PharmaceuticalPatents and Paraphernalia

Amit Ratn Gangwal JainSmriti college of Pharmaceutical Education, Indore

Amit ka PPT

Disclaimer Views expressed in this PPT are fair-

minded. Proprietary names used in this article are of respective firms. Efforts have been made to make this PPT comprehensive but owing to space limitations and continuous development and case studies in the field, PPT can not be termed highly exhaustive.)

Amit ka PPT• Where language per se is used, original

reference/source/photos of personality have been mentioned at appropriate place.

• This PPT of mine (Amit ka PPT) is not to make money; this I have prepare to spread right information for various readers.

• All the images are taken from internet. Thanks

This world is being driven by

R & D, which is being incentivized by patent.

Requirements for Patentability

USEFUL

NOVEL

NON-OBVIOUSNESS

– Must have some utility; achieve some objective; not against public policy, must be disclosed

– Must be new, i.e., different from available information

– Subject matter as a whole would not have been obvious at the time to person of ordinary skill in the art

What is not patentable

•Naturally occurring things•Generally you cannot patent living things, although you can patent certain live matter, such as genetically engineered animals, plants, etc., or the process of extracting a natural product.•You cannot patent laws of nature, mathematical formulas and abstract ideas. •Idea

Patentstwo decades

Exclusive rights

• There is provision for pre-grant rejection.• May be revoked any time, if something foul is

reported. (post grant opposition)• Product and process patent (from 2005) both

are in force – Closing down various reverse engineering

chapters

• Before 2005 reverse engineering was flourishing (Much to the dissatisfaction of overseas player).

Patents

Types of patent application(1)Ordinary patent application- It is a simple application for patent without any priority claim and not being convention or National phase application .It should be accompanied by a provisional or complete specification at the time of filling.

(2)Convention Application- An application who files an application for patent in a convention country can make convention application in India within 12 months from the date of basic application

(3)National phase application under PCT- PCT stands for the patent co-operation treaty. It is a sister treaty of the Paris convection administered by the world intellectual property organization. The PCT system facilitated filing of patent application under a single umbrella and provide for simplified procedure for the search and examination of application

National, regional and international applicationsNational applications

generally filed at a national patent office.

Regional applications

A regional patent application is one which may have effect in a range of countries. The European Patent Office (EPO) is an example of a Regional patent office. The EPO grants patents which can take effect in some or all countries contracting to the European Patent Convention, following a single application process.

(Taken from Wikipedia)

Patent of addition

is granted for additional information in original application, if found adhering to the laws.

WIPO The World Trade Organization's Trade-Related

Aspects of Intellectual Property Rights (TRIPS) Agreement establishes minimum standards for intellectual property rights, including patent protection for pharmaceuticals; therefore, it may make it difficult for developing countries to gain access to medicines, especially those countries that are the least developed. This study aims to determine whether implementation of the TRIPS Agreement in Latin American and Caribbean countries has generated patent legislation that is sensitive to public health needs. (Taken from Wikipedia)

PTC• The Patent Cooperation Treaty (PCT) is an

international patent law treaty, concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its contracting states. A patent application filed under the PCT is called an international application, or PCT application. (Taken from Wikipedia)

TRIPS• The Agreement on Trade Related Aspects of

Intellectual Property Rights (TRIPS) is an international agreement administered by the world trade organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. It was negotiated at the end of the Uruguay round of the general agreement on tarrifs and trade (GATT) in 1994. (Taken from Wikipedia)

Generic versions(ANDA)

• If products goes off patent, molecule/product goes to public domain.

• Its open for generic players.• F2F (first to file) will get the green signal to

launch first generic version in world/chosen area/protected area.

• F2F will get exclusive rights for 6 months.• Then anybody may launch with permission.

If products goes off patent, molecule/product goes to

public domain.

Paragraph IV filingPatent listings are important in the generic drug approval process because challenges to listed patents can lead to stays in approval of generic versions of original molecule. As per the FD&C Act, a generic drug applicant need to include in its application; a certification for each patent listed in the Orange Book for the innovator drug. Similar information is required for applicants filing 505(b)(2) applications under section 505(b)(2) of the FD&C Act. This certification must state one of the following: Para I: that the required patent information relating to such patent has not been

filed;

Para II: that such patent has expired;

Para II:I that the patent will expire on a particular date; or

Para IV: that such patent is invalid or will not be infringed by the drug, for which approval is being sought.

