Patent Docs

Judiciary Committee Votes on Patent Reform Bill

February 3, 2011

By Kevin E. Noonan —

The Senate Judiciary Committee met today and passed S. 23, the Patent Reform Act of 2011, sending it to the Senate floor for consideration. The vote was 15 ayes, no nays, and on abstention (by Senator John Cornyn, R-TX). But prior to the vote, there were several (but fewer than expected) amendments presented and adopted, and several Senators who voiced their intention to bring amendments to the Senate floor and, if they were not included in the final bill, these Senators could not pledge their support.

Senator Jon Kyl (R-AZ) spoke extensively on changes in this bill from the Managers' Amendment to S. 515 passed by the committee in the last Congress. These changes, specifically to the post-grant review provisions of the bill, made it possible for him to support the measure, as he proposed it be amended. He voiced his "deep misgivings" about previous versions of the bill, and praised Committee Chairman Patrick Leahy (D-VT) for taking his suggestion and meeting with senior U.S. Patent and Trademark Office officials to address concerns that post-grant review would be difficult to implement and increase the backlog and patent application pendency. The bill as amended would have two differences from earlier versions that the Senator believes will be important: first, inter partes post-grant review would be conducted by the USPTO as an adjudicated proceeding, unlike the present system which is substantially similar to ex parte prosecution (albeit with third party requestor commentary). Senator Kyl called these proceedings "cumbersome" and "slow" and said that the system proposed in the bill would address these concerns by having each party present their evidence (and, presumably, rebuttal by patentee) to the Patent Office, which would then render a decision on whether the requestor had shown one or more claims to be invalid. The evidence would be limited to prior art printed publications and patents, and there would be no discovery (and, presumably, no evidence of on-sale activity or § 112 deficiencies). In addition, the threshold for granting review would be heightened from the present "substantial question of patentability" standard to a "reasonable likelihood of invalidity" standard, which the Senator hailed as being fair to patentees (by reducing or eliminating spurious or non-meritorious requests) and challengers (since there should be little justification for complaint if a requestor did not have sufficient evidence to satisfy a reasonable likelihood standard). The Senator contrasted this expected outcome with the present ex parte and inter partes re-examination regimes, where 95% of requests are granted, "many clearly unnecessary and some sought to gain advantage in litigation," which he characterized as a "gross waste of PTO resources." The Senator also noted that these provisions would provide incentives for challengers to "front-load" their evidence, enable the Patent Office to meet the one-year deadline for deciding post-grant review challenges, and to protect patentees from harassment by requests of dubious merit. Senator Kyl's amendment was unanimously approved by the committee by voice vote.

Several Senators voiced concerns over business method patents, but while an amendment by Senators Charles Schumer (D-NY) and Kyl was not put to a vote, the sentiments of several of the committee members were strongly expressed. Senator Kyl called the Federal Circuit's State Street decision allowing business method patents a "serious error," something not permitted by other patent systems, and that has resulted in "thousands of invalid business method patents [that] remain on the books and [are] used to extract large sums of money from defendants." He supports the establishment of a temporary procedure for the PTO to invalidate these patents, to remove a "blight on the economy" more cheaply than by litigation. Senator Schumer said he would offer a business method patents provision on the Senate floor, calling business method patents a "plagu[e on] the financial sector," "anathema" to a patent system intended to protect technological innovation, and that business methods permit protection of "abstract and common concepts" because the nature of the financial services industry prevents the Patent Office from recognizing prior art (presumably because most businesses have traditionally kept such methods as trade secrets). He said that business method patents are litigated thirty times more frequently than all other patents, and that his amendment would let companies "targeted" by business method holders to go before the PTO and demonstrate the patent invalid over prior art, using an undescribed "efficient administrative proceeding." Senator Schumer also stated that he would not be able to support passage of the bill by the Senate if it did not contain some provisions for addressing business method patents. Senator Feinstein (D-CA) would go even further in her remarks, suggesting that the bill should simply ban business method patents altogether.

Senator Grassley (R-IA) proposed an amendment that passed on voice vote to ban methods for tax (avoidance) strategies. He noted that this problem came to his attention when several Certified Public Accountants were sued by a tax strategy patentee, and that his amendment was intended to protect taxpayer rights (i.e., the inalienable right to pay as little in taxes as possible legally). He said that such patents "encumber the use of the tax laws" by taxpayers, and can result in taxpayers having to pay a fee to a patentee for merely complying with the tax code, citing protection that would give private parties the "exclusive use" of loopholes in the tax code. "All taxpayers" should have equal access to tax strategies, in the absence of which the fairness of the system could be threatened, according to Senator Grassley. He specifically pointed out that his amendment would not ban software tools for preparing tax returns.

