The development of pharmaceuticals is an expensive and time-consuming process. Pharmaceutical companies invest heavily in the research and development of drugs and biologics for drug products. Unfortunately, the time devoted to research and development tends to erode the patent exclusivity period attached to a product.
Once a drug target has been identified, pharmaceutical companies often take steps to outsource the process of getting this target commercialized and begin to work with a contract development and manufacturing organization (CDMO). It is extremely important when outsourcing projects to a CDMO that contractual agreements clearly spell out ownership of discoveries and data uncovered during the outsourced development process.
From an intellectual property perspective, an overarching theme common throughout the use of these organizations is the importance of capturing and protecting all points of novelty associated with a drug's chemistry, manufacturing, and controls (CMC). Frequently, during the CMC development period, novel compositions, processes, and conditions may be discovered that may be used to strategically extend the product's life cycle.
The Prilosec Patent
It is imperative that companies that outsource to a CDMO have procedures in place to recognize and protect intellectual property that arises during development and, in particular, development activities that occur during the CMC process. A prime example of CMC being used to extend market exclusivity came with the over-the-counter product Prilosec OTC.
Prilosec OTC is a proton pump inhibitor used to treat heartburn, stomach ulcers, and gastroesophageal reflux disease (GERD).
As the 2001 patent expiration date approached,
Had
Developing a racemic drug is one of many ways to extend patent protection through CMC development activities. Pharmaceutical companies have employed numerous other strategies to boost the life cycles of their products.
Alternative Methods Of Extended Protection
Successful Production Conditions and Methods
Discoveries commonly made by a CDMO during the CMC process include optimal production methods and conditions and controls for the manufactured drug. It is essential that pharmaceutical companies harvest patentable subject matter from these potentially novel methods of manufacture and controls contained within a quality control system. Patented conditions and production methods may extend a company's term of exclusivity by protecting how a drug is manufactured. Variables such as temperature, pressure, yield, and numerous other production conditions may be protected if they improve manufacturing parameters or the drug target's clinical benefit. Upon expiration of the primary patent of a drug (e.g., composition), several more valuable years of protection may be had by possessing a patented manufacturing process and/or quality control step that may be innovative and, therefore, patentable.
Polymorphism
Polymorphs of a patented drug often come to light during the various stages of drug development and manufacturing. When working with a CDMO, it is important that these discoveries do not go unnoticed by the outsourcing organization and that the outsourcing agreement clearly spells out ownership in favor of the pharmaceutical company. However, noticing and protecting polymorphs can be difficult. The outsourcing organization must be adept at both identifying and documenting a polymorph in a way that allows for its strategic use later on.
A crucial step for pharmaceutical companies working with CDMOs is verifying that all polymorphs of a patented drug have been protected. A polymorph of a drug molecule will have the same chemical composition as the molecule but a different internal structure.4 Drugs typically receive regulatory approval for only a single polymorph. For example,
Conclusion
Pharmaceutical companies that utilize the expertise and experience of CDMOs and are diligent about documenting discoveries that may occur during the CMC development period may be able to extend their patent exclusivity for their product or prevent similar biologics from entering the market. Whether it is a more efficient production process, a quality control step that ensures clinical efficacy, a polymorph, specific ratios or mixtures of a mixture of multiple enantiomers, biological complexity of molecules, or clinical data on a variety of regulatory approval parameters, pharmaceutical companies that are sensitive to the patentable subject matter in the later stage of discovery will benefit by the potential to extend a patent or regulatory position. However, it is imperative that throughout this process, pharmaceutical companies are diligent in protecting all discovered patentable subject matter and ownership is clearly set forth in outsourcing agreements. From optimal manufacturing conditions and processes to patentable quality control steps, pharmaceutical companies have the potential to see a significant increase in a patent or regulatory exclusivity period and, in turn, an increase in the product life cycle.
Footnotes
1. Gupta H, Kumar S, Roy SK, Gaud RS. "Patent protection strategies." J Pharm Bioallied Sci. 2010 Jan;2(1):2-7. DOI: 10.4103/0975-7406.62694.
2. Conley,
3.
4.
5. Thomas, Sajesh P.; Nagarajan, K.; Row,
Originally published by Outsourced Pharma
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