Drug developers often search for new leads in the biodiversity often found in developing countries. Often, a new theraputic or genetically engineered product is developed and patented.

Depending upon your view, this is either the free market at play in creating new and better products (so-called bioprospecting) or exploitation of developing nations (so-called biopiracy).

However, a lot of tension has arisen from such patents, such as the Enola patent derived from Mexican traditional crop mayocoba bean and the patent on Ayahuasca, a sacred plant. These disputes show that some genetic engineering exploitation and patents based on certain species may be offensive to certain indigenous people’s spiritual, religious, or cultural traditions.

Our Associates at Dannemann Siemsen, a law firm with offices in Rio de Janeiro, São Paulo and Brasília, have alerted us to a new proposed legislative bill that has recently published by the Brazilian Government. Currently, access to genetic resources and associated traditional knowledge, as well as benefit sharing in Brazil are regulated by Provisional Measure 2.186-16 of August 23, 2001.

The new bill, which is open to public consultation until February 28, 2008, is available in Portuguese at the website here. Although the proposed bill is somewhat long, some of its highlights are set forth below:

Genetic Resources And By-Products

The proposed bill makes it clear that access and benefit sharing rules will also cover activities involving the by-products of genetic resources and not only involving information of genetic origin, as provided for in the current Provisional Measure.

Records and Databases

The proposed bill provides for a number of databases and most of the activities involving access to genetic resources and traditional knowledge must be recorded.

No Need of Access Authorizations in Some Cases, in Special Research Without Commercial Purpose

Access to genetic resource for scientific and/or technological research without commercial purposes in some cases will not need previous authorization.

Benefit Sharing Agreement

According to article 86 of the proposed bill, a benefit sharing agreement may be executed after the access, provided that certain conditions are met.

Federal Sales/Royalty Tax

The proposed bill creates a sales/royalty tax (CIDE) directed to governmental funds aimed at financing R&D, supporting traditional communities, conserving biodiversity and benefit sharing.

Agricultural Biodiversity

A new category of biodiversity is created and the corresponding access and benefit sharing are regulated under more flexible rules.

Prison and Administrative Penalties

A number of penalties, such as fines and product seizure, are provided for in case of irregular access to genetic resources and traditional knowledge. Prison terms are defined, e.g., in case of the illegal remittance abroad of biological material.

Patent Disclosure

The corresponding access license must be attached to patent applications covering subject-matter obtained via access to genetic resources and to its by-products and associated traditional knowledge.

Please feel free to contact Dannemann Siemsen should you require further details on the current rules and on the provisional bill concerning biodiversity access and benefit sharing.

See also:

India Fights Back Against Biopiracy

Bioprospecting Discussed at the UN

Article on the Convention on Biological Diversity (“CBD”), the first international agreement aiming at the protection of biodiversity, sustainable use of biological resources and the sharing of benefits of its exploitation.

Posted February 15th, 2008 by Stephen Albainy-Jenei in BioAg, Biotech News
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To paraphrase Ronald Reagan, “Well, There You Go Again!” The Court of Appeals for the Federal Circuit again affirmed that, while the practice of savings seeds after a harvest to plant the next season is as old as farming itself, you can’t save patented seeds.

After the district court held that Loren David knowingly infringed Monsanto’s seed patent, it awarded Monsanto damages, attorney fees, prejudgment interest, and costs of $786,989.43. On appeal, the CAFC affirmed that the patent was infringed but that some of the damages awarded were wrong. See Monsanto v. Loren David (07-1104).

Monsanto went after the farmer for breaching a technology agreement over genetically modified crops that resist glyphosphate herbicide. After planting these crops, farmers can spray glyphosphate herbicide over their fields to kill weeds while leaving the resistant crops intact. Monsanto sells seeds of the genetically modified crops, in this case soybeans, under the trade name Roundup Ready.

Monsanto’s U.S. Patent No. 5,352,605 claims a plant seed containing a genetic promoter sequence that facilitates a plant’s production of the modified enzyme that allows plants to survive exposure to glyphosphate herbicide. Monsanto distributes the patented seeds by authorizing various companies to produce the seeds and sell them to farmers. Monsanto required those seed companies to obtain a signed “Technology Agreement” from purchasers.

The Technology Agreement stipulates that buyers may use the seeds for the planting of only a single commercial crop, but that no seeds from that crop may be saved for future harvests. The Technology Agreement assures Monsanto that farmers must purchase new Roundup Ready® seeds each harvesting season, rather than simply saving seeds from the prior year’s harvest, as they normally would with conventional soybean seeds. Monsanto also charges a Technology Fee for each unit of Roundup Ready® soybean seeds sold. The Technology Agreement also contains a clause granting Monsanto the full amount of its legal fees and other costs that may have to be expended in enforcing the agreement.

