Medicines For Europe Conference Tackles Top Legal Issues For Generic Drug Makers

LONDON — Biosimilars, supplementary protection certificates and European Patent Office patent quality are among the priority issues for the generic drug manufacturing sector, speakers said Wednesday at a Medicines for Europe conference.

The Medicines for Europe 14^th Legal Affairs Conference took place on 25 April. It is followed by the group’s 16^th Biosimilar Medicines Conference on 26-27 April. A press release from the event is here.

Last year was a key one for biosimilars litigation in the United States, which will significantly affect the sector there and in Europe, said Barbara Levi Mager, Sandoz global legal head and general counsel. A Medicines for Europe handbook defines biosimilar medicines as a sub-category of biopharmaceuticals which are made using, or derived from, living organisms using biotechnology. In 2017, the US Food and Drug Administration approved five biosimilars, bringing the total to six. One biosimilar medicine launched last year, and 11 new court challenges were filed, up from six in 2016, she said. Meanwhile, 88 US Patent and Trademark inter partes review petitions were submitted, compared to 15 the year before; and 2017 was also an intense year in terms of regulatory and judicial guidance, she said.

Biosimilars saw $150 billion in global sales in 2013, said Taylor Wessing UK attorney Simon Cohen. By 2020, the medicines are predicted to generate $290 billion in revenues and comprise 27 percent of the pharma market, he said. The EU has approved 42 authorisations since 2006 but despite them, it doesn’t appear that biosimilars companies are making all that much money, he said.

Over the past decade, competition enforcement actions in the life sciences arena have increased, said Floris ten Have, a lawyer with Stibbe NV in the Netherlands. He predicted the trend will continue and will include more complex drugs such as biologics (for example, monoclonal antibodies, interferon or heparin products). The European Commission may launch an investigation of the biologics domain, he said.

The generic drug industry must be able to rely on the quality and presumed validity of patents granted by the European Patent Office (EPO), said Polpharma Group Intellectual Property Director Karin Pramberger. She noted that the number of patent applications filed with the office rose from some 146,000 in 2008 to around 166,000 in 2017, but that the number of patents granted increased by 76 percent during that period. The rise is not due to the greater number of applications, nor to having more patent examiners, she said. Examiner’s targets have gone up but the question is whether patent quality has improved or stayed the same, she said.

In March, 924 examiners signed a petition to the EPO’s governing body, the Administrative Council, saying they are being constrained from carrying out their search and examination duties and that the timeliness and number of “products” shouldn’t be the only criteria for assessing staff performance, Pramberger said. It’s unclear how the EPO will deal with this, but it should be followed up, she said.

The quality of a patent examination is important for the biogenerics sector because companies must evaluate their patent situation at the very beginning of their product development process, Pramberger said. If the EPO, which can take around six years to finalise a patent, has not yet done so, generics manufacturers must predict the outcomes of the relevant patents. EPO decisions and timings have major impacts on the generic industry and can lead to abandonment of medicines if the wrong decisions are made, she said.

Laurence Brüning-Petit, head of the EPO department for matters relating to search, examination and fees in Directorate Patent Law, said examiners are given much more time to do their jobs than those in older and larger offices. She discussed various reforms under way at the office to improve patent quality and action times.

The European Commission defines supplementary protection certificates (SPCs) as “an intellectual property right that serves as an extension to a patent right. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities.” EU legislation on SPCs that hasn’t been fully thought through, and the passage of time, have raised SPC issues on which the generics industry needs guidance, said Insud Pharma Associate General Counsel Tomos Shillingford.

Medicines for Europe is pushing for a manufacturing waiver, which is intended to address disadvantages faced by EU-based generics makers, Shillingford said. An EC consultation on the proposal ended in January and a decision is expected soon, he said. Currently, companies must transfer the manufacture of their drug products out of Europe to secure the availability of a drug from its Day 1 launch, said Pramberger. That’s not possible for every product, particularly biologic drugs; it takes a great deal of time and costs more; and there are risks associated with such technology transfers, she said.

There is an ongoing study by the Max Planck Institute on the overall SPC system, said Taylor Wessing UK attorney Amanda Ebbutt. It is expected to produce recommendations for possible improvements to the existing regime, including potentially a unitary EU SPC. The report is due to the EC soon but it’s unclear when it will be made public, she said The SPC legal review is one step in a long process, so there will be no developments any time soon, she added.

 

Image Credits: Medicines for Europe