Subscribe

Recent Articles

Popular Posts

Site search

Follow Us

Tag: biotech

The Passage of Patent Reform: Is this Really a Win for the Biotech Industry?

Written by on Sunday, September 25th, 2011

Now that President Obama signed the patent reform bill into law on Sept. 16, 2011, it is only fitting to ask whether the passage of this bill was a win for the biotech industry?

According to Roy Zwahlen, manager of intellectual property and technology transfer policy at BIO, the answer is a clear “yes.” He posted a blog posting on the BIO website, in which he articulated a number of reasons why he thought the bill was good for biotech:

1) Greater resources and operational flexibility for the PTO;
2) New and improved proceedings for patent quality review;
3) Will end the abuse of a loophole in false patent marking litigation;
4) Change America’s first to invent system to a first to file system;
5) Make it easier for inventors to file a patent; and
6) Eliminate the “best mode” requirement in patent litigation.

I thought Mr. Zwahlen’s apparent support for the patent reform bill was interesting in light of the industry he represents. Like many of my Bay Area counterparts, I have a completely different take on the issue.

While I am all in favor of making government agencies work better, as someone who regularly works with start-ups, I simply fail to see how changing our prior first to invent system in the U.S. to a first to file system could possibly have been good for the biotech industry. There is no question that the rest of the world has been using a first to file system and that our system was out of sync with the system adopted by the rest of the world. Yet, I would argue that our first to invent system was beneficial to cash-strapped start-ups and small businesses, which often do not have the budget when they first launch their businesses to immediately file patents to protect their inventions. As a lawyer working with start-ups, I frequently get the question “how much time do I have to file?” Particularly in the current times, when start-ups and small businesses are arguably more cash-strapped than they have ever been and investment money is so difficult to come by, patent prosecution costs are a huge concern. It’s hard to see how it can be in the best interests of a start-up to have to race to file a patent on an invention or to risk losing the opportunity to own the rights on the invention altogether.

Moreover, I can’t help but ask the question: in light of the challenges posed by the current economy, why in the world did Congress and the President choose now to impose yet another burden on start-ups and innovators?

Stepping back from this issue a bit, as a small business owner myself, I’ve been very vocal in my criticism over what I think is our country’s recent misguided financial support for so-called too-big-to-fail businesses at the peril of small businesses, which I would argue are the backbone of our country and of our country’s future. The average small business in this country (with a few notable exceptions such as the scandal-ridden and bankrupt Solyndra) has not been able to so much as pay a financial institution to loan it money in this environment. Yet, all kinds of taxpayer money has been handed out to large institutions since the recession started. This is not a criticism of any particular administration, as both the Bush and Obama administrations have taken this approach, as well as the past few Congresses. Moreover, while I’ve listened over and over again to the arguments in support of why these decisions have been made, I continue not to agree with them. My position is that the innovation we are all seeking to give our economy a much-needed boost is just not going to come from a large business, and that starving small businesses of capital and funding instead the largest businesses in this country is just a very misguided policy approach. So, this is the perspective I come from as a small business myself, whose business is largely comprised of working with start-ups. And that is the perspective from which I approach this issue.

The bottom line: I would argue that the decision to move to a first to file system in a bad economy is yet another example of enacting policies that hurt the little guy in tough times. And I think that it ultimately is bad for the biotech start-up out there who is trying to come up with cash to fund a patent program, or for the inventor who is trying to do something productive with his or her invention.

4,809 total views, 1 views today


Category: Biotech Industry News, Biotech Legislative Developments  |  Comments Off on The Passage of Patent Reform: Is this Really a Win for the Biotech Industry?

Patent Reform Debate Revived in Congress

Written by on Thursday, March 26th, 2009

Here we go again. . . .Patent reform is back on the table: two bills have been introduced and are again being debated in Congress.

