13 minute read
Patents and Exclusivity A US perspective
the present and the PDF images of the patents from 1790 to the present are housed by the USPTO.
Exclusivity
Exclusivity is originated to promote a balance between new drug innovation and generic drug competition. It is a period when an innovator drug is protected from generic drug competition. There are different types of exclusivities for different circumstances.
Types of Marketing Exclusivity in Drug Development:
Unlike a patent, marketing exclusivity is generally acquired early in drug development, runs considerably longer and is based upon intellectual property rights, rather than evidence of safety and effectiveness. When the constitutional or statutory requirements are met for a drug, the FDA would issue the approval and also the marketing exclusivity, where the exclusivity is a period of time during which no other applications can be accepted and/or approved for the same active ingredient. This means that, other manufacturers that may wish to develop alternative formulations or generic versions of the drug will not be able to have their products approved during the exclusivity period. The type of exclusivity would decide the length of the exclusivity period. Importantly, the exclusivity period is not added to patent life, so sponsors will need to be mindful of both durations and plan, accordingly.
The exclusivity duration: There are a few types of marketing exclusivity, and all of them vary in duration and the statutory requirements that must be met. Some are based on product classification, others on the indication being treated on the intended patient population.
The types of exclusivity include: • Orphan Drug Exclusivity (ODE):
This type of exclusivity is seven (7) years and is granted to drugs designated and approved to treat a rare disease or condition affecting fewer than 200,000 or more than 200,000 and no hope of recovering costs in the United States. • Biologic Exclusivity: For Biologics License Applications (BLAs), Under section 351(k)(7)(A) of the Public Health Service Act, the duration of the exclusivity is twelve (12) years. The USFDA will not accept biosimilar filings (under its 351 (K) pathway) until five (5) years after the original biologic is licensed.
• New Chemical Entity (NCE)
Exclusivity: In most cases, a brandname drug with a new active moiety has a five-year exclusivity. During this five-year exclusivity period, no other company can submit an Abbreviated New Drug Application (ANDA) to the FDA seeking approval of a drug product containing the NCE.
• Generating Antibiotic Incentives
Now (GAIN) Exclusivity: GAIN is a new law that addresses the antibacterial drug resistance by encouraging the pharmaceutical research, development and approval of new type of antibacterial and antifungal drugs. The drug products have been granted or designated by the FDA as “Qualified Infectious Disease Product” (QIDPs) and have the additional five (5) years of exclusivity.
• New Clinical Investigation
Exclusivity: A brand industry’s new brand-name drug with an active ingredient that has been approved before may be awarded a three-year exclusivity in certain circumstances, such as, if a new way of delivering the active ingredient is proposed (for example, a tablet rather than a liquid) or a different disease or condition the drug can treat is identified. To get this approval, the drug company must conduct new clinical studies in humans. • Paediatric Exclusivity (PED): A patent protection for a new drug applicant for which the sponsor has done paediatric studies (in response to a written request from the FDA) may be eligible for a six-month exclusivity, which is added on to any other exclusivities or patents for that drug (six months added to existing Patents/Exclusivity). This exclusivity is an effective tool for drug developers, delaying the FDA ANDA and 505(b) (2) approvals six months after the patent expiration. • Patent Challenge (PC): This exclusivity is for Abbreviated New Drug Applications (ANDAs) only and the exclusivity period is 180 days.
• Competitive Generic Therapy (CGT) or Generic Drug Exclusivity (GDE):
This exclusivity is for 180 days and is applicable for ANDAs only.
• Qualified Infectious Disease Product
(QDIP) Exclusivity: This exclusivity is for five years and it can be added to any existing exclusivity.
An Exclusivity Board has been established by the Center for Drug Evaluation and Research (CDER) to give oversight and recommendations about exclusivity determinations made by the Center. The CDER exclusivity board manages the granting of exclusivity determinations, that means whether and what type of exclusivity will be granted. The CDER board will not review or provide any recommendations with respect to exclusivity determinations. The five year New Chemical Entity (NCE), three year new clinical trial exclusivity and biological product exclusivity will be focused by the CDER board.
