As of late, there has been a lot going on in the world of
pharmaceutical intellectual property (IP). One nonprofit organization in
particular, I-MAK, is the only global legal entity defending the public
interest on drug patent challenges, pharma patent informatics and
market intelligence, with no commercial benefit.
Over the past decade, I-MAK attorneys have filed or supported patent challenges in 48 countries. Through their evaluation of Gilead’s patents for sofosbuvir—the base compound in blockbuster hepatitis C drugs Sovaldi and Harvoni—I-MAK has found that Gilead is claiming existing, public knowledge as their own. In fact, the group recently filed challenges in five countries against sofosbuvir, which already been rejected by China and Ukraine.
Health attorneys and I-MAK co-founders Priti Radhakrishnan and Tahir
talked with Inside Counsel about what it’s like to challenge unmerited
patents, and how they are working to restore consideration of the public
interest in the patent system and increase access to life-saving drugs.
I-MAK’s co-directors and their team of lawyers and scientists around the world, including Amin and Radhakrishnan, have over 15 years of experience in prosecuting, licensing, opposing and litigating patents, have been quoted in the New York Times, Wall Street Journal, and other national outlets, and have authored opinion pieces for CNN on Gilead and its Sovaldi patents.
There are key highlights in the world of pharma IP that have been in the focus and likely to remain so for the rest of this year, according to Amin and Radhakrishnan. First, Inter Partes Review (IPR) and whether generic manufacturers increase their use of this mechanism to challenge branded company patents. Data is showing more generic companies are using this forum rather than district court litigation, which is far more expensive and lengthy. Second, related to IPRs is it remains to be seen whether they will lead to higher invalidation rates than challenges in district courts. Also how IPRs will impact the tradition route generics have used to date of filing ANDA (abbreviated new drug applications) when trying to overcome patents.
Third, there has been legislation proposed by the Pharma lobby to have pharm patents removed from the IPR process given the increase in uptake of the forum by generics and actors like the Hedge-fund manager Kyle Bass’s Coalition for Affordable Drugs – the latter being accused of abusing the system and why Pharma has pushed for pharma patents to be exempted from challenge under IPRs. And finally, there are procedural issues relating to IPRs that will get more clarity in the near future, including the new rules for the PTAB which hears cases filed under IPRs.
Additionally, there are many other issues outside of the IPRs, Amin and Radhakrishnan. Antitrust issues including pharma mergers and reverse payments/pay for delay settlement. The 2013 Supreme Court’s decision in Actavis left open a number of questions to answered and these may emerge again this year through ongoing cases such as King Drug C of Florence v Smithkline Beecham Corp Case and Teva Pharmaceutical Industries. In addition, ‘Product hopping’– where brand name drugmakers make small formulation changes to existing products whose patents are about to expire and as generics are about to enter in order to keep hold of the market. The FTC has not enforced in this area but a ruling from the US Courts of Appeals for the Second Circuit in 2015, which found such product hopping could violate antitrust laws may invite more investigations and cases by the FTC.
Amin and Radhakrishnan founded I-MAK a decade ago. Since then, their team of lawyers and scientists has filed/ technically supported patent challenges in 48 countries, including Europe and the four largest emerging markets (Brazil, China, India and Russia). They have found that unmerited patents are a central strategy employed by pharmaceutical companies to maintain market control to increase their profits at the expense of people’s health, and are filing legal challenges to stop pharmaceutical companies from abusing patent law by claiming existing, public knowledge as their own.
“While patents are rights governments give to products proven to be novel, non-obvious and useful, too often big corporations that sell vital drugs try to increase profits by seeking exclusivity on medicine that’s already in the public domain. This in turn blocks people from getting the medicine they need to survive and lead healthy lives,” explained Amin.
I-MAK has been looking closely at how illegitimate patents for sofosbuvir – or the base compound in Gilead’s hepatitis C drugs Sovaldi and Harvoni – are actually one of the root drivers of exorbitant pricing. Sofosbuvir is a vital medicine for people with Hepatitis C and can cure the illness. But, it was developed using previously published information and routine compounds, and uses obvious scientific techniques. Gilead has effectively gained monopoly on the hepatitis C drug market, and it’s done this by acquiring “old science,” or science that was previously in the public domain.
