Intellectual Property Owners (IPO) has made a call to arms agains the patent reform legislation in the Senate (S.1145), which may be considered for a vote within the next few weeks. IPO is all-out against the dreaded Applicant Quality Submissions (AQS).

Section 11 on AQS would require nearly all patent applicants to (1) search the prior art and (2) submit a search report and analysis to the USPTO with their applications.

As it appears in S.1145, if enacted, AQS would:

1. impose substantial new costs on applicants without meaningful benefits to the USPTO;
2. create additional opportunities for inequitable conduct claims to be raised at trial;
3. open up opportunities for litigation claims related to the adequacy of the mandatory search; and
4. subject applicants to different standards by exempting micro-entities from the requirement.

The provision adds additional burdens on applicants, increases the cost and complexity of prosecution and litigation and fails to provide meaningful assistance to help the PTO do a better job of examining patent applications. It will deter filing of applications and weaken incentives to invent.

You may find additional information along with instructions on how to contact your Senators on the IPO website at: www.ipo.org/AQSCampaign.  The IPO Staff is available to answer any question you may have on this or other parts of the bill. Call (202) 466-2396 or email Dana Colarulli at: dana@ipo.org.

Make your voice heard.

Posted March 28th, 2008 by Stephen Albainy-Jenei in Patent Reform
| | 15 Comments »

We’ve been quite busy these days and so I wanted to pass along that my firm is currently looking to hire an IP attorney.

The Position:

Patent Associate with at least 2+ years of experience in patent prosecution, counseling and licensing.  The candidate should have an advanced degree in a chemical field (Ph.D. preferred), with a concentration in analytical, biochemistry, organic, medicinal or pharmaceutical chemistry, or a closely related field. 

The Place:

The Cincinnati, Ohio office of Frost Brown Todd LLC, one of the 150 largest law firms in the United States, with a top rated Midwest intellectual property practice. Not to mention the opportunity to work closely with the Patent Baristas.

The Rest:

To learn more about us and the communities we serve, visit our home page at www.frostbrowntodd.com.  Send resume, law school and undergraduate transcripts and writing samples to Karen Laymance, Frost Brown Todd LLC, 2200 PNC Center, 201 East Fifth Street, Cincinnati, Ohio 45202 or by email to klaymance@fbtlaw.com. Frost Brown Todd LLC is an equal opportunity employer.

Posted March 27th, 2008 by Stephen Albainy-Jenei in Jobs, Frost IP
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The Kentucky BioAlliance has established a fund to provide stipends for Kentucky-based biotech companies to attend the annual Biotechnology Industry Organization BIO2008 conference. Companies that are selected will be awarded a stipend to cover up to $800 in expenses associated with attending the annual BIO International Conference. To apply, fill out an application here.

Biotech companies say they are ready for legislation covering biogenerics. BIO is making the legislation a priority in 2008 and is working to negotiate guidelines favorable to its members.  The U.S. currently spends $40 billion per year on biotech drugs and the leading presidential candidates — Sens. Barack Obama, Hillary Rodham Clinton and John McCain — have all advocated generic drugs as a health care cost-cutter. The Bush administration said it would like to see the FDA gain the power to approve biogenerics this year.

Gibson Guitar said that the “Guitar Hero” video games infringe one of Gibson’s patents and Activision has asked a U.S. court to declare the claim invalid.  Gibson’s U.S. Patent No 5,990,405 claims a method for simulating a live performance using a musical instrument, a 3D headset with stereo speakers, and a pre-recorded concert. If you go by the old patent law maxim that claims thicker than about “three fingers” are probably too narrow to enforce, then Gibson’s seven part method claim will have a tough way to go.  Note: The first element requires “(a) a musical instrument, the musical instrument generating an instrument audio signal at an instrument audio output, the instrument audio signal varying in response to operation of the instrument by the user of the system.”

Pfizer got a Canadian appeals court ruling blocking regulatory approval of Ranbaxy’s generic version of the cholesterol pill Lipitor. Canada’s Federal Court of Appeal reversed a lower-court ruling that Ranbaxy could sell a competing generic before Pfizer’s patent expires in 2010. Pfizer’s Lipitor sales were $12.7 billion last year.

