Patent Infringements in Pharmaceutical and Related Fields: An Update

 

Dr. Shoaib Ahmad

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

 

ABSTRACT:

Patents denote one of the most important types of intellectual property. The patents are granted legal protection of in exchange for disclosure of information related to an invention. The cases of patent infringements are arising and getting more attention than ever before. This move is obviously has its origin in the commercial interests and the revenue one can earn from commercialization of patents. Many academicians are of the view that Patents may hamper academic research. Patent infringement for drugs and pharmaceuticals has assumed greater significance and has been reviewed by many concerned parties (innovators / experts, patent offices and courts). Several cases of infringement related to drugs, medical procedures, medical devices and biotechnological works have been reported. Patent infringement remains a complicated issue. Its determination requires understanding of industrial and legal complexities. Hence, the patent offices and appellate bodies need to play their important role while deciding the matters related to patents and their utilization. After all, public benefit can also not be neglected.

 

 

INTRODUCTION:

Patents are one important type of intellectual property. The patents are granted for protection of inventions made as technical solutions to the problems. The patent protection is granted in exchange for disclosure of information related to an invention. Nowadays, cases of patent infringements are gaining more attention than ever before. The reason for this move is obvious – commercial interests. Patents have been thought to hamper academic research¹. Patent infringement for drugs and pharmaceuticals is quite an important issue and has been reviewed in detail². Several cases of infringement related to drugs, medical procedures, medical devices and biotechnological works have been discussed in the recent past.

 

Patent Infringement of Drugs:

In a landmark move, BPMC dropped its patent infringement case against Kaiser for hCG³. Isotopic ratios have also been demonstrated to find pharma patents’ infringements⁴. Idenix has filed three cases of patent infringements in European courts⁵. Commil and Cisco have fought over induced infringement claims⁶. Pfizer's Celebrex(R) patent was cancelled by US judiciary⁷. Pfizer's detrol patent was upheld by Indian IP appellate board⁸. A case was filed against Actavis for a cardiovascular drug⁹.

 

Patent and Medical Procedures:

Laws of the land may lead to serious effects on patented medical procedures¹⁰.

 

Patent Infringement of Devices:

PMA primacy for has raised concerns for medical devices patent infringement¹¹.

 

 

Patent Infringement in Biotechnology:

Gene patents have been demanded to be kept from infringement¹². Biotechnologists have discussed ways to avoid patent infringement^13-14. Battling infringement has been considered a taxing task¹⁵. A farmer from Canada was found indulging in infringement of Monsanto canola patent¹⁶.

 

Patent Infringement and Patent Offices:

In a policy decision, it was ruled that drugmaker's claim has time-boundations¹⁷. The issue of patent infringement in post-approval testing has been discussed¹⁸. Uncertainty shrouds cover infringement after post-approval studies¹⁹. Eli Lilly alleged violation of NAFTA agreement²⁰.

 

Reported Problems in Indian Sector:

Several pharma companies have many arguments against Indian Patent Office for generic products²¹. Pharma manufactures find Indian patents troubles²². Novartis has reportedly faced pressure to withdraw its patent case against Indian authorities²³. Supreme Court of India rejected Novartis's on drug patent appeal²⁴.

 

Patent Infringement Cases in Courts:

Many times courts have been approached to interpret novelty of an idea²⁵. In a case, court refused to change its decision on patent claim²⁶. A court took lenient view of patent infringement in case of research tools²⁷. Even US courts face difficulty with new standards of patent infringement²⁸. Guidance from US courts on qualification for exemption from infringement of health care invention patent has also been documented²⁹. Several judicial developments have taken place in the concept of safe harbor vis-à-vis Hatch-Waxman infringement³⁰. It has been reported that a promise made to a court is not sufficient to avoid infringement proceedings³¹.

 

Miscellaneous issues:

Proper testing has assumed importance for patent infringement cases³². Concern for indirect infringement has also been raised³³. Academic researchers are also feared to come under patent infringement³⁴. In Europe, Bolar exemptions to patent infringement are under discussion³⁵. UK Patent Act has recently added exceptions to patent infringement³⁶.

 

CONCLUSIONS:

Patent infringement is a complicated issue and it requires understanding of industrial and legal complexities. The role of patent offices and appellate bodies becomes quite important in deciding the fate of patents and their utilization – for public benefit.

 

 

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Received on 07.03.2017       Accepted on 22.05.2017     

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