With the cost of developing drugs continually rising, squeezing every last penny out of existing drugs has become a key strategy for the pharmaceuticals industry. Life-cycle extension, in which companies try to extend their drugs' period of market exclusivity, has been the most popular strategy to date. However, changes in legislation and, more importantly, increasingly sophisticated generics manufacturers have trained R&D companies to use a broad set of patent life extension techniques a routine procedure in their product life cycle management plans. Manufacturers now have to try even harder to get value for their R&D spend.
The life of a patent follows the following phases: invention, patent application, patent grant, and patent expiry. Life and death of a patent has one very important policy consideration – the patent right is granted for a limited period of time to promote technological and industrial progresses. Against the expiry of a patent industry players utilise various means to prolong the market position gained through patent protection and to delay the decline in profitability of a commercially successful product.
Life Cycle Management Теам
One of the key principles of efficient management says that a problem turns to task once there’s a person or team dedicated to work on it. Following this principle, effective drug life cycle management begins with the establishment of an effective team of individuals connected with the development and marketing of the new product, which should include persons with both broad understanding of the project, and persons who have more specialized vision of the project stages. In addition to patent counsel, key personnel from other departments should also be included in the team: drug discovery, drug formulation, drug regulatory affairs, clinical, pharmacokinetics, marketing, licensing, and, perhaps someone in upper management. Obviously, not all of these personnel are necessary in all situations. The team should meet regularly so that everyone on the boat is aware of issues that arise in each person’s area of expertise, and to address how those issues may impact the product, potential patent protection, and patent clearance.
Life Cycle Management Strategies
Typical strategies will most certainly allow for maximisation of standard exclusivity periods allotted by both the patent system and the sector regulatory authorities, including patent life, patent term restoration, patent term extension, patent term adjustment, trademarking, enforcement of these IP rights through litigation and forming strategic alliances, and the independent exclusivities offered by the pharma regulatory authorities in different jurisdictions for approval of a new chemical entity, new product or indication for an existing active ingredient, paediatric and orphan drug exclusivity (in some jurisdictions).
But successful strategies are always more creative and comprehensive and, in line with IP and regulatory measures, experience teaches skilled teams to be inventive in applying various production, marketing and advertising techniques to extend the life of their pharmaceuticals on the market. With respect to the pharmaceuticals whose exclusivity period is about to expire these may include launch of authorized or branded generics, revision of the pricing strategies, introducing changes in the drug, its active ingredient, administration dosage and regimen, delivery system, etc.
Below we will discuss some of the successful techniques applied by R&D companies to extend their market exclusivity and yield maximum value of their investments in research and development of innovative pharmaceuticals.
Isomers
Isomers are compounds with the same molecular formula but different structural formulas. Isomers play important part in drug design. Biological systems are sensitive to very small changes in structure and can respond very differently to isomers of the same compound. In the past, this has been used as a way of extending the 'life' of a compound. Replacing the original compound with its patented, more efficient isomer, extends the period of protection from generic competition.
As with all other patents, the applicant must prove that the invention is novel, innovative and not obvious. With regard to isomers, patent examiners assume that, because there are large amounts of publicly available information on separating isomers and finding differential activity, simply separating isomers and proving one to be more effective than the other is not patentable. However, if the difference in activity is significantly greater than expected, in terms of potency or side-effects, it may be possible to patent the other isomer.
Patenting an isomer discovery much later than the original compound may allow such isomer to have patent exclusivity long after the original compound has faced generic competition. However, inventions not yet covered by a patent are at risk of being discovered by somebody else. This means timing is all important.
Polymorphs
In application to drug discovery, polymorphism is the ability of material to exist in more than one form or crystal structure. Different arrangements of the drug molecules in their crystalline state also can affect the action of the drug.
The melting points and solubilities of these polymorphs can be very different, as can the potency of the drug. Again, this means that discovering a more effective polymorph, or a method of producing or sustaining that polymorph, can be considered a patentable invention in some situations.
However, as with isomers, there is the risk that the increasingly sophisticated generics companies will find the superior polymorph before the originating R&D company does. Generics manufacturers often investigate whether patented drugs have an undiscovered polymorph that could make a better drug.
This makes the establishment of a dedicated team and developing and implementing a lifecycle management strategy for a specific drug a must for an R&D company to avoid prevent the product from becoming an easy catch for generics.