Difference between Drug Patents and Drug Exclusivity
Regardless of the drug product approval
status, the patents can be issued or expired at any time – before, during or after the FDA approval process. If the drug product meets the statutory requirements of the FDAs, the drug product will be approved with an attachment of an exclusivity. Further, few drug products have both patent and exclusivity protection while others have just one or none.
The patents will expire in 20 years from the date of filing, but the exclusivity is granted upon the basis of the drug product. For instance, the New Chemical Entity (NCE) gets five years of exclusivity, while orphan drugs get seven years of exclusivity.
According to the FDA, the other major difference between patent and exclusivity is patents can be issued or expired at any time irrespective of the drug approval status,, while the exclusivity is granted upon approval.
The expired patent or exclusivity drug products may not be available, or it is removed from the Orange Book. Patents and Exclusivity protection may or may not run concurrently and may not run the same aspects of the drug product. Exclusivity was developed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.
In some countries, like India and Brazil, they have compulsory licenses, which basically allow local companies to produce and locally market drugs that have not reached a point in time when generic competition is legally allowed.
AUTHOR BIO
Praveen Kumar B is a Postgraduate in Pharmacy with a significant experience in the field of Medical Writing. He has been working in medical writing profession for the last ten years. He has a few international and national publications and presentations to his credit. His experience spans across authoring and review of the various clinical and Regulatory documents. He has been a part of Freyr Solutions for a year now and currently holds the position of an Assistant Manager in the department of Medical writing.
Conclusion
The applicants/sponsors should fully be aware of the Regulatory patent protection and exclusivities. These exclusivities are developed to encourage the innovation in pharmaceutical research and development of new, safe and cost-effective treatment. While taking the advantage of Regulatory exclusiveness of the target country, it can help to sponsor to realise a return on investment by utilising the Regulatory exclusivities. In the way of product identification or broadening of the line of products or market extension, one needs to evaluate patent as well as Regulatory exclusivities of the target country to have profit-making products, while serving the patient population.
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Down to The Tiniest Particle
Dispersing of powders in the pharmaceutical industry
The production or refinement of pharmaceutical products often involves dispersing dusty, sticky or fine powders in liquids. Conventional technology often encounters problems - such as when agglomerated powders are not completely wetted - and this is precisely where modern vacuum dispersing systems come in.
Denis Hunn, Process- and Application Engineering, Ystral
Example of a process plant in Ex version for the production of tablet lacquer.
Gels, creams and suspensions or coatings on tablets are among the pharmaceutical products manufactured using powders or refined powder mixtures. They usually consist of an active ingredient, the thickening or swelling agent, such as CMC and HPMC, and colourants such as iron oxide, titanium dioxide or talc.
Manufacturing companies can have complex requirements and the topic of reliability is particularly important and so pharmaceutical processes need to be established. These processes must be reproducible and adapt to the often meticulously coordinated requirements of the production chain.
Example of a process system in Ex-design for the production of tablet coating.
Producers also have another objective: To be able to produce the widest possible range of batch sizes using a single system, meaning that the system they use must be versatile and easy to clean.
No agglomerates, air pockets or foam
The system design aims to prevent the operator from coming into contact with the materials for precisely this reason. And the aim is to achieve the longest possible storage stability after production without any foam. Agglomerates or air pockets in the product have to be completely ruled out. This is a prevalent problem, because if long dissolving times or the formation of agglomerates occur during the production of a suspension, this can lead to long waiting times.
We come across several problems when conventional technology is employed. Traditional agitators or dissolvers wet the powdered fillers as an agglomerate rather than singularly- This is something that cannot be avoided, as it is the principle of these systems. Powder inside these agglomerates is not completely wetted. The inside of the agglomerates may be wetted later by capillary effect, but this is only possible on a selective basis. The way in which the powder is added is the cause of the pseudowetting. It occurs when the powder is added to the vessel from above. However, it also occurs when it is inducted into a liquid from below in a vacuum vessel by compact flow or inline by using so-called injectors. The problem is caused by the fact that the powder particles touch each other during wetting and are not dispersed.