The first of the two bills, the Leahy-Hatch bill, S. 515, was introduced on March 3, 2009.  According to a summary by the Congressional Research Service, the key points of this patent bill, also known as The Patent Reform Act of 2009, are as follows:

Defines “effective filing date of a claimed invention” as the filing date of the patent or the application for patent containing the claim to the invention (thus establishing a first-to-file system).
Declares that, to the extent consistent with U.S. obligations under international agreements, patent examination and search duties are sovereign functions. Requires that those functions be performed within the United States by U.S. citizens who are federal employees.
Revises various other rights and requirements related to patents, including regarding: (1) damages; (2) post-grant procedures; (3) citation of prior art; and (4) inter partes reexaminations; (5) preissuance submissions by third parties; (6) venue and jurisdiction; and (7) the regulatory authority of the Patent and Trademark Office.
Replaces the Board of Patent Appeals and Interferences with the Patent Trial and Appeal Board.
Revises provisions concerning the residency of federal circuit judges and the facilities and administrative support which must be provided to them.
The second of the two bills, S. 610, was introduced by Senator Kyl on March 17, 2009.  The most noteworthy distinction between the Kyl bill and the Leahy-Hatch Bill involves how the calculation of damages would be treated by each of the bills.  The Progress & Freedom Foundation explained this distinction as follows:

The most contentious issue for patent reform (lately, at least) regards calculation of damages.  Damages consumed much if not most of the time during the Senate hearing on the Leahy-Hatch bill a few weeks ago.  At the risk of over-simplification, the Leahy-Hatch bill tried to ensure a couple of things regarding reasonable royalties for damages:

(1)  If a patent covers a discrete component of an infringing system (e.g., the modem in a computer), damages should ordinarily be based on the value of the modem and not the entire market value of the computer.  This is the “entire-market-value rule” question and is currently up for decision in the Court of Appeals for the Federal Circuit.  (Disclaimer:  Several years ago, I worked on that case at the trial level.)

(2)  Damages should be assessed with reference to the “claimed invention’s specific contribution over the prior art.”  (quoting from page 27 of the Leahy-Hatch bill).  An extensive critique of such methodology appears here.  Such critics argue that the “specific contribution” formulations are unreasonably vague and sell short the value of patented inventions.

The Kyl bill backs off of both of these reforms.

Patently O provides an excellent summary of the controversial Leahy-Hatch damages provisions,  summarizing his points as follows:

Jury verdicts are quite unpredictable, and because the royalty rules are so loose, damages appeals are rarely successful.

The new legislation appears to take on these problems in a way to (1) reduce the average damage award; (2) make damage awards more rational and predictable; and (3) make damages judgment more subject to appellate review.

The practical approach of the legislation is to create a “standard for calculating reasonable royalty” which require a determination of the “specific contribution over the prior art” to determine damages. Some courts already follow the rules set out in the proposed legislation. Thus, legislation advocates may refer to the damages reforms as simply a clarification that limits the actions of rogue courts.

So, is this the year that one of these two patent bills will be enacted?

I have long held the opinion that some type of patent reform is inevitable.  I represent clients in the on both sides of the issue, and there is no question that high tech has been hammered by lawsuits and that this is a major problem for the industry.  So, there is certainly a lot of support on the high tech side for some sort of reform.

As for whether or not it will happen this year, that is a tougher question.  While on one hand it seems incredible to think that in the midst of such economic turmoil a patent reform bill could be voted into law, on the other hand, the truth of the matter is that the economic turmoil could provide just the right climate for patent reform to actually be enacted.   If you question that premise, just take a look around at the other legislation on the table right now–regardless of your political persuasion, I think many Americans would agree that legislation is on the table right now and is getting voted through Congress that would never in normal times get through so easily.

Moreover, I think most commentators would agree that the reason we have been at standstill on patent reform is in large part due to the vigorous lobbying efforts by both the tech and life sciences industries.  I think there is some question given the economy that either industry will have the same level of funds to spend on patent reform lobbying efforts right now.  Biotech companies are running out of money and in some cases filing for bankruptcy.  Tech companies are doing mass layoffs in an attempt to try to stay solvent.  And pharma companies are out looking for bargain basement deals to fund.  Which of these parties will be able to really invest in patent reform lobbying this year?  Your guess is as good as mine.

