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Life Tech Seeks to Invalidate Patent in Ongoing Legal Row with Oxford Biomed, Vanderbilt

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Life Technologies asked a Tennessee court this month to invalidate a patent held by Vanderbilt University and licensed by Oxford Biomedical Research, and to rule that Life Tech does not infringe the IP.

Life Technologies' suit, the latest maneuver in a six-year-old legal dispute, comes three months after a similar complaint it filed in a Wisconsin court ended with the court dismissing Vanderbilt from the proceedings for lack of personal jurisdiction.

The new suit, filed in the US District Court for the Middle District of Tennessee, surrounds US Patent No. 5,888,157, which was issued to Vanderbilt toxicology researcher Peter Guengerich in 1999 and covers either a method for expressing and purifying human cytochrome P450, materials for doing so, or both, depending on whom one asks.

According to the suit, Oxford, Vanderbilt, and Wisconsin biotech firm PanVera engaged in a series of negotiations as early as 1994 regarding licensing the '157 patent which, at the time, was a patent application owned by Vanderbilt.

As a result of these negotiations, the suit claims, Vanderbilt exclusively licensed the patent application to Oxford, which, as the exclusive licensee, exercised its right to sub-license the patent by granting a license to PanVera.

In 2003, Life Technologies predecessor Invitrogen acquired certain assets of PanVera for $95 million, including its license agreement with Oxford. Soon after, disputes arose between Oxford and Invitrogen regarding several provisions of the licensing agreement, according to the latest suit.

In October 2005, Oxford sued Invitrogen in Michigan accusing the company of breaching the terms of the licensing pact by not making certain royalty payments, not supplying Oxford with certain recombinant proteins, and not offering Oxford a 40 percent discount on products produced by Invitrogen and PanVera.

Almost two years later, according to the most recent suit, Oxford sent a letter to Invitrogen claiming that the licensing agreement originally inked with PanVera would not terminate until the '157 patent expires in 2016.

Invitrogen subsequently responded in a letter to Oxford that the agreement had expired on Sept. 11, 2006. To support this assertion, Invitrogen pointed to the final licensing agreement between Oxford and PanVera, which stated that the licensing agreement would continue for the life of any patent covering licensed material or, if no patent issued, for 10 years following execution of the agreement.

This is where the dispute about whether the patent covers methods or materials arises. In its letter to Oxford, Invitrogen asserted it is a method patent, that its terms do not cover licensed materials, and that no patent has issued covering licensed material. The company has also argued that regardless of the claims of the IP, it had never practiced the method described for purifying cytochrome P450.

Further, Invitrogen asserted that it offered in early 2007 to extend for one year the term of the original agreement between Oxford and PanVera by presenting an annual royalty check, which Oxford accepted by depositing. In addition, Invitrogen asserted in its letter, Oxford never refuted or responded to the claims Invitrogen made in its letter.

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Nevertheless, in June 2008 Oxford filed an opposition to Invitrogen's motion for partial summary judgment in the Michigan case, asserting — for the first time in a legal setting, according to Invitrogen — that the '157 patent covered licensed materials and thus would not terminate until 2016.

Life Technologies has maintained in all of its countersuits that Oxford is incorporating assumptions regarding the scope of the '157 patent, and therefore "proceeding as if these matters have been litigated in its favor." The result would be to deny Life Tech the opportunity to challenge the validity of the patent or raise other defenses to the claims Oxford is making.

One month after Oxford filed its opposition, Oxford served Invitrogen with reports from its damages expert claiming that Invitrogen's breach of contract had cost the company $173 million in damages.

In October, Invitrogen filed a motion in the Michigan litigation seeking to amend its position by asking the court to reduce the scope of the '157 patent claims and declare the patent invalid and expired.

However, the Michigan court denied that motion, stating that the case before it was limited to matters of contract interpretation. Trial for the Michigan litigation is set to begin in March.

Also in October, Invitrogen sued Oxford and Vanderbilt in the US District Court for the Western District of Wisconsin, asking the court, among other things, to declare the '157 patent invalid and rule that Invitrogen does not use the method outlined in the patent to purify any of its P450 products.

In December, the court dismissed Vanderbilt for lack of personal jurisdiction, which spurred Invitrogen – since then called Life Technologies after merging with Applied Biosystems – to seek relief in the Tennessee court "because Vanderbilt is an essential party to any suit seeking adjudication of the scope and/or validity of the '157 patent," Life said in the new suit.

Life added in its suit that it has been in negotiations with Vanderbilt regarding a potential stipulation that the patent is invalid in light of certain prior art, which Life has provided to the school. However, Vanderbilt has so far refused to enter such a stipulation, Life said, and "continues to assert the validity of the '157 patent despite the evidence to the contrary."

Besides seeking a judgment that the '157 patent is invalid and that it does not infringe on methods introduced in the patent, Life is also seeking "costs and any such relief as is just and proper," according to the suit. In addition, Life presents as part of its suit at least six cited references from prior peer-reviewed scientific publications that "render obvious" certain key claims of the '157 patent.

It is unclear exactly what financial stake Vanderbilt has in the legal proceedings. Details of the university's original licensing agreement with Oxford have not been disclosed. Vanderbilt officials could not be reached for comment.

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