Innovation on the Rise among Indian Pharmaceutical Companies

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe. Read more »

Myriad Ruling Will Undermine Global Biotech investment But All Is Not Lost

Guest blog written by Adrian Tombling, partner and patent attorney at Withers & Rogers LLP.

The US Supreme Court ruling in the so-called ‘Myriad case’ regarding the patentability of human genes will undermine global biotech investment but all is not lost. Judge Thomas, in Association for Molecular Pathology v. Myriad Genetics, effectively tightened the rules on the patentability of human genes, finding that all naturally occurring gene sequences, even when isolated in the laboratory, are not patentable. In future, only non-naturally occurring gene sequences (e.g., sequences that have been modified or entirely created in the laboratory), will be patentable, and therefore, attract investment from biotech companies. Read more »

Drug Development: To Sue or Not to sue?

Guest blog written by Dr Nicholas Jones, partner and patent attorney at Withers & Rogers LLP.

While it may not happen often, clinical trials can sometimes be halted by patent disputes, leading to costly delays in bringing new drugs to market. At last, the UK Government has decided to do something about this in a bid to make UK patent law more consistent with that in some other parts of the world. Read more »

Third Quarter Revenues Wounded by Patent Expiries

VLUU L110  / Samsung L110As 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 »

Drugmakers Seek to Outwit Generic-Drug Competitors

Erik Greb PharmTech editorThe 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 »

Bright Future, Big Molecules

Erik Greb PharmTech editor

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 »

Georgia Researchers Develop Multicompartment Gel Capsules

Erik Greb PharmTech editorA 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 »

Weak Pipelines? Don’t Blame FDA.

Erik Greb PharmTech editorFacility 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 »

Stanford versus Roche: The Winners and Losers

Patricia Van Arnum PharmTech editor 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 »

Round Two in Patent Reform

Patricia Van Arnum PharmTech editor

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 »

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