Amin explained, “The bottom line is that sofosbuvir does not meet the legal requirements to justify a patent. Instead of ensuring treatment for all who need it, Gilead creates barriers that block people with Hepatitis C from getting the medicine they need to get healthy. Already, we’ve seen patents rejected on sofosbuvir in China, Ukraine and Egypt."
Through I-MAK’s work around the world they are calling for a coordinated approach of policymakers, health advocates, patients and scientists to get more people the medicine they need to get well, to ensure treatments are priced fairly and to improve the medicine innovation pipeline. According to Amin, this includes strengthening patent examination and rejecting patent applications that don’t meet the legal requirements of patentability.
“Our successful patent challenges in countries around the world have helped government health programs and patients save hundreds of millions of dollars and get the medicine they need to survive and lead healthy lives,” said Amin.
Last year, as a result of our challenge, China rejected Gilead’s patent for the sofosbuvir prodrug. Shortly after the China decision, Ukraine rejected Gilead’s sofosbuvir patent application. Egypt also rejected sofosbuvir patents in 2015. Following challenges filed by our partners that we supported, patents for the sofosbuvir base compound and prodrug are pending in Brazil and Argentina.
He said, “Unjustified patents are an under-the-radar threat to people’s health. By filing and winning challenges, we’re working to ensure Gilead cannot abuse the patent system and claim existing public knowledge as its own. We envision a world where millions of people around the world with hepatitis C get the medicine they need to survive.”
So, where is pharmaceutical IP going in the next five years?
According to Amin and Radhakrishnan, the IPRs issue will continue to play out over the next five years, especially if evidence shows that many patents are being successfully invalidated. If this is the case it would be interesting to see if the USPTO changes its examination guidelines to curb such patents being granted or even if there may be a push for patent law reforms for pharmaceuticals. Unlikely to happen so quickly as the pharma lobby is doing all it can to prevent these changes.
They explained, “But, with the escalating drug pricing conversation, especially during the election cycle and proposals by Clinton and Sanders to bring prices down, and with people slowly connecting the issue of IP/patents with the larger debate we may see some change in the next administration.”
Over the past decade, I-MAK attorneys have filed or supported patent challenges in 48 countries. Through their evaluation of Gilead’s patents for sofosbuvir—the base compound in blockbuster hepatitis C drugs Sovaldi and Harvoni—I-MAK has found that Gilead is claiming existing, public knowledge as their own. In fact, the group recently filed challenges in five countries against sofosbuvir, which already been rejected by China and Ukraine.
I-MAK’s co-directors and their team of lawyers and scientists around the world, including Amin and Radhakrishnan, have over 15 years of experience in prosecuting, licensing, opposing and litigating patents, have been quoted in the New York Times, Wall Street Journal, and other national outlets, and have authored opinion pieces for CNN on Gilead and its Sovaldi patents.
There are key highlights in the world of pharma IP that have been in the focus and likely to remain so for the rest of this year, according to Amin and Radhakrishnan. First, Inter Partes Review (IPR) and whether generic manufacturers increase their use of this mechanism to challenge branded company patents. Data is showing more generic companies are using this forum rather than district court litigation, which is far more expensive and lengthy. Second, related to IPRs is it remains to be seen whether they will lead to higher invalidation rates than challenges in district courts. Also how IPRs will impact the tradition route generics have used to date of filing ANDA (abbreviated new drug applications) when trying to overcome patents.
Third, there has been legislation proposed by the Pharma lobby to have pharm patents removed from the IPR process given the increase in uptake of the forum by generics and actors like the Hedge-fund manager Kyle Bass’s Coalition for Affordable Drugs – the latter being accused of abusing the system and why Pharma has pushed for pharma patents to be exempted from challenge under IPRs. And finally, there are procedural issues relating to IPRs that will get more clarity in the near future, including the new rules for the PTAB which hears cases filed under IPRs.
