Pharma giant Amgen in multiple generics disputes

Pharma giant, Amgen, are at the centre of a number of disputes involving generics and patents.

Multiple disputes

Amgen are embroiled in a number of disputes in the US surrounding their generic version of Roche’s own biosimilar, Avastin and their own bestseller, Neulasta, as it also being alleged by Coherus.

Roche’s Genentech made an official complaint earlier this year, citing Amgen as having deliberately obstructed the pharma company in determining if the sale and/or production of Amgen’s biosimilar would infringe on their patents.

Roche further alleges that Amgen has now opted-in to the information exchange mechanism provided by the BPCIA. Genentech also says that it has not been given access to several specific categories of Amgen production information, which would allow it to decide whether the Amgen generic actually infringes its patents.

Amgen defence motion

In response, Amgen filed a motion to dismiss the claims, based on their precedent case in generic pharma law, Amgen versus Sandoz. The Federal Circuit Judge decided in this case that it should be optional for a generic applicant to disclose its full biosimilar application. Amgen therefore argued that it would be incorrect to distinguish the company for deciding to disclose its application. The court agreed, dismissing the Genentech complaint in its entirety.

Amgen’s alleged delaying tactics

A month following this precedent case, Amgen filed a further action alleging that Coherus BioSciences had head-hunted and effectively stolen Amgen employees purely with the intention of stealing information on Neulasta so that it could develop a generic competitor.

The President and CEO of Coherus, Denny Lanfear, categorically rejected the claims, stating that his company does not need Amgen’s proprietary information in order to compete or be successful. Mr Lanfear also alleges that this ‘baseless litigation’ is merely an attempt by Amgen to delay his company’s entry into the market as a potential competitor.

Originator companies have been accused of using similar delaying tactics before. In a recent report produced by the US FDA, other pharma companies have resorted to using citizen petitions as a last-ditch means of holding off potentially damaging competition in especially profitable generics markets.

Other pharma giants and generics companies will be watching the ongoing debacle with interest to see whether further legal precedents will be set.




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