Filed under yet another thing to be worried about, a report shows that medical devices can be hacked. About 100,000 Americans have a new kind of defibrillator implanted near their heart that’s vulnerable to hacking and even reprogramming. The devices rely on wireless transmissions that weren’t encrypted. Regulators and defibrillator makers say there’s just a slim chance of hackers targeting the devices but expect to see more of this as devices go wireless.

A Superior Court judge on Thursday ordered Starbucks Corp. to pay its California baristas $106 million in back tips and interest that the company had taken from its baristas and gave to shift supervisors.  San Diego Superior Court Judge Patricia Cowett also issued an injunction saying state law prohibits managers and supervisors from sharing in employee gratuities. Starbucks spokeswoman Valerie O’Neil said the decision “represents an extreme example of an abuse of the class-action procedures in California’s courts.” But barista attorney Laura Ho said “Starbucks illegally took a huge amount of money from the tip pool to pay shift supervisors, rather than paying them out of its own pocket.”  If only the Patent Baristas could get tips.

Finally, the pharmaceutical business (reporting) has become a soap opera.  Pharmalot stimulated some comments after posting about an Rx video soap opera. We haven’t viewed the clips so take it as it is.

Posted March 21st, 2008 by Stephen Albainy-Jenei in Friday Round-Up
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Eighteen states and the District of Columbia have filed suit against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier for allegedly entering into a scheme to block the generic version of the cholesterol lowering drug TriCor®  (fenofibrate), indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.

According to the AGs in the states, the companies made trivial changes to the formulations of TriCor, and marketed those while withdrawing the original drug from the market. The companies deleted references to the original forms of the drug from national drug databases, according to prosecutors, making it more difficult for a generic version of TriCor to obtain generic status

The states filed their lawsuit in federal court in Wilmington, Delaware, accusing Abbott and of undermining efforts to bring generic drugs to market by patenting new formulations of TriCor with only minor changes to the drug.

TriCor, which costs more than $3 a pill, generated sales of $1.2 billion for Abbott in 2007, but the company, according to the lawsuit, has tried to maintain a monopoly on the market by obtaining term-extending patents. Abbott denies the allegations saying it has not prevented other fenofibrate drugs from being marketed.

The prosecutors say Fournier obtained patents covering the variations of TriCor and then filed patent infringement lawsuits against generic companies that tried to compete. The litigation meant that the Food and Drug Administration could not approve generic versions of TriCor.

In a long-running battle with Teva Pharmaceutical, Abbott has tried to stay one step ahead of the generic entry. Originally, Teva filed an ANDA for ANDA for a TriCor capsule formulation and made a Paragraph IV certification that U.S. Pat. No. 4,895,726 was invalid so not infringed. A bbott sued and initiated a 30-month stay of FDA approval.

While the capsule battle was continuing, Abbott filed a new NDA for 54 mg and 160 mg TriCor in a tablet formulation arguing that the tablet was bioequivalent to the capsule. After this was approved, Abbott stop selling the capsules and bought back all the capsules from the market.

The Abbott, in a move that was probably too smart for their own good, changed the code for TriCor capsules in the National Drug Data File (NDDF) to “obsolete.” The NDDF is a private database that provides information about FDA-approved drugs. Changing the code to obsolete then removed the TriCor capsule drug formulation from the NDDF, which prevented pharmacies from filling TriCor prescriptions with a generic capsule formulation.

Needless to say, Teva took it kind of hard and added antitrust counterclaims to its suit against Abbott. Abbott is no longer marketing the 54 mg and 160 mg strength tablets because it has now changed its Tricor product to 48 mg and 145 mg strength tablets. Abbott even filed a new NDA for 48 mg and 145 mg TriCor tablets looking to change the label to state that the new tablets do not need to be taken with food (the dissolvable version).

Teva claims that Abbott’s actions have frustrated generic competition in Fenofibrate products through a combination of two market conversions and the gaming of the Hatch-Waxman Act, denying consumers access to a generic alternative to Abbott’s products.

The dissolvable version of TriCor retains patent protection until 2018.