Drug Delivery Systems
The application of drug delivery is a valuable, cost-effective life cycle management resource. By infusing drugs with new and innovative therapeutic benefits, drug-delivery systems extend products’ profitable life cycle, giving pharmaceutical companies competitive and financial advantages.
Drug delivery technologies make medicines more convenient and acceptable to patients. They can simplify the dosing regimen, and improve administration. These improvements, in turn, bolster compliance, which improves patient outcomes and quality of life and reduces costs.
Commercially, delivery technologies give new life to drugs, repositioning them with a new or improved therapeutic benefit and a competitive power. By extending the product’s life cycle with a line extension, they sustain the drug’s market value.
Novel drug delivery systems can protect or prolong a product’s patent exclusivity. When patents are expiring, the R&D company and companies seeking to benefit from the patent expiration can use drug delivery technologies to seize this market opportunity. Below are some commonly used strategies.
Develop a generic. Developing a generic that requires use of sophisticated drug delivery technology that must not only match the pharmacokinetic profile of the reference drug, but must also avoid the innovators’ patents. Technologies known for ease, flexibility and rapid development time will increase the chances of being first to market by generics manufacturers.
Develop an improved product. Drug delivery technologies give formulators a value-added opportunity to develop innovative, therapeutically enhanced alternatives to compete against generics and branded products. They enable the originator drug company to extend exclusivity by developing an enhanced version with therapeutic benefits or new therapeutic indications.
Introduce a new product. To replace sales of a product with an expiring patent, drug delivery technologies can be used to develop a new product with a different chemical entity and brand name. Or transfer value from the branded drug to a successor product by switching the ethical drug to an over the counter product.
Extend exclusivity. From the earliest stage of development of a drug, speed to market should be a key consideration. A product that is first to market may soon lose that advantage, as similar products with improved formulations erode its market share. Using a drug delivery technology to introduce a novel new drug with enhanced benefits can deter competition and lengthen the period of product exclusivity.For mature products, a drug delivery system can extend life only if it provides a significant enough benefit to warrant the inevitable price premium that can occur after patent expiration.
Conclusion
Innovative pharma companies can successfully revitalize expiring pharmaceutical products to counteract generic threats and to preserve market share and income streams, when appropriate strategic planning and life cycle management are implemented, preferably in advance of generic launch. Such future successes can be accomplished through a variety of proactive and defensive strategies, e.g. patent, regulatory, research and development, and marketing strategies, coordinated and planned well in advance. It is the complimentary and coordinated use of these strategies that can inject a breath of new life into all but written-off products.
By: Anastasija Sinitsa
Ukrainian Patent and Trademark Attorney
Partner at ARTEX Law Firm (www.artex.ua)
for Ukrainian Journal of Business Law, 2010
Life Cycle Management Теам
One of the key principles of efficient management says that a problem turns to task once there’s a person or team dedicated to work on it. Following this principle, effective drug life cycle management begins with the establishment of an effective team of individuals connected with the development and marketing of the new product, which should include persons with both broad understanding of the project, and persons who have more specialized vision of the project stages. In addition to patent counsel, key personnel from other departments should also be included in the team: drug discovery, drug formulation, drug regulatory affairs, clinical, pharmacokinetics, marketing, licensing, and, perhaps someone in upper management. Obviously, not all of these personnel are necessary in all situations. The team should meet regularly so that everyone on the boat is aware of issues that arise in each person’s area of expertise, and to address how those issues may impact the product, potential patent protection, and patent clearance.
Life Cycle Management Strategies
Typical strategies will most certainly allow for maximisation of standard exclusivity periods allotted by both the patent system and the sector regulatory authorities, including patent life, patent term restoration, patent term extension, patent term adjustment, trademarking, enforcement of these IP rights through litigation and forming strategic alliances, and the independent exclusivities offered by the pharma regulatory authorities in different jurisdictions for approval of a new chemical entity, new product or indication for an existing active ingredient, paediatric and orphan drug exclusivity (in some jurisdictions).
But successful strategies are always more creative and comprehensive and, in line with IP and regulatory measures, experience teaches skilled teams to be inventive in applying various production, marketing and advertising techniques to extend the life of their pharmaceuticals on the market. With respect to the pharmaceuticals whose exclusivity period is about to expire these may include launch of authorized or branded generics, revision of the pricing strategies, introducing changes in the drug, its active ingredient, administration dosage and regimen, delivery system, etc.
Below we will discuss some of the successful techniques applied by R&D companies to extend their market exclusivity and yield maximum value of their investments in research and development of innovative pharmaceuticals.
