Patent Baristas

The European Patent Office, after conducting opposition hearings, said that it will amend a BRCA1 gene patent (EP 705903) held by Myriad Genetics.  See announcement here.  The original patent related to 34 mutations in the BRCA1 gene sequenced from the human genome and diagnostic methods for detecting these mutations to show predisposition to breast cancer.  According to the EPO, the amended patent now relates to a gene probe of a defined composition for the detection of a specific mutation in the breast- and ovarian cancer susceptibility gene and no longer includes claims for diagnostic methods. Full details of the decision will be published shortly on the EPO website.  The patent, “17q-linked breast and ovarian cancer susceptibility gene” was originally granted May 23rd, 2001.

Opponents believe that the breadth of these patents meant that Myriad could block further research on the gene. Opposition to the patents in Europe has been led by French medical organizations since 2001: the Institut Curie and Institut Gustave Roussy, with support from the Dutch and Austrian health ministries and research organizations from across Europe, including the UK. Their concern was that the Myriad BRCA1 and BRCA2 patents gave Myriad a virtual monopoly on genetic testing. But, to state the obvious, isn’t that why we have patents? To give inventors a monopoly for limited times in exchange for disclosing their inventions? There is a lot of sentiment in Europe against gene patenting although no one seems to know how research will be funded.  Without patent protection, no one is going to invest the money in the first place.

Apparently, Myriad was requiring that all samples be sent to their laboratories in the US for analysis at a fee of over $2600 (approximately ?1380). European laboratories had developed their own methods of BRCA1 testing and did not want to have to pay Myriad for analysis. There are a lot of things I don’t want to pay for either. Making Myriad out to be the bad guy for doing exactly what the patent system is designed to do just doesn’t make sense.

After a public hearing with the parties to the opposition proceedings against the patent, the opposition division panel, consisting of three technical members and one legal member, concluded that the patent can be maintained but in in amended form.  The patent now relates to a gene probe of a defined composition for the detection of a specific mutation in the breast- and ovarian cancer susceptibility gene and no longer includes claims for diagnostic methods.

Last year, the EPO revoked Myriad?s first patent (EP 699754) for methods to diagnose a predisposition to breast or ovarian cancer using the normal BRCA1 sequence. The parties to the proceedings are entitled to challenge the opposition division’s decision.

Opposition hearings on another Myriad patent, EP 705902, were also held earlier this month and a decision is expected soon and details of these decisions will be posted at www.epoline.org as part of the EPO’s public file inspection service.

See key dates in the time-line for the Myriad patents here.

The USPTO released a report that it granted 187,170 patents, including 169,296 utility (inventions), 16,533 design, and 998 plant patents as reported in fiscal year 2004. Since 1790, over seven million U.S. patents have been granted.  See the complete report here.

As reported earlier by MSNBC, however, the patent application backlog will only continue to grow.  While the average pendency is now more than two years, it is predicted to double in five years, unless major changes are made. Obviously, this could have a chilling effect on innovation if venture capitalists feel like the life-cycle of the technology and the uncertainty of getting a patent make the risk of patenting too great. 

Already, the number of pending patent applications has ballooned, especially for complex fields like semiconductors, biotechnology and nanotechnology. There is also a fear that patent quality could go down if examiners don’t take the necessary time to evaluate the technology.  There is a risk that patents will only become of value to the large corporations able to duke it out in court over the validity of a patent’s claims.

As usual, the finger is pointed to the pilfering of patent office fees by Congress to use in the general fund – more than $650 million as of last year.  This, after fees were raised yet again in December. Nice.

Under the current PTO five-year plan, the office will move to a system that uses fully searchable, Web-like documents. Look for more fee penalties for not filing electronically.  If only someone could come up with a good relacement for ABX.

Forbes ran an article that Credit Suisse First Boston expects Pfizer to hold onto its Lipitor patent until March 2010, which is "earlier than the pre-litigation expectation of December 2011, but later than some estimates for 2006." It doesn’t expect a decision for the Lipitor patent trial before the summer of 2005. This would reduce the patent protected period by 21 months." 