Dispersing under high shear-effect and vacuum
The solution is provided by a system that can completely wet and optimally disperse powder particles in both liquid and viscous medium. This is exactly what ystral’s powder wetting and dispersing system ContiTDS does. The system is used to produce solvent- and water- based coating suspensions - but this is only one example of the many possible applications. A suction
Under vacuum, the air contained in the powder expands
hose is used to draw in the powder or it is taken directly from the container, whereby the powder only comes into contact with the liquid in the dispersing zone. Dispersing takes place under a massive shear-effect and vacuum.
The vacuum has an extraordinary effect. Under vacuum, the air contained in the powder expands by up to 98%. All the particles in the powder are in flight when they are inducted at high speed by the vacuum conveyor. When the powder is transported, the vacuum in the powder constantly increases when it moves from the point where it is added to the maximum vacuum zone and the distances between the individual particles increase accordingly.
The system generates its suction effect directly in the liquid. The maximum vacuum prevails the wetting and dispersing zone and the distances between the individual particles are largest when they enter this zone. No additional transport or fluidisation air is needed for this effect because the air in the powder expands and subsequently contracts again after dispersing. The particles are individually separated and thoroughly wetted. The powder inlet is closed once the adding of powder has been completed. The system can then be continued to be used as a normal Inline Disperser or for degassing in low-viscose systems, whereby installation both on existing vessels and in complete systems is possible.
Lower temperatures required
The system allows dispersions and emulsions to be produced with particle or droplet sizes on the nanometre scale. A higher product quality can be achieved due to the fact that the formation of agglomerates is avoided. In addition, wetting and dispersing take place at significantly lower temperatures than when conventional technology is used and this often achieves a beneficial advantage in subsequent process steps.
The storage stability of the suspensions produced using the system can be increased by up to 90 %, meaning that the coating process can be carried out hours, or even days, after producing the coating. This can even be done without a separate agitator in the feed vessel, and energy consumption is also almost two-thirds lower than when using conventional technology.
In pharmaceutical production, powders often have to be dispersed in liquids. Conventional technology often achieves only incomplete wetting, because the powders are introduced agglomerated. One solution is modern vacuum technology, in which the particles are separated and wetted.
AUTHOR BIO
Denis Hunn was born on 31.01.1990 in Freiburg. He obtained apprenticeship as a mechatronics technician in Bahlingen am Kaiserstuhl. His professional journey started as mechatronics technician at Braunform GmbH and joined ystral in 2011. He gained advanced technical college entrance qualification and studied at the DHBW Baden-Wuerttemberg Cooperative State University (industrial engineering). He is also active in the local university council of the DHBW.
Biomedical Market Leaders
Learning to thrive
In a rapidly changing market, the only competitive advantage that lasts is the ability to learn. Here is how our enduring biomedical market leaders do that.
Brian D Smith, Principal Advisor, PragMedic
If you have worked in the biomedical industry for more than a couple of years, you will have noticed one of its most characteristic features: change. Pharma, medtech and related businesses operate in a complex environment of two halves: the sociological and the technological. Our sociological environment, including demography, epidemiology and politics is in flux as we master the diseases of youth and enter the battle with the implications of old age and lifestyle. And our technological environment is a storm of ‘omics, systems biology, nanotechnology, and information technology. Business environments tend to exhibit “punctuated equilibrium” in which periods of slow change are interrupted with bursts of rapid transformation. There seems little doubt that our industry is in the midst of just such a spurt of evolution.
The challenge of change
Change poses a problem for biomedical companies, especially large ones. Technical complexity, regulation and culture make them slow, ponderous beasts whose proven capacity to improve lives is countered by their inability to respond to rapid market change. Anyone who has attempted significant change in a large biomedical company will recognise this issue. This inertia accounts for the demise of many organisations, as shown by the turnover of names in the “top 50” lists of companies. Yet those lists also pose a question: if the success of many companies is fleeting and ended by market change, what about the others, those that survive for decades or centuries? What is it that those enduring companies do differently from their short-lived rivals?
The ultimate advantage
The question of what causes longevity in a changing market has been investigated by many researchers, who converge onto one simple answer: organisational learning. In short, companies sustain their competitive advantages by drawing new knowledge from what is going on around them and then acting on that insight. But such a simple answer creates another set of questions: how do biomedical companies learn? What is the process by which longlasting companies learn faster and better
