Monthly Archives: January 2011

Soy Meal a “Dead Material”- No Functional DNA

A Patent Infringement suit was filed by Monsanto Technology LLC against Cefetra, Vopak Agencies and Alfred C. Toepfer International GmbH, for exporting soy meal from Argentina to European Community. The judgement was carried out by the court of justice of European Communities “Grand Chamber”. Preliminary ruling under Article 234 EC from the Rechtbank’s’Gravenhage (Netherlands).

Introduction:

Monsanto’s European patent EP0546090 (‘090) granted on 19 June 1996, discloses “Glyphosate tolerant 5-enolpyruvylshikimate-3-phosphate synthases”, the patent being valid, inter alia, in Netherlands. Glyphosate, a non-selective herbicide, exhibits an anti-growth effect on plants by inhibiting Class I enzyme 5-enol-pyruvylshikimate-3-phosphate synthase (also called ‘EPSPS’). As a result plants die due to its toxic effect.

The patent ‘090 describes a class of EPSPS enzymes i.e. Class II EPSPS enzymes instead Class I which are resistant to glyphosate. Hence, plants containing such enzymes survive the use of glyphosate, and only the weeds get destroyed. The genes encoding these Class II enzymes have been isolated from three different bacteria. Those genes were incorporated into the DNA of a soy plant, called RR (Roundup Ready) soybean plant. As a result, the RR soybean plant produces a Class II EPSPS enzyme called CP4-EPSPS, which is glyphosate-resistant. It thus becomes resistant to the herbicide ‘Roundup’.

Infringement Suit Filed:-

The RR soybean is cultivated on a large scale in Argentina, where Monsanto did not hold any patent protection for his invention. Importing soy meal from Argentina into Amsterdam port on 16 June 2005, 21 March and 11 May 2006 by Cefetra, Vopak and Toepfer had led to a case of Patent infringement and hence Monsanto applied for injunctions against the three before Rechtbank’s-Gravenhage, on the basis of Article 16 of Regulation No 1383/2003, and for a prohibition of infringement of the European patent in all countries in which the patent is valid. Samples of exported soy meal were tested by Monsanto to determine whether they originated from RR soyabeans. Results revealed the presence of CP4-EPSPS in the soya meal and the DNA sequence encoding it.

In turn, Cefetra, supported by Argentine State, argued that Article 53a of the 1995 Law is exhaustive in character, stating that if the DNA present in the soy meal can no longer perform its function in that substance, Monsanto opposing the marketing of the soy meal solely on the ground that the DNA is present in it. It claimed the connection between the limited patentability referred to in recitals 23 and 24 in the preamble to the Directive and the scope of the protection conferred by a patent. Recital 23 in the preamble to the Directive (European Union Law) states that a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention. Recital 24 in the preamble to the Directive (European Union Law) indicates that, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs. Monsanto argued stating that “The purpose of the Directive is not to limit the protection for biotechnological inventions that exists in Member States neither does it affect the protection conferred by Article 53 of the 1995 Law, which is absolute. A restriction on protection would be incompatible with Article 27 of the TRIPS Agreement”

But, the key statement by Rechtbank’s-Gravenhage (where the case was filed initially) after observing Article 53a(3) of the 1995 Law, like Article 9 of the Directive, stands were:-

–          The DNA/genetic material hold the exclusive right of the proprietor of the patent if the genetic information is found in that material and performs its function therein.

–          This concludes that soy meal being a dead material does not expresses the functional DNA.

Hence, Article 53a(3) of the 1995 Law and Article 9 of the Directive, does not go in favor of Monsanto’s arguments of his patent being infringed and explicitly states that DNA function was observed in the soy plant at the given moment, and it could again express its function when isolated from soy meal and transferred to a living material.

On the above circumstances, the following articles were discussed:-

1.      Article 9 of Directive 98/44/EC of the European Parliament states that the patented product (enzyme and its encoding DNA) is contained in the soy meal, where it does not perform the function for which it is patented, but did perform that function previously in the soy plant, of which the meal is a processed product, or would possibly again be able to perform that function after it had been extracted from the soy meal and inserted into the cell of a living organism.

2.   Article 9 of the Directive effects an exhaustive harmonization of the protection it confers, with the result that it precludes the national patent legislation from offering absolute protection to the patented product as such, regardless of whether it performs its function in the material containing it.

3.      Article 9 of the Directive precludes the holder of a patent issued prior to the adoption of that directive from relying on the absolute protection for the patented product accorded to it under the national legislation then applicable.

