Tag Archives: patents

Health Alerts

Martin Shkreli A Creature of FDA Regulation, Not Pharma Industry’s Greed

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HSA(A version of this Health Alert was published by Forbes.)

Perhaps it is just unfortunate coincidence, but Hillary Clinton’s proposal to impose federal controls on prescription drug prices was perfectly timed to ride the public outrage over a hedge-fund manager turned pharmaceutical executive, Martin Shkreli, who raised the price of a  decades-old drug drug from $13.50 per pill to $750.

Mrs. Clinton lumps all nominally expensive prescription drugs into the same category of so-called “specialty drugs.” However there is a world of difference between Mr. Shkreli’s Daraprim and specialty drugs like Sovaldi and Harvoni. The latter are newly invented medicines that required many years and huge amounts of capital investment to achieve therapeutic advances for patients suffering Hepatitis C that radically increase their quality of life. They comprise intellectual property protected by patents, which allow the drug makers to compete without fear that their innovations will be copied immediately by manufacturers who made no comparable investment in R&D. Continue reading Martin Shkreli A Creature of FDA Regulation, Not Pharma Industry’s Greed →

Health Alerts

Cross-Over Investors Key Players in Health Deal Boom

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(A version of this Health Alert was published by Forbes.)

Silicon Valley Bank has published its mid-year report on the state of financing in biotech, medical devices, and diagnostics. The key take-away is that both private financing and exits continue to be strong. One development in the structure of the market that has made deals easier to move through the pipeline is the rise of cross-over investors. These are mutual funds or hedge funds (usually investors in listed securities) which are increasingly investing in private health deals. Continue reading Cross-Over Investors Key Players in Health Deal Boom →

Policy Updates

Trans Pacific Partnership and Intellectual Property Protection

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vaccine-shotOn July 31, trade ministers from countries (including the U.S.) seeking a final draft of the Trans Pacific Partnership (TPP) went home from Maui disappointed. Negotiations got hung up on a few things, especially intellectual property protection (patents) for pharmaceuticals.

The policy associated with the TPP that has been most controversial within the U.S. is Trade Promotion Authority (TPA or “Fast Track”). TPA is not a features of the treaty itself, but an entirely domestic policy defining the power of the Senate to ratify the agreement signed by the President’s men.

At NCPA, we were concerned that giving President Obama fast track authority would result in a poorly negotiated agreement, without adequate protection for intellectual property rights – the fuel of innovation. Congress went ahead and gave the president TPA, so all we can do is wait until we see what comes out of the hitherto confidential discussions.

There have been some positive signals that the administration is standing up for strong intellectual property rights. If that is why the negotiations broke up without a final agreement, then we should be glad to take a breather until other countries recognize the value of pharmaceutical patents like the U.S. does. Continue reading Trans Pacific Partnership and Intellectual Property Protection →

Policy Updates

Leaked: Obama’s Trade Deal Includes Strong Intellectual Property Rights

I had been concerned that the Trade Promotion Authority, which Congress just granted the president, would be problematic because the president would not push for strong intellectual property protection in international trade agreements, especially the Trans Pacific Partnership.

I am glad to learn that I was wrong (or that the administration heeded my concerns):

A recent draft of the Trans-Pacific Partnership free-trade deal would give U.S. pharmaceutical firms unprecedented protections against competition from cheaper generic drugs, possibly transcending the patent protections in U.S. law.

The draft text includes provisions that could make it extremely tough for generics to challenge brand-name pharmaceuticals abroad. Those provisions could also help block copycats from selling cheaper versions of the expensive cutting-edge drugs known as “biologics” inside the U.S……

(Michael Grunwald, “Leaked: What’s in Obama’s trade deal,” Politico, June 2015)

When the official draft comes out, this will cause lots of controversy in the U.S. and abroad.

Policy Updates

Trans-Pacific Partnership: Intellectual Property Rights Won’t be Strong Enough

A few days ago, I discussed my concern that intellectual property rights for pharmaceutical innovators would not be strong enough in the Trans-Pacific Partnership agreement for which President Obama seeks Trade Promotion Authority.

Well, they won’t be strong enough, according to information leaked from the negotiations:

Facing resistance from Pacific trading partners, the Obama administration is no longer demanding protection for pharmaceutical prices under the 12-nation Trans-Pacific Partnership, according to a newly leaked section of the proposed trade accord.

