By Nuala Moran

BioWorld International Correspondent

SAN DIEGO ¿ The U.S. Patent and Trademark Office (PTO) is struggling to keep up with the pace of developments in biotechnology, with 300 biotech examiners to deal with an expected 40,000 applications in 2002.

¿There are issues of money and resources and how the PTO will handle all the great things we are doing,¿ Jim Davies, senior vice president, general counsel and secretary of Human Genome Sciences Inc., told BIO 2001 delegates at a session on the policy prospects and challenges facing biotechnology with the new 107th Congress and the Bush administration in full force.

The patent office will see an 84 percent increase in applications by 2006, and between then and now there will be a 400 percent increase in the number of applications awaiting action, Davies said. ¿The PTO also needs funding for infrastructure ¿ the computer system is in great need of updating to allow them to look at our applications.¿

In addition, there has been no leader since January, and the new head of the PTO, Jim Rogan, will not be in place until later this year.

However, Davies said ¿things are starting to happen¿ to address the shortcomings. ¿It has been a very active year so far, and it will continue to be. I expect a lot of action on PTO quality and latency issues.¿ The Senate Judiciary Committee is expected to hold hearings in July on the quality of the PTO, and there are moves to allow the PTO to retain all the fees it takes. In 2002 the PTO will take in $1.2 billion in fees, but will retain only $800 million of that.

There are also moves to change re-examination procedures so that this mechanism could be used in place of litigation to allow issued patents to be challenged. ¿This would be similar to the process of opposition hearings in Europe, Davies said. ¿There will still be significant costs, but it will be cheaper than litigation.¿

The protection of intellectual property of biotechnology companies also is under challenge on the international front, said Lee Skillington, counsel at Powell, Goldstein, Frazer & Murphy LLP in Washington. ¿In prior years, we could recount improvements in developing countries and international forums, but in the past year, very few countries have improved their [IP protection] laws, and developing countries are coalescing in international forums to reduce the level of IP protection.¿

Skillington said one of the main drivers of this is the catastrophic AIDS crisis in Africa. ¿African leaders say they need access to nonexpensive drugs to save lives. What is surprising is that many African leaders focus on patents as a problem.¿ In fact, most companies have not got patents in Africa, apart from South Africa. ¿Nevertheless, there is a battle cry that the patent system is part of the problem,¿ Skillington said.

Mary Prendergast, executive vice president of government affairs at Elan Pharmaceuticals, said that, ¿somewhat surprisingly,¿ the Bush administration has taken a softer stance on patent protection than had the Clinton administration. ¿Bush has indicated there will be some relief from patents where life is at stake.¿

The situation could deteriorate at the next round of World Trade Organization negotiations, starting this autumn, when Skillington said countries would use patent rows as a bargaining chip to gain other concessions.

¿Developing countries don¿t think they get a fair share of the pie. They supply raw materials and genetic materials, and don¿t think they get the economic benefits. They believe the patent system has failed them and needs to be overhauled,¿ he said.

No Comments