Despite the fact that an official announcement is not due until sometime later this morning, it seems likely that everyone already knows that President Barack Obama has selected Judd Gregg, the Senior United States Senator from New Hampshire, to be his Secretary of Commerce. All the political pundits have offered expert commentary on why President Obama might choose a Republican Senator to be his Secretary of Commerce, but maybe it is as simple as he actually paid his federal income taxes on time and in full, who knows? One thing is for certain though, Judd Gregg does not have a long history to review on patent matters, but the man who will be the boss of the next Director of the United States Patent and Trademark Office does have one thorny patent issue in his past, namely the misguided attempts by Columbia University to extend its patent protection on a multi-million dollar process. If failure to pay federal income taxes does not disqualify a nominee from serving in the President’s Cabinet I doubt this issue will present any problems for Gregg, although it certainly deserves to be an interesting footnote in his political career. This is particularly true given that he will head the Agency under which the US Patent Office falls.
In 1980, Columbia University filed for a patent for the process of inserting foreign DNA into a host cell in order to create specific proteins used to fight disease. Columbia received the original patent in 1983, and two subsequent patents, also based on the experimental research described in the original 1980 application, were issued in 1983 and 1987, respectively. Between the issuance of the original patent in 1983 and the date these patents expired in 2000, Columbia licensed the technology to more than 30 biotech companies, and collected hundreds of millions of dollars for the use of the patented process and related technology.
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As the original patent was approaching expiration in 2000, Judd Gregg, an alumnus of Columbia University, attached an amendment to an agricultural spending bill that had already been approved by the Senate Appropriations Committee. This particular amendment would have extended the patent life of the Columbia patent, which would have reportedly brought Colubmia University an additional $150 million in revenue. The Biotechnology Industry Organization opposed this special interest legislation, which never was enacted into law. For more see Columbia Gets Help From Alumnus on Patent Extension.
The reason Senator Gregg gave for seeking the patent extension was that he was trying to remedy an inequity in the laws relating to drug patents. Under the Hatch-Waxman Act drug companies can apply for extensions for drug patents to compensate for the time lost while waiting for approval from the Food and Drug Administration (FDA). Unfortunately for Columbia, this patent extension provision for drugs does not apply to process patents that relate to methods of making drugs. Senator Gregg explained: “Patents like the Columbia University cotransformation patent should be eligible for patent extensions just like any other drug patent.”
Perhaps it is unfair to criticize Judd Gregg too much for trying to extend the life of the Columbia University cotransformation patent, after all drug companies seek to extend their patent rights and engage in all kinds of gaming that is allowed under Hatch-Waxman. The trouble is that Judd Gregg inserted himself into this matter, perhaps with good intentions, and then after not being able to extend the patent Columbia University got desperate and things turned very ugly.
The Columbia patent tale takes a sad and strange turn for the worse when one learns that on September 24, 2002, Columbia obtained a patent that covered the identical invention that fell into the public domain in 2000. This new patent, US Patent No. 6,455,275, extended to Columbia the exclusive rights to the original patented process until 2019, which I suppose was far better than any special interest legislation could have ever accomplished.
How did Columbia manage to engineer such a neat trick? US Patent No. 6,455,275, which was the patent issued in June of 2002, is related in lineage to the application filed in 1980. Yes, the ancestor of the ‘275 patent dates back to 1980. This could not happen today given that in the US the patent term is calculated from the filing date, but given the relevant filing dates predated the June 8, 1995 switch over to the new patent term regime Columbia was able to keep this patent pending for almost 23 years, and for 2 years longer than the life of the related patents. Despite the fact that the discoveries that are the base for the ‘275 were made in 1980 or earlier, the ‘275 patent would have remained in effect until 2019, breathing new life into the term “submarine patent.”
Biogen, Genzyme, Abbott Laboratories, AmGen, Genentech, and Wyeth Pharmaceuticals all filed lawsuits to challenge the new Columbia University patent. These companies all believed, and rightfully so, that this new patent is invalid and unenforceable. The real problem here, as Biogen pointed out in its complaint, is that Columbia did not file a terminal disclaimer. Had Columbia filed a terminal disclaimer then no re-patenting would occur. That is exactly what a terminal disclaimer is for – the prevention of patent term extension. In this case, however, had a terminal disclaimer been filed a patent would have issued that would have lapsed into the public domain 2 years prior to issuance. A strange result indeed.
On September 1, 2004, Columbia filed with the United States District Court for the District of Massachusetts what they characterize a written, unequivocal commitment to each of the plaintiffs that it would (1) not assert any claim of patent infringement against plaintiffs under the patent in question, with respect to any product currently made, used, offered for sale, sold, or imported by plaintiffs, or any product which was made, used, offered for sale, sold, or imported by plaintiffs prior to the date of this covenant; and (2) not assert the patent as it presently reads against any plaintiff as a basis to recover royalties. As a result of this covenant not to sue the district court dismissed the complaint against Columbia University on November 5, 2004. The dismissal was not due to the fact that Columbia deserves exclusive rights, but rather because Columbia agreed not to assert its patent rights against the defendants.
The district court explained that the fact that it was dismissing the complaint really was of no consequence because it was extremely unlikely that the patent would survive given that the ‘275 patent was a substantial duplicate of Colubmia’s earlier patents and the fact that the Patent Office had already initiated Reexamination proceedings at the request of the Public Patent Foundation. In fact, on December 1, 2004, Columbia University voluntarily abandoned the ‘275 patent, putting an end to this strange patent tale.
About the Author
|Eugene R. Quinn, Jr.
President & Founder of IPWatchdog, Inc.
US Patent Attorney (Reg. No. 44,294)
B.S. in Electrical Engineering, Rutgers University
Gene is a US Patent Attorney, Law Professor and the founder of IPWatchdog.com. He teaches patent bar review courses and is a member of the Board of Directors of the United Inventors Association. Gene has been quoted in the Wall Street Journal, the New York Times, the LA Times, CNN Money and various other newspapers and magazines worldwide