Monthly Archives: January 2012

Cookie “Companies” sued by University and Exclusive Licensee thereof

Infringement suit was filed on September 7th 2011 in Western District of Wisconsin by Brandeis University, USA (Brandeis) along with its exclusive licensee GFA brands (“Plantiffs”), against a dozen of cookie companies including Nestle USA, Inc., The Pillsbury Company, LLC, Keebler Co., Famous Amos Chocolate Chip Cookie Company, LLC, East Side Ovens, Inc., Murray Biscuit Co. LLC, Voortman Cookies Ltd., Bremner Food Group, Inc., Wessanen U.S.A., Inc., Cookie Specialties, Inc., Topco Associates LLC (collectively “Defendants”) for illegally using a formula that manipulates the balance between good cholesterol and bad cholesterol, providing “significant health improvements”.

US patent 5,843,497 issued on December 1998 (Patent ‘497) and its family patent US patent 6, 630,192 issued on October 2003 (Patent ‘192) assigned to Brandeis University discloses method of “Increasing the HDL Level in the HDL/LDL Ratio in Human Serum by Balancing Saturated and Polyunsaturated Dietary Fatty Acids”. Brandeis granted a worldwide, sole and exclusive license of ‘497 and ‘192 patents, with the right to sublicense to GFA Brands. This license grants GFA Brands the right to sue for infringement of the ‘497 and ‘192 patents.

The claimed inventions in the ‘497 and ‘192 patents are directed to fats and fat blends that decrease low-density lipoprotein cholesterol (LDL) and increase high-density lipoprotein cholesterol (HDL) in the human serum. This adjustment/balance of the LDL/HDL ratio according to the claimed inventions results in significant health benefits.

Claim(s) Proposed to be Infringed by Companies:

Cookie companies mentioned above are said to have found to be infringing one or more claims of either ‘497 or ‘192 patent or both, by manufacturing, using and marketing the products in US claimed in the patented invention. Typically, independent claim 7 of ‘497 patent and claim 1 of ‘192 patent are found to be infringed by cookie manufacturers.

Claim 7 of ‘497 patent recites:

“7. A prepared food product, comprising a cholesterol-free fat composition suitable for human or animal ingestion for increasing the HDL concentration and the HDL/LDL concentration ratio in the blood serum, comprising one part by weight polyunsaturated fat and at least one part by weight cholesterol-free saturated fat, where said fat composition comprises linoleic acid and at least one saturated fatty acid selected from the group including lauric acid, myristic acid, and palmitic acid, said linoleic acid constituting between 15% by weight and 40% by weight of the fat in said fat composition and said saturated fatty acid constituting between 20% and 40% by weight of the fat in said fat composition.”

Claim 1 of ‘192 patent recites:

“1. A cholesterol-free margarine, comprising a blend of at least one polyunsaturated fat and at least one saturated fat, forming a cholesterol-free blended fat composition, wherein said blended fat composition comprises between 15% by weight and 40% by weight linoleic acid, between 20% and 40% by weight saturated fatty acids, wherein said saturated fatty acids comprise at least one saturated fatty acid selected from the group consisting of lauric acid and palmitic acid, and no more than 1% elaidic acid or other unnatural trans fatty acids by weight; wherein the ratio of polyunsaturated fatty acids to saturated fatty acids is from 0.5:1 to 2:1, and wherein said cholesterol-free margarine is suitable for ingestion by a human as a food product and for increasing the HDL concentration and the HDL/LDL concentration ratio in the blood serum following ingestion by a human.”

Cookies, cookie doughs and products used in making/producing such cookies and selling under company’s respective brand names include for example:

–          Nestle’s: Tollhouse Chocolate Chip Cookie Dough;

–          Pillsbury’s: Grands Flaky Layers Reduced Fat Biscuits and Reduced Fat Crescent Rolls; Topco’s: ShurFine® Vanilla Wafers and ShurFine® Animal Crackers;

–          East Side Ovens’s: Cranberry Orange Cookies;

–          Keebler’s: Chips Deluxe Chocolate Lovers Cookies, Chips Deluxe Oatmeal Chocolate Chip Cookies, and Chips Deluxe Rainbow Cookies;

–          Famous Amos’s: Bite Size Chocolate Chip & Pecans Cookies and Chocolate Chip Cookies; Murray’s: Murray Sugar Free Chocolate Chip Cookies;

–          Voortman’s: Fudge Striped Oatmeal Cookies;

–           Bremner’s: Rippin’ Good® Vanilla Wafers and Rippin’ Good® Animal Cookies

–          Wessanen’s: Baker’s Row Mini Oyster Crackers;

–          Cookie Specialties’: Matt’s® Oatmeal Raisin Cookies

which have been claimed to be infringing at least Claim 7 of the ‘497 patent either directly or indirectly under the doctrine of equivalents.