The California Biotech Law Blog will continue to keep you posted on any patent reform developments as this bill moves through Congress.  This should be interesting. . . .

2,259 total views, no views today


Biotech Companies Filing for Bankruptcy in Bad Economy

Written by on Friday, November 21st, 2008

Biotech companies are facing the new reality of having to contemplate bankruptcy filing in the bad economy.

Bloomberg.com is reporting that five biotech companies have already had to seek bankruptcy protection in the last month, and that more bankruptcies are likely on the way.  According to Bloomberg.com, the companies most at risk have less than six months of cash on hand, only a few drugs in development, and no "definitive" clinical data.  Bloomberg.com reports that a quarter of biotech companies currently fall into this category.

Bankruptcies have in the past been rare in the biotech world.  Troubled biotech companies have historically been acquired or have entered into licensing and other types of deals to survive.  However, the scope of this particular financial crisis is making bankruptcy filings more likely for biotech companies, since no one is available to bail them out from their current financial situation. 

Bloomberg.com reports on the reasons for this new biotech reality as follows:

The amount raised this year by biotechnology companies fell by $9.7 billion through September, or 54 percent, compared with the same period in 2007. . .  Biotechnology companies in the U.S. are raising less cash than they have in a decade. . . .Financing fell to $8.2 billion through September, from $17.9 billion last year. Venture capital funding fell 16 percent, to $2.9 billion. . . .

So what can biotechs in this situation do to survive?

Well, if they are lucky, they will be acquired by a pharmaceutical company.  Otherwise, they can try to just go into hibernation until the economy is better–a strategy that many businesses out there will likewise be doing.

The biotech community can only hope that this will be a short-lived crisis.  But isn’t that what we all are hoping for right now?

1,899 total views, no views today


Category: Biotech Industry News  |  Comments Off on Biotech Companies Filing for Bankruptcy in Bad Economy

Biotech Industry Begins to Assess Likely Impact of New Administration

Written by on Monday, November 10th, 2008

The biotech industry is beginning to assess what the impact of the new Obama administration is likely to mean for individual biotech companies.

A key concern for the industry is the likely financial implications of the Obama presidency on biotech companies, according to an article by SFGate

What financial concerns are at issue?

While biotech companies are definitely concerned about the bad economy and the credit crisis, they are also  concerned about an anticipated push for cheaper drug prices, which could potentially have a very detrimental impact on biotech companies, since any such increase could negatively affect the profits that biotech companies could potentially achieve on their drugs and would perhaps impact companies’ valuations as well.

Another concern for the industry is what will happen to the Food and Drug Administration under an Obama presidency, accoding to the SFGateDuring the Bush Administration, Congress criticized the Administration for how the Food and Rug Administration was run–in particular, they viewed it to be "underfunded" and "ineffective." As Adam Feuerstein of the Street.com reported: "The agency is in turmoil. Morale is low, resources are scarce and too many drug approvals have been delayed at best, or worst, have become politicized."  President-Elect Obama will presumably sink some money into the organization and try to take it in a new direction, which he may begin by choosing new leadership.  According to SFGate and  Feuerstein, a few of the names being considered include: Dr. Steven Nissen, a cardiologist for the Cleveland Clinic;  Dr. Scott Gottlieb, who worked directly under Mark McClellan when he was FDA commissioner; and Janet Woodcock, a veteran agency official who is the favored choice of drug manufacturers.

One highly anticipated change by the new administration is the likely adoption of a new view on stem cell research, reported Yahoo News, which reported that  Obama’s Transition Chief John Podesta indicated this weekend that Obama is currently reviewing President Bush’s executive order on stem cell research and may reverse that order fairly quickly.

