Biopharmaceutical manufacturers have successfully patented isolated DNA molecules for some time. The Biotechnology Industry Organization recently described these patents as critical tools that enable the research and development of new biotech therapies. A new development in a federal court case, however, could redefine what legitimately can and cannot be patented. The court’s decision could have ramifications for all biopharmaceutical manufacturers. Read more »

Wall Street analysts gave Eli Lilly (Indianapolis, IN) executives the third degree last Thursday when the company presented its third-quarter results. Lilly’s revenue had increased only 2%, mostly because it had raised its prices. Although demand for its products had stayed flat, the company boosted its profits by 38% mostly through layoffs and cost-cutting measures. The patents on many of the company’s top drugs (e.g., Zyprexa and Actos) will expire in the next few years, however, and no new drugs seem poised to replace them. Analysts wanted to know how Lilly would weather the storm. Read more »

Patients who take biological drugs traditionally have had little choice but to submit to injections. Yet needlephobes should take heart. Several partnerships are developing other ways to deliver large molecules that seem to show promise. Read more »

Now it’s official. Rumors about sanofi-aventis’s (Paris) desire to purchase Genzyme (Cambridge, MA) have stirred speculation for weeks. The French drugmaker laid its cards on the table on Sunday by publishing its offer letter to Henri Termeer, Genzyme’s CEO. Sanofi proposed to pay $69 in cash per Genzyme share, or a total of about $18.5 billion, to acquire the biologics manufacturer. On Friday, Genzyme shares closed at $67.62.

Termeer’s response came this morning. It can be summed up in two words: nothing doing. Read more »

In the current economic slump, generic versions of branded drugs have become a bigger thorn in innovators’ sides than before. To safeguard their profits for just a bit longer, many companies have paid generic-drug manufacturers to delay the introduction of their products to the market. US and European authorities have called these arrangements anticompetitive, though, and events on Capitol Hill last week indicate that they might not be tolerated much longer. Read more »

Companies always want the longest patent protection possible for their products — and with good reason considering the immense costs of R&D. However, some companies go a little too far in seeking patent protection to the point that they may even try to mislead the regulators in order to extend the life of patents. Read more »

Patent expiries and the imminent threat of competition from generics is the bane of many pharmaceutical companies’ lives and I’m frequently reading and writing about the doom and gloom pharma is facing because of these issues. This is of course a serious issue for the industry, but there are many beneficiaries, including healthcare providers. Read more »

In a controversial ruling late last month, a federal judge ruled that several patents held by the molecular-diagnostics company Myriad Genetics in a genetic-testing product that covered two genes, BRCA1 and BRCA2, which are associated with risk for developing breast and ovarian cancers, were invalid. The decision raises the larger question of the patentability of genes, a significant issue in determining the rules of the game not only in molecular diagnostics but also in drug discovery and development. Read more »

These days, research scientists, much like Rodney Dangerfield, can’t get any respect. The latest evidence of this arrived on Friday, when AstraZeneca (London) proposed to cut 3500 research and development (R&D) jobs by 2014. Read more »

The European Commission has said it will be taking a close look at patent settlements where an originator has paid off a generic competitor in return for delayed market entry of a generic drug. Only yesterday, the EC released a statement saying that it has asked certain pharmaceutical companies to submit copies of their patent settlement agreements completed between originator and generic companies between July 2008 and Dec. 31, 2009. Read more »