Similarly, it has also been mentioned that cookies and/or products for making the same by companies like Unilever, Keebler and Bremner, constitute to wilful infringement of at least Claim 1 of the ‘192 patent either directly or indirectly under the doctrine of equivalents. Some of the products of the specified companies include but for example:

–          Unilever’s: Promise Buttery Spread;

–          Keebler’s: Vanilla Wafers and Mini Vanilla Wafers;

–          Bremner’s: Rippin’ Good® Vanilla Wafers

Plaintiffs seek relief from the court about its judgement and respective award of damages from the cookie companies for wilful infringement of their patents. We look forward to the analyze the final outcome on infringement but believe that this trend of university’s exclusive licensee suing potential infringers would grow on a larger scale going forward, with more technology transfer offices looking forward to grant exclusive licenses or sell the IP rights in totality.

Minusmita Ray, Patent Associate, IIPRD, Minusmita@iiprd.com

Technology Transfer/Licensing Opportunity of Crop/Agri Technologies with Syngenta

IIPRD is among the leading Indian IP Consulting Firms focusing on Technology Transfer and Licensing for numerous Indian and Global Corporates and Research Institutes. IIPRD is highly active in the Technology Transfer and Licensing of Patent Backed Technologies/IP’s in the domains of Pharmaceutical, Life Sciences, Diagnostics, Biotechnology, Telecommunications, Software and Medical Devices among others.

Syngenta is one of the world’s leading companies with more than 26,000 employees in over 90 countries and has a core focus on agri-business committed to sustainable agriculture through innovative research and technology.

Syngenta is looking for innovative technologies in specific grower solutions domain and is interested in partnership as well as in-licensing/buying technologies. It is an excellent opportunity for the Indian/ Foreign companies, Universities and Institutes for technology transfer/out-licensing/commercialization of their technologies in the following technology areas.

Types of opportunities that are of interest to Syngenta:

  • Access to technology (e.g. purchase or license)
  • Collaborative proposals
  • New products or concepts for agriculture or lawn and garden

Syngenta is primarily looking for grower solutions comprising genetics, chemistry and/or adjacent technologies for core crops in the areas of:

  • Weed control
  • Disease control
  • Insect control
  • Nematode control
  • Abiotic stress tolerance (e.g. drought, heat, nitrogen)
  • Breakthrough yield
  • Output quality (e.g. shelf life, taste, etc.)

In order to achieve this, Syngenta is also interested in enabling technologies supporting:

  • Formulation technologies
  • Application technology
  • Precision agriculture
  • Seed technologies (seed coating, seed priming, etc)
  • Breeding technologies (double haploids, hybridization systems, quantitative genetics, etc.)
  • Phenotyping technologies for field, greenhouse and lab
  • Bioinformatics
  • Omics (genomics, proteomics, metabolomics, epigenetics, etc.)
  • Genome engineering (plant transformation, recombination, trait stacking, RNAi, etc.)
  • Expression technologies
  • Analytical techniques (small molecule, protein, polymer)
  • Logistics (seed sowing, liquid handling, sample handling, data capture)
  • Modeling (chemical design, environmental studies, field resistance)
  • Chemical process technology.

IIPRD requests all the interested companies/institutes/individuals having the above mentioned technologies to write us at commercialization@iiprd.com or Dayanand@iiprd.com and share the non-confidential data of the same with so that we can, if desired, take forward the discussion with Syngenta for a potential licensing opportunity.

Gevo – Butamax back and forth Ongoing Infringment Lawsuits

It looks like a never ending infringement lawsuits between Gevo Inc. and Butamax Advanced Biofuels LLC on IP rights of bio-isobutanol, a well known biofuel.

On September 13, 2011, Gevo Inc. was granted two patents by USPTO that involved technologies enabling low-cost, high-yield production of bio-based isobutanol. Gevo’s patent 8,017,375 (‘375), “Yeast Organism Producing Isobutanol at a High Yield” focuses on the modification of yeast to produce isobutanol instead of ethanol. Patent 8,017,376 (‘376), “Methods of Increasing Dihydroxy Acid Dehydratase Activity to Improve Production of Fuels, Chemicals, and Amino Acids” covers enzymatic steps on isobutanol production from yeast.

