Novozymes: Company Overview / Patent Strategy

1407 words | 5 page(s)

Abstract
Biotech companies have emerged within the past 30 years as leading producers of novel pharmaceutical products. One company, which has certainly captured the essentials of business and humanitarian causes in Denmark, based Novozymes. As the worlds leading producer of industrial enzymes, this company normally enters into patent infringement cases that are based on pure strategy. This report addresses one patent infringement scenario, currently implemented by Novozymes.

Introduction
A humanitarian outlook of the major Biotech company Novozymes leads one to beleive that this company is not just an innovator in the Biopharma industry, but is also a leader in assessing the needs of the poor and underserved, worldwide. While this may or may not be the case, the fact remains that this company holds the licensing and ownership rights for over 6,000 international patents (Novozymes, 2014). Additionally, the ownership of a patent will not always translate to income generation. A patent does not give the patent holder any rights or incentive to actually sell the intellectual property but does bar other entities from practice and marketing, with respect to the purported technology (Novozymes, 2014). This company is particularly interesting not simply for its diverse patent portfolio of active pharmaceutical ingredients, manufacturing processes, and new uses for old drugs, but their business and humanitarian model has allowed it to gain notoriety and subsequently, vast income and market presence in the drug development and manufacturing world. Although Novozymes produces products that are not limited to pharmaceuticals, including: Bioenergy, Food and Beverage, Agriculture, Textile, and Waste water treatment chemicals, this report will focus mainly on the production of Biopharma products. In addition, a brief overview of Novozymes is presented.

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Novozymes – Overview
Novozymes is currently headquartered in Denmark, where it enjoys a lower global tax rate than most places in the world. Employing over 6,000 people, the company has been a target for eager job seekers whom are attempting to find long-lasting careers with upward growth potential. The company was founded in 1925, by brothers Harald and Thorvald Pedersen and is affiliated with the famed Novo Nordisk, which is a leading provider of insulin for diabetes management. The goal of the founders at this time was to create a company that could produce drug product that is safe and effective for meeting the clinical needs of diabetic patients. Currently, Novozymes is the worlds leading producer of industrial enzymes and boasts a market share of almost 45%, in this area (Novozymes, 2014). From the healthcare perspective the company purports itself as an innovative body that is in constant compliance with US/EU/ICH standards for Good Manufacturing Practices (GMPs). It therefore maintains the highest level of Quality System compliance in all large scale manufacturing facilities. One particular product that is currently in the developmental phase for proposed commercial manufacture is: a formulation consisting of “alpha-amylase mutants with altered properties” (Alpha-Amylase, 2014). U.S Patent number 7,713,723 is intended for use at Novozyme for production of an API that may be used within a formulation of a drug product intended for application in patients with DM (Ojan et.al, 1997). The subsequent role of controlling the production of the altered Amylase mutants will aid researchers in designing inhibitory molecules. The goal of Novozyme is therefore to restrict the production of this mutant form, and perhaps license its sale to drug developers whom intend to conduct research in this field. In addition, Novozyme may also intend to conduct internal research within their proprietary labs, to screen for and/or develop the appropriate inhibitory molecule.

Alpha-amylase Mutants with Altered properties
For systemic issues related to the progression of dental and renal disorders, alpha-amylase has been identified as an effective target for inhibition (Alpha-Amylase, 2014). This molecule is produced naturally in humans for break down of starch (carbohydrates). The end product of starch breakdown is the generation of two (2) or three (3) molecules of glucose units. Naturally, alpha-amylase is produced in the saliva, where it begins the breakdown of starch prior to swallowing (Alpha-Amylase, 2014). Additional alpha-amylase is also produced in the pancreas, where its task at this point will be to complete the process of producing glucose for energy. It should be noted that this is a natural molecule and patenting it will appear to be a task that is simply not feasible. However in the event that the molecule can be produced in a mutant form that will select for specific interactions, a new molecule is generated that serves a novel purpose. Essentially this is the claim of Novozyme.