In the current suit by various AGs, the states involved are Arizona, Arkansas, California, Connecticut, the District of Columbia, Florida, Iowa, Kansas, Maine, Maryland, Minnesota, Missouri, Nevada, New York, Oregon, Pennsylvania, South Carolina, Washington, and West Virginia.

No word yet on when Abbott’s new magic orange-colored TriCor comes out.

See a timeline at the Orange Book blog.

Posted March 21st, 2008 by Stephen Albainy-Jenei in Generic drugs, FDA, IP Litigation
| | 4 Comments »

The Office of Technology Transfer and Commercialization at the University of Cincinnati is looking for a Senior Licensing Associate to manage an academic technology portfolio in a multidisciplinary team environment. 

The position requires an advanced degree in (MS or PhD) engineering, chemistry, life sciences or related fields along with excellent written and verbal communication skills.  A sense of humor doesn’t hurt.  Experience with technology licensing and familiarity with patent law preferred.

This is my old office so I can recommend it from personal experience.

If interested, send a resume to:

Anne H. Chasser
Associate Vice President
Intellectual Property Office
University of Cincinnati
PO Box 670829
3130 Highland Ave, Third Floor
Cincinnati, OH  45219-2374

Posted March 21st, 2008 by Stephen Albainy-Jenei in Jobs
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The University of California and Abbott appealed after the district court turned down their attempt to stop Dako from making and selling its HER2 FISH pharmDXTM kit, allegedly infringing U.S. Patents 5,447,841 and 6,596,479.   The Regents of the University Of California, Abbott Labs v. Dakocytomation California (06-1334, -1452; 07-1202)

The inventions claimed in the patents are improved methods for identifying and classifying chromosomes to detect chromosomal abnormalities associated with genetic disorders, degenerative diseases, and exposure to agents known to cause degenerative diseases, such as cancer.

There are three general types of chromosomal abnormalities: extra or missing individual chromosomes, extra or missing portions of a chromosome, or chromosomal rearrangements. Procedures in the prior art required that chromosomes be in the metaphase phase of the cell cycle because it was not possible to visualize nonmetaphase, or interphase chromosomes due to their dispersed condition in the cell nucleus, which is extremely difficult and time consuming, and almost impossible for tumor cells.

Other prior art techniques used probes comprised of DNA and RNA fragments for gene mapping and were limited by the nonspecificity of that technique — due to repetitive nucleotide sequences that were present throughout the chromosomes. Labeled probes would not only hybridize with the target chromosomal DNA, but with repetitive sequences as well, thereby producing false-positive results.

Abbott’s new technique allowed detection of chromosomal abnormalities in both metaphase and interphase cells using standard clinical and laboratory equipment.

In denying a preliminary injunction, the court concluded that appellants failed to show a likelihood of success on the merits of their infringement claim under the ’479 patent based on its claim construction of two claim limitations, of “morphologically identifiable chromosome or cell nucleus” and “heterogeneous mixture of labeled unique sequence nucleic acid fragments.” The court also based its conclusion on appellants’ failure to show a likelihood of success that the accused product met the “blocking nucleic acid” limitation of the ’841 patent under the doctrine of equivalents.

While an appeal was pending, the district court amended its basis for rejecting appellants’ proposed construction of the term “heterogeneous mixture of labeled unique sequence nucleic acid fragments.” The court amended “its previous order to the extent it improperly cite[d] 35 U.S.C. § 102 as the basis for questioning the validity of the claims of the ’479 patent” in light of the ’841 patent, and instead stated that the ’479 patent would likely be rendered invalid under the doctrine of nonstatutory (obviousness) double patenting.

After the district court held a Markman hearing, the court granted summary judgment of noninfringement of the ’479 patent as to all of the accused products based on its construction of the “heterogeneous mixture” limitation. The court further granted summary judgment of noninfringement on the ’841 patent, concluding that Abbott was barred from asserting infringement of the “blocking nucleic acid” limitation under the doctrine of equivalents. The court also denied summary judgment on the ’841 patent as to the remaining twenty accused products. The court did not address whether Dako’s products met the “morphologically identifiable” limitation — a claim limitation that was at issue in the preliminary injunction motion.