Earlier, Indian generic drugmaker Ranbaxy filed suit against Pfizer claiming that the main Lipitor patent does not cover the form of a key ingredient, atorvastatin, used in the drug. Ranbaxy alleges that Pfizer misrepresented that fact to the Patent and Trademark Office when it won an extension on the patent until 2010; the patent was originally scheduled to expire in 2006. (Ranbaxy also argues noninfringement and invalidity of the two patents at issue.) Lipitor is on track to produce $10 billion in sales this year and would be the first drug to ever break that mark.

See more here.

The Boston Globe reported that Genzyme Corp. sued Transkaryotic Therapies Inc. in the District Court of Tel Aviv, claiming that their method of purifying a treatment for Gaucher’s disease infringed on Genzyme’s Israeli patent No. 100,715, which covers certain cell culture processes involved in the manufacture of glucocerebrosidase.  TKT is conducting a clinical trial in Israel of its investigational gene-activated glucocerebrosidase (GA-GCB) for the treatment of Gaucher disease.  Genzyme believes that TKT infringes Genzyme’s patent by importing into Israel and using in Israel the GA-GCB product manufactured by the processes protected by Genzyme’s patent.

Genzyme’s patent covers novel culture processes that have been critical in the production of  Cerezyme(R) (imiglucerase for injection) on a large scale for the treatment of thousands of patients around the world. In 2004, Genzyme sold $839 million of Cerezyme, accounting for 37 percent of Genzyme’s total revenue. TKT is challenging Cerezyme with an investigational drug, and has recruited 12 patients to its trial in Israel.

In an agreement in October 2003, the two companies ended disputes over two key drugs, and agreed to become partners in developing another of TKT’s drug candidates. They remain partners in the development of TKT’s I2S, an experimental treatment for Hunter’s disease, another rare genetic disease in which patients are unable to process certain carbohydrates, leading to disfiguring and fatal complications.

Angiotech Pharmaceuticals, Inc. got a favorable decision on its European Patent (No. 0706 376) from the European Patent Office Opposition Division. The European Patent Office maintained the validity of Angiotech’s patent with various claims, including claims to stents coated with paclitaxel and a polymeric carrier. Stents are tiny wire mesh tubes that are inflated inside plaque-congested blood vessels to prop them open. Drug-coated stents prevent irritated tissue from growing back through the mesh.

Angiotech also has an exclusive license to supply Boston Scientific Corp. with the cancer drug paclitaxel to coat the Taxus stent. Taxus paclitaxel-coated stents accounted for $640 million of Boston Scientific’s third-quarter coronary stent revenue of $686 million.   See more.

A new report out says that all federally approved lines of embryonic stem cells are contaminated with a non-human sialic acid molecule.  New research now suggests those lines may not prove useful as therapeutic agents.

The sialic acid, Neu5Gc, is found on the surface of some animal cells, e.g., pigs, dogs, and mice, and human immune systems recognize the molecule as foreign and automatically attack Neu5Gc-bearing cells.  Inspection in the laboratory proved that all U.S. embryonic stem cell lines currently used in research have picked up Neu5Gc during the culturing process

While the federally approved lines remain useful for in vitro or animal studies in the lab, it points out a reason to look at non-embryonic [adult] stem cell sources, such as umbilical cord blood, bone marrow, fat cells, other types, which can be harvested and transplanted whole, without the need for culturing.  Researchers are also working to develope new methods of culturing stem cells without animal-cell contamination.

The full details of the study are published in the Jan. 23 issue of Nature Medicine after being outlined to a panel of stem cell experts at the National Academies of Science in October.  More here.

The Intellectual Property Owners (IPO) announced a call for nominations for their 32nd National Inventors of the Year Award. See the brochure here.

An inventor is eligible for the 2005 award if the invention:

1. Originated in the U.S.;
2. Is covered by a U.S. patent; and
3. Was either patented or first made commercially available since the beginning of 2001.

Nominations are solicited from independent inventors and from inventors employed in industry, universities, and government. Nominees should epitomize the American traditions of technological leadership and "Yankee ingenuity." The IPO publicizes Inventors of the Year with an awards ceremony, which this year is scheduled to be held on Capitol Hill on June 14, 2005. In addition to promoting recognition, IPO provides a $10,000 honorarium to be shared by the winners.

The Deadline for Entries is March 24, 2005.