Clinical Application
From a therapeutic perspective the inhibition of this molecule will aid in the processes related to enhanced glycemic control (Ojan et.al, 1997). DM patients do not have full capabilities for maintaining their blood glucose levels and will either have increased glucose, perhaps after eating a meal that is rich in carbohydrates, or decreased serum glucose, if carbohydrate consumption is inefficient. Carbohydrate uptake is modulated by inhibition on alpha-amylase (Ojan et.al, 1997). What occurs on the molecular level is a blockade within the starch breakdown and subsequent absorption process. Alpha-amylase may not bind its active site to starch molecules to initiate the break down process and therefore glucose is not absorbed because it is not produced. For events in which obesity and diabetic patients suffer from consistent elevated glucose levels, inhibition will enhance the glycemic control. Drug product may be administered daily in order to maintain glucose levels and will likely lead reduced need for injection with insulin (Alpha-Amylase, 2014).

Novozymes Patent Strategy – Stall Tactics
A close look at the Novozyme patent is to protect the manufacturing process for use in generating a “dry-grind” product with ethanol. Novozyme has claimed legal infringement. The company that may be infringing is Danisco. This company appears to “poach” the technology of Novozyme, as this is not the first time in which Novozyme has had to file a patent protection lawsuit. However, due to the fact that Novozyme does own the rights to thousands of processes and APIs, the company may not actually have a “legitimate” patent. One strategy is to bar any other manufacturers from marketing a product which may yield $1 to $10 billion over the course of five (5) years (MaRS, 2014). The company may intend to maintain the market for as long as possible by utilizing legal maneuvers. Barring a competitor from the market by using obscure patents is a strategy that is used by organizations, worldwide. A final decision must be made by the court system within the respective territory. At this point it is unclear of what the actual location will be for patent litigation. It will be most beneficial to Novozyme to file patent infringement within the U.S and conduct global decision making within this territory. As opposed to EU patent courts which will usually make a final decision in ninety (90) days, the U.S patent process must fall under civil court challenges and the same legal rules apply (cite). Individuals, whom do not have an extensive background in the sciences and certainly not in pharmaceuticals, are likely to also not have the necessary scientific background to make a true assessment. The individuals executing ruling will be considered “not skilled in the art”, and although the invention should be “reducible to practice” by a layperson, this becomes a difficult task in the ruling within litigation practices (MaRS, 2014).

Conclusion
In summary the humanitarian aspects of Novozymes does not appear to “checkout” from the pharmaceutical perspective. Perhaps these organizations additional markets are more focused on humanitarian causes. However, this particular patent and business strategy contains no practical humanitarian benefits. The company is certainly a large Biotech company with an intellectual property portfolio that is extensive. Perhaps it is the overall strategy of the organization to utilize fiscal resources to generate income that may then be applied to greater humanitarian causes. Regardless of the end game, Novozymes remains one of the oldest and most innovative Biotech companies in the world’s history.

    References
  • Alpha – Amylase Activity. (2014). RCSB PDB-101. Retrieved from http://www.rcsb.org/pdb/101/motm.do?momID=74
  • Novozymes. (2014). Novozymes – Leading Producer of Industrial Enzymes. Retrieved fromhttp://www.novozymes.com/en/about-us/brochures/Documents/TodaysFacts-2013.pdf
  • Qian, M., Spinelli, S., Payan, F., & Driguez, H. (1997). Structure of a pancreatic α-amylase bound to a substrate analogue at 2.03 Å resolution. Protein Science. doi:10.1002/pro.5560061102
  • MaRS. (2014). Patent strategy for tech startups: Protecting intellectual property.http://www.marsdd.com/mars-library/patent-strategy/.
  • National Centers for Biotechnology Institutes. (n.d.). AMY1A amylase, alpha 1A (salivary) [ Homo sapiens (human) ]. http://www.ncbi.nlm.nih.gov/gene/276.

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