Office action response of Gevo’s 375 patent

The Examiner had rejected claims 131-149 of Gevo’s application over US 7,851,188 (of Donaldson/Butamax) citing that it disclosed the genes encoding the enzymes for isobutanol synthesis. On 28 April 2011, Gevo made a response to the rejection by the Examiner stating Butamax had NOT disclosed pdc disruption. Further for pdc disruption, the Examiner cited van Maris (2004), and thus gave a 103 rejection. Gevo overcame this by adding the requirement: an .alpha.-ketoisovalerate decarboxylase from Lactococcus lactis to catalyze the conversion of .alpha.-ketoisovalerate to isobutyraldehyde.

Claim 1 of issued US 8,017,375 states:

A recombinant yeast microorganism for producing isobutanol, the recombinant yeast microorganism comprising an isobutanol producing metabolic pathway, wherein said isobutanol producing metabolic pathway comprises the following substrate to product conversions: (i) pyruvate to acetolactate; (ii) acetolactate to 2,3-dihydroxyisovalerate; (iii) 2,3-dihydroxyisovalerate to .alpha.-ketoisovalerate; (iv) .alpha.-ketoisovalerate to isobutyraldehyde; and (v) isobutyraldehyde to isobutanol; wherein said recombinant yeast microorganism expresses: (a) an acetolactate synthase to catalyze the conversion of pyruvate to acetolactate; (b) a ketol-acid reductoisomerase to catalyze the conversion of acetolactate to 2,3-dihydroxyisovalerate; (c) a dihydroxy acid dehydratase to catalyze the conversion of 2,3-dihydroxyisovalerate to .alpha.-ketoisovalerate; (d) an .alpha.-ketoisovalerate decarboxylase from Lactococcus lactis to catalyze the conversion of .alpha.-ketoisovalerate to isobutyraldehyde; and (e) an alcohol dehydrogenase to catalyze the conversion of isobutyraldehyde to isobutanol; wherein the recombinant yeast microorganism has been engineered to disrupt, mutate, or delete one or more endogenous pyruvate decarboxylase (PDC) genes, wherein said recombinant yeast microorganism has reduced endogenous PDC activity as compared to the corresponding yeast microorganism that has not been engineered to have reduce endogenous PDC activity, and wherein said recombinant yeast microorganism produces: (A) isobutanol at a yield which is at least 10% of the theoretical yield of isobutanol from glucose; and/or (B) ethanol at a yield which is 1.8% or less of the theoretical yield of ethanol from glucose.

The first claim of the Butamax ‘188 patent states:

A recombinant microbial host cell comprising heterologous DNA molecules encoding polypeptides that catalyze substrate to product conversions for each step below: i) pyruvate to acetolactate; ii) acetolactate to 2,3-dihydroxyisovalerate; iii) 2,3-dihydroxyisovalerate to .alpha.-ketoisovalerate; and iv) .alpha.-ketoisovalerate to isobutyraldehyde; wherein said microbial host cell produces isobutanol; and wherein a) the polypeptide that catalyzes a substrate to product conversion of pyruvate to acetolactate is acetolactate synthase having the EC number 2.2.1.6; b) the polypeptide that catalyzes a substrate to product conversion of acetolactate to 2,3-dihydroxyisovalerate is acetohydroxy acid isomeroreductase having the EC number 1.1.1.86; c) the polypeptide that catalyzes a substrate to product conversion of 2,3-dihydroxyisovalerate to .alpha.-ketoisovalerate is acetohydroxy acid dehydratase having the EC number 4.2.1.9; d) the polypeptide that catalyzes a substrate to product conversion of .alpha.-ketoisovalerate to isobutyraldehyde is branched-chain .alpha.-keto acid decarboxylase having the EC number 4.1.1.72.

Prior to this case, Butamax on January this year, filed two infringement lawsuits against Gevo, alleging Gevo unlawfully used Butamax technology regarding the 7,851,188 (‘188) patent issued on December 2010 and its related patent related 7,993,889 (‘889) granted on Auhust 9, 2011. The patent ‘188 covers biocatalysts that Butamax developed to produce isobutanol. Second patent ‘889 covers methods for low-cost production of biobutanol.

