5 COMMON QUESTIONS ABOUT GENERIC DRUGS
What are Generic Drugs?
• A generic drug is a copy of a brand name drug. To be sold, a generic drug must be ‘bioidentical’ to the brand name drug.
• This means that the generic drug must be proven to be the same as the original brand name drug in the following ways:
• dosage form (tablet, capsule, liquid, etc.)
• strength (same amount of drug in both)
• how it is taken (by mouth, injection, etc.)
• how the medicine gets into the bloodstream and works in the body
• The manufacturer must prove that their generic drug meets these requirements before the Food and Drug Administration (FDA) will approve it and allow it to be sold to the public.
Why are Generic Drugs Cheaper Than Brand Name Drugs?
• A brand name drug has to go through 10-15 years of research and testing in animals and people before it can be sold to the public. During this testing, the company making the drug must prove that it is safe and effective for people to use. All of this testing can cost over $1 billion. Once the new drug is approved, the company that made and tested it receives a patent. This means that no other company can make the drug until the end of the patent, which is usually 10-15 years after the drug is released.
• When a patent for a brand name drug expires, any other company can copy the drug and sell a generic version. These other companies must only prove that their product is the same as the brand name drug. This means that generic drug companies do not have to spend as much time and money because they do not have to invent or test the drug for safety and get FDA-approval. This is why generic drugs cost less.
• When a patent for a brand name drug expires, there are usually a number of companies that begin to make a generic version of the drug. Since there is more than one company making the drug, the price is lowered even farther due to competition between all of the different generic drug makers.
Are Generic Drugs as Safe and Effective as Brand Name Drugs?
• The short answer to this question is “usually yes”. A company must prove that its generic version of a drug is both safe and effective before it can be sold to the public. The company that made the original brand name drug proved during years of testing that the drug is both safe and effective.
• A company that makes a generic drug must show that its version of the drug is 80%-125% ‘bioequivalent’ to the original brand name drug. For example: a brand name drug is taken and it is found that 100mg of medicine reaches the person’s bloodstream. For a generic version of the drug to be considered safe and effective, the active drug in the tablet or capsule must release between 80mg and 125mg to reach the bloodstream (80-125%). This means that some companies might make generic versions that have 80mg reach the bloodstream and other companies might make generic versions that have 125mg reach the bloodstream. This difference isn’t a problem in most drugs.
If This Generic Drug is the Same as the Brand Name Drug, Why Do They Look Different?
• Just because two versions of the drug do not look the same does not mean they act differently in the body.
• There are laws in the United States that say that a generic version of a drug cannot look the same as a brand name version. The company that makes the generic version of the drug can make it whatever colour, shape, or flavour they want as long as the amount of active drug remains the same as the brand name drug.
How Do I Know if There is a Generic Version of the Drug that I Take?
• There are a few different ways to find out if there is a generic version of the drugs you take.
• The easiest way is to ask your pharmacist. They will be able to tell you if there is a generic version of a drug available or when a generic version will most likely become available.
CIPLA Vs ROCHE (Generic Industry Rejoices)
• Delhi High Court has been the battleground for a pharmaceutical war between Roche and Cipla, over Roche’s patent for anticancer drug ‘Erlotinib’, sold by Roche as TARCEVA.
• On 24 April 2009, the Division bench of the Delhi High Court dismissed Roche's appeal against the refusal of a single judge to grant an injunction restraining Cipla from manufacturing, offering for sale, selling and exporting its generic version of ‘erlotinib’. Both Roche and Cipla drugs are based on a compound that goes by the name of ’Erlotinib Hydrochloride.’
• This case is regarded as a very important case in a series of high profile patent battles between multinational pharmaceutical companies and Indian generic drug companies.
FACTS OF THE CASE
• In February 2007,Roche along with Pfizer (as a joint applicant), claimed that it had been granted a patent for ‘erlotinib’
• The patented product, which Roche introduced onto the Indian market was marketed under the brand name TARCEVA.
