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Archive for March, 2009

Genetic Engineering & Biotechology News Interviews Kristie Prinz

Written by on Friday, March 27th, 2009

Following up on our recent coverage of the patent reform debate, Genetic Engineering & Biotechnology News recently interviewed me for their article Patent Reform Battle Pits Biotech against High-Tech. The interview addressed the competing perspectives of the biotech and high tech industries on the issue of patent reform.

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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. . . .

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Federal Circuit Rules on Case Involving New USPTO Patent Rules

Written by on Monday, March 23rd, 2009

The Federal Circuit issued a long-awaited decision late last week in  the case of Tafas v. Doll. 

At issue in this case was whether or not the USPTO had the authority to adopt a set of rules in 2007, which were aimed at reducing the backlog of unexamined patent applications and also at addressing the USPTO’s difficult in examining applications that contained a large number of claims.  The Federal Circuit held in its decision that the rules at issue were procedural in nature, and that they therefore did fall in the scope of the USPTO’s rulemaking authorit y.  However, the Court found that one of the rules, Final Rule 78, conflicts with 35 U.S.C. Section 120 and is therefore invalid.  The final decision on the status of the other rules is left to the lower courts, to which this issue is remanded. 

What were the particular USPTO rules at issue in this case?

Final Rule 78: This rule provided that an applicant is entitled to file two continuation applications, but to file any additional applications, the applicant is required to make a showing as to why the amendment, argument, or evidence could not have been submitted in a prior continuation application.

Final Rule 114: This rule provided than an applicant is entitled to file on request for continued examination per application family, but to file any additional requests, the applicant is required to make a showing as to why the amendment, argument, or evidence could not have been submitted prior to the close of prosecution in the application.

Final Rule 75: This rule provided an applicant who submits either more than five independent claims or twenty-five total claims must provide the examiner with an examination support document.

Final Rule 265: This rule set forth the requirements for the examination support document, which were as follows: (i) conducting a preexamination prior art search, (ii) providing a list of the most relevant references, (iii) identifying which limitations are disclosed by each reference, (iv) explaining how each independent claim is patentable over the references, and (v) showing where in the specification each limitation is disclosed. 

The decision focused on an analysis by the Federal Circuit on whether the rulemaking exercised by the USPTO was substantive or procedural.  The Federal Circuit found that Congress did not intend to give the USPTO substantive rulemaking authority, but that procedural rulemaking was in the scope of the USPTO’s delegated authority, stating:

While we do not purport to set forth a definitive rule for distinguishing between substance and procedure in this case, we conclude that the Final Rules challenged in this case are procedural.  In essence, they govern the timing of and materials that must be submitted with patent applications.  The Final Rules may "alter the manner in which the parties present . . .  their viewpoints" to the USPTO, but they do not, on their face, " foreclose effective opportunity" to present patent applications for examination.  JEM, 22 F.3d at 326, 328.

As for why Rule 78 was held to be invalid, the Federal Circuit stated:

Rule 78 is invalid because it attempts to add an additional requirement–that the application not contain amendments, arguments, or evidence that could have been submitted earlier–that is foreclosed by the statute. . . .[T]he statute is clear and unambiguous with respect to this issue.

The commentary on this case has been mixed, but there seems to be an overall feeling among commentators that a more definitive decision on the issue would be desirable. 

The Patent Baristas expressed some exasperation at the result, stating:

Apparently, the U.S. Court of Appeals for the Federal Circuit could not bear to see an end to the drama between the U.S. Patent and Trademark Office and its customers over proposed patent application rules. . . . .Expect everyone to find something to dislike about this ruling. . . .Will Congress ever step up and fix this mess?

Peter Zura of The 271 Patent Blog wrote:

While many are hopeful for en banc review, the odds don’t seem in favor of it right now. 

Since I do not personally prosecute patents, I must admit that my reaction to this decision is a bit muted.  As a patent and copyright licensing attorney, my practice is only tangentially affected by USPTO rulemaking, so I just do not have a strong opinion on the issue. 