The committee also approved by voice vote "technical" amendments, and Senator Feinstein's "compromise" on willfulness, but did not vote on amendments to the "first-inventor-to-file" provisions or Senator Schumer's "generic drug" amendment. The committee also did not vote on Senator Tom Coburn's (R-OK) fee diversion amendment, which he will introduce during debate on the Senate floor. Senator Leahy gave Senator Coburn the floor for a (relatively) long discussion of his proposed amendment, which was supported by several other committee members. Senator Coburn asserted that there was a "contract with America" that patent fees were collected to pay for patent examination, and that "if an American pays a fee he should get what he pays for" and not for funding other aspects or parts of the government. He called intellectual property protection something that needs to be done in an expeditious and timely manner and produce "quality" patents, and that excess monies collected by the Patent Office should be used to provide additional services by the Office to examine and grant additional patents, rather than being diverted for other uses. He said he believed this was part of a bigger effort to adjust spending, debt, and the economy.

Senator Durbin (D-IL) raised a question that shed light not only on why Senator Coburn did not offer his amendment for consideration by the committee but also how legislators think about questions involving revenue. He asked who should be responsible for oversight on how PTO monies are spent, in view of the interests of the Appropriations Committee in federal revenue. Senator Coburn indicated that he believed the Judiciary Committee had that authority, although he backtracked slightly when Senator Durbin mentioned the Appropriations Committee staff dedicated to monitoring how monies were spent by various agencies. Senator Coburn countered that there is "not enough" oversight by Congress, although comments by other Senators indicated that this was not merely a "turf war" but a more fundamental question of how appropriation decisions are made (and perhaps the consequences of having other committees exert influence on these issues). Senator Coburn's comments on fee diversion were supported by Senators Grassley and Christopher Coons (D-DE) (the latter saying there is a "delicate relationship" between how the different Congressional committees could exercise oversight), and Senator Orrin Hatch (R-UT) called fee diversion "despicable" in supporting this amendment, also saying fee diversion was a "tax on innovation." Senator Cornyn called these provisions "central to the bill" which he predicted would have a "big impact on the country, on intellectual property rights and the economy."

The bill now moves to the Senate floor for eventual consideration. There has not yet been a patent reform bill introduced in the House of Representatives.
Sen. Kohl Introduces Bill to Prohibit Reverse Payments

February 2, 2011

By Donald Zuhn —

Last week, Senator Herb Kohl (D-WI) (at right) introduced the Preserve Access to Affordable Generics Act (S. 27) in the Senate. The bill, which is co-sponsored by Senators Sherrod Brown (D-OH), Susan Collins (R-ME), Richard Durbin (D-IL), Al Franken (D-MN), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Bernard Sanders (I-VT), is designed to prohibit brand name drug companies from compensating generic drug companies for delaying the entry of generic drugs into the market.

In a section entitled "Findings," the bill notes that "[p]rescription drugs make up 10 percent of the national health care spending but for the past decade have been one of the fastest growing segments of health care expenditures." The bill states that "[u]ntil recently, the [Drug Price Competition and Patent Term Restoration Act (or Hatch-Waxman Act)] was successful in facilitating generic competition to the benefit of consumers and health care payers — although 67 percent of all prescriptions dispensed in the United States are generic drugs, they account for only 20 percent of all expenditures." According to the bill, "[i]n recent years, the intent of the [Hatch-Waxman] Act has been subverted by certain settlement agreements between brand companies and their potential generic competitors that make 'reverse payments' which are payments by the brand company to the generic company." The bill asserts that "[t]hese settlement agreements have unduly delayed the marketing of low-cost generic drugs contrary to free competition, the interests of consumers, and the principles underlying antitrust law," and contends that "[b]ecause of the price disparity between brand name and generic drugs, such agreements are more profitable for both the brand and generic manufacturers than competition, and will become increasingly common unless prohibited."