As for other changes that might be in the works which would affect the industry, the Patent Baristas have provided an extended list of potential changes that we may see under the new administration, including but not limited to doubling federal funding for basic research over the next ten years, making the research and development tax credit permanent, and reforming the Patent and Trademark Office.

All in all, it seems clear that the new administration will bring "change" to the biotech industry; however, the jury is still out as to whether any such "change" will be for the better or for the worse.   The industry is hoping–like the majority of Americans that voted for Obama on election day–that the "change" Obama will bring will be for the better.

2,250 total views, no views today


Category: Biotech Industry News  |  Comments Off on Biotech Industry Begins to Assess Likely Impact of New Administration

Biotech Facing a Long IPO Dry Spell

Written by on Monday, November 3rd, 2008

The biotech industry is facing the likelihood of a long IPO dry spell, which could extend beyond what is being forecasted in other industries, according to a report by Reuters.

According to Reuters, the last biotech IPO was in November 2007 with Nanosphere, Inc., which develops diagnostic tests, and in the last few weeks, over half of the biotech companies in the IPO pipeline have dropped out, including drug delivery company CyDex Pharmaceuticals Inc., Xanodyne Pharmaceuticals, which focuses pain management, and Phenomix Corp, which specializes in diabetes treatments. Reuters reports that only  five companies remain in the IPO pipeline.

Instead of IPOs, Reuters reports that biotech companies are continuing to turn to mergers; however, pharmaceutical companies are only interested in biotech companies that have products ready for sale, which means that they need to be past Stage 1 and Stage 2.  Pharmaceutical companies are not interested in investing another five years in research and development right now.  Rather, they are looking for products that can quickly replenish their pipelines.

When the IPO market returns, Reuters reports that biotech companies with marketable therapies for hepatitis C, cancer and Alzheimer’s therapies will be the best prospects for an IPO.

Having said this, Reuters reports that what may delay the return of the biotech IPO is the poor price of biotech stocks, and the fact that the biotech companies who have gone public have not increased their stock prices since their IPO.  Reuters reports:  "Only seven of the 61 biotech companies to have gone public since 2000 are currently trading above their IPO prices."

Thus, it appears that biotech is headed for a long IPO dry spell that is not likely to change course, until after the economy picks back up and the industry can show that IPOs make financial sense.   In the meantime, biotech companies will have to continue to rely on alternative exit strategies.

2,516 total views, no views today


Category: Biotech Deals  |  Comments Off on Biotech Facing a Long IPO Dry Spell

Senate Committee Passes Compromise SBIR Reauthorization Bill

Written by on Monday, August 18th, 2008

The Senate Committee on Small Business and Entrepreneurship ("SBE") recently passed a compromise Small Business Innovation Research ("SBIR") reauthorization bill that would allow small companies that are majority-owned by venture capital firms to be eligible for SBIR awards.

According to the SBIR Reauthorization Insider, the SBIR/STTR Reauthorization Act (S. 3362) is a  "completely new bill" that is "not related to H.R. 5819, the House’s SBIR/STTR Reauthorization Act passed in the House" back in April, 2008.  The complete draft of the bill is attached.

According to the SBIR Reauthorization Insider, some of the highlights of this bill are as follows:

