Patent Office as a Stakeholder for Market Access
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Has a third barrier to market access emerged to hinder the pharmaceutical Industry?

First, it was regulators that stood in the way of pharmaceutical products getting to market. The past decade or so has been a fallow period for the pharmaceutical industry in terms of the number of NMEs approved by regulators in the US and other major markets. However the past two years have seen an uptick that suggests that the industry might be, at long last, reaping the rewards of its investments in R&D and licensing to bring products to regulators with the data necessary to receive approval. While increasing its success at getting over the regulatory hurdles, the industry has faced increasing challenges in getting someone to actually pay for its products once approved for sale.

The second hurdle has been - and continues to be - payers who refuse to reimburse for products that do not demonstrate both economic and clinical value compared to the existing standard of care (see NICE, CMS lowering reimbursement rates, step-through programs instituted by private payers, etc.). Companies are only just beginning to realize the importance of market access as a goal rather than a corporate function that negotiates prices and rebates with a formulary manager. Building the capabilities to deliver the data that supports a product's value proposition to payers (as well as physicians and patients) has been a long, and in some cases, painful journey.

Even as pharmaceutical companies come to terms with the needs for CER and RWE in support of efforts to market their products, they may need to deal with an additional access barrier in certain markets: The patent office.

While pharmaceutical companies had to defend their patents against challenges from generic manufacturers in the past, they have not had to demonstrate any benefit for their products in order to receive and maintain patents. The sole criteria for being granted a patent was that the product was novel - not that it worked or that it was even safe.

In recent months the Indian patent office has refused to grant or has rescinded patents on pharmaceutical products on the grounds that they were not innovative enough. In addition to recent revocations of patents for two Allergan eye drugs (Ganfort and Combigen) the Indian patent office has rescinded patents on Pfizer's cancer drug Sutent, Roche's Hep C drug Pegasys, and a Merck asthma medication.

While this trend has not yet extended to other emerging markets, the Indian market is one of the highly anticipated engines of future growth for the industry. Pharmaceutical companies will need to demonstrate economic and clinical evidence of their product's innovation in order to persuade yet another stakeholder - the patent office - that the product is of sufficient benefit to the Indian population to be granted and to hold onto a patent.

The good news is that the same capabilities and data that are needed to convince payer stakeholders can be leveraged with the patent office. This additional hurdle simply provides added urgency for companies to undertake a fundamental rethinking of market access from the days when the regulator presented the largest barrier to entry.

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