The Biologics Price Competition and Innovation Act of 2007 (Senate bill S 623) was approved on Wednesday by the Senate Health, Education, Labor and Pensions ("HELP") Committee. 

According to a press release issued by Senator Orrin Hatch, the key provisions of the bill are as follows:

• Creates an abbreviated pathway the FDA will use to approve “safe, pure, and potent” biosimilar products, the legal standard for biological approvals.
• Gives incentives for innovators to continue developing new breakthroughs in biologics. The incentive is crucial because currently those incentives only lie in patent law. And because the low-cost versions will be only similar, but not identical, it was unclear if all of the innovator’s patents would be protected.
• Creates a mechanism to resolve legal challenges to the follow-on products. It allows innovators, generics, and the universities that partner with them in developing biologics, to adjudicate expeditiously whether or not follow-on products are violating an innovator’s intellectual property rights.
• Allows FDA to determine if a biosimilar product is interchangeable, meaning that it could be substituted at the pharmacy level under state law. Under the law, FDA can designate a product as interchangeable if it is biosimilar in composition and action in the body and if the patient is not harmed by switching from one product to another.
• Bases its guidance on scientific standards that FDA has always relied on, giving tremendous deference to FDA in developing and administering the new program. 

DrugResearcher.com reported:

[The draft bill] finally reaches a compromise between warring factions within the US senate over three main bones of contention regarding the new legislation, first proposed in February, which would be an amendment to the Public Health Service Act. .  . .

So firstly, under the proposed compromise bill, all follow-on biologics will be required to undergo appropriate animal studies along with one clinical trial in humans in order to demonstrate adequate comparability with the innovator drug, although the FDA will retain the discretionary power to deal with companies on an individual basis on the extent of testing actually required.

Secondly, on the thorny issue of whether or not to give the green light to interchangeability between a branded biologic and its follow-on counterpart, the bill will allow for this in certain cases where the FDA deems it appropriate.

Thirdly, in order to placate the industry who are fuming over the lack of incentive to innovation that allowing follow-on biologics may cause, the length of time a branded biologic would be protected under patent has been guaranteed at 12 years under the proposed compromise bill.

The Patent Baristas provided the following explanation on the bill:

The Act amends section 351 of the Public Health Service Act to provide for an approval pathway for safe biosimilar and interchangeable biological products (relying in part on the previous approval of a brand product) while preserving the incentives that have fueled the development of these life-saving medicines. . . .

The legislation allows, but does not require the FDA to issue guidance documents to inform with the public of the standards and criteria the agency will use in approving biosimilar and interchangeable products. Development of these guidance documents will require public input. Applications can be filed in the absence of guidance documents. . . .

The Act provides incentives for the development of both new life-saving biological products and interchangeable biosimilar products: 12 years of data exclusivity for the brand company during which a biosimilar product may not be approved, and 1 year of exclusivity for the first interchangeable biological product.

How is the biotech industry going to receive this proposed bill, in light of the concerns that the industry has had about biogenerics?

A press release issued by the Biotechnology Industry Organization ("BIO") gives an initial glimpse into the biotech response, stating as follows:

“Senators Kennedy, Enzi, Clinton and Hatch deserve credit for their hard work in crafting this complex legislation, and for the bipartisan support they have achieved for the bill.  Biotechnology innovators share the goal of ensuring all patients have access to life-enhancing and life-saving biologics.  We support the development of a pathway for the approval of follow-on biologics,” said BIO President and CEO Jim Greenwood.  “Toward that goal, we will continue to work with Congress to make certain the legislation is improved to ensure it supports the principles we have outlined for a pathway to follow-on products, namely providing better protections for patient safety and the patient-doctor relationship. 

“In addition, the patent litigation rules included in the bill must be revised to improve protections for the intellectual property rights of innovators, ensure timely resolution of all patent disputes and maintain incentives to develop future medical breakthroughs,” Greenwood stated.

It will be interesting to see how the introduction of this new legislation unfolds.  I suspect that it definitely will not be embraced by the industry, but I still don’t have a sense of how strong the opposition will be.  Is this legislation something that biotech companies can work with as the BIO press release suggests, or is this something that will be fiercely opposed?  Only time will tell.

We will be following this issue as this legislation is introduced outside of the committee, and we will keep you posted.

I recently sat down with LexBlog’s Rob La Gatta, who interviewed me in conjunction with LexBlog’s "Five Questions Series."  In the interview, Rob explored how I stay on top of developments in the blogosphere, how I’ve set myself apart to reporters who use me as a source, how I’ve set myself apart from other bloggers, what I see happening with regulation in the blogosphere, and whether I’ve accomplished what I aspired to yet with my blog. 

Since I try to stay on topic with this blog and don’t often talk about myself, this interview provides some insight into me, my firm, and my views on blogging generally that likely goes beyond what you will read in my blog yourself.  