Key Take Away:-

In this context of patent infringement case, I would like to highlight two facts :-

Firstly, though the soy meal as stated by the court to be a “dead material” exported from Argentina is likely to be produced from soy plant, incorporating with the modified DNA encoding CP4-EPSPS, revealed by the tests could be a ardent fact of infringing, evidently, Monsanto’s protected process patent (though not product patent) in the European territory while trading the plant product into its (European) community where Monsanto holds still a valid patent.

Secondly, if Monsanto would have hold a Patent protection of RR soybean in Argentina, then Cefetra along with Vopak and Toepfer, certainly had to bear the cost for infringing Monsanto’s invention for the respective territory. Hence, the Infringement Suit would have been in Monsanto’s favor. This reminds our Indian corporates/Inventors and R&D Institutes to rethink their IP Portfolio strategy and to make sure that the patent has been protected globally.

CASE NO – C-428/08

About the Author:- Ms. Minusmita Ray, a Patent Specialist in IIPRD and can be reached at minusmita@iiprd.com

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“Clear and Convincing Evidence”

Case “Microsoft Vs i4i” interests me as I saw the recent Supreme Court decision to hear this case again.

Long story in short, i4i filed a patent in 1994 and gets granted on 07/98 (US 5,787,449). ‘449 relates to a system and method for the separate manipulation of the architecture and content of a document, particularly for data representation and transformations. Interestingly, Microsoft, in its new product, described the new feature as “truly integrate your documents with business processes and business data,” and explained the role of XML Data Store in MS Office 2007 documents. Unfortunately, description of the MS Office document XML Data Store basically equates to the i4i patent’s description of the “raw content area.” Similarly, Microsoft description of the “relationship from the main document” to the data stored in the XML Data Store relates to the i4i patent’s metacode mapping.

I4i sued Microsoft for Patent infringement and in turn Microsoft requested and filed a Re-examination of the ‘449 Claims citing Prior arts ”DeRose” and “Cowan”. The Lower court said that the ‘449 Claims are valid and Microsoft decided to appeal to the Federal court. Even CAFC, affirmed the lower courts decision and ordered a heavy injunction on Microsoft. With a clear infringement, Microsoft has got less or no space in fighting for technicality or Novelty requirements of ‘449 Patent.

Knowing this, Microsoft has appealed to the apex court in an interesting manner. Microsoft is expected to attack the system of validating patents itself.  For sure, it will request the apex court to consider and lessen the burden of defendants to show prior arts for“clear and convincing evidence”. On the other hand i4i Chairman Loudon Owen warned about Microsoft’s argument that patent invalidity should be held to a lower standard. “The attack on patent holders and the adverse implications from the standard Microsoft is proposing is unprecedented and would deal a devastating blow to any U.S. patent holder, large or small,” Owen said. “Naturally, the proposed standard would be particularly destructive to the value of patents for inventors, technology pioneers and entrepreneurial companies that don’t have the resources of Microsoft and other giants.

We will come to know, whether the Supreme Court will nod for the change in Legal system, particularly the burden of Proof section, when the case to be heard in Spring 2011.

Author – Veera Raghavan Rajendran,

Senior Patent Consultant, IIPRD.

The Author of the Blog can be reached:  Raghavan@iiprd.com.

 

 

Claim Construction – Interpretation to Determine Obviousness

The present case relates to reexamination (Reexamination No. 90/008,482) of US Patent No. 5, 236, 503, referred to as ‘503 hereinafter. The concerned Applicant GLATT AIR TECHNIQUES, INC. (referred to as Glatt hereinafter) appealed against the order of the Board of Patent Appeals and Interferences, which was decided on 5’th Jan 2011.

As an introduction, a third party requested ex parte reexamination of the patent. The U.S. Patent and Trademark Office (“PTO”) granted reexamination as to claims 5-8 and 10 of the ’503 patent. During reexamination, Glatt canceled claims 6, 7, and 9-11, limiting the reexamination to un-amended claim 5 and amended claim 8. The examiner rejected claim 5, but allowed amended claim 8. Glatt appealed the examiner’s rejection of claim 5 to the Board, which affirmed the examiner’s rejection.

The invention relates to a coating apparatus known as a “Wurster Coater” used to coat particles, e.g., pharmaceutical ingredients. Wurster coaters work by spraying the desired coating material onto particles circulating within the apparatus. The existing coating apparatus suffer from particle agglomeration, which increases the amount of time it takes to coat the particles. This agglomeration occurs because the circulating particles prematurely enter the stream of coating spray before the spray pattern has fully developed. This premature entry causes the particles to become overly wet and to stick together thereby causing blockages in the apparatus.