But Pacific accord negotiators appear ready to grant pharmaceutical and medical device makers more power to influence participating governments. The 12 countries involved, and any others that might join later, would have to disclose rules and guidelines for deciding which medical products would be made available through government programs and at what rate providers would be reimbursed.

(Jonathan Weisman, “U.S. Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals,” New York Times, June 10, 2015)

Call me old-fashioned, but I think that’s a pretty reasonable request.

Policy Updates

Trans-Pacific Partnership: Will Intellectual Property Rights Be Strong Enough?

Having passed the Senate, it is now up to the House of Representatives to decide whether to give President Obama Trade Promotion Authority (TPA, or “fast track”) to negotiate the Trans-Pacific Partnership.

Most Congressional Republicans who support TPA also advocate strong intellectual property rights. However, one concern with TPA is that it is uncertain the President will negotiate strong intellectual property rights in the TPP. What will these Republicans do if the final version of the TPP does not have adequate protection for investment in intellectual property?

One example is the protection of data exclusivity for inventors of new biotech products. The U.S. has the gold standard – 12 years – and it is reasonable to seek this standard in the TPP.

When it comes to pharmaceutical patents, U.S. Senator Orrin Hatch is on the side of protection intellectual property with respect to current trading partners. He recently criticized the president for not doing enough to pressure India (which is not in the TPP) to improve its patent protection.

On the other hand, he was the Senate champion for fast track for TPP. Is this consistent?

Health Alerts

Intellectual Property Rights for Global Health

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(A version of this Health Alert was published by Forbes.)

patent-pendingRepublican congressional leaders are eager to give President Obama Trade Promotion Authority, or “Fast Track.” Proponents argue that Fast Track will break the logjam holding up important international trade agreements like the Trans Pacific Partnership (TPP), which includes countries as diverse as Australia, Canada, Peru and Vietnam.

Fast Track would allow the president to finalize the agreement before sending it to Congress for a straightforward up-or-down vote within a limited time. However, the likelihood of Fast Track resulting in TPP getting a “thumbs up” from Congress is limited by potential differences between the president and the congressional majority on intellectual property rights.

In a recent Wall Street Journal op-ed, Representative Paul Ryan (R-WI) and Senator Ted Cruz (R-TX) asserted that the administration must pursue a number of negotiating objectives, including “beefing up protections for U.S. intellectual property” if it wants Congress to approve the TPP.

It is uncertain the president is as committed to intellectual property as Mr. Ryan and Mr. Cruz hope, especially with respect to patents for medicines. Although the text of the TPP is not yet available to the public, the U.S. Trade Representative, who negotiates in the president’s name, insists that “TPP countries have agreed to reflect in the text a shared commitment to the Doha Declaration on TRIPS and Public Health.”

The 2001 Doha Declaration was an attempt to limit international trade agreements’ commitment to patent rights that were accepted in the World Trade Organization’s 1995 Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. It insists that low and middle-income countries should have broad latitude to allow generic drug makers to make copies of patented medicines through a legal mechanism called “compulsory licensing.” Continue reading Intellectual Property Rights for Global Health →

Policy Updates

Patent Policy Cost India $10 Billion Investment

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Variety of Medicine in Pill BottlesLegal support for intellectual-property rights is essential to innovation. In health care, patents protect intellectual property in pharmaceutical innovation. Not all countries respect pharma IP equally, according the Global IP Index.

India has long been a problem because of its successful generic drug industry. Generic drug makers make copies of brand-name drugs once their patents have expired. This means that they have an incentive to lobby for weaker patents. If the political economy of a country’s pharmaceutical industry is dominated by generic competitors, it is difficult for innovative companies to gain a foothold.

One Indian innovative drug maker is speaking out:

Hyderabad-based Hetero Pharma that the country has lost nearly $10 billion worth of investment by not respecting IP norms. “The Compulsory Licence (CL) that we issued did more harm to our image than actually helped patients,” Srinivas Reddy, director, Hetero Pharma, told ET. (Economic Times)

A compulsory license is one which the government orders a patent-holder to issue to a generic competitor at low-market fees. Let’s hope more Indian entrepreneurs speak out like Mr. Reddy has.