Having said this, I must say that if you read over the rules that were at the heart of this case, it is easy to see why the USPTO set off a controversy when it enacted these rules.  Should the USPTO be able to enact this type of rule, which certainly puts some serious constraints on patent filing?  I think that the Patent Baristas are right: perhaps Congress needs to take a look at this issue as it revisits the patent reform issue this session.

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Biosimilars Legislation Introduced in House

Written by on Friday, March 20th, 2009

Two biosimilars bills have just been introduced in the House, each of which would establish regulatory path for biosimilars to be approved.

The first bill, HR 1427, the Promoting Innovation and Access to Life Saving Medicine Act, was introduced on March 11, 2009 by Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ), Nathan Deal (R-GA), and Jo Ann Emerson (R-MO).

A second bill was introduced the following week. H.R. 1548, the Pathway to BioSimilars Act, was introduced on March 17, 2009 by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX).

What are the key elements of each of the bills?

According to the HR 1427 Bill Summary, highlights of HR 1427 include as follows:

  • FDA authority to approve biosimilars;
  • approval process will require showing that (1) there are no clinically meaningful differences between the two products and (2) that the two products are highly similar in molecular structure and share the same mechanisms of action;
  • biosimilar may establish that it is “interchangeable” with the original product, and the first such biosimilar able to make such a showing will receive six months of exclusive marketing;
  • an original product with a novel molecular structure is entitled to five years of exclusive marketing, and a modification of a previously approved product is entitled to three years of exclusive marketing.  These periods can be extended by up to one year if it can be established that the product can be used for a new disease or that it conducts pediatric studies; and
  • a new procedure is established to resolve patent disputes prior to approval of the biosimilar, and penalties are put in place for failure to timely litigate such disputes.

In contrast, highlights of HR 1548 are as follows:

  • establishes safey standards for establishing interchangeability;
  • establishes exclusivity for the first  product found to be “interchangeable”  for a period of 24 months after the product has either been deemed to be interechangeable or goes on sale;
  • the reference product receives 12 years exclusivity, and that period of exclusivity will extend to 14 years in the event that a new indication is found for the product in the first 8 years after licensure;
  • an additional exclusivity period is also established for pediatric studies and use of product;

Which bill has been more widely received by the biotech industry?

Well, the biotech industry group BIO has indicated its preference for the second bill, according to reports by Fierce Biotech.    Fierce Biotech explained as follows:

For biotech companies, the difference between five years and 12 years of exclusivity could amount to billions of dollars.

In contrast, BIO did not have such a positive opinion of the first bill, stating in a press release as follows:

Unfortunately, the legislation introduced today would take patients and our industry down the wrong path – a path that jeopardizes the continued development of new breakthrough therapies and potential cures for debilitating diseases such as multiple sclerosis, HIV/AIDS and Alzheimer’s. . . .

“This bill seeks to cut prices but instead cuts corners.  This proposal leads us off the map as we seek an effective, fair and safe pathway to a biosimilars market.

“The legislation introduced today does not strike the necessary balance for patients or the economy.   Any biosimilars legislation must ensure safe and effective biosimilars, promote the continued development of new therapies and cures, and ensure the benefits of additional competition among biologics through the entry of biosimilars.

The California Biotech Law Blog will continue to follow this issue as debate on each of the proposed bills continues.

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Congress Reaches Compromise to Extend SBIR

Written by on Monday, March 16th, 2009

The House and Senate have reached a compromise to extend SBIR through July 31, 2009, according to a report that broke late this evening by the SBIR Insider.

The SBIR Insider reports that the House will originate the bill and that the legislation will amend PL 110-235 (the current CR), which expires on March 20, 2009.

The compromise was announced on the same day that President Obama announced his new plan to assist small businesses.  The President’s plan is intended to unfreeze the credit markets for small businesses by providing additional liquidity and guarantees of small business loans, and to also reduce lending fees and provide tax breaks for small businesses.