Reuters reported that Teva Pharmaceuticals Industries Ltd. lost its bid to keep 180 days of exclusivity for its generic version of Pfizer Inc.’s popular Zoloft antidepressant. The U.S. Court of Appeals for the Federal Circuit, in Teva Pharmaceuticals, Inc v. Pfizer Inc., 04-1186, rejected Teva’s bid to overturn a lower court ruling over whether the company can seek a court ruling that it does not infringe on Pfizer’s brand-name patent before it releases its generic version. Teva had sued Pfizer after the drug giant made a deal with Ivax Pharmaceuticals, a subsidiary of Ivax Corp., to sell a different generic version of the drug, whose chemical name is sertraline.

Pfizer, has already made a deal with Ivax Pharmaceuticals to sell a generic version of Zoloft. Under the law, the first generic company to seek approval for a drug gets 180 days to sell it exclusively after the brand-name patents expire. However, major drug companies could use a legal loophole to make deals with the exclusive generic maker and delay sales. The move, known as "parking," delays the 180-day period and prevents competition. The only way around the potential delay is to seek a pre-emptive, or declaratory, court order.

The Court of Appeals stated upheld the lower court’s ruling Teva appealed the lower court holding claiming that the court erred as a matter of law in holding that there was no actual controversy between it and Pfizer. The court determined that Teva failed to show that Pfizer had taken actions giving rise to a reasonable apprehension on its part that Pfizer would sue it for infringement of the ?699 patent.

Teva submitted an ANDA to the FDA for its generic version of Zoloft?. Like Ivax, Teva filed a paragraph III certification as to the ?518 patent and a paragraph IV certification as to the ?699 patent. Pfizer elected not to file suit against Teva for infringement of the ?699 patent within the forty-five days following receipt of notice of Teva?s paragraph IV certification, and to date no such suit has been filed.

Teva argued that Pfizer had created a reasonable apprehension of suit based upon the following considerations: (1) Pfizer had listed the ?699 patent in the Orange Book; (2 ) Pfizer had refused to grant Teva a covenant not to sue; (3) Pfizer had aggressively asserted its patent rights against alleged infringers of other patents; (4) Pfizer sued Ivax, the first generic manufacturer of sertraline hydrochloride; and (5) it was in Pfizer?s self-interest to leave a "cloud of litigation" hanging over Teva. With respect to the final consideration, Teva argued that Pfizer?s settlement with Ivax gave Pfizer a vested interest in seeing Ivax preserve its 180-day exclusivity period. The district court rejected Teva?s contentions.

Teva argued that Pfizer had created a reasonable apprehension of suit based upon the following considerations: (1) Pfizer had listed the ?699 patent in the Orange Book; (2 ) Pfizer had refused to grant Teva a covenant not to sue; (3) Pfizer had aggressively asserted its patent rights against alleged infringers of other patents; (4) Pfizer sued Ivax, the first generic manufacturer of sertraline hydrochloride; and (5) it was in Pfizer?s self-interest to leave a "cloud of litigation" hanging over Teva. With respect to the final consideration, Teva argued that Pfizer?s settlement with Ivax gave Pfizer a vested interest in seeing Ivax preserve its 180-day exclusivity period. The district court rejected Teva?s contentions.

Teva asserts that the only way a patentee in Pfizer?s situation can defeat jurisdiction over an ANDA filer?s declaratory judgment action is by affirmatively representing that it will not sue the filer. Teva?s reliance on Pfizer?s listing of the ?699 patent in the Orange Book is misplaced. The listing of a patent in the Orange Book by an NDA filer is the result of a statutory requirement . Without more, Pfizer?s compliance wit h the Hatch-Wax man listing requirement should not be construed as a blanket threat to potential infringers as far as Pfizer?s patent enforcement intentions are concerned. The Orange Book is a listing of patents with respect to which claims of infringement " could be reasonably asserted . . . ." 21 U.S.C. ? 355(b)(1), (c)(2 ) (emphasis added). More is required for an actual controversy than the existence of an adversely held patent, however. See Capo, Inc. v. Dioptics Med. Prods., 387 F.3d 1352, 1355 (Fed. Cir. 2004) ("More is needed than knowledge or notice of an adversely held patent. . . . The standard is objective, and focuses on whether the patentee manifested the intention to enforce the patent, and would be reasonably expected to enforce the patent against the declaratory plaintiff."

The Court of Appeals refused to hold that listing a patent in the Orange Book evinces an intent to sue any ANDA filer who submits a paragraph IV certification with respect to the patent.

See appellate ruling here.