Butamax stated that “Butamax and its owners were the first to develop this technology and it is our belief that the protection of intellectual property serves the best interest of the biofuels industry, our customers and the U.S. energy policy.”

However, Gevo highlighted that it did not use the technology claimed in Butamax’s patents, but employed its own distinct technology, GIFT® (Gevo Integrated Fermentation Technology®), which is covered by more than 150 patent applications that enables the efficient production of isobutanol.

Later Gevo filed a lawsuit against Butamax and its parent company DuPont in charge of infringing Gevo’s two newly-issued patents (‘375 and ‘376). The invention described in the two patents involves Gevo’s unique technology to produce isobutanol. Hence the lawsuit is based on Butamax’s own publications describing their use of the technology that Gevo invented first and for which they have received patents.

In regards to this infringement suit, Paul Beckwith, CEO of Butamax stated:

“When Butamax makes isobutanol, we do not use the technology claimed in the Gevo patents. We are so confident about this, that we offered Gevo an opportunity to independently verify that Butamax does not infringe either of these patents. Ignoring both our offer to verify and the facts, Gevo instead filed its lawsuit.”

Butamax further added that it plans to seek legal relief from this frivolous suit and was confident in the eventual result from the court.

The Gevo patents are for a limited technology, which when applied for isobutanol production, are dominated by Butamax’s intellectual property and are invalid, as claimed by company officials.

Moreover Gevo’s patents are based on Butamax’s technology and cannot be practiced to make isobutanol without infringing Butamax’s rights. Indeed, Gevo’s patents include clear evidence of Gevo’s use of Butamax’s technology and infringement.

Continuing the chain of law suits Gevo further filed two petitions in USPTO to re-examine Butamax’s both patents ‘188 and ‘889 stating that the two patents were already known in the scientific community and were already been invented by others before Butamax applied for the patents.

For patent ‘188 of Butamax, Gevo cited references under light of obviousness under 35 USC 103 of the ‘188 patent. The references include US 2004/0146996 published by Yocum, a Ph.D. thesis “Formation of Amino Acid Derived Cheese Flavour Compounds”, 2004,  by Smit, Nakamura’s US 6,013,494 on producing 1,3 propanediol by recombinant microorganisms, a screen capture from the ExPASy Proteomics Server and also a citation from 3rd edition of Lehninger Principles of Biochemistry. None of these were cited the prosecution history of patent ‘188.

Secondly, for patent ‘889, Gevo identified references anticipating claims 1, 3, 11 and 16-19 based on Larroy, Chemico-Biological Interactions (2003), which discloses the pathway from pyruvate to isobutanol. Apart from these, other references include Yocum’s US 20040146996 and Bekkaoui, Current Genetics (1993).

Key take aways:

It is pretty strange for small companies to go against chemical giants like Dupont or its subsidiary companies like Butamax. However, this patent fight seems to signal the growing potential importance of bio-butanol for the biofuel and chemical industries worldwide. In addition, it also gives us a view that if patents are quite strong in their claims and use novel technologies, then any company unlawfully adapting the same technology will be infringing the invention, no matter how big it is.

Minusmita Ray, Patent Associate, IIPRD, Minusmita@iiprd.com

Practice Pointer Series: Brief on Patenting Diagnostic Methods in India

Patenting of medical methods is prohibited in India according to Section 3 (i) of the Indian Patent Act, which states that “any process for the medicinal, surgical, curative, prophylactic [diagnostic therapeutic] or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products.” This flexibility has been conferred by TRIPS in its Article 27(3) which states that “members may also exclude from patentability diagnostic, therapeutic and surgical methods for the treatment of humans or animals”.

Among various medical methods as described in Section 3 (i), such as surgical and therapeutic methods, patentability of diagnostic methods in particular has been questionable and is not objectively interpreted.

This article tries to focus on understanding the Indian patent scenario with respect to patenting of diagnostic methods and providing some key points for more efficient protection of the same.

The Indian “Manual of Patent Office Practice and Procedure” describes that Diagnosis is the identification of the nature of a medical illness, usually by investigating its history and symptoms and by applying tests. Further the Manual explains that determination of general physical state of an individual (for example a fitness test) is not considered to be diagnostic if it is not intended to identify or uncover pathology. Thus, the diagnostic methods excluded from Patentability include methods which determine or identify existence of a disease or disorder. However, if a method does not include the identification of a disease or disorder, then the method would be patentable. Had this been the case, the scope of diagnostic methods excluded from patentability would have been construed very narrowly. However the Indian Patent Act provides a flexibility in a form such that only diagnostic methods practiced on the living body are not patentable and the diagnostic methods performed on tissues or fluids which have been permanently removed from the body are not be excluded, that is the in-vitro methods are patentable.