As the California Biotech Law Blog previously reported, support for SBIR reauthorization has been waning in Congress and there were genuine concerns that Congress would let the SBIR expire without taking action to save it before the March 20th deadline.  Apparently there was a last minute change of heart, however, with the President’s announcement today of his plans to help small businesses.

Of course, this bill has not yet been signed, so it is not yet a done deal.  The California Biotech Law Blog will keep you posted as any news breaks on this effort.

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Gilead Sciences to Buy CV Therapeutics for $1.4 Billion

Written by on Sunday, March 15th, 2009

Gilead Sciences has agreed to buy Palo Alto-based CV Therapeutics for $1.4 billion dollars.

According to SF Gate, Gilead Sciences will pay $20 per share for CV Therapeutics, which reported $154.5 million in revenue in 2008.  Most of that revenue comes from Ranexa, a drug from chronic angina.

Is this a good deal for Gilead Sciences?

Well, SF Gate reported that a Citi investment research analyst backed the deal as making "strategic sense" but described the price as "very steep."

The Mercury News explained the purchase as part of an overall Gilead strategy to acquire other companies and product lines in order to bolster their pipeline, which has been historically focused on HIV drugs.  The Mercury News reported:

[T]he company primarily owes its commercial success to its HIV drugs — Viread, Emtriva, Truvada and Atripla — which won FDA approval respectively in 2001, 2003, 2004 and 2006.Those drugs dominate the HIV-drug market and provide the vast majority of Gilead’s revenue, which totaled $5.34 billion in 2008, a 26 percent increase from 2007. On the basis of those sales, Gilead is the world’s third-biggest biotech company, behind Amgen of Thousand Oaks and Genentech of South San Francisco, according to data compiled by investment bank Jefferies & Co.To stay profitable, Gilead has been eager to branch out.

Some commentators, however, have suggested that the real value to this deal for Gilead Sciences is not so much the CV Therapeutics pipeline as it is the CV Therapeutics sales force. 

The In Vivo Blog reported as follows:

[Gilead] has also built a budding cardiovascular franchise centered around its pulmonary arterial hypertension drug Letairis and a Phase III drug for resistant hypertension called daruesentan. There’s a strategic fit argument, therefore, when it comes to Gilead’s buying CVT: the Palo Alto-based biotech provides the company with some additional diversification in a bulked up cardiology franchise–CVT already markets Ranexa and Lexiscan–as well as a ready-made sales force to market the products.

According to In Vivo Blog, there is the potential, however, for one additional Gilead benefit to doing this deal: full ownership rights in Lexiscan may eventually revert to CV Therapeutics, pending the outcome of litigation with Astellas.  if Gilead were to obtain full rights in Lexiscan, In Vivo Blog anticipates that this would be a real boost to Gilead’s bottom line. 

All in all, the consensus seems to be that Gilead took a bit of a financial risk in going forward with this deal, but that the risk is a reasonable one, which is in line with Gilead’s overall business strategy.  In the end, however, only time will tell if the move truly pays off for Gilead.

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Genentech and Roche Agree on Acquisition Deal; Employees End Up as Big Winners

Written by on Saturday, March 14th, 2009

On Thursday, an agreement on the prospective deal we have been discussing for months finally was reached: Roche formally agreed to acquire Genentech for $95 per share at a total price of $46.8 billion.

Who came out the big winner here?  Well, while Roche ended up with the Genentech pipeline prize, it has been suggested that the real winners are the Genentech employees and of course all of the Genentech investors.

The San Francisco Business Journal reported on the deal as follows:

On paper, Roche appears to have won. The final price of $95 per share is only $6 above the July bid. That’s significantly below the $100-plus estimates of many analysts. . . . The final price also is significantly below the $112 to $115 pegged by a Genentech analysis last fall.

However, the deal on paper really doesn’t take into account the significance of the retention program put in place last fall to keep employees from leaving.

