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May 25, 2012

Pharmaceuticals giants go head-to-head for intellectual property rights

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Expertise|Adcock Ingram|Africa|Defence|Merck & Co|Safety|Africa|South Africa|Manufacturing|Pharmaceutical Brands|Pharmaceutical Products|Pharmaceuticals|Pharmaceuticals Giant|Pharmaceuticals Heavyweight|Product|Products|Treatment Of Hypertension|Hypertension|Abofele Khoele|Carl Van Rooyen|David Cochrane|Lisinopril|Zemax|Biotechnology
Expertise|Africa|Defence|Safety|Africa||Manufacturing|Products|||||
expertise|adcock-ingram|africa-company|defence|merck-co|safety|africa|south-africa|manufacturing|pharmaceutical-brands|pharmaceutical-products|pharmaceuticals|pharmaceuticals-giant|pharmaceuticals-heavyweight|product|products|treatment-of-hypertension|hypertension|abofele-khoele|carl-van-rooyen|david-cochrane|lisinopril|zemax|biotechnology-technology
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The Supreme Court of Appeal (SCA) last month ruled in favour of pharmaceuticals giant Adcock Ingram over a trademark dispute with competitor Cipla Medpro.

The companies locked horns over their registered trademarks for the generic of Lisinopril, which is used to treat mild to moderate hypertension and certain cardiac conditions. Lisinopril was originally patented by international pharmaceuticals heavyweight Merck & Co in 1989.

Last year, Adcock Ingram submitted an application to the Pretoria High Court to have Cipla’s registration for its Zemax trademark revoked, arguing that it was too similar to Adcock Ingram’s Zetomax trademark, which was registered before Zemax.

The High Court dismissed Adcock Ingram’s application, ruling in favour of Cipla. Adcock Ingram then appealed the decision with the SCA, which overturned the High Court ruling last month and ordered that Cipla’s Zemax trademark be removed from the Register of Trademarks.

The SCA also confirmed the right of patients in South Africa to be involved in the process of deciding on their medication, even prescription medication, a decision that countered Cipla’s defence.

Cipla argued that both Zetomax and Zemax can only be obtained with a doctor’s prescription and that, because doctors and pharmacists are trained to know about the products, it is not possible for them to confuse the two competing trademarks.

Cipla’s argument was supported by a 1983 Pretoria High Court decision that found a patient’s prescription to be the sole responsibility of the doctor and not the patient.

The SCA, however, took into account Section 8 of the National Health Act, which gives a patient the right to participate “in any decision affecting his or her personal health and treatment”. The SCA also referred to Section 22(F) of the Medicines and Related Substances Act, which deals with generic substitution.

The SCA agreed with Adcock Ingram that this section of the Medicines and Related Substances Act obliges pharmacists to inform patients of the advantages of generic substitution and so involve patients in the decision-making process. Adcock Ingram’s argument is that the patients contribute to the decision regarding whether trademarks are likely to be confused and their views should, therefore, also be taken into account.

The SCA also remarked that the Pretoria High Court’s 1983 ruling that a patient’s prescription is the doctor’s responsibility is unrealistic in present-day circumstances, where patients play an active role in relation to their health.

“Adcock Ingram is delighted with this ruling,” says medical executive Dr Abofele Khoele, adding that Zetomax will continue to be available as a generic alternative for the treatment of hypertension and certain cardiac conditions.

“The SCA ruling finalised the ongoing debate about whether the views of patients should be taken into account, specifically with regard to the questionable confusion between pharmaceutical brands,” says patent and trademark firm Spoor & Fisher partner Carl van Rooyen, who is also part of Adcock Ingram’s team of attorneys at Spoor & Fisher.

“Pharmaceuticals companies will have to take greater care when choosing names for medicines to ensure they are not confused with other medicines,” he says, adding that this ruling could have far-reaching implications for Cipla, as it will probably be forced to rebrand its Zemax product.

Medical and Pharmaceutical Patents
Trademarks refer specifically to the brand of a particular product and the name that identifies it. Companies who trademark their products are entitled to protect that brand name for the rest of the product’s existence.

Patents, however, which protect new ideas and innovations, are limited to a 20-year period. In the medical and pharmaceuticals world, patents protect products, including the active ingredients in a particular medicine, new pharmaceutical formulations and medical devices.

“The 20-year monopoly provided by a patent incentivises companies to develop new products. Once developed, the product will become available to the generics market.

“However, the development of new pharmaceutical products and medical devices, which involves testing the efficacy and safety of those products and securing regulatory approval to get those products on the market, is very costly,” says Spoor & Fisher patent attorney David Cochrane.

“Most pharmaceuticals companies obtain patents because it’s quite easy to analyse products once they’re on the market,” he says. “So, to protect themselves, most pharmaceuticals companies use patents.”

He adds that the patent document has to provide full details of the product, and that this actually encourages development. “A pharmaceuticals company gets 20 years of protection for bringing in the new product but, in return, [the company has] to share that knowledge to help develop better products.”

However, patents also become contentious issues when it comes to pharmaceutical intellectual property. “It’s about the generic companies wanting to get into the market,” says Cochrane. “If they think the patent is weak or should not have been granted, they can attack that patent and apply for it to be revoked before the 20-year period has ended.”

Alternatively, generic companies wait until the end of the 20-year period and, thereafter, bring the generic of that product onto the market as soon as possible.

Medical devices can also be protected by registered designs, which protect what a product looks like, because each medical device will look different from other devices. A registered design can protect the appearance of a product for up to 15 years.

“Biotechnology is another field where the development of new genes and new technolo- gies is patented,” says Cochrane, adding that attorneys who handle patents in medicine and biology need to have specialised in each specific area to understand it, and know how to protect it by law.

Cochrane mentions that companies like biopharmaceutical discovery company Shimoda Biotech and drug development company iThemba Pharmaceuticals, which are developing new pharmaceutical products, as well as orthopaedic implant specialist Southern Medical, which is developing and manufacturing advanced and high-quality orthopaedic implants, are protecting their research with patents locally and internationally, with a view to commercialising the products internationally.

“We need more South African companies to follow this route,” he says.

Cochrane is a patents attorney with a background in chemistry, whose expertise is handling pharmaceutical patents, formulations and how the active ingredients in medicines are made. “When it comes to biotechnology patents, however, [Spoor & Fisher] has patent attorneys with a biotechnology background who under- stand that technology.”

Similarly, a patent attorney who is also a mechanical engineer, and who under- stands exactly how medical devices work, handles the medical device patenting at the law firm.

Edited by: Chanel de Bruyn
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