, unique brand-name drugs. This requires careful planning, foresight, and constant targeted research and development. "Innovation in drug discovery over the last decade has been considerably slower than before, and the necessity for a differentiable drug is imperative for sustained success among large pharmaceutical companies ... There will be a greater need to create a multitude of drugs that are specific and differentiable for patenting purposes and portfolio diversity for a company" (Ahmed 2014).

Quality assurance is necessary in our current product manufacturing, given that under the law "a manufacturer is required to exercise reasonable care under the circumstances in the production of its product" (Meiners, Ringleb, & Edwards, 2015, p. 189). For pharmaceuticals in particular, given the consequences of even the slightest error in production, strict standards are necessary to ensure that all requirements are upheld. This is not only true domestically but also internationally. Facilities abroad, particularly in developing countries such as China, may not necessarily adhere to the same strict standards as a U.S. firm might. "Businesses can face regulatory fines, costly litigation and product recalls, and reputational damage in the event of a product failure or contamination. It's essential that a product liability insurance program considers the interplay of policies and regulations in all countries where an organization operates" ("Managing," 2014).