The San Francisco Business Journal reported:

According to the retention bonus plan, if the merger occurs by the end of June and 100 percent of outstanding vested stock options accelerate as part of the merger — which is provided under the merger agreement — employees will receive 50 percent of the retention bonus when the merger is completed and 50 percent one year after the merger is completed.

If an employee is “involuntarily terminated” without cause or resigns for “good reason,” the retention bonus is paid out soon after the employee leaves.

Plus, Genentech employees could pocket millions of dollars more from the sale of their stock holdings to Roche.

What does this mean for most employees?  That this deal will provide a nice windfall for them in an otherwise bleak economy.

For Roche, on the other hand, the real battle now is going to be to find a way to retain Genentech’s best and brightest.  Roche may find that to be a much tougher challenge than negotiating to acquire Genentech.

SF Gate reported on this issue as follows:

Among the minority Genentech investors who will receive billions cashing in their stock under the agreement announced late Thursday are the biotech company’s executives and employees. Their windfall, industry experts say, might liberate many of them to launch their own dream companies rather than stick around.

Veterans of Genentech, a quintessential California trailblazer, might chafe at the more formal culture of a pharmaceutical conglomerate based in Basel, Switzerland, insiders say.. . .  .Members of the tight-knit Bay Area biotech community say Genentech staffers have been circulating their resumes, and suitors such as venture firms have been talking them up about possible new enterprises.

So, all in all, while Roche may have come out the winner on this deal in terms of the price per share and winning the Genentech pipeline, there is a good argument that the real winner is not the acquiring company but the Genentech employees and investors.  We will all have to watch over the long-term to see how Roche fairs down the road, and to see whether this deal really pays off for Roche in the future.

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Roche Reported to Be Close to Deal in Genentech Acquisition

Written by on Tuesday, March 10th, 2009

Roche is reportedly close to reaching a deal over the Genentech acquisition.

The Wall Street Journal reported Monday night that the terms of the current deal under consideration would provide for a share price of $95 per share, which is 6% higher than Roche’s initial offer back in July.

Reuters is reporting that a source close to Roche says that the company would pay as high as $105 per share to close the deal, but that the source currently doubts that this will be necessary.

According to the San Jose Mercury News, sources close to the negotations are saying that this is basically a “done deal.”

So, we may finally be on the verge of losing a Bay Area icon.  Before the first Roche bid back in July, it seemed almost unfathomable to imagine the Bay Area biotech community without Genentech.  Now, it is all but a certainty that Genentech will be absorbed into Roche, and we in the biotech world little by little have grown to accept a community without Genentech.

In looking at this deal, it is impossible not to believe that the declining economy played an important role in the negotiations.  As the value of shares tumble, what shareholder wouldn’t seriously consider the possibility of cashing out?  In this case, shareholders knew they had an eager buyer waiting on the sidelines, so as the economy continued to deteriorate, the willingness to sell likely grew.

Furthermore, both Reuters and the San Jose Mercury News are reporting that Genentech at least seems to be growing weary of the shadow of uncertainty hanging over the company.  There is only so long that you can keep a company in limbo and prevent it from disintegrating.  I expect that Genentech is starting to recognize the impact that Roche’s ongoing acquisition efforts are having over the company generally, and that perhaps some key people over at Genentech are starting feel that it is time to move forward with what is increasingly perceived as the inevitable.

So, the California Biotech Law Blog anticipates that an announcement of a done deal is forthcoming.  We will keep you posted as the developments arise.

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SBIR/STTR Program Set to Expire Later This Month; Support for Reauthorization Waning

Written by on Wednesday, March 4th, 2009

As we reported previously, he SBIR/STTR program is set to expire on March 20th of this month, unless Congress takes last minute emergency action to save it.

Unfortunately,  SBIR Insider author Rick Shindell reports that there is growing opposition in Congress to saving the SBIR/STTR program.

