• Friday, May 25, 2012
  • Print
  • Comment (8)

Federal Appeals Court Deals a Blow to Patenting Basic Research

The federal appeals court that handles patent cases has upheld a ruling that could make it harder for universities to obtain patents on the basic research most academics undertake.

The ruling, issued Monday, also makes clear that the court was well aware of the effect of its decision.

"The patent law has always been directed to the 'useful arts,' meaning inventions with a practical use," the judges of the U.S. Court of Appeals for the Federal Circuit wrote in the 9-to-2 decision. "Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others."

The ruling came in a case involving the validity of a 2002 patent on a technique for identifying how a "messenger" protein regulates how cells function. The technique was developed by three teams of eminent researchers from Harvard University, the Massachusetts Institute of Technology, and the Whitehead Institute for Biomedical Research.

On the day the patent was awarded, the three institutions and Ariad Pharmaceuticals, the Cambridge, Mass., company that holds exclusive rights to commercialize the invention, sued Eli Lilly and Company, claiming that two of Lilly's drugs—Evista, used for osteoporosis, and Xigris, used for sepsis—infringed the patent. In 2007 a federal district court upheld a jury verdict ordering Lilly to pay the parties $62.5-million in damages plus royalties on future sales.

But Lilly appealed, arguing that the patent was invalid because it failed to adequately demonstrate how to actually make the new technique. In pressing its challenge, Lilly invoked some of the same legal arguments used by another pharmaceutical company in its successful 2003 challenge of another academic patent (held by the University of Rochester), which was also later upheld.

In a ruling last year, a three-judge panel of the appeals court agreed with Lilly, but Ariad petitioned for a rehearing before the full court. In its decision on Monday, the full court also ruled in favor of Lilly.

"Universities may not have the resources or the inclination to work out the practical implications" of the research they do, the judges wrote, and that might mean universities become 'disadvantaged" when seeking patents. But the appeals court said that was "no failure of the law's interpretation but its intention."

In a news release, Ariad, which has taken the lead on the litigation, said it was reviewing the decision to "assess our options in the case."

Comments

1. 11211250 - March 24, 2010 at 07:45 am

Well, universities by and large are ill-equipped to meet the new standards this decision seems to require. In fact in the life cycle of taking new medical products and pharmaceuticals universities play a role in the conception of innovations based on their fundamental research, which academic theory by its very definition is not taken to the level of useful art. For that to happen, a company needs to come in and take the conception and the theoretical reduction to practice and develop the actual product before it can be patented. So if I am understanding this correctly, the courts seem to be saying that fundamental research, no matter how scientifically provable it might be, is only an academic theory and not a patentable invention until it is actually in a useful art that produces tangible products. So if the inventor and the assignee want to profit from an invention, inventors would have to treat discoveries as secrets until an arrangement can be made with a company to reduce it to practice in the non-theoretical world. This would totally disrupt the flow of research results into the scientific community and pretty much cancel many of the benefits that the Bayh-Dole Act made possible. This would cause a deceleration of discovery and advancement of knowledge since publishing a "theory" would still be a public disclosure of the essence of any resulting invention and therefore make any subsequent development unpatentable. How many companies are going to want to risk capital on bringing a theory to product if the resulting product can't be protected. This is a damned if you do, damned if you don't situation and a drastic blow to the system that allows taxpayers to benefit from the research it sponsors. I sure hope I am wrong about this and that a closer reading of the case by IP lawyers will yield a different picture, but from what I've heard so far, this decision could be deadly.

2. 11164868 - March 24, 2010 at 08:07 am

It just means that universities need to function more as agents of knowledge discovery and knowledge dissemination, rather than as machines to produce patents.

3. 22067030 - March 24, 2010 at 09:00 am

The problem is ... if universities aren't going to get reimbursed for said knowledge discovery and dissemination from licensing and patents, where is the money going to come from? The governments are cutting back on allocations, and that leaves...

4. johntoradze - March 24, 2010 at 11:53 am

Academic research is paid for by the federal government allocating NIH, NSF, DOE and DOD grants. Academic research is not and never has been paid for by patent income! Bayh-Dole act income is used for administration and building budgets. Grant income to universities is already a huge source of income all by itself, that causes large conflict of interest problems within university administrations when "doing the right thing" conflicts with receiving several million dollars in overhead budget fees from a grant.

There are plenty of instances where academic research results in patentable inventions. PCR for instance, plasmids, vaccines, instruments, specific techniques. All this decision does is prevent universities from patenting things that are not inventions.

There are still major problems with university patents. The intent of Bayh-Dole was to spark the economy by creating stake-holders for patents that used to belong to the federal government. But while university portfolios have grown, and the portfolios are of pretty high quality, most of those portfolios are not producing income. This is because universities are usually very hard to make deals with, want large amounts of money up front when most real innovations start out in garage start-ups, etcetera.

