While krill oil arch rivals Aker and Neptune are on the same page when it comes to rogue traders peddling ‘fake' krill products, they have been at loggerheads for years over intellectual property (IP) issues.
Their most recent bone of contention is a US patent awarded to Neptune (#8,030,348) covering marine phospholipids to which the omega-3 fatty acids EPA and DHA are bound.
Aker says the claims in it are ‘unpatentable’ (and has just persuaded the patent office to reexamine them), while Neptune says it has complete confidence in its IP.
If you are the first to purify and isolate a natural product, you can patent it in its isolated form
But who is right? And what can and cannot be patented when it comes to plants and animals?
More than you think, says Speier.
“You always get people saying ‘you can’t patent what’s found in nature’”, he says.
“Well that’s not strictly the case. While lots of patents in this area are process patents [where you are patenting the extraction process, for example] if you are the first to purify and isolate a natural product, you can patent it in its isolated form.”
The devil is in the detail, says Speier, a patent attorney at Schwegman, Lundberg & Woessner.
The compound must be novel (that is, there must have been no description of the compound in the literature), non-obvious (the compound cannot be too similar to a compound known in the literature), it must be useful, and you must describe how to make it (eg. purify it) and how to use it.
Inter Partes re-examinations
But what about re-examinations?
Where the US Patent and Trademark Office (USPTO) agrees to re-examine a patent, there is a reasonable chance of success for the challenger, he says.
According to USPTO data as of September 30, 2011, it has received 1,389 requests for inter partes re-examinations since 1999. Of the 1,246 cases in which it has made a decision, 95% of these inter partes re-examination requests were granted.
Of the 305 inter partes re-examination certificates issued over this period, in 35 (11%) all claims were confirmed; in 133 (44%), all claims were cancelled or disclaimed. In 137 (45%), amendments/changes were made.
In other words, claims were either changed, disclaimed or cancelled in 89% of cases.
Ex parte re-examinations
According to data from the USPTO as of September 30, 2011, the USPTO has received 11,782 ex parte re-examination requests since 1981.
Of the cases in which it has made a decision, about 92% of these re-examination requests (10,333 out of 11,262) were granted.
From the granted requests, 8,578 ex parte reexamination certificates have been issued over this period: 1,943 (23%) with all claims confirmed, 974 (11%) with all claims canceled, and 5,661 (66%) with some claims amended.
As such, claims were either canceled or amended in 77% of these cases.
The costs… and is it worth it?
Securing a patent typically costs $25,000 and takes five to six years, he said. But costs and timelines will obviously vary from case to case.
Now he would say this, but hiring a decent patent attorney is essential if you want to get some bang for your buck, and to ensure that the document is watertight, says Speier.
“A patent is a legal document, and when they are drafted by technical people, you can get problems. I have seen some very badly drafted ones.”
Hanson: Food supplement companies are at a disadvantage vs drug companies
Clyde G. Hanson, managing director of IP and technical advisory firm Venture Isles – which has just commissioned some research for Speier’s firm - says it is difficult for companies dealing in many natural ingredients to justify paying considerable sums on clinical research if the extracts or extraction methods are not patentable - as others will piggyback off your research.
“Many foods and botanicals have had traditional medical applications that might prevent one from gaining a patent, as they show it is not novel.”
He adds: “I do think food supplement companies are at a disadvantage compared to drug companies in being able to earn higher margins during the patent period to pay for the clinical research."
NutraIngredients-USA.com would like to make it clear that Mr Speier has no personal or professional involvement with litigation relating to Neptune's krill oil patents and has not examined Neptune's patents.