Isomers
Isomers are compounds with the same molecular formula but different structural formulas. Isomers play important part in drug design. Biological systems are sensitive to very small changes in structure and can respond very differently to isomers of the same compound. In the past, this has been used as a way of extending the 'life' of a compound. Replacing the original compound with its patented, more efficient isomer, extends the period of protection from generic competition.
As with all other patents, the applicant must prove that the invention is novel, innovative and not obvious. With regard to isomers, patent examiners assume that, because there are large amounts of publicly available information on separating isomers and finding differential activity, simply separating isomers and proving one to be more effective than the other is not patentable. However, if the difference in activity is significantly greater than expected, in terms of potency or side-effects, it may be possible to patent the other isomer.
Patenting an isomer discovery much later than the original compound may allow such isomer to have patent exclusivity long after the original compound has faced generic competition. However, inventions not yet covered by a patent are at risk of being discovered by somebody else. This means timing is all important.
Polymorphs
In application to drug discovery, polymorphism is the ability of material to exist in more than one form or crystal structure. Different arrangements of the drug molecules in their crystalline state also can affect the action of the drug.
The melting points and solubilities of these polymorphs can be very different, as can the potency of the drug. Again, this means that discovering a more effective polymorph, or a method of producing or sustaining that polymorph, can be considered a patentable invention in some situations.
However, as with isomers, there is the risk that the increasingly sophisticated generics companies will find the superior polymorph before the originating R&D company does. Generics manufacturers often investigate whether patented drugs have an undiscovered polymorph that could make a better drug.
This makes the establishment of a dedicated team and developing and implementing a lifecycle management strategy for a specific drug a must for an R&D company to avoid prevent the product from becoming an easy catch for generics.
Drug Delivery Systems
The application of drug delivery is a valuable, cost-effective life cycle management resource. By infusing drugs with new and innovative therapeutic benefits, drug-delivery systems extend products’ profitable life cycle, giving pharmaceutical companies competitive and financial advantages.
Drug delivery technologies make medicines more convenient and acceptable to patients. They can simplify the dosing regimen, and improve administration. These improvements, in turn, bolster compliance, which improves patient outcomes and quality of life and reduces costs.
Commercially, delivery technologies give new life to drugs, repositioning them with a new or improved therapeutic benefit and a competitive power. By extending the product’s life cycle with a line extension, they sustain the drug’s market value.
Novel drug delivery systems can protect or prolong a product’s patent exclusivity. When patents are expiring, the R&D company and companies seeking to benefit from the patent expiration can use drug delivery technologies to seize this market opportunity. Below are some commonly used strategies.
Develop a generic. Developing a generic that requires use of sophisticated drug delivery technology that must not only match the pharmacokinetic profile of the reference drug, but must also avoid the innovators’ patents. Technologies known for ease, flexibility and rapid development time will increase the chances of being first to market by generics manufacturers.
Develop an improved product. Drug delivery technologies give formulators a value-added opportunity to develop innovative, therapeutically enhanced alternatives to compete against generics and branded products. They enable the originator drug company to extend exclusivity by developing an enhanced version with therapeutic benefits or new therapeutic indications.
Introduce a new product. To replace sales of a product with an expiring patent, drug delivery technologies can be used to develop a new product with a different chemical entity and brand name. Or transfer value from the branded drug to a successor product by switching the ethical drug to an over the counter product.
Extend exclusivity. From the earliest stage of development of a drug, speed to market should be a key consideration. A product that is first to market may soon lose that advantage, as similar products with improved formulations erode its market share. Using a drug delivery technology to introduce a novel new drug with enhanced benefits can deter competition and lengthen the period of product exclusivity.For mature products, a drug delivery system can extend life only if it provides a significant enough benefit to warrant the inevitable price premium that can occur after patent expiration.
Conclusion
Innovative pharma companies can successfully revitalize expiring pharmaceutical products to counteract generic threats and to preserve market share and income streams, when appropriate strategic planning and life cycle management are implemented, preferably in advance of generic launch. Such future successes can be accomplished through a variety of proactive and defensive strategies, e.g. patent, regulatory, research and development, and marketing strategies, coordinated and planned well in advance. It is the complimentary and coordinated use of these strategies that can inject a breath of new life into all but written-off products.
By: Anastasija Sinitsa
Ukrainian Patent and Trademark Attorney
Partner at ARTEX Law Firm (www.artex.ua)
for Ukrainian Journal of Business Law, 2010
RSS Feed