Abbott argued that the district court erred in its construction of the claim limitation “heterogeneous mixture of labeled unique sequence nucleic acid fragments” to mean “heterogeneous mixture of labeled nucleic acid fragments that includes only unique sequence fragments,” whereas Dako’s kits contain repetitive sequences. Abbott said that the court erred by interpreting that language to mean that the heterogeneous mixture excludes repetitive sequences.

According to Dako, the claim language supports a construction that excludes repetitive sequences because the specification supports that construction in statements and embodiments and in light of the prosecution history of the ’479 patent. In addition, Dako argues that the doctrine of claim differentiation is not an absolute rule. Where construction of an independent claim leads to a clear conclusion inconsistent with a dependent claim, the doctrine of claim differentiation must yield.

The CAFC held:

Although the district court erred in its reasoning as set forth above, we nonetheless will affirm the court’s construction of the heterogeneous mixture limitation. The court correctly evaluated the prosecution history and determined the proper claim construction. We also agree with the court’s conclusion set forth in its summary judgment decision that the patentees disclaimed embodiments that include repetitive sequences during the prosecution of the ’479 patent. Thus, the district court was correct in concluding that the accused products, which employ a mixture that includes repetitive sequences, do not infringe the ’479 patent.

Posted March 20th, 2008 by Stephen Albainy-Jenei in IP Litigation
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The Court of Appeals for the Federal Circuit upheld a lower court ruling that Teva Pharmaceutical Industries Ltd. infringed two patents held by Pfizer Inc. for Celebrex, a non-steroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis and rheumatoid arthritis. Pfizer v. Teva (07-1271).

Pfizer has three patents listed in the FDA’s Orange Book protecting its arthritis drug Celebrex (celecoxib), selective non-steroidal anti-inflammatory drug used to treat pain and inflammation. Pfizer sued Teva in 2004 after the company filed an Abbreviated New Drug Application (ANDA) filing for generic approval with the U.S. Food and Drug Administration. Because the patents covering celecoxib were listed in the Orange Book, Teva was required to certify that those patents were invalid or will not be infringed by the manufacture, use or sale of the new drug. Teva’s ANDA challenged the validity of the patents covering celecoxib.

Last year, the U.S. District Court for the Northern District of New Jersey ruled that all three of Pfizer’s Celebrex patents, U.S. Patent Nos. 5,466,823, 5,563,165, and 5,760,068, were valid and infringed by Teva’s ANDA filing. The district court also held that the asserted claims of the three patents were not invalid for a best mode violation and that the asserted claims of the ’068 patent were not invalid for obviousness-type double patenting. The court stopped Teva from selling its generic drug until until December 2015, when the ‘068 patent expires.

In a split decision, the Court of Appeals for the Federal Circuit held that one of the patents, the ‘068 patent, is invalid for double patenting in view of the earlier filed ‘165 patent.

Pfizer originally filed one patent application covering multiple inventions encompass a broad genus of non-steroidal anti-inflammatory compounds, compositions using those compounds, and methods of using those compositions. The claims of the patents include celecoxib—the active ingredient in Celebrex. During review of the application, the patent the patent examiner issued a restriction requirement, which required an election of the following inventions under 35 U.S.C. §121: <

1. Claims 1-20, compounds.
2. Claims 21-26, compositions.
3. Claims 27-37, methods of use.

In response, Pfizer chose to prosecute the generic compound claims and, within that genus, the single compound species celecoxib. The resulting compound claims ultimately issued as the ’823 patent. Subsequent to the restriction requirement but before the ’594 application issued, Pfizer filed a series of continuation applications claiming priority to the ’594 application and covering the non-elected subject matter which it had elected not to prosecute in the original ’594 application.

In particular, Pfizer filed a divisional application, which ultimately issued as the ’165 patent, that included the restricted-out composition claims, and a continuation-in-part application (”CIP”), which ultimately issued as the ’068 patent, that included the restricted-out method claims.

The issue in this case is that patent law prohibits getting more than one patent on the same invention — that is, you cannot get a second patent if it claims an invention that was disclosed or would have been obvious in light of the first patent. However, there is also a rule that says the first patent can’t be used against the second one if the second one is filed in response to the restriction requirement made in the earlier parent application.