Another problem with Bayh-Dole is that the amount of money going to the actual inventors, as opposed to the university varies a great deal, but is usually tiny. That has resulted in many professors intentionally not reporting patentables to their technology office.

This is a good thing.

5. gerald_barnett - March 24, 2010 at 11:55 am

It means that universities are claiming as patentable inventions stuff that is not. The decision should come as some relief to people who want to collaborate without the stifling "cone of silence" that university-controlled patent claims often force on the research community. It shows universities going the wrong way with their patent administration. It's a fine line between providing a useful service by marking research inventions with patent rights, and using those patent rights to interfere in the development of products. In the former, use = success. In the later, use = infringement. When the distinction is lost on TLOs and university administrators, point made.

6. slothers - March 24, 2010 at 03:44 pm

Test

7. 99488909 - March 25, 2010 at 02:36 pm

Contrary to the tone of the article and the accompanying comments, this most recent court decision is not a surprise to university TLOs nor necessarily unwelcomed. We are well aware that, in the current patent climate, no one is going to be granted patents on drug targets that claim any drug inhibiting the target, patents on the mechanism of action of drugs, or patents claiming disease pathways and any drug that modulates the pathway (the later represented by this case). We make it clear to our researchers that groundbreaking scientific discoveries with no demonstrated practical application may earn them academic recognition and a Nobel Prize, but not a patent.

It has become increasingly more difficult to get patents that are relevant to pharmaceutical development, but successful licenses are still being negotiated. Researchers are more attuned than ever to translation of basic science to commercial application, and we and other institutions are investing in translational development programs to develop patented inventions with clear proof of potential.

To counter a number of the errors or misconceptions in previous comments:
Industry relationships (licenses and sponsored research programs) still represent important sources of funding for academic scientists, although investment from industry has declined significantly with the economic crisis at the same time that government funding is being scaled back. Although pharmaceutical companies are increasing pushing early research to external alliances, most of those alliances are being directed to biotechs with better capacity to push the development to later stages. Our technology development programs are directed to draw that industry development back to the academic institutions.

I really can't understand the perceived "cone of silence" purported by gerald_barnett. Academic science is a competitive field, and being cagey about unpublished results is in the nature of the game. But a patent filing works to eliminate the secrecy- the investigators feel "covered" if a patent application has been filed and open up more freely in disclosing results. As any TLO will attest, the offices work with remarkable speed in filing patent applications when notified at the last minute that a public disclosure is imminent (having myself arranged a patent filing from my hotel room on vacation).

To gerald_barnett's comment that some licenses allow use and others prevent competition, this is a misunderstanding of the patent principle. The only right conveyed by a patent is the right to exclude others from practicing the claimed invention. Exclusivity is necessary to get a product to market where substantial investment in R&D is needed (especially true of the early stage inventions created by academics). However, we grant many non-exclusive licenses to allow multiple companies the freedom to operate. Still, the value of these non-exclusive licenses remains in the concept that only those that pay-to-play will be allowed to compete. Enforcing a patent against a company producing an infringing product is not optional; failure to enforce the patent will be grounds to invalidate it.

To johntoradze's point, implying that academic institutions are rolling in the dough from federal grant funding is ridiculous. We lose money on our research, which is subsidized by our hospital's clinical revenues. Most universities lose money on research, which is paid for by tuition, donations and return from their endowments. Not all researchers can get the funding for their work, and our institution steps in to fund the work. Even with our comparatively high overhead rate, NIH grants don't cover the total expense of the funded projects.

Our inventors get 70% of the first $100,000 in revenue and still 25% over $500,000. We are more generous than some, but revenues to inventors are not tiny. It may not be true of other institutions, but license revenue that is retained by our institution is dedicated to funding research and technology development, and is not contributed to our endowment or general operating expenses.

Academic institutions are no more difficult to negotiate with than any other licensing partners. Up-front fees are commensurate with the value of the technology and we have found plenty of creative ways to fund dozens of start-up companies.

8. jameskatt - March 28, 2010 at 07:31 pm

This judgment is a GOOD judgment that benefits all of society.

The fact that academic research comes up with new discoveries is fantastic. But these new discoveries are NOT PATENTABLE items when they are NOT INVENTIONS as the court has stated.

A Patent is for an invention. The university in question did NOT come up with an invention. It came up with a "wish" or "plan" as the court said. A "wish" or "plan" is NOT AN INVENTION AND CANNOT BE PATENTED. That is all the court said.

This is NOT a blow to basic research. This is a blow to frivolous lawsuits. This is a blow to patent trolls.

Society is better off to be without patent trolls.

And it is a shame for a university to become a patent troll. Shame on it.

Add Your Comment

Commenting is closed.