Additionally, there are many other issues outside of the IPRs, Amin and Radhakrishnan. Antitrust issues including pharma mergers and reverse payments/pay for delay settlement. The 2013 Supreme Court’s decision in Actavis left open a number of questions to answered and these may emerge again this year through ongoing cases such as King Drug C of Florence v Smithkline Beecham Corp Case and Teva Pharmaceutical Industries. In addition, ‘Product hopping’– where brand name drugmakers make small formulation changes to existing products whose patents are about to expire and as generics are about to enter in order to keep hold of the market. The FTC has not enforced in this area but a ruling from the US Courts of Appeals for the Second Circuit in 2015, which found such product hopping could violate antitrust laws may invite more investigations and cases by the FTC.
Amin and Radhakrishnan founded I-MAK a decade ago. Since then, their team of lawyers and scientists has filed/ technically supported patent challenges in 48 countries, including Europe and the four largest emerging markets (Brazil, China, India and Russia). They have found that unmerited patents are a central strategy employed by pharmaceutical companies to maintain market control to increase their profits at the expense of people’s health, and are filing legal challenges to stop pharmaceutical companies from abusing patent law by claiming existing, public knowledge as their own.
“While patents are rights governments give to products proven to be novel, non-obvious and useful, too often big corporations that sell vital drugs try to increase profits by seeking exclusivity on medicine that’s already in the public domain. This in turn blocks people from getting the medicine they need to survive and lead healthy lives,” explained Amin.
I-MAK has been looking closely at how illegitimate patents for sofosbuvir – or the base compound in Gilead’s hepatitis C drugs Sovaldi and Harvoni – are actually one of the root drivers of exorbitant pricing. Sofosbuvir is a vital medicine for people with Hepatitis C and can cure the illness. But, it was developed using previously published information and routine compounds, and uses obvious scientific techniques. Gilead has effectively gained monopoly on the hepatitis C drug market, and it’s done this by acquiring “old science,” or science that was previously in the public domain.
Amin explained, “The bottom line is that sofosbuvir does not meet the legal requirements to justify a patent. Instead of ensuring treatment for all who need it, Gilead creates barriers that block people with Hepatitis C from getting the medicine they need to get healthy. Already, we’ve seen patents rejected on sofosbuvir in China, Ukraine and Egypt."
Through I-MAK’s work around the world they are calling for a coordinated approach of policymakers, health advocates, patients and scientists to get more people the medicine they need to get well, to ensure treatments are priced fairly and to improve the medicine innovation pipeline. According to Amin, this includes strengthening patent examination and rejecting patent applications that don’t meet the legal requirements of patentability.
“Our successful patent challenges in countries around the world have helped government health programs and patients save hundreds of millions of dollars and get the medicine they need to survive and lead healthy lives,” said Amin.
Last year, as a result of our challenge, China rejected Gilead’s patent for the sofosbuvir prodrug. Shortly after the China decision, Ukraine rejected Gilead’s sofosbuvir patent application. Egypt also rejected sofosbuvir patents in 2015. Following challenges filed by our partners that we supported, patents for the sofosbuvir base compound and prodrug are pending in Brazil and Argentina.
He said, “Unjustified patents are an under-the-radar threat to people’s health. By filing and winning challenges, we’re working to ensure Gilead cannot abuse the patent system and claim existing public knowledge as its own. We envision a world where millions of people around the world with hepatitis C get the medicine they need to survive.”
So, where is pharmaceutical IP going in the next five years?
According to Amin and Radhakrishnan, the IPRs issue will continue to play out over the next five years, especially if evidence shows that many patents are being successfully invalidated. If this is the case it would be interesting to see if the USPTO changes its examination guidelines to curb such patents being granted or even if there may be a push for patent law reforms for pharmaceuticals. Unlikely to happen so quickly as the pharma lobby is doing all it can to prevent these changes.
They explained, “But, with the escalating drug pricing conversation, especially during the election cycle and proposals by Clinton and Sanders to bring prices down, and with people slowly connecting the issue of IP/patents with the larger debate we may see some change in the next administration.”
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