In fact, the idea of even providing funding for the SBIR/STTR program was rejected with the passage of the Stimulus Bill in Congress, where according to The SBIR Coach’s Blog, a provision that would have provided the SBIR/STTR programs $250 million was struck at the last minute from the bill and language was inserted which explicitly precluded the NIH from using the stimulus money for the SBIR/STTR programs.

Does this really make sense?  Regardless of how you feel about the Stimulus Bill that was passed, does it make sense to exclude funding for small businesses from a bill that is supposed to stimulate the economy and create jobs?

The SBIR Coach’s Blog voices its opinion on this issue as follows:

What were they thinking? As Ann said in her alert, “Such an exclusion is underhanded and entirely inappropriate.” There’s the understatement of the year (so far)!

Entirely inappropriate for sure. Does it make sense for the NIH to not seek additional innovative solutions from our small businesses — a sector hailed by President Obama himself as being the most likely one to create the jobs that we so desperately need? 2.5% +0.3% of $7.4B is $207.2M that’s been inappropriately withheld from our small businesses. That could be used to create a whole bunch of jobs!

And underhanded to boot! They snuck the wording into the fine print in “code” so we wouldn’t spot it. A search for “SBIR” or “STTR” won’t turn anything up.

While I agree that the SBIR/STTR program is far from perfect, and I have been critical of the whole SBA program in the past based on my personal experiences with the SBA in trying to secure loans for my business, it is my personal opinion that, at a time like this when the economy seems to many of us to be in freefall, reauthorizing SBIR/STTR should be a no-brainer.  Why wouldn’t Congress want to maintain support for small businesses, which, in my opinion, are the lifeblood of our economy?  Moreover, why in the world wouldn’t Congress want to include funding for small business programs like the SBIR/STTR in a huge spending bill intended to stimulate the economy?

I can tell you personally that it is nothing short of impossible right now to secure funding for a small business, period.  The help seems to be going to Detroit, the banking system, and AIG, as well as to all kinds of random programs in various states across the country (which to be honest, have made me scratch my head a little bit and wonder why we are funding many of them with taxpayer dollars),  but there is little or nothing that small businesses can do right now  to get access to additional funding.  Supposedly there is some provision that did make it into the Stimulus Bill which will free up some funding fo help small businesses refinance debt, but this funding is not yet in effect and most small businesses have yet to get much in the way of details on this particular program.

So, back to the topic of the SBIR/STTR program, which will shortly expire: in this economic climate,  why in the world  isn’t Congress acting to ensure that this doesn’t happen?

Your guess is as good as mine.  However, the bottom line is that the expiration of SBIR/STTR is all but a done deal now.  If this is a concern to you, you have 16 days left to take action and get your voice heard by Congress.  Perhaps there is still time to save this program from extinction.

Rick Shindell has provided a list of instructions for how to get your voice heard on this issue:

Develop a brief message urging an SBIR extension for a year, stating its importance to you, your business and community. Stress that a collapse of SBIR could be catastrophic not just for you, but the entire high tech small business community. Stress that SBIR community is a pillar of America’s innovation and economic stimulus . Do it in your own words because boilerplate language is far less effective.

  1. Call your Senators, both their local and DC offices. http://www.senate.gov/general/contact_information/senators_cfm.cfm
  2. Call your Representative, both their local and DC offices. http://www.house.gov/house/MemberWWW.shtml
  3. Go to their web sites and use the email or webmail links to send them your message.
  4. Contact the Senate Committee on Small Business and Entrepreneurship info@small-bus.senate.gov – 202-224-5175
  5. Contact the House Small Business Committee (202) 225-4038 www.house.gov/smbiz/
  6. Contact the House Committee on Science (202) 225-6375 – http://science.house.gov/contact/contact_generalform.shtml
  7. Go to the President’s web site at http://www.whitehouse.gov/contact/
  8. Write to your local newspapers, TV and radio stations.
  9. Work with other small business groups to form a united effort.

The California Biotech Law Blog will continue to keep you posted on any new developments on this issue, and will let you know if there seems to be any movement towards saving the program.

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