• In December 2007 and January 2008, Indian newspapers reported Cipla’s plan to launch a generic version of ‘erlotinib’
• Soon after that, Roche commenced patent infringement proceedings.
CIPLA’S DEFENCE AND COUNTERCLAIM
- It had been selling its drug under the brand name ERLOCIP since December 2007.
- Roche’s patent was invalid because ‘erlotinib’ was a derivative of Quinazolin, which had been used in cancer treatment. Pursuant to s.3(d) of the Indian Patents Act, a derivative of a known compound is not patentable.
- Roche’s invention, as disclosed in the complete specification and claims was obvious or did not involve any inventive step, having regard to what was publicly known or publicly used in India, or what had been published in India or elsewhere before the priority date
4. The complete specification did not sufficiently and fairly describe the invention or the method by which it was to be performed
5. The huge difference in price between Roche’s drug (Rs.4,800 tablet (approx. US$ 100) and Cipla’s drug (Rs.1,600 (approx US$ 33) should be taken into account when deciding whether or not to grant an interim injunction.
ü Cipla strongly argued that because the drug in question was a life saving drug, the public interest issue was an important factor to be taken into account .
- Section 3 (d) of the Patents Act is not applicable as it prohibits only derivatives of ‘a known substance’. ‘Erlotinib’ is not ‘salts, esters, polymorphs, particle size, mixture of isomers, etc.’ of a ‘known substance’. It is a novel compound.
- The prior art argument was adequately dealt by the Patent Office during opposition proceedings. In any case, ‘erlotinib’ is a different compound; its properties differ from those of Astra Zeneca’s Gefatinib, which was cited as prior art.
- When determining where the balance of convenience lies, it is appropriate to consider the issue of ‘accessibility’ to, and use of, the invention in the territory. It is not, however, necessary that the drug should be manufactured in India.
SINGLE JUDGE RULING
While hearing the case, the judge noted the following points:
• Public interest: The generic drug version of ‘erlotinib’ manufactured and marketed by Cipla is available at one-third the price of Roche’s drug, Tarceva.
• Further, the Court noted that Tarceva is not manufactured in India, it is imported. The Court noted that the right to access to life-saving drugs, and the need for secure long term supplies, is a serious issue in India.
• In such case, the injury that would be caused to the general public if the generic version of the drug were not available is a strong point in favour of a refusal to grant an injunction.
THIS POINT COMPLETELY FAVOURED CIPLA’s DEFENCE
• Validity of the patent: The doubts about the validity of the patent raised by Cipla on the ground of obviousness, and ‘erlotinib’ being a derivative of a known compound which did not meet the ‘increased efficacy’ requirement provided for in s.(d) of the Patents Act, were dismissed by the judge as having been adequately dealt by the Patent Office at the opposition stage.
• The Court reviewed the observations that had been made by the Controller while granting the patent, and concluded that Cipla had not substantiated this objection.
THIS POINT STIFLED CIPLA’s DEFENCE
Overall, the judge was of the view that while Roche had established a strong case in support of its patent infringement claim, the 'public interest' and lower pricing of Cipla's drug tilted the balance in favour of Cipla.
DIVISION BENCH RULING
• Roche filed an appeal against the Order of the single judge, arguing that a failure to protect the rights of the patentee, is contrary to the public interest of encouraging further research in the pharmaceutical field.
• The division bench in its ruling observed:
• Non infringement: The bench was of the view that the patent in question related to a mixture of Polymorphs A and B, whereas Roche’s Tarceva drug consisted of only Polymorph B, for which a patent had not yet been granted. The division bench considered that this fact ought to have been disclosed by Roche both at the time of examination, and during the proceedings before the single judge. The bench gave weight to the fact that Polymorph B of ‘erlotinib hydrochloride’ was the subject of a later patent application, and that this had not been considered by the single judge.
The bench criticised Roche for:
1. Its failure to provide a sufficient and fair description of the invention; and
2. For not having filed X-ray diffraction data for Tarceva and Erlocip that would have shown whether or not the crystalline structure of Cipla’s Erlocip tablets corresponded to Roche’s patented invention.