  1. Higher Award Amounts – The SBIR and STTR awards are increased to $150,000 in Phase One, $1 million in Phase Two, and are now able to exceed the guidelines by up to 50%.
  2. Increase in the SBIR/STTR Cap– The SBIR cap will be increased from 2.5% to 3.5% at a rate of .1% over 10 years.  The one exception is the NIH, which will stay at 2.5%. The STTR cap will double from 0.3% to 0.6% over 6 years.
  3. Venture Capital Eligibility-A "small business" that is majority owned and controlled by multiple VCs will be eligible to participate in the SBIR program under certain conditions. No single VC can own more than 49% of the small business entity; the VC must be a United States Venture Capital Company; the VC owned small business must register with the SBA when they submit an SBIR proposal. The NIH will be limited to awarding not more than 18% of their SBIR award funding to such VC owned small businesses, and the remaining 10 agencies are limited to 8%.
  4. Length of Reauthorization – The new bill would be reauthorized for fourteen (14) years, resulting in new sunset dates of September 30, 2022, for SBIR and September 30, 2023, for STTR.
  5. Crossover Between Agencies– The new bill would allow Phase One awards at one agency and Phase Two awards at another.
  6. Crossover Between SBIR and STTR Programs-The new bill would allow Phase One awards through the SBIR and Phase Two awards through the STTR, or vice versa.
  7. SBA Waivers Will Not Be Required–SBA waivers will not be required for partnering, subcontracting, or entering into a Cooperative Research and Development Agreement ("CRADA") with a  federal lab of a federally funded research and development center.
  8. Reorganization of the SBA’s Office of Technology.  The bill will move the Office of Technology out from the contracts department and make the Office of Technology directly reportable to the SBA Administrator.  The aim is to restore some of the authority to this office, which was intentionally rendered ineffective in the past due to funding and staff cuts.

This bill obviously falls short of what the biotech industry was seeking in reauthorization legislation, as there is a cap on the percentage of awards that can be given to vc-backed businesses.  However, the industry should be pleased at the fact that a reauthorization bill is now likely to be passed, and some progress has been made toward opening  up awards to vc-backed businesses.  In all likelihood, the final legislation will no longer include a ban on awards to vc-backed companies, which is in itself a victory for the biotech industry.

1,308 total views, no views today


Category: Biotech Legislative Developments  |  Comments Off on Senate Committee Passes Compromise SBIR Reauthorization Bill

More Evidence that Outsourcing is on the Rise in Biotech Industry

Written by on Monday, February 25th, 2008

The Boston Business Journal ran a story this past week on the increasing number of contract research organizations in the Boston area and around the nation.

The article profiled Blue Stream Laboratories, a Woburn contract research organization with eight employees that launched the summer of 2006, reporting that Blue Stream Laboratories President Michael Kouchakdjian had indicated that “his client base is growing as biotechnology companies and contract pharmaceutical manufacturers try to save money by farming out development work to companies like his.”

The Boston Business Journal article provides further evidence that  outsourcing is on the rise in the biotech and pharmaceutical industries–a trend we have been following at the California Biotech Law Blog since last year (see our blog postings from May 23, 2007 and April 2, 2007).  As we have indicated previously, it is almost inevitable that outsourcing will continue to play an increasing role in the biotech and pharmaceutical industries, given the success that the high tech industry has had with offshore outsourcing in recent years. If companies can dramatically cut their costs by outsourcing work, why wouldn’t they pursue that option in order to become more profitable?  I think it is difficult to deny the clear business case for utilizing outsourcing to the extent possible.  I expect that we will continue to see more stories on outsourcing in the life sciences industry over the next few years.

896 total views, 1 views today


Category: Biotech Industry News  |  Comments Off on More Evidence that Outsourcing is on the Rise in Biotech Industry

Debating the Future of the SBIR Program

Written by on Monday, February 4th, 2008

Given the impending expiration of the SBIR Program this October, 2008, the future of the SBIR Program is once again being re-visited.

As The California Biotech Law Blog reported last October, the biotech industry has been actively lobbying for the Small Business Administration ("SBA") to reverse its decision of January, 2001 to make venture-backed companies ineligible for SBIR grants.  This issue, by far, has received the most press in recent years, and of course, is the issue receiving the most attention as the expiration date nears.  The rule excludes many if not most biotech companies from being able to take advantage of SBIR funding, which of course is a serious concern to the industry as a whole. 

Interestingly enough, even the more established pharmaceutical industry has been very vocal on this issue.  While at first glance, this concern seems a bit misplaced, on further consideration, it makes perfect sense that pharma would support biotech’s efforts to change the SBA’s policy.  It is a well-known fact that pharma is looking to biotech companies to supply new products to fill its drug pipeline, which is increasingly becoming depleted.  The more money these companies can access at the early stages, the more likely it will be that enough biotech companies will survive to fill that pharma need.