Glatt’s solution to this problem involves shielding the coating spray nozzle to prevent the particles from entering the spray prematurely. Glatt does this by creating a cylindrical partition that surrounds the coating spray nozzle and acts as a physical shield to prevent premature entry of the circulating particles. Col 5 Lines 3-12 of the Specification of Glatt’s patent additionally notes that “other shielding arrangements may be utilized. For example, shielding of the spray nozzle may be accomplished by formation of an air wall or stream that surrounds the nozzle and prevents particles from prematurely entering into the spray pattern.”

Following is the contested claim 5 of Glatt:

5. In a fluidized bed coater having a product container opening upwardly into an expansion chamber and downwardly into a lower plenum chamber through an air distribution plate/screen having openings formed therethrough for upward air flow from said lower plenum chamber into said product container, said product container including a substantially cylindrical partition spaced above said air distribution plate/screen for defining an inner upbed area and an outer downbed area, and an upwardly discharging spray nozzle mounted substantially centrally within said cylindrical partition,

the improvement comprising

shielding means positioned adjacent said spray nozzle for shielding the initial spray pattern developed by said nozzle against the entrance of particles moving upwardly through the upbed.

As can be seen, Claim 5 of the Glatt is written as a Jepson Claim, wherein the preamble is rendered as the prior art and the invention is the improvement. i.e., a shield used in the Wurster coater. Improvement portion of claim 5 also has a means-plus-function limitation—a “shielding means.”, wherein in a means-plus-function claim, scope of the claim is limited to the embodiments listed in the specification of the patent.

As the proposed novel part of the claim was considered as “shielding means positioned adjacent said spray nozzle”, during the re-examination procedure, the examiner identified DE 3323418 (“Naunapper”) and rendered Claim 5 (Jepson Claim) as obvious keeping in mind the embodiment put across in the specification of ‘503 Patent, which stated “shielding means” to include “formation of an air wall or stream that surrounds the nozzle and prevents particles from prematurely entering into the spray pattern”. The examiner contended that Naunapper discloses “an air wall, or air jacket, surrounding said spray nozzle” thereby rendering the Applicant’s invention obvious. After an appeal to the  board, the board of appeals too affirmed with the examiner and contended that the claimed subject matter was obvious as an air wall that surrounds the nozzle as disclosed by Naunapper would render all possible physical or air wall based shielding mechanisms of Glatt obvious.

When the matter was appealed to the US Court of Appeals, the Circuit Judges held that as Glatt does not contest that the preamble to claim 5 is admitted prior art, the inquiry is limited to whether Glatt’s invention as a whole would have been obvious to a person of ordinary skill in the art in view of the prior art Wurster coaters described in the claim and the Naunapper reference. It was understood that both Glatt’s invention and Naunapper’s coating apparatus contain coating spray nozzles and that both also include an air source located below the coating spray nozzle. Further, the air is used to circulate the particles in the apparatus into the spray of coating material.

However, additionally, Glatt’s invention includes an element that reduces particle agglomeration, described and claimed as “a shielding means that prevents the circulating particles from prematurely entering the initial spray pattern”. Naunapper, on the other hand, contains no such element and the PTO argues that the air source itself can be used to generate an air wall that shields the particles from the initial spray pattern. It was further held that the PTO indicates that Naunapper combats the particle agglomeration problem by temporarily increasing the airflow from the air source. The modulated “burst” of air/gas flow generated by this technique clears blockages by blowing through the agglomeration and dispersing the particles.

It was finally held that, that the proposed technique of Naunapper does not shield circulating particles from entering the initial spray pattern and rather merely teaches to remedy the blockage caused by particle agglomeration using bursts of air. In contrast, Glatt’s invention prevents the agglomeration from occurring in the first place. This led to the decision that the Board’s finding that Naunapper teaches shielding the nozzle to prevent particles from prematurely entering into the initial spray pattern is not supported by substantial evidence because Naunapper does not teach shielding but instead discloses the prevention technique of using airflow for combating and clearing of blockages by blowing through the agglomeration. Because Naunapper does not teach shielding, the federal circuit concluded that the Board has failed to make a proper prima facie case of obviousness.

Key Take Away’s:

1.      Determination of scope of protection of a means plus function claim should take into consideration all embodiments disclosed in the specification of the patent application and specifically the preferred embodiments as illustrated/described in the specification.

2.      Disclosing a potentially similar structure but a completely different purpose (an air wall of Naunapper vs.  formation of an air wall or stream of Glatt) does not objectively render the concerned application obvious. The intended purpose too plays a crucial role in determining the teaching or suggestion of the claimed subject matter by the prior art.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.com.