The Court dismissed Roche’s appeal, and upheld the order of the single judge. It did not fully elaborate the public interest point relating to the pricing of the drugs, basing its judgment instead on the ground that Cipla had raised a credible challenge to the validity of the patent.
WHY WAS NOVARTIS DENIED A PATENT FOR GLIVEC IN INDIA?
'Novartis AG v. Union of India (UOI) and Ors.; Natco Pharma Ltd. v. UoI & Ors.; M/S Cancer Patients Aid Association v. UoI & Ors. Decided on 1.4.2013
• From 1972 to 2003, India only allowed process patents, which meant that even a patented product could be produced by someone other than the patent-holder if they could find a different method to manufacturing it. However, in 2005 the law was amended retrospectively to allow for product patents so that India could be compliant with the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
• But even before the law was amended, India agreed to invite applications for product patents under the TRIPS agreement. These "mailbox" applications were opened in 2005 when the law was finally enacted. Novartis filed an application for patent for Glivec, the blood cancer drug, under the mailbox provision.
• The key issue revolved around whether Glivec was a "new product" under the terms of the law. In January 2006, the Indian patent office ruled that the drug was not substantially different from one for which patents had already been given in the US and Europe. Thus, it did not pass the novelty test. While moving to the new patent regime, Indian lawmakers had inserted a provision — section 3(d) in the Patents Act — to check against 'evergreening'.
• (This is the term used to describe a practice under which firms slightly tweak an existing process or product to seek a fresh patent once the original protection expires. This helps them retain monopoly rights for a longer period. The patent office's ruling was upheld by the Intellectual Property Appellate Board (IPAB) and now by the Supreme Court.)
• If Novartis had won the case, it would have been granted a monopoly on Glivec, and denied Indian companies the right to make the drug. This would obviously have allowed Novartis to sell the medicine at a much higher price. Already, there is a huge differential with generic versions by Indian companies costing Rs 5,000-9,000 for a month's treatment, compared to Glivec's cost of around Rs 1.2 lakh a month.
• The order is also likely to encourage existing Indian manufacturers to step up production and perhaps new players to enter the market. This should lead to a further fall in prices.
• What will be the impact on the drug industry?
• The multinational drug companies are worried that this could be a trendsetter and are even threatening to block supplies of new patented medicines to India. But this is unlikely to deter Indian industry from developing "copycat" versions that would sell at a lower price.
• In short, while this is bad news for Big Pharma, it is as much good news for domestic manufacturers as it is for consumers. Big Pharma could also be worried that the Indian example may be emulated by others.
MERCK VS. GLENMARK OVER “SITAGLIPTIN”
• Anti-diabetes drugs are the top-selling therapy area in India, where about 65 million people live with the disease and that number is expected to reach 100 million by 2030.
• Merck sued Glenmark in 2013 for infringing a patent it has on sitagliptin, the chemical compound in Januvia and Janumet, both of which the company has been selling in India since 2008.
• A month's dose of Merck's drugs costs about 1,300 Indian rupees ($20) and 1,900 Indian rupees ($30), respectively. Merck has licensed the drugs to Sun Pharmaceutical Industries Ltd (SUN.NS) for sale in India.
• Glenmark sells the medicines under the brand names Zita and Zita-met at a nearly 30 percent discount to Merck's price.
• The Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug* Sitagliptin till 28th April 2015.
• Merck Sharp & Dohme filed an application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals from using its patented product Sitagliptin (Indian Patent No. 209816) at Delhi High Court.
• The Delhi High Court conclusively held that all the three ingredients (Prima facie, Irreparable injury and balance of convenience) for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.
• On 15th May 2015 India's Supreme Court has blocked Glenmark Pharmaceuticals Ltd from selling copies of U.S. drugmaker Merck & Co Inc's diabetes drugs Januvia and Janumet, sources with knowledge of the matter said after a court hearing.
• The court has, however, allowed Glenmark to continue to sell existing inventory, the sources said.