The bill would allow the Federal Trade Commission to initiate an enforcement proceeding "against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product." In such proceedings, "an agreement shall be presumed to have anticompetitive effects and be unlawful if — (i) an ANDA filer receives anything of value; and (ii) the ANDA filer agrees to limit or forego research, development, manufacturing, marketing, or sales of the ANDA product for any period of time," unless "the parties to such agreement demonstrate by clear and convincing evidence that the procompetitive benefits of the agreement outweigh the anti-competitive effects of the agreement." The bill lists a number of factors to be considered in determining whether the parties to the agreement have met the above burden. The bill also provides a number of penalties for violating the Act, including a civil penalty in the amount of three times the value received by an NDA holder or given to an ANDA filer that is in violation of the Act.

Senator Kohl's bill is similar to the bill (S. 369) that he introduced in the last Congress, which would have added a new section to The Clayton Act (15 U.S.C. 12 et seq.) that would have made it unlawful "for any person, in connection with the sale of a drug product, to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which — (1) an ANDA filer receives anything of value; and (2) the ANDA filer agrees not to research, develop, manufacture, market, or sell the ANDA product for any period of time" (see "Bill to Prohibit Reverse Payments Introduced in the Senate"). When introducing S. 369, Senator Kohl called reverse payment agreements "backroom" deals that constitute "one of the most egregious tactics used to keep generic competitors off the market." The new bill marks the third straight Congress in which Senator Kohl has introduced legislation intended to prohibit reverse payments.
Biotech/Pharma Docket

February 1, 2011

By James DeGiulio —

Jury Awards Abbott $16M in Tarka Patent Suit Against Glenmark

Abbott Laboratories has been awarded $16 million in its suit against Glenmark Pharmaceuticals over a generic version of the blood pressure drug, Tarka, after a federal jury found Glenmark liable for infringement. In October 2007, Glenmark notified Abbott and Sanofi that it had filed an Abbreviated New Drug Application (ANDA) with the FDA to make a generic drug containing trandolapril and verapamil hydrochloride, the active ingredients in Tarka. Sanofi and Abbott responded by filing the current lawsuit in December 2007, alleging that Glenmark was planning to infringe U.S. Patent No. 5,721,244, which covers Tarka (see "Court Report," December 16, 2007). In June 2010, Sanofi and Abbott failed to block Glenmark's launch of its generic version of Tarka after their motion for a preliminary injunction and temporary restraining order was denied (see "Biotech/Pharma Docket," June 10, 2010). Glenmark subsequently launched its generic Tarka at-risk in June. In July, the plaintiffs succeeded in getting sanctions against Glenmark on the grounds that the generic-drug company had destroyed evidence relevant to the likely litigation that would follow the filing of its ANDA.

On January 14, the jury handed down its verdict in the U.S. District Court for the District of New Jersey, confirming the validity of the Sanofi-owned and Abbott-licensed '244 patent. Glenmark has been ordered to pay Abbott $16 million in damages, out of which about $15.2 million were awarded by the jury for lost profits and the balance for higher prices that Abbott could have charged had Glenmark not infringed the '244 patent. Glenmark is expected to appeal.

Mylan Settles with Pfizer in Lipitor and Caduet Patent Suits

Pfizer has entered into a deal with Mylan that permits the generic producer to sell versions of the cholesterol drug Lipitor and the combination blood pressure/cholesterol treatment Caduet. Pfizer first filed suit against Mylan in June 2009, accusing Mylan of infringing U.S. Patent Nos. 5,969,156; 6,087,511; and 6,274,440, covering Lipitor, by filing its ANDA (see "Court Report," June 22, 2009. The asserted patents, owned by Pfizer subsidiary Warner-Lambert, expire in July 2016, and Lipitor was granted a further period of exclusivity until January 2017. In February 2010, Pfizer sued Mylan for infringement of U.S. Patent No. 6,455,574 over Mylan's attempt to make a generic version of Caduet (see "Court Report," February 8, 2010).

On January 25, in separate press releases covering the Lipitor and Caduet settlements, Mylan announced that it had entered into agreements with Pfizer that will resolve both infringement cases. Under the terms of the Caduet settlement, Mylan can begin marketing and selling a generic version of Caduet on November 30, 2011. The terms of the Lipitor settlement remain confidential. Both settlement agreements are subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Sanofi-Aventis Uroxatral Patent Found Valid and Infringed by Apotex

