navigating the patent maze

The U.S. Supreme Court has agreed to hear KSR v Teleflex, which will address the appropriate standard to apply in order to find an invention obvious.  According to the current standard, multiple prior art references,each of which disclose an element of the claimed invention, can be combined to show the whole invention - but only if the references contain some "motivation, suggestion, or teaching" to do so.  Many critics of the patent system often consider this standard to be too lax, leading to patents protecting "trivial inventions", in their view.  On the other hand, most inventions are new combinations of old elements, and in the extreme, a strict standard would lead to very few patents being granted at all.  Hopefully, the Supreme Court will come down somewhere in between these two highly divergent viewpoints. 

For more information, see Patently-O. 

In a previous post, the issue at stake in the U.S. Supreme Court case, Lab Corp v. Metabolite, was discussed.  This morning, the Supreme Court dismissed the case on a procedural basis thus not needing to reach a decision on the merits.  A dissent, written by J. Breyer and joined by J. Stevens and J. Souter, however provides insight into what might have been a "majority opinion" of the merits.  The dissent emphatically believed that the claim, directed to assaying homocysteine levels and correlating an elevated level with a vitamin deficiency, was a claim for a "natural phenomenon".  Natural phenomena are not patentable under U.S. law. 

Until such time as the Federal Circuit or Supreme Court in the U.S. revisit issues of patent eligibility, the claim - and claims like it - are valid. 

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. 

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. 

When it comes to patentability, my working theory is "the most damaging prior art is your own."  It makes sense though - whose work is more like your own than your own?  Dr Crish fell victim this way and lost his chance for a patent as a result (In re Crish, Fed. Cir., No. 04-1075, 12/21/04). 

The patent application claimed purified DNA molecules having promoter activity for the human involucrin gene (hINV).  Involucrin is a protein that interacts with keratin along with other intracellular proteins to form a cross-linked structure within dead cells and strengthens the plasma membrane.  Skin cells, which are mostly dead cells, benefit from this.  The hINV promoter was sequenced from a plasmid that was the subject of an article authored by Dr Crish and others. 

Crish tried to distinguish the claims from the damaging effect of his publication first by asserting that the rejected claims did not encompass the whole plasmid, and second, by asserting that the publication did not disclose any nucleotide sequence of the promoter.  The Court did not buy either of these arguments because (1) the use of "comprising" in the claim language meant that the whole plasmid was encompassed by the claim, and (2) the sequence conferred indentification and characterization of a prior art material and "one cannot establish novelty by claiming a known material by its properties." 

The following shows how I think Crish could have successfully claimed the promoter sequence. 

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The blog "Law under the Microscope’" has two excellent discussions about this case.  The story of the collaboration and fall-out between City of Hope and Genentech demonstrates why wording in contracts is so important.  The jury awarded City of Hope USD 500 million.  (In my opinion, contracts are important to do right although they are rarely appreciated and only consulted when something goes wrong - and that is exactly when the wording becomes important.)

See original post on this site.
See Post 1 at Law under the Microscope about contractual interpretations.
See Post 2 at Law under the Microscope about fiduciary duty of licensors.

One form of legal protection for biotechnology inventions, which is not often used, is trade secrecy. This right, in contrast to patents and copyrights, is not registered and is of unlimited duration, as long as the holder of the trade secret makes reasonable efforts to maintain secrecy. With regard to keeping parental lines of hybrid seed as a trade secret, for example, identification by private code of fields of inbred parent lines of corn has been deemed, in the 1994 Iowa case Pioneer Hi-Bred v. Holden Foundation Seeds, sufficient to constitute a reasonable effort to maintain secrecy, even though the corn was grown outdoors and subject to misappropriation by informed “flashlight breeders.”  Furthermore, acquisition of the viable parent seeds that occasionally appear in bags of hybrid seeds is not antithetical to trade secrecy. But what if the parental lines are protected by Plant Variety Certificates (akin to plant breeder’s rights)?  One might think that the disclosure requirement to register a plant variety would destroy the secrecy necessary for maintaining the lines as trade secrets. 

The short answer from the District Court of the Western District of Wisconsin is NO, registration does not extinguish trade secrecy. 

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