Dr. Triantafyllos Tafas at Jefferson Medal Award Dinner, June 4, 2010.
On April Fool’s day 2008 the entire patent field released a great sigh of relief (and wondered if the reports of success were only a joke). On that day Dr. Triantafyllos Tafas and GlaxoSmithKline (“GSK”) succeeded in enjoining the U.S. Patent Office from implementing its proposed continuation and claim restriction rules, “Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications” (the “Final Rules”), which sought to revise the rules of practice in patent cases relating, in part, to the filing of continuing applications and requests for continued examination.
Although such Final Rules were widely criticized by most companies in the United States, a sole individual, Dr. Triantafyllos Tafas, a co-inventor of a computerized automated microscope, stood alone against the Rules package for nearly three months against the might of the USPTO. Dr. Tafas filed suit because he truly believed the U.S. patent system was being manipulated by a few large entities to the significant detriment of research-intensive entities such as emerging companies, universities, and research institutes, particularly those in the chemical, bioengineering, pharmaceutical, and biotech fields. Dr. Tafas’ beliefs grew from his experience attempting to start his company in Europe where he found few investors willing to invest in small companies whose only major asset was a patent portfolio. However, he found investors in the U.S. to be much more respectful of U.S. patents and willing to invest in companies with a good patent portfolio, irrespective of whether they were owned by a large multinational or the new kid on the block. This cemented Dr. Tafas’ belief in the importance of the U.S. patent system.
Five years ago today, on Monday, August 20, 2007, while many of us were otherwise preoccupied with the impending doom of the claims and continuations rules promulgated by the Patent Office, the United States Court of Appeals for the Federal Circuit unceremoniously changed the law as it applies to the awarding of willful damages. Sitting en banc in In re Seagate Technology, LLC, the majority of the Court determined that the negligence standard for determining whether to award enhanced damages for willful infringement is not the appropriate standard, but rather that a reckless standard should be and now is the law of the land.
Curiously, the Federal Circuit announced this significant change to the law relating to willfulness in a case that related to a discovery dispute. Seagate Technology, LLC petitioned the Federal Circuit for a writ of mandamus directing the United States District Court for the Southern District of New York to vacate Orders compelling disclosure of materials and testimony that Seagate claimed was covered by the attorney-client privilege and work product protection. The Court, per Judge Mayer, would say that this case requires confrontation “the willfulness scheme and its functional relationship to the attorney-client privilege and work product protection.”
When the Supreme Court remanded the Federal Circuit’s original panel decision in AMP v. USPTO for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., I said that nothing would change in that remand. In particular, I predicted that the same two-to-one majority from that Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) would again rule that the claimed isolated DNA sequences were patent-eligible under 35 U.S.C. § 101. My primary reason for my confidence in that prediction was that the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) would control on that claimed subject matter, not Mayo Collaborative Services. See Chakrabarty Controls on Isolated DNA Sequences, not Mayo*.
So guess what happened in the AMP remand of? As I predicted, simply “déjà vu”: the same two-to-one majority ruling for essentially the same reasons, as well as confirming that Chakrabarty (not Mayo Collaborative Services) controlled on the patent-eligibility of the claimed isolated DNA sequences. For the full decision see AMP v. USPTO II (August 16, 2012).
A key provision of the Hatch-Waxman Act resides in 35 U.S.C. § 271(e)(1) which provides immunity from a patent infringement suit where the testing of the patented invention is for the purpose of securing regulatory approval from the FDA. Or to use the specific language of 35 U.S.C. § 271(e)(1), there is no patent infringement if the use of the patented invention is “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”
This Hatch-Waxman provision, commonly known as the “safe harbor,” has been construed twice by the Supreme Court, and in an expansive manner to immunize alleged infringing activity. First, in the 1990 case of Eli Lilly & Co. v. Medtronic, Inc., the Supreme Court ruled that this “safe harbor” applied to medical devices, not just drugs as was originally believed (including by the respective House and Senate floor managers for the Hatch-Waxman Act). In fact, the basis for the holding in the Medtronic case makes this “safe harbor” essentially applicable to the testing of any patented invention that is for the purpose of securing regulatory approval from the FDA (e.g., food additives, cosmetics, etc.). See Guttag, “The Ever Expanding ‘Safe Harbor’ of Hatch-Waxman: The Merck v. Integra Lifesciences Case,” Cincinnati Bar Association Report, page 16 (August 2005).
The inventions described in Bancorp’s US Patents 5,926,792 and 7,249,037 concerned methods, media and systems for administering and tracking the value of life insurance policies. A representative claim reads:
A life insurance policy management system comprising:
a policy generator for generating a life insurance policy including a stable value protected investment with an initial value based on a value of underlying securities of the stable value protected investment;
a fee calculator for calculating fees for members of a management group which manage the life insurance policy;
a credit calculator for calculating credits for the stable value protected investment of the life insurance policy;
an investment calculator for determining an investment value and a value of the underlying securities of the stable value protected investment for the current day;
a policy calculator for calculating a policy value and a policy unit value for the current day;
digital storage for storing the policy unit value for the current day; and
a debitor for removing a value of the fees for members of the management group which manages the life insurance policy.
The Bancorp Services case involved two patents, U.S. Pat No. 5,926,792 (the ‘792 patent) and U.S. Pat No. 7,249,037 (the ‘037 patent), relating to methods, systems, and computer-readable media for administering and tracking the value of life insurance policies in separate accounts. Both the ‘792 patent and ‘037 patent share a common patent specification having a priority date going back almost 16 years (September , 1996). Also, this is not the first time the Federal Circuit has grappled with ‘792 patent. There was an earlier 2004 Federal Circuit decision which reversed a grant of summary judgment of invalidity of the ‘792 patent based on “indefiniteness,” as well as a 2008 Federal Circuit decision which vacated a judgment of noninfringement of the ‘792 patent.
On Friday, July 20, the Federal Circuit heard oral arguments in the remand of the AMP et al. v. USPTO et al. appeal – the case better known as the Myriad Genetics “gene patent” case. The supplemental briefing in this case, and the oral argument itself, continue to reveal how those with diverse perspectives on DNA patents misunderstand each other. Scientists are making dubious assumptions about the operation of patent law. Patent lawyers are making inaccurate assumptions about how the science works. And those who are neither patent lawyers nor scientists just go by what they’ve been told. The Department of Justice’s (DOJ) supplemental amicus brief and oral argument in this case are a good example of the widening disconnect.
“Kitschy, Not Catchy”
Readers will recall that this is not the first time DOJ appears in this case. Two years ago when the Myriad case first reached the Federal Circuit, DOJ filed an unsolicited brief, replete with hypothetical examples of elemental lithium, cotton, coal, isolated electrons, and other things having nothing to do with molecular biology, siding in part with the American Civil Liberties Union (ACLU), and arguing that Myriad’s claims to BRCA-encoding DNA molecules are patent-ineligible under Section 101.
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