Apotex was found to infringe the patent covering Sanofi-Aventis' prostate drug Uroxatral after a District Court judge followed his earlier ruling upholding the validity of the patent. Sanofi brought an infringement suit against Apotex, Mylan, Aurobindo, Torrent, and others in 2007 following the generics' ANDA filings, alleging that each defendant's generic alfuzosin hydrochloride infringed U.S. Patent No. 4,661,491 (see "Court Report," October 14, 2007). After the actions were consolidated in the U.S. District Court for the District of Delaware, Sanofi and Apotex stayed their claims. Apotex agreed in October 2009 that if a judgment was entered in favor of Sanofi and against any defendant, the stay would be lifted and a similar judgment would be entered against it. However, Apotex also indicated in the October 2009 stipulation that it could appeal any judgment siding with Sanofi. Mylan attempted to invalidate Sanofi's patent by asserting that the '491 patent was obvious in view of three pieces of prior art. In May, Judge Sleet issued an opinion upholding the patent, disagreeing with the defendant's argument that the patent was invalid due to obviousness (see "Biotech/Pharma Docket," May 27, 2010). The District Court in August upheld the validity of the asserted claims of the patent-in-suit, found that Mylan's proposed generic infringed the '491 patent, and enjoined Mylan from making and selling the generic in the U.S. until after the patent's expiration.

On January 11, Judge Gregory Sleet signed off on a stipulation to enter judgment against Apotex, holding that the defendant's proposed product violated the patent and blocked the effective date of its ANDA until after the expiration of the patent-in-suit. Sanofi proposed the stipulation to Apotex in December, based on Judge Sleet's earlier ruling against Mylan. Judge Sleet's judgment can be found here.
Another Academic with Solutions to Problems that Don’t Exist

January 31, 2011

By Kevin E. Noonan —

Speaking of Oakland, Gertrude Stein famously said "There is no there, there." The quote comes to mind when reading much of the academic literature on patenting genes and diagnostic method claims, which continues to follow the pattern of "there could be a problem, there should be a problem, in the future there might be a problem, so the fact that there is no evidence that there is a problem is irrelevant to my theory about the best way to solve the problem."

The latest example of this genre is by Geertui Van Overwalle (at right), from the Centre for Intellectual Property Rights, University of Leuven, Belgium, in an article in Science entitled "Turning Patent Swords into Shares." The article sets forth the "usual suspects" of premises: claims that "genes are difficult to design around," and that patents could hamper research and development, clinical access and availability of high-quality tests." This portion of the article raises the first (of many) red flags in its citations: the threat to "clinical access and availability of high-quality tests" is supported by no citation (representing the problem that "should exist"), and the statement that "genes are difficult to design around" is supported by a citation that reads (in very small type at the end of the article) "[i]n some empirical studies, a negative impact of patents could not be found (citing Walsh et al., 2005, "Science and Law: View from the Bench: Patents and Material Transfers," Science 309: 2002-03)" — really, there are several such studies, all with the same message. In other words, despite the empirical evidence that there is no current problem, the Professor postulates that there is, and then devises ways to address the non-existent problem. This portion of the article also cites the SACGHS report, another example of an attempt to identify and address a problem that proved elusive at best.

The article similarly cites the possibility of a "patent thicket" caused by gene and diagnostic method patenting, but then supports the argument with the now thoroughly discredited (except in academia) "tragedy of the anticommons" idea (see "The Tragedy of a Bad Idea"). The article even admits that the problem does not exist:

Empirical data do not yet confirm existence of a patent thicket in genetics at large . . . . However, thicket problems in genetic diagnostics could grow with shifts (i) from monogenetic to multifactorial testing (multiplex diagnostics) and (ii) toward diagnostics based on genome-wide association studies driven by the high-throughput of single nucleotide polymorphism platforms and next-generation sequencing possibilities.

And then:

Although not an illustrative example of this phenomenon, the Myriad decision has invigorated concerns about potential negative effects of a dense and dispersed patent landscape.

Having arrived at this description of the problem, Professor Van Overwalle proposes solutions, most taking as their starting point practices prevalent in Europe. These include compulsory licensing, as has been instituted in France, Belgium, and Switzerland (despite the fact that "they have not yet been put to work"; but, the Professor informs us, "they may have an indirect, preventive effect on unduly restrictive licensing behavior by patent owners"). Another possibility is the exercise of "march-in" rights by the National Institutes of Health under provisions of the Bayh-Dole Act (35 U.S.C. §§ 200-213). Also mentioned is a "diagnostic use" exemption, as proposed in the SACGHS report.