So, while the issue of excluding venture-backed companies from SBIR grants is taking center stage to the renewal debate, I would argue that Congress should look beyond that stage at some more fundamental problems with the program as it debates SBIR’s future.

What are those problems?

First and foremost, there has never been a good clarification of the SBIR Program’s priorities. 

The SBIR Program falls under the umbrella of the SBA, which according to its website, has a mission based on the following principles:

Creativity  Our people inspire creativity in the American economy by developing and supporting entrepreneurs through a vast network of resource partners.

Advocate  We advocate for all small businesses by taking leadership in building a productive partnership between the American people and its government.

Results  Our team focuses on delivering results for small business, being accountable, accessible and responsive.

Empower  We empower the spirit of entrepreneurship within every community to promote and realize the American dream.

Success
We facilitate the environment necessary for America’s small businesses to succeed, measuring our performance by small business success.

Based on the principles listed on the SBA’s website, it is clear that its chief mission is to support entrepreneurism and thereby help the economy.  A second mission is to help promote. women, minorities, and socio-disadvantaged businesses.

In contrast, the SBIR’s mission is a little less clear.  The SBIR’s website describes the mission of the SBIR and its companion program, the STTR ("Small Business Technology Transfer"), as follows:

Through these two competitive programs, SBA ensures that the nation’s small, high-tech, innovative businesses are a significant part of the federal government’s research and development efforts. . . .

Contrary to the mission of the SBA, the stated mission of the SBIR seems to focus on supporting research and development rather than entrepreneurism.  Yet, the SBIR falls under the umbrella of the SBA.  

This dual and somewhat conflicting dichotomy of SBA and SBIR missions is played out in practical ways through the program as well. 

For example, Phase I awards are made at the complete discretion of the participating government agencies on research and development grounds and Phase II awards are made on the basis of the scientific and technical merit of an idea.  In contrast, Phase III awards are made on commercial viability grounds and require the use of private funds.

Additionally, there is evidence to suggest that university spin-offs may  be one of the primary recipients of SBIR grants rather than other types of businesses, which may have more of a commercial and less of an academic or research and development emphasis. 

In fact, even the debate as to whether accepting venture funds should exclude companies from being able to accept SBIR awards reflects this issue, since if the focus of the program was on successfully commercializing small businesses, then presumably the notion of supplementing private funds with public funds would be preferred rather than prohibited.

A second problem with the program is that there is inadequate data to measure the SBIR Program’s success.  The Government Accountability Office ("GAO") published a report in October, 2006 outlining the SBIR Program’s failures in collecting data from each of the agencies participating in the Program.  One of the conclusions of the GAO was that the "SBA is Five Years Behind Schedule in Meeting its Obligation to Implement a Government-Use SBIR Database."  How do you judge the success of anything without adequate data to draw any significant conclusions?

A third problem with the SBIR Program is that there is evidence to suggest that certain organizations are repeatedly winning many of the awards and that those organizations may have succeeded in achieving the status of becoming SBIR award mills by learning how to successfully work the system.  Is this really what was intended by Congress and the SBA?

All in all, it is safe to say that SBIR is riddled with some fundamental problems that Congress would be wise to address as it evaluates the Program’s future.  While there is no doubt that the SBIR Program plays a valuable role in early -stage biotech start-ups, the industry should perhaps consider redirecting its efforts toward clarifying the goals of the Program and generating useful data over focusing on the more narrow issue of overturning the prohibition on making awards to venture-backed companies. 

 

 

 

 

 

923 total views, no views today


Category: Biotech Legislative Developments  |  Comments Off on Debating the Future of the SBIR Program

Kristie Prinz Interview with Dow Jones Marketwatch on Patent Holding Companies, Patent Reform

Written by on Thursday, September 6th, 2007

Dow Jones Marketwatch Reporter John Letzing recently interviewed me regarding patent holding companies and the subject of patent reform generally.  While the interviews focus more on the high tech industry than the biotech industry, I think that my blog readers will want to read the articles, as  John did an excellent job in addressing the issues.