35 U.S.C. § 121 provides a safe harbor to patents that issue on applications filed as a result of a restriction requirement:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.

In addition to the express requirements of section 121, the statute requires consonance: the applicant must maintain the line of demarcation between the independent and distinct inventions that prompted the restriction requirement. The court held that this safe harbor applies exclusively to divisional applications since a divisional application contains an identical disclosure to its parent application. This consonance requirement prevents an applicant from amending the claims in the divisional application in a way that would violate the originally imposed restriction requirement and thereby impermissibly extend the patent term as to that subject matter.

In the present case, Pfizer had filed a continuation-in-part application, which includes some portion of the original application but also introduces new matter. Teva argued that section 121 applies exclusively to divisional applications, and that because the ’068 patent issued on a CIP rather than on a divisional application, it does not fall within the terms of the statute.

Pfizer tried arguing that the terminology of the application did not matter but the appeals court pooh-poohed it:

There is no suggestion, however, in the legislative history of section 121 that the safe-harbor provision was, or needed to be, directed at anything but divisional applications. The commentary and materials published since section 121’s enactment similarly contain no suggestion that section 121 was meant to cover any applications other than divisionals. Although the legislative history reveals no reason why Congress drafted section 121 only to benefit divisional applications, there are certainly plausible reasons why Congress would have concluded that section 121 should be limited to divisional applications, and not include CIPs. The need for the protection only existed when a divisional application was filed as a result of the restriction.

Because the second application then was without the safe harbor, the court held that it was invalid for obviousness-type double patenting, a judicially created doctrine that prohibits someone from obtaining an extension of their patent rights by filing a later patent that are not patentably distinct from the first. The Appeals Court ruled in Teva’s favor that the patent covering the use in the treatment of inflammation was invalid.

The court ruled that two other patents covering the active ingredient in Celebrex are valid, enforceable and infringed by the Teva’s product. The decision will keep Teva from selling a generic counterpart in the U.S. until May 2014.

It is obviously good news for Pfizer tht they did not lose all of the patents, given that it is one of its biggest sellers with global sales of Celebrex totalling $2.3 billion a year, including $1.7 billion in the U.S. alone. However, the decision will cut Pfizer’s patent term by one and a half years.

Posted March 20th, 2008 by Stephen Albainy-Jenei in IP Litigation
| | 1 Comment »

The Intellectual Property Owners association (IPO) recently reported on the fifteen possible Judiciary Committee Amendments to S. 1145, that were circulated by the Judiciary Committee last week. IPO noted that the amendments do not address the most hotly debated portions of the bill. Meanwhile, IPO believes Senate leaders will attempt to pass the much-delayed, massive patent reform bill S. 1145 in April or May.

The PharmaBiotech IP Summit held on May 28-30 at the Ritz-Carlton Philadelphia will be addressing how this reform could impact IP practitioners within the pharmaceutical & biotech industries. A high level panel featuring John T. Li from Novartis, Gary Creason from AVEO Pharmaceuticals and Robert Hrubiec from Cephalon will kick off the summit and focus on understanding the reform efforts and what the patent office is attempting to do.

Other speakers include Kathleen Fonda, Legal Advisor Office Of Patent Legal Administration, USPTO, James Gould from Schering-Plough, Robert Hrubiec, VP Intellectual Property and Chief Patent Counsel, Cephalon, Lee Caffin, DVP Global IP Strategy for Abbott Laboratories, and Luisa Bigornia, Vice President Intellectual Property, BioMarin Pharmaceutical.

What:  PharmaBiotech IP USA 2008:  Protect Critical Patents and Drive Sustainable Growth Through IP-Driven Business Strategies. 

When:  28-30 May, 2008. 

Where:  Ritz-Carlton Philadelphia, PA.

Update:  Patent Baristas readers save 15% off registration to Pharmabiotech IP with code 13299.001XZ299.

For more information: www.pharmabiotech-ip.com
Email:  pharmabiotech-ip@wbresearch.com

Posted March 17th, 2008 by Stephen Albainy-Jenei in Conferences
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