LexBlog has, of course, written about me in the past–Kevin O’Keefe was kind enough to compliment me in a prior blog posting "Be an A-List Blogger in Your Niche to Succeed," where he pointed to me as an example of how you can become successful by blogging in a niche such as biotechnology. 

To follow up on this recent LexBlog interview, as well as Kevin’s earlier posting, I think that that in many ways the web is the great equalizer for legal practices–it enables the small firm practice to distinguish itself in ways that small firms previously could not.  By providing quality content on a relevant subject, lawyers can absolutely become known as experts in a field, even without doing it from the corner office of a swanky large-firm office building.  I have been building my firm for a little over three years now, which was a challenge I took on unexpectedly only after the sudden collapse of my former firm, Pennie & Edmonds LLP.  While, at the time of the collapse, when I decided to start the firm, I had a sixth sense that I should put my resources into developing my web presence and I had a definite vision about how to accomplish this, even I would not have expected to be getting the caliber of media calls and speaking engagements that I am now getting three years later.   

So, thank you to Rob La Gatta and LexBlog for interviewing me, and I hope you, as my blog readers, enjoy this brief glimpse into the story behind the blog. 

Well, it happened again–President Bush vetoed yet another stem cell bill.

MSNBC reported on the President’s action as follows:

This was the third veto of Bush’s presidency. His first occurred last year when he rejected legislation to allow funding of additional lines of embryonic stem cells — a measure that passed over the objections of Republicans then in control. The second legislation he vetoed would have set timetables for U.S. troop withdrawals from Iraq.

According to MSNBC, the Democrats do not currently have enough votes to override the veto; however, Senate Majority Leader Harry Reid is set to schedule an override vote. 

The President’s action today really should not have come as a surprise to anyone.  I certainly anticipated that this bill would be disposed of by veto when I discovered that a new bill was being considered by Congress.  But apparently Congress thought it was worth its time to send another bill through Congress.  Isn’t it nice to know our taxpayer dollars are being put to good use?

The California Healthcare Institute ("CHI") is warning that the California’s biotech industry is at risk as a result of recent court decisions, according to the San Jose Mercury News.

The San Jose Mercury News reported:

[The organization was] critical of several recent Supreme Court rulings, including its decision in January in MedImmune vs. Genentech, which eliminated a longstanding requirement for businesses licensing another company’s patented technology.

The decision allows companies licensing such technology to challenge the patent without first having to breach their license agreement and risk being sued.  As a result, many biotech executives fear the ruling could trigger a flood of patent challenges.

In other cases, the report said, the Supreme Court has made it tougher for biotech companies to obtain court injunctions against companies that infringe upon their patents and to prove their technologies are novel enough to warrant patents in the first place.

According to the San Jose Mercury News, CHI also expressed concern about the patent reform debate in Congress and the potential effects of patent reform on the industry.  At the heart of its concern is the fact that biotech products take many years and significant expense to develop.  If biotech companies are forced to overcome additional obstacles, what will this do to the industry?

I agree with CHI that California’s biotech industry will be impacted by some of the recent decisions by the courts as well as by patent reform; however, I can’t help but think that CHI is focusing on the wrong issues.  In my view, the issues that pose the greatest risk for the biotech industry are not these recent patent decisions, nor patent reform, but rather the push for biogenerics and for adopting universal healthcare, both of which could have serious and even devastating consequences for the industry.  How will the industry survive and flourish in a world, where biotech companies are unable to profit from the next big blockbuster?  As an entrepreneur myself, it’s difficult to believe that biotech entrepreneurs will be out there launching new biotech start-ups to the same degree they are today without the promise of a big payoff at the end.  How many well-intentioned people would really do that to themselves?  As much as I enjoy what I’m doing in building my firm and practice, I’m not sure I would do it if you took away the profit potential.  It’s just too much work.

Don’t get me wrong–I am as concerned as the next person with the rising costs of healthcare and the challenges with obtaining affordable health insurance and medications.  When my former law firm closed its doors unexpectedly and decided to terminate my COBRA six months later, I was surprised to find myself uninsurable.  Then, I had the pleasure of paying full price for brand-name medications for a year as I struggled to get my firm off the ground in a bad economy.  I even became very ill at one point and found myself in the situation of not being able to go to the doctor due to the expense and the fear of being hospitalized.  Coming from a family of healthcare professionals, it was a shock to the system to experience first-hand the other side of the story and to realize how easy it was to find myself–when I was young and basically in almost perfect health–in the position of not being able to obtain the insurance I needed.

And, of course, now that I do have insurance, I just received a letter from my insurer that the prescription drug benefits are being slashed this summer as a cost-saving measure–a move that will likely hit me and a lot of other Californians in the pocketbook.

However, the flip side of argument is that the biotech industry is a for-profit industry, which is just not going to thrive if you take away the "profit" element.  You don’t have to be an entrepreneur to understand that reality. 

With all of the innovation coming out of the biotech world today, a profitable industry could be the difference between any one of us dying from a horrible illness and our being able to avoid getting sick altogether.

So, does CHI have the right focus?  I guess it is up to us to decide.