30 month stay provisionsIf the generic counterpart of a branded product is intended to be marketed before expiration of the patent, then applicant is liable for legal action against him and the ANDA applicant, filing an application citing a paragraph IV certification, may be tried for patent infringement. Within 45 days the NDA holder or patentee can file a patent infringement suit against the ANDA applicant after receiving notice from FDA which may be followed by disapproval (of ANDA application) by FDA. This disapproval remains in force for at least 30 months from the date of that notice.

Recent never-before announcement by Indian courts

There has been series of pronouncements by Indian courts, including the Apex Court (Supreme Court). Most of these were not in favour of MNC. Few notable cases are: Nexavar and Gleevac. Moreover, both these products are used in treatment of rare cancers for which these are the most successful medicaments so far.

• Nexavar ruling was historical in that, it became the first product in pharmaceutical realm in India, which is now being produced and sold (other than the innovator company) by Indian company using compulsory license provision.

• Gleevac became the historical brand in the sense that first time in India, Apex Court rejected the ground (minor change in drug form) furnished by defendant MNC and not granted the fresh patent to milder modification in the molecule present in Gleevac.

Historical decrees by Indian court

Glivec/Gleevec was already in the

market, however company decided to seek a patent on a slightly modified

version potentially giving it longer period of market exclusivity. 

Such was the need and success

of Imitanib that this was featured on

thecover of Time magazine in

2001

Dr. Brian J. Druker an oncologist at Oregon Health and Sciences University and a Howard Hughes Medical Investigator, played a major role in discovering Imitanib.

Dr. Brian J. Druker

Section 3(d) of the Indian Patents Act does not allow

patents of new version of known drug molecules if they don’t make it more effective than before. In the mean time many Indian companies produced generic drugs at very cheap rate which was consumed by 300000 people . Whereas 16000 people use glivec. (Generic versions can be manufactured when the product expires the patent). http://www.slideshare.net/BizandLegis/patent-overview-in-novartis-case

Word efficacy is important.

Until efficacy is increased and proved, new patents are not granted in India, after slight/bigger change in existing molecule/product

Patent evergreeningWhat is Patent evergreening?Patent evergreening is a potentially dubious and sometimes derogatory term that generally refers to the strategy of obtaining multiple patent that covers different aspects of the same product, typically by obtaining patents on improved versions of existing products.

What has accelerated is not so much patenting or innovation but evergreening, the effort to extend patents.

Historical decrees by Indian court

Natco

Sorafenib tosylate

Compulsory licenseIn certain cases, without patentee’s consent and with state intercession, generic version can be produced and sold through the provision of compulsory license. A compulsory license, also known as statutory license or mandatory collective management, provides owner of a patent patentee) the rights against payment either set by act or determined through some form of negotiation. Government intervention is indispensable. It is one of the flexibilities in patent rules mentioned in the world trade organization (WTO)’s agreement on intellectual property, the TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement. The TRIPS agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha declaration on TRIPS confirms that countries have liberty to decide the basis on which compulsory licenses could be granted. The TRIPS agreement lists a number of conditions for issuing compulsory licenses, in Article 31.In particular:

Nexavar became a blockbuster with $1 billion in sales in 2011 for Bayer. The revenue growth was 7% over the 2010 sales of $934 million. Bayer holds Indian patent (215758) for this chemotherapeutic agent. But all that changed on March 13, 2012, when India's patent office accepted a request from Hyderabad-based Natco Pharma and granted permission to compulsorily make Bayer's patented drug and make it available to patients at 97 percent discounted price of 8,800 rupees for a month's dose (while Bayer charges 284,428). Of course, Natco has been ordered to pay 6 percent royalty on Nexavar’s sales to Bayer.

