navigating the patent maze

The Metabolite patent claimed a method for detecting a cobalamin or folate deficiency in a patient by "assaying a body fluid for an elevated level of homocysteine" and "correlating an elevated level … with a deficiency…." 

The issue from Metabolite in front of the U.S. Supreme Court is whether a method patent claim "directing a party simply to ‘correlate’ test results" is validly awarded over "a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result."

This case will attract attention not only from the biotechnology industry, but also from the software and business methods industries.  Although the issue to be considered is drawn narrowly and specifically in terms of medical treatments, it actually touches on wider policy controversies.  The main controversy is primarily voiced by the press and public interest groups as the perception that patents are wrongly granted for abstract ideas (e.g., software patents, business method patents) or natural phenomena (e.g., patents to gene sequences and the method of the Metabolite patent). 

The expected date for a decision in this case is June 2006. 

Because Australian patent law is silent with respect as to an experimental use exception, it’s been unclear whether such an exception exists.  Although the consensus of patent attorneys in Australia that I know advised "no experimental use exception".  In view of the widespread uncertainty and concerns that the lack of an exception is inhibiting research and development - especially in biotechnology - the Advisory Council on Intellectual Property (ACIP) in Australia examined the need and desirability of an exception and has issued a report of their conclusions. 

Briefly, ACIP recommended the following amendment to the Patents Act:

The rights of a patentee are not infringed by acts done for experimental purposes relating to the subject matter of the invention that do not unreasonably conflict with the normal exploitation of a patent. 

Acts done for experimental purposes relating to the subject matter of the invention include:

• determining how the invention works;
• determining the scope of the invention;
• determining the validity of the claims; and
• seeking an improvement to the invention.

In other words, the amendment would allow experimentation on the invention, but not use of the invention for its intended purpose. 

No word on if or when this amendment will be adopted. 

Scientists and lawyers can sometimes use the same words but mean different things.  "Experimental use" is one such term.  Scientists often refer to the use of an invention  - patented or not - in performing an experiment as "experimental use".   In patent law, "experimental use" of a patented invention is an exception to the rights of the patent owner. 

The rights granted to the patent owner are to exclude others from making, using, selling or offering to sell the invention.  These rights can be circumscribed by exceptions that the granting country enumerates.  For example, in the United States some of the specific exceptions are for uses reasonably related to submission of data to the FDA (Food and Drug Administration) and for practice of patented medical or surgical procedures by medical professionals.  Note the lack of a general exception for "experimental use". 

In countries that have exceptions for experimental use, the use is generally for experimenting on the invention.  Rarely is an exception given for using the invention as intended.  A model law allowing experimental use may include exceptions for:

• determining how the invention works;
• determining the scope of the invention;
• seeking an improvement to the invention.

Thus, under an experimental use exception, a scientist may be testing different additives in PCR to find one that markedly improves amplification.  In that case, the scientist is experimenting on the invention, not using it in her experiments.  Whereas, using PCR to assay for presence of a gene sequence would be an experimental use of PCR and not an excepted use under this model.

Photograph of Barbara McClintock using a microscope from National Library of Medicine Profiles in Science website. 

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In 2001, at a WTO (World Trade Organization) meeting in Doha, Qatar, a declaration by member countries gave voice to world health problems and provided a mandate for implementing a solution within the framework of the TRIPS (Trade-related aspects of intellectual property) agreement to facilitate access to medications. 

…we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.

The solution finally forged was to waive the restriction in TRIPS with respect to
pharmaceutical patents that products made under compulsary licenses
must be "predominantly for the supply of the domestic market" of the
Member country granting such a license.  The waiver has now been made permanent.

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At
last the Federal Circuit has ruled on whether EST sequences are patentable.  The genesis of this was well over a decade ago when NIH
filed a patent application claiming heaps of ESTs characterized by Craig Ventner.  Before that application was examined by the US Patent & Trademark Office (USPTO) however, it was
withdrawn from examination at the request of Dr Harold Varmus, then the new
chief of NIH.  The years then went by without
resolving the uncertainty of whether ESTs are patentable subject matter.  During this time, the USPTO has been inconsistent in its approach, both issuing a few patents (e.g., US 5,817,479, claiming ESTs homologous to protein kinases) and
waffling (its own guidelines state that ESTs might
be patentable if they had specific, substantial and credible utility).

Finally now we can all sleep better at night because the
Fed. Cir. considered a test case, In re Fisher, in which Monsanto (the owner of the technology) claimed EST sequences.  In agreement with the US Patent Office, the Fed. Cir. held that the EST sequences were NOT patentable. Why not?  Because the
specification did not particularize a "specific and substantial utility" (utility of an invention being one of the requirements for granting a patent).  That’s PTO-speak for "EST sequences are incomplete sequences and neither the genes or proteins they encode are known".   

The holding wasn’t really very surprising as the EST
sequences in question were essentially a random five sequences selected from a
large group of EST sequences isolated from a maize cDNA library.  Moreover, at least one commentator suggested that Monsanto wanted the outcome they got.  For sure, the biotechnology industry didn’t want ESTs to be patentable.  In any case, Monsanto asserted
seven different uses for the ESTs, including use as molecular markers, as probes to measure RNA levels, as probe for polymorphisms.  While you may think these are real and important uses, the Court concluded that the stated uses are so general as to be meaningless.  Additionally, they noted that the ESTs were not like other patentable research tools (e.g., microscope) but merely a starting point for further research, and a long time ago, the U.S. Supreme Court held that research intermediates are not patentable under U.S. patent law. 

Claim construction: The past several years have been increasingly tumultuous for patent lawyers  advising
clients on the meaning of claims.  At
times the maxim and mantra of patent law — that patent claims define the “metes and boundaries” of the invention — feels like a cruel joke.  If the
Federal Circuit (one stop short of the Supreme Court) can’t agree on the
proper way to construe claims, what hope is there for the rest of us? 

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After a long hiatus, "Navigating the Patent Maze" blawg is returning - and with a new format.  Posts will be mainly directed to providing information and identifying resources of interest to the types of clients serviced by Cougar Patent Law  — very small biotechnology companies and non-profit research institutes. 

Most patent-related "blawgs" appear to be written for patent practitioners and others well-versed, or well-steeped, in patent law.  Yet, many in the biotechnology industry — such as business developers, venture capitalists, scientists, and technology transfer specialists — are also involved with or affected by patents and related areas of law but without very many self-help resources.  In my experience, these groups cannot always afford to turn their projects and problems over to lawyers; some don’t even know that they have projects and issues that need addressing.  For those that take the time to visit this blawg, I hope that what you learn here increases your ability to deal with both everyday and more esoteric patent matters.  That is how I measure the success of this blawg.