ERICSSON VS. XIAOMI
What is the fuss about?
• According to Ericsson, Xiaomi needed a licence from Ericsson for selling and marketing the phones imported to India and using Ericsson’s patents.
• Ericsson alleged standard essential patents (SEPs) used in AMR, 2G, 3G and Edge technologies for mobile phones were being infringed upon by Xiaomi.
• An SEP is the patent for the core technology essential to create something of a particular technical standard. In this case, mobile phones cannot be made without the GSM, GPRS, EDGE and WCDMA technology, which are patented by Ericsson.
• Xiaomi apparently uses 3G- and EDGE-compliant technologies on its smartphones in India. Ericsson said it had several patents on these connectivity standards, and that the Chinese manufacturer was required to acquire licences for those or pay royalties.
• The Delhi High Court was satisfied that Ericsson had made out a prima facie case for grant of ad interim injunction in its favour, and directed Xiaomi to stop sale of all its handsets/devices in India.
• Xiaomi in its appeal against the injunction alleged that Ericsson, while obtaining the ex parte injunction order, did not inform the court that Xiaomi also made, imported and sold handsets having Qualcomm chipsets. It contended that it did not infringe Ericsson’s patents, as Qualcomm had obtained a licence from the Swedish company for this patented technology.
• This implied that Xiaomi would be unable to sell 3G-variant of the Redmi Note (which features a MediaTek chipset) in India, while the Redmi Note 4G and all other sets running on Qualcomm-based chips would still be sold.
• Eventually, the court on December 16th 2014 permitted Xiaomi to sell its Qualcomm chipset-based devices as a ‘pro tem’ (temporary) measure till the issue of patent infringement was heard and decided by a single-judge Bench of the high court.
• Xiaomi can now sell other devices in India apart from the ones that feature Media Tek chipsets. Thus, from now, Xiaomi phones working on Qualcomm chipsets will be available for customers in India.
• Redmi 1S, Mi 3, Mi 4 and Mi 4i, fitted with Qualcomm chips, are very popular Xiaomi handsets.
• After landing in 2014 over patent infringement, Chinese handset maker Xiaomi, which was asked to stop the sale of some of its handsets by the Delhi High Court, has been allowed to send back its Redmi Note 3G handsets to Hong Kong.
• A vacation Bench of high court judge Mukta Gupta permitted Xiaomi to return over 100,000 handsets to their point of origin, Hong Kong, after Swedish telecom firm Telefonaktiebolaget LM Ericsson agreed to the arrangement.
• In December 2014, the court had barred Xiaomi from selling or importing phones into India, after a complaint from Ericsson alleging patent infringement. The move was seen as having dealt a severe blow to Xiaomi’s prospects in what was considered its most important international growth market.
• Xiaomi, though, got a reprieve in a second ruling, which stated the company was forbidden only from importing and selling phones containing components linked to the Ericsson dispute. This referred specifically to parts made by MediaTek, a Taiwanese chipmaker.
• The court had directed Xiaomi to maintain an inventory of handsets, currently lying unused with e-commerce site Flipkart, through which the Chinese company sells its phones under an exclusive arrangement.
NOVARTIS VS. CIPLA
• Delhi High court barred Indian generic drugmaker Cipla from making or selling generic copy of Novartis’s “Onbrez” (for chronic obstructive pulmonary disease) by giving temporary injunction to Novartis. Citing famous Roche vs Cipla case, the court observed that Novartis has a strong prima facia case and as the validity of the patent is not seriously questioned, there is a clear way out to grant injunction. Further, the court observed that Cipla did not provide any figures about the “inadequacy or shortfall in the supply of the drug.”
• Earlier Cipla launched its generic version of Indacarterol in October 2014 claiming “urgent unmet need” for the drug in india.
• Without going conventional way, Cipla, also approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol. Cipla argued on the basis of 3 main points i.e. “epidemic” or a “public health crisis” of COPD, unable to manufacture the same in India by Patentee and high cost of patented drug.