Speculator of Mundane Patents Casts a Long Shadow

Lawmakers Take Aim at Patent Speculators

963 total views, no views today


Category: Biotech Blog in the News  |  Comments Off on Kristie Prinz Interview with Dow Jones Marketwatch on Patent Holding Companies, Patent Reform

Biotech Takes Steps to Fight Generic Threat

Written by on Monday, August 13th, 2007

The San Francisco Chronicle ran an interesting article last week on the steps that the biotech industry is taking to protect itself against the threat of generic copies, as patents run out and the threat of biogenerics legislation looms ahead.

The Chronicle reported on the issue as follows:

Whether many biotech companies will be able to beat the generic threat through innovation is an open question. But many will try. . . .

Traditional pharmaceutical companies, whose pills and tablets have been vulnerable to generic competition since 1984, have struggled to roll out significantly improved medicines before patents expired. Revenues for drugs such as the antidepressant Zoloft and the sleeping pill Ambien are plunging as generic sales rise.

“It remains to be seen if the same thing will happen in biotech,” Citigroup analyst Yaron Werber said. Some of the signs for biotech are favorable. “The industry continues to be a leader in innovation,” he said. That capacity for innovation is a significant added business risk for generic manufacturers who venture into the biotech realm, Werber said.

So what is the industry doing to prepare?

According to the Chronicle, Genentech is putting brand-names of its drugs on the market to compete with the drugs that are about to lose protection, and is also putting next-generation versions of its own drugs on the market.

In contrast, the Chronicle reported that other companies are racing to develop improved generic versions of the brand name drug.  The Chronicle stated as follows:

Two Bay Area companies, Affymax Inc. of Palo Alto and FibroGen Inc. of South San Francisco, are among the manufacturers working on next-generation drugs they hope will capture market share from Epogen and similar branded drugs. Affymax’s experimental compound Hematide requires less-frequent dosing. Theoretically, it could help patients avoid a very rare side effect associated with Epogen-like drugs.

All in all, the Chronicle put a positive spin on the issue, emphasizing that the industry was not concerned, arguing that the threat of biogenerics and the impending loss of patent protection just encouraged the industry to move forward with the development of more innovations.

Is this media spin or an accurate reflection of the mood of the industry?  My guess is that it is a little of both.  Smart industry players have to think ahead on how they will survive if biogenerics legislation becomes a reality, but one cannot help but question whether they are really as unconcerned as the Chronicle suggests.

943 total views, no views today


Category: Biotech Legislative Developments  |  Comments Off on Biotech Takes Steps to Fight Generic Threat

© 2008-2015 The Prinz Law Office. All rights reserved.

The Prinz Law Office | Silicon Valley, CA | Los Angeles, CA | Orange County, CA | San Diego, CA | Atlanta, GA | Tel: 1.800.884.2124

Mailing Address: 117 Bernal Rd., Suite 70-110, San Jose, CA 95119; Silicon Valley Office: San Jose- 2033 Gateway Place, 5th Floor, San Jose, CA 95110 (408)884-2854; Los Angeles Office: 3110 Main St., Building C, Santa Monica, CA 90405 (310)907-9218; Orange County Office: 100 Spectrum Center Drive, 9th Floor, Irvine, CA 92618 (949)236-6777; San Diego Office: 4455 Murphy Canyon Road, Suite 100, San Diego, CA 92123 (619)354-2727 Atlanta Office: 1000 Parkwood Circle, Suite 900, Atlanta, Georgia 30339 (404)479-2470

Biotech Lawyer & Attorney: Serving Silicon Valley, San Jose, San Francisco, Santa Cruz, San Diego, Los Angeles, Orange County, Irvine, Anaheim, Santa Monica, Silicon Beach, Santa Barbara, Sacramento, Atlanta. Licensed in California and Georgia.
Follow

Get every new post delivered to your Inbox

Join other followers