Thus, the Patent Scenario in Indian is similar to European Patent Law where according to Article 52(4) of the EPC, in-vitro diagnostic methods are found to be patentable. However the exact scope of such exclusion is not clearly defined at the moment due to the lack of the interpretation of the Courts unlike in Europe where the extent of the auspices of patentable subject matter is litigated a large number of times in Courts. Under US Patent Law, all medical methods including Diagnostic Methods are patentable.

Additionally, under the Indian Patent Law, there have been instances when the examiners have rejected the in-vitro diagnostic methods too under the pretext of Section 3 (d) of the Act citing lack of inventive step involving “mere use of a known process”.

For example, if the detection method  per se as well as the biomarker in the sample are already known and the proposed invention only identifies use of the marker in the detection of a disease, there are high chances that the method would not be patentable. Thus, where the method involves a novel biomarker or one or more novel detection method steps, the chances of patentability become high. Indian Granted Patent IN 228031, for example, claims a rapid method for heat mediated ELISA characterized in using an activated solid support for detection of minute quantities of biomolecules such as antigen, antibody etc. The method has a profound technical advancement of reduction in the total time required for ELISA to around 3 h. Another Indian granted Patent IN 223553 claims an in vitro method of determining an expression level of a plurality of genes in the sample consisting of gene No. 1 to 562 in predicting the prognosis of a biological condition in animal tissue. The Indian Patent IN 220274 claims a method for detecting a risk of gastro esophageal reflux disease on assaying the analytes pepsinogen I, fasting gastrin-I7 and a marker for Helicobacter pylori infection. Another Indian Patent claims a method of for detecting antibodies to INGAP 104-118 peptide contacting test sample with the peptide bound to solid support. The Indian Patent IN 233723 claims a new Scintillation Proximity Assay for the detection of peptidoglycan synthesis. Thus we have seen that all these granted patents describe one or more novel procedural steps in the diagnostic methods described therein. However, subject to the lack of the exact scope, the patenting of diagnostic methods in India is still decided more often on a case-by-case basis.

 

Conclusion

The diagnostic methods are patentable in Indian provided they are not practiced on living body and are performed on tissues or fluids which have been permanently removed from the body. Further, for the best protection, either the biomarker or any of the steps involved in the method should be novel, involving “inventive step” and deviating away from the “mere use of the known process” rejection. The scope of the Patentability of Diagnostic methods in India is still not clearly defined due to the lack of the interpretation of the Courts unlike in Europe where the extent of the auspices of patentable subject matter is litigated a large number of times in Courts.

About the Author:  Meenakshi Khurana, Patent Specialist, IIPRD and reachable at Meenakshi@iiprd.com or Meenakshi@khuranaandkhurana.com

Adams Respiratory Therapeutics, Inc. Vs. Perrigo Co.- Dispute Related to Pharmacokinetic Claim Terms

Adams Respiratory Therapeutics, Inc. Vs. Perrigo Co.- Dispute Related to Pharmacokinetic Claim Terms

Adams Respiratory Therapeutics, Inc. (Adams)-“Plaintiff” holds patent 5,372,252 (‘252 patent), which covers an extended release formulation containing guaifenesin (an expectorant used to thin, loosen, and helps expel mucus that causes congestion). Adams markets Mucinex® which is the preferred embodiment of the ’252 patent. Perrigo Co. (Perrigo)-“Defendant” sought FDA approval for a generic version of Adams’ product, Mucinex® to market 600 mg guaifenesin extended release tables, with a paragraph IV certification to the ‘252 patent. Adams sued Perrigo for infringement of claims 26, 33, 34, and 39 of the ‘252 patent. After construing the claims, the District Court granted Perrigo summary judgement of non-infringement.  But later on appeal by Adams, the Federal Circuit panel reversed the grant of summary judgement and remanded because the court based its judgment of noninfringement on an erroneous claim construction.

The claim terms in this dispute related to pharmacokinetic parameters.  Such parameters are used to characterize the rate and extent of absorption of the active pharmaceutical ingredient (API).  The primary term at issue was Cmax which indicates the maximum concentration of the API following dosing.

