Alejandro Luna
Partner and Life Sciences Co-Chair

Progress Still to Be Made in Data Package Exclusivity

Wed, 09/06/2017 - 10:15

Intellectual property is preciously guarded in all sectors and countries due to its high intangible value and as a result, patent litigation is prevalent. According to PwC, four of the 10 largest initial adjudicated damages awards globally between 1996 and 2015 were in the health sector. NAFTA partners the US and Canada have beefed up their regulations and law firm Olivares says Mexico also needs to step up when it comes to data package exclusivity.

Olivares, a Mexico-based leader in intellectual property law, presented evidence to the regulating authorities for data package exclusivity to be changed, namely to mirror the rulings in other NAFTA countries. Whereas in the US and in Canada certain pharmaceutical products are protected for five years and new formulations and new indications are protected for three years, biologics and orphan drugs are granted 12 years of protection. “In Mexico, there is only an incipient and weak protection for five years, granted through an internal COFEPRIS paper that would have difficulty standing up in a court of law. Data package exclusivity terms remain at five years for biologics and orphan drugs. This is not satisfactory,” says Alejandro Luna, Partner and Life Sciences Co-Chair at Olivares.

The firm has presented evidence to the regulating authorities showing that these drugs require over 12 years of R&D and therefore should be granted longer exclusivity periods.

“Most patent litigations occur in pharma because of the rise of generics. This began around 20 years ago and there is little case law to rely on because most cases were either settled or are still ongoing,” explains Luna, who is negotiating on behalf of AMIIF in international free trade agreements. He is lobbying for a change in Mexican law in data package exclusivity and in patentability. He was previously negotiating for the TPP, and should NAFTA renegotiations go ahead, would look to represent the pharmaceutical industry.

In 2003, linkage regulations came into effect in Mexico to avoid these disputes. “The Mexican Institute of Industrial Property (IMPI) publishes patent registrations in its journal, which COFEPRIS checks before registering a new patent to ensure one does not already exist. In addition, the registrant must swear under oath that to their knowledge there is no other existing patent. Before this regulation came into effect, there were 20 compound molecules under litigation. Now, there are none,” says Luna, adding that new formulations are the most commonly disputed. “The easiest way to fight an unlawful marketing authorization is to have it nullified, rather than filing an infringement lawsuit before IMPI, which can take years to reach a decision. By having a patent published in the linkage regulation it should prevent or nullify marketing authorizations in violation of patents.”

Counterfeiting is often seen as a major problem in pharma. According to the US-based Pharmaceutical Security Institute, in 2015, there were 3,002 incidences globally of counterfeit medicine involving 1,095 pharmaceutical products. In Mexico, El Universal reports that between Jan. 1, 2007 and Dec. 31, 2015 the Attorney General’s Office seized 945,152 fake medicines, just under 942,000 of which were confiscated in Mexico City. The Attorney General has been granted stronger powers in Mexico to pursue action against counterfeits without the prior authorization of the title holder, yet Luna believes that the most efficient course of action to reign in counterfeit medicine in Mexico would be to confiscate them at the borders. “Under current law, products cannot be seized because they are considered in transit between countries. If this is changed, it would be much more difficult for counterfeit products to make their way into the Mexican market,” he adds.

To protect against counterfeiting, filing a patent is a necessary step. However, many are unaware of intellectual property procedures in life sciences, including in the highly patented pharma sector. Luna says this happens most often with researchers and universities. “Because they are often required to publish papers, they do so without knowing the intellectual property ramifications. Once a paper is published, the knowledge it contains can no longer be protected by IP law, which many are unaware of.”