Article Written by Sagar Singla, a 3^rd-year student of Gitarattan International Business School, Delhi.

Case: Bayer Corporation v. Union of India

Citation: 162 (2009) DLT 371

Date of Decision: 18/08/2009

Bench: HON’BLE MR. JUSTICE S. RAVINDRA BHAT

Issues of the Case:

1. whether or not a license will be granted by DCGI for selling a drug to the other company on that some company already contains a patent.
2. whether or not the grant of such selling approvals derogates provisions of the Patent Act.
3. whether or not linkage is going to be established between Patent Act and DCA. This issue had been created supported a combined reading of Section 2 of the DCA and Sections 48 and 156 of the Patents Act, 1970.
4. Whether the term “spurious drugs” includes any drug or formulation which infringes previously granted patents. This issue was important to be discussed because spuriousness of the drug would amount to infringement of the patent.

Facts of the Case:

1. The petitioner could be a corporation incorporated under the laws of the United States of America (USA). Resulting in its analysis and development (R & D) activities, the petitioner made up and developed its proprietary drug to alter its administration to human beings. The patented drug is employed within the treatment of patients laid low with kidney cancer i.e. Renal Cell Carcinoma(RCC) and liver cancer i.e. hepatocellular carcinoma (HCC). The aforementioned proprietary drug acts a lot as a palliative i.e. relieves patients from pain and to an extent conjointly slow down the spread of cancer by limiting the speed with that the cancer cells grow.
2. The aforementioned invention of the proprietary drug was worn out in the USA. The proprietary drug is for the treatment of Cancer of RCC and HCC. However, because the individuals suffering in America from the aforementioned cancer of RCC and HCC are rare/few i.e. but 2,00,000 patients, the proprietary drug is identifiable as an ‘Orphan drug’ within the U.S.A.
3. On the winning invention of the proprietary drug in 1999, the petitioner applied for a patent within the U.S.A. Thereafter, on 12 Jan 2000, the petitioner applied for an international patent in India the Patient Co-operation treaty (PCT) and on 5 July 2001 applied in India for a grant of the patent to the proprietary drug. On 3 March 2008, the workplace of the Controller granted the petitioner’s application dated 5 July 2001. This patent was granted in the Republic of India on 3 March 2008 and DCGI permitted them to import the aforesaid drug from 8th Jan 2008 to 31st Dec 2010. As a consequence of being granted a patent, the petitioner had the right to make/manufacture, use, and sell the proprietary drug either by itself or through its retail merchant to the exclusion of all others for an amount of twenty years from the date of its application. Thus, the petitioner had a right to stop third parties from making/manufacturing, using, selling, or mercantilism the proprietary drug in the Republic of India while not with the petitioner’s permission/license.
4. In July 2008 the petitioner came to understand that DCGI was granting license about “sorafenib” to Cipla which might act as a substitute for “sorafenib tosylate”.
5. Petitioner wrote to DCGI to not enable Cipla to induce the license during this respect.
6. They conjointly prayed that Cipla shall be asked to supply an enterprise that sorafenib wasn’t a substitute for sorafenib tosylate and thence wasn’t its imitation.
7. Bayer wrote to Cipla seeking a reply if that they’d applied with DCGI, however didn’t receive any reply.
8. Bayer then filed a cleverly written document petition within the city supreme court to issue directions to the Director Controller General of the Republic of India (DCGI) to retrain them from giving license about the manufacturing of a drug to Cipla and to Cipla to prevent them from producing and merchandising sorafenib.

Judgment:

• A decision was made on the primary issue in favor of the defendants, who claim that such an interpretation that DCGI cannot enable the sale of a drug that somebody has already proprietary is predicated on an incorrect reading of Article 156 of the Patent Act. DCGI may fairly enable the commercialization of generic medicines, albeit their invention has already been proprietary. By doing so, DCGI doesn’t support violation, however, is just to blame for failing to authorize counterfeit product to be placed on the market to avoid infringement.
• Article 48 of the Special and Negative Rights Act needs that even the patent owner acquire a DCGI license to import and sell medicine. It was additionally noted that the reading of Section 2 of DCA is predicated on the belief that DCGI is to blame for deciphering the provisions of law. Therefore, a relationship can’t be established between DCA and law. If a relationship might be established between these 2 laws, the varied provisions of law would be ineffective
• Parliament has never planned to put a patent management authority or police authority with drug enforcement authorities once enacting the law. Enact any provision to determine a relationship between the two procedures in a very method that goes on the far side of the law that defines court boundaries. Parliament deliberately opposed the institution of any such partnership, therefore it might not be right for the court to try to too, therefore. 
• In support of the respondents, the question of “false alcohol” was known. So Cipla wasn’t identified to be a counterfeit. Once ruling on this issue, the court noted that falsehood indicates a shot to deceive and prohibit themselves and represent themselves as another person. The that means of this word isn’t ample to supply another. The court, therefore, rejected the petitioner’s claims. The court more noted that the procedure for linking drug patents as follows by the United States can’t be viable in India for public health policy.

Critical Analysis:

• The Petition was dismissed with prices, quantified at Rs. 6,75,000/- collectible in equal shares to the Union of India, and Cipla. The amounts shall be paid by the petitioner within four weeks.
• The case for the India Patent Union is that it will forestall generic medicative merchandise from coming into the market. This affects vulnerable and burdened groups of society who are unable to afford costly medicines. Generally, proprietary pharmaceutical medications are costly and can’t satisfy anyone’s poor in society. Therefore, alternatives to generic medicines should be accessible within the market so they are oversubscribed at a cheaper price and everybody can have the good thing about higher medical facilities, in addition, because the poor and marginalized in society.