Basically, the dispute was over the meaning of the term “equivalent” in independent claim 24, and claims 26, 33, 34, and 39 depend on claim 24. Claim 24 recites:

24.  A modified release product having two portions, wherein a first portion comprises a first quantity of guaifenesin in an immediate release form which becomes fully bioavailable in the subject’s stomach and a second portion comprises a second quantity of guaifenesin in a sustained release form wherein the ratio of said first quantity to said second quantity provides a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed every four hours over a 12 hour period and wherein said product also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis.

 

“Equivalent Cmax”

The District Court construed “equivalent” as “within 80% to 125% of the value with which it is being compared, at a 90% confidence interval,” basing its construction on Adams’ statements during reexamination that ‘equivalent’ meant ‘the FDA bioequivalence guidelines’[i.e., the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” which reflect both an 80 to 125% range and a 90% confidence interval]. But Adams argued that ‘equivalent’ meant within the 80 to 125% range, and not 90% confidence interval. Adams further stated that % confidence interval, makes sense when seeking FDA approval, but not when proving infringement.

In response to Adams statement, Perrigo argued that 80 to 125% range “means absolutely nothing in terms of establishing bioequivalence under FDA’s guidelines without the 90% confidence interval, as, among other things, it is the confidence interval itself that must fall within the 80-125% range.”

The court agreed with Adams and construed “equivalent” to require a Cmax that is 80% to 125% of the value to which it is being compared and not meant (“equivalent”), meeting all of the requirements of the FDA’s bioequivalence guidelines.

Adams compared the accused product of Perrigo to Mucinex by citing the concept of A=B=C, therefore, A=C. Adams’ argued that the accused product was bioequivalent to Mucinex, and Mucinex was bioequivalent to a standard immediate release (“IR”) product, then the accused product had a Cmax equivalent to the IR product.

Adams also presented PK and Cmax data, which made it more evident that Perrigo’s product was equivalent to Adam’s product. In this way, summary judgement for Perrigo was therefore reversed on this ground.

 

Construction of “Bioavailable”

Next, Perrigo highlighted that the claim term “Bioavailable” of the ‘252 patent is ambiguous in its meaning. Perrigo’s alternative way to seek summary judgement of noninfringement by Distirct court was also rejected by Federal circuit. The dispute revolved over the fact on whether the phrase “fully bioavailable in the subject’s stomach” meant “both release and availability in the stomach for absorption, wherever that absorption might occur.”

Perrigo did not agree on the point of infringement, that the ANDA product with IR portion of guaifenesin would become “fully bioavailable in the subject’s stomach” as claimed in claim 24 of Adams patent. Perrigo further argued stating “bioavailable” is commonly understood to mean absorption, thus requiring the guaifenesin to be absorbed in the stomach.  But as guaifenesin is primarily absorbed in the small intestine, this construction of “Bioavailable” would not suffice a finding of infringement.

In response to this, Adams pointed to the specification, which repeatedly states that the IR portion of guaifenesin is released in the stomach, but never states that it is absorbed in the stomach. The Federal circuit agreed to Adams’ consistency in using/construction of this term in the specification and denied Perrigo’s approach. The panel highlights that although the specification never expressly defines bioavailable, it uses the term when describing the availability of the drug for absorption, not the actual absorption.

 

Doctrine of Equivalents

Finally, Adams argued that Perrigo’s ANDA product would infringe the dependent claim 34 under the “doctrine of equivalents”.

Claim 34 recited:

34.  The modified release product of claim 26 [which claims the modified release product of claim 24 wherein the total quantity of guaifenesin is 600 mg] wherein the Cmax of said product is at least 1000 ng/mL and said product has an AUCinf of at least 3500 hr*ng/mL.

This appeal of Adams to show infringement under the doctrines of equivalent was agreed by the Federal Circuit panel that an amount of 3494.38 hr*ng/mL was equivalent to 3500 hr*ng/mL.

 

Conclusion:

We all know that a particular patented drug for commercialization/marketing finally needs a FDA approval to enter the medical market. Hence, according to me it is practically meaningless to specify a numerical range without a confidence interval and not importing/considering the FDA values and guidelines into the claim construction. However, I would appreciate Adams’ explanation over the numerical values of doctrines of equivalent because biologically speaking, such minor variations in pharmacokinetic parameters are practically acceptable in humans and animals.

Minusmita Ray, Patent Associate, IIPRD. Minusmita@iiprd.com