Along comes Farmer David, a commercial farmer who owns soybean fields in North and South Dakota. He signs a Monsanto Technology Agreement in 1999 and plants some of the magic soybeans again in 2003. Monsanto claims that the seeds that David planted were Roundup Ready® soybeans improperly saved from the previous year’s harvest but David claims he did not save any seed.

Earlier, David purchased 645 units of Roundup Ready® soybean seeds, an amount of seeds that could not have covered David’s soybean fields in 2003. David also bought over 1,000 gallons of glyphosate-based herbicides in 2003, herbicide. Monsanto, ever vigilant for seed savers, tested David’s crops and found that they were from patented seeds.

David cleverly tried to show he purchased 993 units of Roundup Ready® soybean seed on May 31, 2003, but that was nearly a month after he claimed to have planted the majority of his soybean crop for the year. The court said “Nice try but no dice!”

Furthermore, the court found David’s testimony regarding his claimed purchase of conventional herbicides “not believable” and that David was unreliable as a witness. Hence, it ordered David to pay up.

It is important to note that the ‘605 patent claims a gene sequence, not a plant variety or a seed. David tried pleading that the ’605 patent cannot be infringed merely by saving seeds from plants containing the patented gene sequence. He argued that the written description of the ’605 patent lacks the specificity that would be required of a patented plant variety under the utility patent statute; thus, the ’605 patent is limited to the gene sequence and does not cover the plant containing such a gene.

David tried to fly under the premise that under J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, plants can only receive patent protection under the Plant Patent Act of 1930, the Plant Variety Protection Act of 1970, or under a utility patent on a plant variety. Thus, a utility patent on a gene sequence does not entitle the holder of that patent to enforce its grant of exclusivity against growers of plant varieties that contain the gene sequence.

Monsanto responded by showing that the holding of J.E.M. is just the opposite of what David claims it to be; patentable subject matter remains unmodified by the existence of the P.V.P.A. and the P.P.A. Moreover, Monsanto points to various decisions of this court that have read the ’605 patent onto plants and seeds containing the patented gene and holding those who save seeds liable for infringement.

The Supreme Court’s decision in J.E.M. stated that the existence of statutes specifically authorizing the patenting of plants (the P.P.A. and the P.V.P.A.) did not eliminate the availability of utility patent protection covering plants.

In smacking David down, the CAFC scolded him saying:

David’s real complaint seems to be that he should be able to save seed from his harvest, regardless of Monsanto’s patent. We have dealt with this complaint before. See e.g. Monsanto Co. v. McFarling, 302 F.3d 1291 (Fed. Cir. 2002). In McFarling, we held that a farmer who saved seed containing a patented gene was liable for patent infringement. Id. at 1299 (citing J.E.M., 534 U.S. at 604). McFarling further established that “the right to save seed of plants registered under the PVPA does not impart the right to save seed of plants patented under the Patent Act.” Id. We note that McFarling dealt with the very patent at issue in this case—the ’605 patent. We may not disregard a prior decision of this court regarding the same matter.

…

Due to his continually changing testimony, the court disregarded much of David’s testimony. See id. Given David’s unreliability as a witness, and a complete lack of other evidence supporting his claims, we conclude that the district court did not clearly err in determining that David planted saved seed.

David also tried to get the seed report tests conducted by Monsanto and the testimony of Monsanto’s expert Koppatschek, which relied on those seed report tests, thrown out.

Rule 702 of the Federal Rules of Evidence allows expert testimony if “(1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.”

This didn’t work since the Federal Rules of Evidence establish that an expert need not have obtained the basis for his opinion from personal perception. Reliance on scientific test results prepared by others may constitute the type of evidence that is reasonably relied upon by experts for purposes of Rule of Evidence 703.

See also:

Monsanto Planted By Patent Office Re-Exam
Re-Planting Biotech Crops A No-No

Posted February 13th, 2008 by Stephen Albainy-Jenei in BioAg, IP Litigation
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Monsanto sued Bayer Bioscience claiming that four Bayer patents relating to chimeric genes, including U.S. Patent Nos. 5,545,565, are invalid and not enforceable. After the district court declared the four patents unenforceable for inequitable conduct Bayer appealed. The U.S. Court of Appeals for the Federal Circuit agreed after finding their researcher was less than forthcoming on her notes. Monsanto Co. v. Bayer Bioscience N.V. (07-1109).

