As third quarter results were being released last week, we hear of several top drugmakers facing hard knocks from the fall off the patent cliff. Pharmaceutical news have been populated with headlines such as the following: Sanofi drops as major patent expiries take hold, Bristol-Myers results fall short as Plavix sales evaporate, AstraZeneca continues to see revenue decline, and Lilly revenues down as generics erode Zyprexa sales. Read more »

The day of reckoning is here. As patent protection expires for top-selling drugs, some firms are scrambling to stay one step ahead of generic-drug competitors. As Amy Ritter wrote last week, Pfizer is drawing scrutiny by asking pharmacy benefit managers to block pharmacies from filling prescriptions with generic alternatives to Lipitor, in exchange for a discount on the product. Rep. John Sarbanes (D-MD) asked the Federal Trade Commission to take action against this arrangement, but another tactic is also causing concern. Read more »

The patent cliff is beginning to reduce Big Pharma’s sales figures as generic versions of branded drugs enter the market. Although FDA has remarked that pharmaceutical innovation is beginning to increase, not all companies are going to be able to market enough new drugs to make up for lost sales. So how will these vulnerable companies maintain their profits? Read more »

A dosage form that delivers several drugs, either at once or in succession, can have many benefits for patients. The administered drugs could have synergistic effects when delivered together, and the convenient dosage form could improve patient compliance. And, of course, reformulating several drugs for codelivery could help breathe new life into a company’s patents. All of these advantages came to mind when I learned about a multiple-compartment gel capsule developed at the Georgia Institute of Technology. Read more »

Facility rationalizations, outsourcing, and staff reductions can provide only so much of a cushion to pharmaceutical and biopharmaceutical manufacturers about to drop off the patent cliff. The ideal way to remain profitable is to discover and develop innovative new drugs, but this task has proven increasingly difficult for drugmakers over the past few years. Jonathan Leff, a managing director at venture-capital firm Warburg Pincus, says that FDA is partly to blame. Read more »

In a ruling issued this week concerning the patent rights of research universities, the US Supreme Court ruled in favor of Roche in a long-standing patent dispute the company had with Stanford University regarding patent rights to technology to detect HIV blood levels using polymerase chain reaction (PCR) technology. The ruling is significant in that it provides clarity in this particular case to technology transfer and related rights between universities using federal funding and private companies. Read more »

The pharmaceutical and biotechnology industries are gearing up for another round of debates on patent reform as the US House of Representatives begins consideration of proposed legislation. Last month, the US Senate, overwhelming passed a bill, The America Invents Act (S. 23), a major piece of patent-reform legislation. The bill, which received bipartisan support, has divided business concerns, including the pharmaceutical industry. Read more »

A sizeable chunk of Big Pharma’s sales will fall off the dreaded patent cliff before the year is out. Patent expirations will allow competitors to market, and patients to buy, generic versions of branded drugs. A renewed focus on discovering and developing new therapies would seem to be the obvious solution for Big Pharma. Yet at least one observer predicts cuts in research and development (R&D) spending throughout the industry. Read more »

Big Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. Read more »

There was no joy in Paris, at least at sanofi-aventis (Paris) headquarters, on Friday. When the company’s offer to acquire Genzyme (Cambridge, MA) at $69 per share expired that day, fewer than 1% of the biopharmaceutical company’s outstanding shares had been tendered. In response, sanofi extended its deadline to January 21, 2011 without modifying the terms of its offer. Why should the company expect a different result in six weeks’ time? Read more »