The Professor does recognize that a ban on gene patents could be as detrimental to "development of drugs and therapies" as it could be beneficial to "upstream" research, although there is no evidence that gene patents have affected such "upstream," non-commercial research at all, and ample evidence that basic research is unaffected by patents on genes (see "The Fantastical Economics of the Gene Patenting Debate"). Nevertheless, the article proposes that gene patents be limited only for those uses appreciated at the time the patent application was filed. While seemingly a "reasonable" compromise, in reality such a restriction would result merely in prophetic disclosure on the one hand, and would (paradoxically) make it easier to obtain patent rights on newly discovered applications or uses of a claimed gene sequence — such as a diagnostic method relating change or mutations in the gene to disease or the propensity for disease. Of course, this is not much different from the current situation, and in addition it is unlikely that patent claims for genes (which are overwhelmingly limited to isolated, full-length copies thereof) are infringed or even necessary to practice such diagnostic methods (patented or otherwise).

Turning to less coercive possibilities, the Professor proposes patent pools or clearinghouses, using as examples the American Society of Composers, Authors and Publishers (ASCAP) for copyright and MPEG LA, the latter group organized to promote distribution of gene sequences in such a manner. Unfortunately, the article cannot stay true to the concept that such an arrangement can be voluntary, and thus posits that the government may need to force such collaborations.

There certainly exists the possibility that any or even many of the possible problems identified in this and other academic articles could one day exist. Of course, it is equally (if not more) likely that gene patents will have expired before the technology advances to a point where a patent thicket would have developed. The history of the past thirty years reflects that possibility: from an initial glacial pace of gene patenting (due in part to the focused effort to isolate particular genes that encode therapeutically useful molecules, and in part to the need for development of biotechnology) to the flood of genetic sequence unleashed by the Human Genome Project and it commercial counterparts. It is certainly the case that success in deciphering the relationship between disease and genetic markers thereof has proceeded much more slowly than expected, and it is unlikely that the pace will quicken in the near term. But patents — i.e., exclusive rights — to genes will expire more or less "all at once" in about 2020, being twenty years from the end of the HGP and about 20 years (or more) from the filing date of most gene patents from that time. Thus, just when the potential for a patent thicket might become relevant (if we are lucky enough that robust genetic markers for disease have been so rapidly developed), the thicket will disappear.

There is a greater potential for diagnostic method patents to raise the kinds of issues referenced in the article, but the complexity of ascertaining these types of genetic relationships, and the potential for these relationships to remain undisclosed if diagnostic methods are unprotected by patenting, is likely to result in a public calculus that trades the relatively short period of exclusivity to the patentee for the economic incentives needed to develop commercial embodiments of these tests. Perhaps the most frightening prospect set forth in Professor Van Overwalle's article is that diagnostic method patents would be unenforceable against "clinicians using their own 'homemade' gene-based tests." To the extent that such tests are compared with tests by companies like Myriad, which has never had a reported false positive, it seems that women would be better served having researchers do research (clinical or otherwise) and commercial clinical labs perform such clinical tests. For diagnoses as important as the propensity to develop cancer, patients deserve no less.

Perhaps the most dangerous aspect of such articles, however, is the tendency for policymakers and even courts (who are not immune to the blandishments of academic "research") to base their decisions on the persistent argument that there is an existing problem that needs a solution. Darwin said that "[f]alse facts are highly injurious to the progress of science, for they often endure long; but false views, if supported by some evidence, do little harm, for every one takes a salutary pleasure in proving their falseness." The non-existent problem becomes the unquestioned premise, and as any student of elementary logic can tell you, a syllogism is only as strong as its premises. Thus can well-intentioned leaders promulgate policies that have harmful unintended consequences, all in the service of solving a problem that simply does not exist.
Court Report

January 30, 2011

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Human Genome Sciences Inc. v. Genentech Inc. et al.
1:11-cv-00082; filed January 25, 2011 in the District Court of Delaware

• Plaintiff: Human Genome Sciences Inc.
• Defendants: Genentech Inc.; City of Hope

Declaratory judgment of non-infringement, invalidity, and unenforceability of U.S. Patent No. 6,331,415 ("Methods of Immunoglobulins, Vectors, and Transformed Host Cells for Use Therein," issued December 18, 2001) based on HGS's manufacture and sale of its Benlysta® product (belimumab, under development for the treatment of seropositive patients with systemic lupus erythematosus). View the complaint here.

Warner Chilcott Co. LLC et al. v. Teva Pharmaceuticals USA Inc.
1:11-cv-00081; filed January 24, 2011 in the District Court of Delaware

• Plaintiffs: Warner Chilcott Co. LLC; Hoffmann-La Roche Inc.
• Defendant: Teva Pharmaceuticals USA Inc.