The ’565 patent claims chimeric genes comprising (a) a truncated Bt toxin gene encoding an approximately 60 kD to 80 kD Bt toxin of a specific amino acid sequence, and (b) the regulatory region of a gene “naturally expressed in plant cells,” which enables the gene to be transcribed in plants, i.e., a plant promoter.

Certain strains of bacteria (Bacillus thuringiensis or Bt) produce proteins, known as Bt toxins, that are harmless for humans and most animals but are toxic to certain insects.

At district court, a jury found the asserted claims of the ’565 patent not infringed and invalid for obviousness and prior invention by Monsanto. In a 99-page opinion, the district court found materiality and intent for two separate acts relating to the ’565 patent and concluded that inequitable conduct made the ’565 patent unenforceable.

Here, Bayer argued that prejudicial evidence was admitted during the jury trial, that there was insufficient evidence to sustain the jury findings of prior invention and obviousness, that the district court erred in finding the ’565 patent unenforceable for inequitable conduct.

To hold a patent unenforceable for inequitable conduct, a district court must find by clear and convincing evidence that a patent applicant breached its duty of candor and good faith to the United States Patent and Trademark Office by failing to disclose material information, or submitting false material information, with an intent to deceive the PTO.

During the prosecution of the ’565 patent, Bayer disclosed as prior art an abstract by Dr. Wayne Barnes from a conference at which Barnes had a poster presentation.

After the Examiner rejected all claims as obvious over various prior art references including the Barnes Abstract, Bayer argued:

Barnes et al. fails to identify which Bt toxin gene should be utilized and also fails to show that the fusion gene would work in plants. Also, if the “second half” of the Bt gene would be deleted, as Barnes et al. suggests, the remaining part would encode a protein of 576 amino acids, which is not toxic.

Although Bayer disclosed the Barnes Abstract during patent prosecution, it did not disclose the notes taken by one of its employees, Dr. Mariani, who viewed the Barnes Poster. The poster contained much more information in showing a truncated Bt toxin gene at or near the restriction enzyme site xho and that this gene fragment encoded a N-terminus 67 kD truncated Bt toxin which retained toxicity.

The Mariani notes were “widely circulated” among Bayer’s Bt group and the intellectual property department. The patent attorney handling the cases, Meulemanns, conceded that “if [the Mariani] notes would add anything of reliable information which could add to the abstract, that could be important” to a patent examiner.

One troublesome point for Bayer was that Bayer argued that its disclosure of a chimeric gene with one version of a truncated Bt gene was sufficient to enable the genus of all chimeric genes with any truncated Bt toxin gene. The court said Bayer can’t have it both ways – that is, they can’t now argue that only those prior art references disclosing the particular Bt toxin described in the specification can be material.

The district court concluded: “[I]t is very obvious that the poster notes, if they were disclosed to the patent examiner, which they were not, would stand in sharp contradiction to the Bayer argument before the patent examiner . . .”

Finding this material, the court explained:

[I]is clear that the Barnes notes coded for the same 67 Kd toxic protein Bayer wanted to claim, that the Barnes gene was 3.4 kb for the full length, that because of the identified xho site, it would be easy to determine the identity of the Bt gene being used, and the chimeric gene used was toxic to insects by the drop. There is a substantial likelihood that a reasonable examiner would have considered the Barnes notes important in deciding whether to allow the application to issue as a patent. . . .

Bayer argued that the district court’s determination that the Mariani notes were material was based on the conclusion that the Barnes construct “coded for the same 67 kD toxic protein Bayer wanted to claim” and “that because of the identified xho site it would be easy to determine the identity of the Bt gene being used.”

Bayer argued that these were unsupported speculations and that without this “erroneous finding of fact, there can be no materiality.”

The Federal Circuit thought differently holding that the district court didn’t need to find that Barnes used the identical Bt toxin to be material:

First, at the time of the Examiner’s rejection, Bayer was not limiting its claim to one species of Bt toxin protein but was broadly claiming a chimeric construct encoding any 60-80 kD N-terminal fragment of a Bt toxin protein. Thus, any species of chimeric gene created by Barnes within this genus would directly implicate the allowability of Bayer’s claims.

Second, none of the Examiner’s rejections, including his rejections of the sequence specific claims, nor any of Bayer’s arguments to overcome these rejections, relied on the exact sequence of Bt toxin used by Barnes.

The court noted that Bayer’s failure to disclose the Mariani notes to the PTO, even if highly material, is not sufficient to prove inequitable conduct. This requires clear and convincing evidence showing an intent to deceive the PTO.