When Natco’s approach for voluntary license [{s. 84(6) (IV)}] was turned down by Bayer then state intervention lead to historical verdict on March 12, 2012 in favour of Natco. Bayer had appealed against this order. This ruling was further upheld by Chennai-based Indian patent appellate board (IPAB). The earlier order had relied on Section 84 (1) (a, b and c) of the Patents Act, which states that “after three years of grant of a patent, a compulsory license can be granted to any applicant on any of the following justifications: (a) the reasonable requirements of the public withrespect to the patented invention have not been satisfied, or (b) that the patented invention isnot available to the public at a reasonably affordable price, or (c) that the patented invention is not ‘worked’ (manufactured to some satisfactory extent) in the territory of India18

Specimen copy of

notificationto innovator company at

USA byGovernment of Zambia, regarding

compulsory license.

Western world raises eyebrowson

• the issuance of unwarranted compulsory licenses

• the unfair revocation of valid patents, and

• the denial of patentability of inventions in India

What lies ahead

Is very clear only three things will get cheaper molecules

–Either compulsory license–Free to all policy–Rigorous R and D by most of the pharma organization

While addressing at Government College of Pharmacy, Bangalore, former President of India APJ Abdul Kalam suggested concept of open source, introduced by CSIR (Council of Scientific and Industrial Research). Open source drug delivery (OSDD) focuses on collaborative effort to achieve breakthroughs in the world of medicines and bringing down cost of medicines. This concept would provide medicines free from monopoly and only generics would be produced.

What research and development brings to the

organization

•It brings name and fame to product•Product then becomes brand•Brand then makes brand range•Ultimately people purchase product of that category by your brand name.

Importance of being pioneer

An ITC product

Bhaiya ak lal wali maggi dena (though its not a maggy).

• Most of the people demand for packed

water bottle by asking bhaiya ak bislery dena.

• Bhaiya ak xerox kar dena.

Uncle Sam’s nation

U.S. is now “first to file”/first to publish

The process of "negotiating" or "arguing“ (or putting one’s point) with a patent office by patentee, and interaction with a patent office with regard to a patent after its grant, is known

as patent prosecution.

Patent prosecution is distinct from patent litigation, which relates to legal

proceedings for infringement of a patent after it is granted.

• Leading scientist, Padma Bhushan awardee and chairman of pharma major

Cipla, Yusuf Hamied shot to global fame in early 2001 when he announced that his company, Cipla, would supply a combination of AIDS drugs to developing countries for less than $1 a day, at a time when first-line antiretroviral (ARV) medication sold for up to more than $15,000 per patient per year. (October 20, 2013, Times of India 11 page)

In other words, the drug companies in the USA who were charging $15,000 a year for this medication were saying that without their brand name, these generic medications were simply not the same despite the fact they were both made with the same cheap active ingredients, as pointed out by Cipla’s Hamied.

India is committing selective genocide in healthcare.

• Drugs for cancer, HIV/AIDS, TB, Malaria should be free from clutches of patents law.

• There should be provision for compulsory licensing.

• There must be policy for compulsory license ; presently system varies case to case.

• In canada there is system of obligatory licenses ; which allows Canadians to copy any drug and pay the patent holder 4 % royalty.

India cannot afford a monopoly in drugs. If there is a monopoly, people won't be able to afford drugs, like the cancer drugs sold today. For example, the top-selling AIDS drug in the world, Atripla, costs $20,000 per patient per year in the US. Cipla's US FDA-approved equivalent product, is being sold for less than $100 per patient per year in Africa where it is not under patent. If they block India, they are essentially blocking the Third World's supply of newer cheaper anti-AIDS drugs and other newer medicine.

Many countries like Malaysia, Indonesia, Thailand, Brazil have already brought in compulsory licensing. Look at the world's top-selling drugs; 70% of them are made and marketed by companies that haven't invented them. They are all in-licensed products. They are paying royalty to the guy who did the invention. So in-licensing is on all the time, but now, it is a specific in-licensing on exclusive basis to one company. I want non-exclusive in-licensing. I want the obligatory licensing system. I don't mind paying royalty.

http://www.frontrowreviews.co.uk/reviews/fireintheblood/21252

Fire in the blood: A heart

touching documentary

on patent issues

Heavy inputs from my earlier published article

“PHARMACEUTICAL PATENTS: THE HATCH – WAXMAN AMENDMENTS, EVERGREENING, 180 DAYS EXCLUSIVITY, LISTING IN ORANGE BOOK AND FEW RECENT UNPRECEDENTED DECREES BY INDIAN COURTS”

Thanks