Patents for Pharmaceutical Products and Technology: An Updated Review

 

Dr. Shoaib Ahmad

University School of Pharmaceutical Sciences, Rayat-Bahra University, Mohali 140104 India

 

ABSTRACT:

Patents are one of the most important forms of Intellectual Property Rights needed for protection of the innovation in pharmaceutical industry. Each innovation in pharmaceutical industry requires considerable amount of investment in research and development activity in the industry. Specialized workers are required for undertaking the activities that could usher in the element of innovation in pharmaceutical industry. These innovations can be in the form of pharmaceutical, biotechnology, nanotechnology and herbal products as well as in the form of technology used in production process, pre-formulation, formulation and packaging of such products. There are market-specific issues that are required to be addressed keeping in view the various trade agreements and court decisions. In many cases, the patents may require compulsory licensing to the third parties. In many cases, pharmaceutical industry feels threatened by bilateral or multilateral trade agreements / treaties, patent protection acts and court decisions. There is an urgent need to address this issue so that the pharmaceutical industry is able to contribute its desired inputs in the welfare of the people in need of new medicines. The present paper is an attempt to give a concise overview of the issues in Patents for Pharmaceutical Products and Technology.

 

 

 

INTRODUCTION:

Patents are one of the several forms of Intellectual Property Rights. Patents have become one of the most assuring ways of protecting the industrially applicable innovation. This holds truth for pharmaceutical industry too.  In the recent decades, the pharmaceutical industry has seen an over-emphasis on securing patents for their pharm. innovation. This scenario has been particularly witnessed in post-WTO era.

 

Few years back, a review of the chemical and pharmaceutical patents was published¹. Pharmaceutical patents are getting monetary incentive in R and D organizations². Pharmaceutical patents are a necessity³.

 

Pharmaceutical Technology:

Pharmaceutical co-crystals have also been patented⁴. Polymorphs and pro-drugs and salts are no exception to patenting moves⁵. Patents have also been granted for pharmaceutical taste masking⁶. Use of starch and its derivatives in pharmaceutical drug delivery has also been patented⁷. Patents have also been granted for the technology involved in modification of polysaccharides for applications in pharmaceutical industry⁸. The process of spray drying in pharmaceutical industry has been protected through several patents⁹. Chromatin control elements have also been patented¹⁰. Several patents have been granted for stabilization and delivery of protein and peptide pharmaceuticals¹¹. Biopharmaceuticals are no exception to this patenting move¹². Patents have been perceived as incentives in biopharmaceutical innovation research and development¹³. Filing and securing patent protection for pharmaceutical products and technology is often seen as a difficult and necessary step. Many a times the functioning of patent office has been criticized¹⁴.

Nanotechnology and Cancer Therapy Products:

Nanopharmaceuticals are also affected by patenting regime and as a result, several such products have been subjected to patent protection^15-18. Several patents have been granted for nanopharmaceuticals¹⁵. Patents have been granted on production of nanoparticles from preformed polymers¹⁶. Spray-drying process of polymeric nanoparticles has also enjoyed patent protection¹⁷. Patents on pharmaceutical nanoformulations have been reviewed¹⁸. Breast cancer targeted therapy has also been patented¹⁹. Trials have been conducted for off-patent doxorubicin use in children affected with cancer²⁰.

 

Herbal Drugs:

Plant based drugs have also been patented. One of the common example is of Withania somnifera. It has been patented for neuropharmacological properties²¹. Phytochemical extraction methodologies have also been patented. Such a move has definitely an impact on food and pharmaceutical industry²².

 

Pharmaceutical Industry and Market Issues:

Computational analysis skills of medicinal chemists play an important role in pharmaceutical patents²³. Fixed-dose combinations have also been enjoying patent protection to a limited extent²⁴. Patents discipline is helpful for big pharma investment²⁵. Secondary patenting of branded anti-HIV drugs has been debated²⁶. Drugs for alcohol abuse and dependence have also been considered for patent protection²⁷.

 

Several studies have been conducted for pharmaceutical and related patents in the different parts of the world^28-32. Pharmaceutical patents have affected the European patients²⁸. Pharmaceutical patents in Chile have been analyzed recently in terms of primary and secondary nature of patents²⁹. Securing good pharmaceutical patents is considered difficult in Japan³⁰. Pharmaceutical and biotech product patents in India have also been subject of debates³¹. Products patents for pharmaceutical and biotech applications face problems in Pakistan³². 

 

Trade Agreements and Other Legal Issues:

Korea-US Trade Agreement may also affect pharmaceutical patents³³. Trans-Pacific Partnership Agreement may help Pharmaceutical Patents and Test Data³⁴.

 

Securing patent protection for pharmaceutical patents is a challenging task under the America Invents Act³⁵. "Pay for delay" policy is applicable in settlements of legal disputes on pharmaceutical patents³⁶. Clinical trial human subjects need to protected. Any violation of the applicable subject protection guidelines may jeopardize the process of granting patents on such studies³⁷. Extraterritorial protection of US pharmaceutical patents is also under discussion³⁸. An overview of the element of obviousness in a patent by court decisions has been overviewed³⁹. Court's judgment in a particular case has been seen as a cause of uncertainty in pharmaceutical industry in India⁴⁰.

 

CONCLUSIONS:

Pharmaceutical industry depends on specialized products and technologies which come into existence after a significant investment on research and development activities. These innovations need protection through patents. Easier and less-complicated norms for patents will definitely contribute to research and development investment which will indirectly benefit the people in dire need of new medicines.

 

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Received on 23.07.2017       Modified on 25.08.2017

Accepted on 10.09.2017     ©A&V Publications All right reserved