We have held that absent a credible reason for withholding the information, “[i]ntent may be inferred where a patent applicant knew, or should have known, that withheld information would be material to the PTO’s consideration of the patent application.”

Having found that Bayer intentionally withheld material information when it failed to disclose the Mariani notes despite taking a position at the PTO that was refuted by the information contained in the notes, the Federal Circuit affirmed the district court’s discretion to hold the ’565 patent unenforceable for inequitable conduct.

Posted January 26th, 2008 by Stephen Albainy-Jenei in BioAg, Biotech, IP Litigation
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In another challenge to patents it just doesn’t like, the nonprofit organization Public Patent Foundation (PUBPAT) got the U.S. Patent and Trademark Office (USPTO) to grant a request for reexamination of four crop science-related patents held by Monsanto. PUBPAT seems to be on a roll after successfully getting reexams of patents on Pfizer’s Lipitor, WARF’s stem cells., and Gilead Sciences.

Basically, Monsanto sells genetically modifies seeds, e.g., canola, soybeans, corn, cotton, that are herbicide-resistant. The seeds are only good for one generation, so the company sells new seeds, plus the herbicide, to farmers every year and producing increased crop yields.

PUBPAT requested ex parte reexamination under 35 U.S.C. §§ 302-307 and 37 C.F.R. § 1.510 claiming they are all invalid under 35 U.S.C. §§102 and 103 and their existence is causing significant public harm and impeding scientific progress. In its Office Actions rejecting each of the patents, the USPTO held that evidence submitted by PUBPAT, in addition to other prior art located by the Patent Office’s Examiners, showed that Monsanto was not entitled to any of the patents.

Monsanto will not get a lot of sympathy from farmers who know Mansanto to be heavy-handed in filing dozens of patent infringement lawsuits asserting the four challenged patents, often for saving seed from one year’s crop to replant the following year, which is not allowed under patent law. PUBPAT argues that Monsanto is using them to harass, intimidate, sue - and in some cases literally bankrupt - American farmers.

The lawsuits filed by Monsanto against American farmers include Monsanto Company v. Mitchell Scruggs, et al, 459 F.3d 1328 (Fed. Cir. 2006), Monsanto Company v. Kem Ralph individually, et al, 382 F.3d 1374 (Fed. Cir. 2004) and Monsanto Company v. Homan McFarling, 363 F.3d 1336 (Fed. Cir. 2004).

The patents involved here are U.S. Patents 5352605, 5164316, 5196525, and 5322938, all of which assert claims to the CaMV 35S promoter, double 35S enhancer, and/or constructs containing them:

5,164,316 describes a plant cell comprising a DNA construct having as components, (a) a duplicated CaMV 35s enhancer sequence comprising an AluI-EcoRV fragment of a CaMV 35S upstream region; and (ii) a promoter comprising an RNA polymerase binding site and an mRNA initiation site; (b) a nucleotide sequence of interest for transcription to mRNA; and (c) a termination region;

5,196,525 provides for a DNA construct having as components, (a) a transcription initiation region including (i) a tandemly duplicated CaMV 35S enhancer sequence comprising an AluI-EcoRV fragment of a CaMV 35S upstream region; (ii) a promoter comprising an RNA polymerase binding site and an mRNA initiation site; (b) a nucleotide sequence of interest for transcription to mRNA; and (c) a termination region ;

5,322,938 provides for transcription initiation regions that provide for enhanced transcription or a DNA sequence, particularly a plant sequence; and

5,352,605 relates to the use of viral promoters in the expression of chimeric genes in plant cells. It also relates to chimeric genes which are capable of being expressed in plant cells, which utilize promoter regions derived from viruses which are capable of infecting plant cells. One such virus comprises the cauliflower mosaic virus (CaMV). Two different promoter regions have been derived from the CaMV genome and ligated to heterologous coding sequences to form chimeric genes. These chimeric genes have been shown to be expressed in plant cells.

Monsanto, of course, will now have an opportunity to respond so it ain’t over till it’s over. The patent office grants over 90 percent of the requests for reexamination and many of those patents are issued with substantially the same claims as before reexamination. This issue could take years to resolve. In the end, the USPTO could allow the claims, reject only certain claims, or allow the claims in an amended form.

See the requests for reexamination and the office actions at PUBPAT here.

PatentLens provides an excellent breakdown of the claims relating to the 35S promoter and duplicated CaMV 35S enhancer sequences. 

Posted August 1st, 2007 by Stephen Albainy-Jenei in BioAg, Biotech, USPTO
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