Infringement of U.S. Patent No. 7,718,634 ("Method of Treatment Using Bisphosphonic Acid," issued May 18, 2010), licensed to Warner Chilcott, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Warner Chilcott's Once-a-Month Actonel® (risedronate sodium, used to treat and prevent postmenopausal osteoporosis). View the complaint here.

Orion Corp. v. Mylan Pharmaceuticals Inc.
1:11-cv-00078; filed January 24, 2011 in the District Court of Delaware

Infringement of U.S. Patent No. 5,446,194 ("Pharmacologically active catechol derivatives," issued August 29, 1995) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Orion's Comtan® (entacapone, used in the treatment of Parkinson's Disease). View the complaint here.

Daiichi Sankyo Inc. et al. v. Watson Pharmaceuticals Inc. et al.
1:11-cv-00074; filed January 21, 2011 in the District Court of Delaware

• Plaintiffs: Daiichi Sankyo Inc.; Genzyme Corp.
• Defendants: Watson Pharmaceuticals Inc.; Watson Pharma Inc.; Watson Laboratories Inc. (NV)

Infringement of U.S. Patent No. 5,693,675 ("Alkylated Amine Polymers," issued December 2, 1997) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of plaintiffs' Welchol® (colesevelam hydrochloride, used to treat primary hyperlipidemia and type 2 diabetes mellitus). View the complaint here.

Fresenius Medical Care Holdings, Inc. v. Zydus Pharmaceuticals USA, Inc.
1:11-cv-10110; filed January 21, 2011 in the District Court of Massachusetts

• Plaintiffs: Fresenius Medical Care Holdings, Inc.
• Defendants: Zydus Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 6,576,665 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued June 10, 2003) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure). View the complaint here.
Conference & CLE Calendar

January 30, 2011

January 31 – February 1, 2011 – Medical Device Patent Litigation*** (American Conference Institute) – New York, NY

February 9-10, 2011 – BioPharma IP Innovations Summit (Strategic Solutions Network) – Miami, FL

February 16-17, 2011 – Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – New York, NY

February 16-17, 2011 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

March 16-17, 2011 – FDA Boot Camp*** (American Conference Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Biotech & Pharmaceutical Patenting Conference

January 28, 2011

IBC Legal will be holding its 19th annual Biotech & Pharmaceutical Patenting conference on February 16-17, 2011 in Munich, Germany. IBC Legal faculty will help attendees:

• Analyze the evolving biotech & pharmaceutical market landscape and what this means for a holistic patent strategy;
• Maximize the chance of a successful patent filing for new scientific processes;
• Optimize patent life cycles and extend market dominance;
• Examine landmark appeal and litigation decisions and analyze the implications for future patent cases; and
• Hear in depth insights on the legal procedures in key European, U.S., Asian, and Brazilian jurisdictions.

In particular, IBC Legal faculty will offer presentations on the following topics:

• Examining how the Commission is assessing antitrust issues since the Pharmaceutical Sector Inquiry;
• Patent filing: Maximizing your chances of success;
• Assessing progress towards establishing patent highways;
• German Patent and Trademark Office's approach to biopatents;
• Emerging opportunities for IP management in Guernsey & other offshore IP jurisdictions;
• Examining current issues relating to plant biotech and breeding;
• Strategies for maximizing patent life cycles;
• Patent strategies in the new biosimilars world;
• Stem cell patenting;
• Personalized medicine: Patenting genes and theranostics;
• Obviousness and inventive step in the U.S. & Europe;
• Evaluating the pros and cons of different European legal systems to maximize your chances of successful patent litigation in each region;
• Examining patent litigation in the U.S.;
• Brazil patent landscape;
• Latin America patent landscape;
• Decoding patent information from Japan, China, Taiwan and Korea;
• Examining how sufficiency is being addressed in Europe;
• Assessing how well functional claims stand up to scrutiny;
• Examining recent case law around supplementary protection certificates; and
• Using second medical use claims to extend patent life cycles.

A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is £1,783.81. Those interested in registering for the conference can do so here, by calling +44 (0)20 7017 5503, or by faxing a registration form to +44 (0)20 7017 4746.
BioPharma IP Innovations Summit

January 28, 2011

Strategic Solutions Network (SSN) will be holding its BioPharma IP Innovations Summit on February 9-10, 2011 in Miami, FL. The Summit will offer presentations on the following topics:

• Are you ready for open innovation? — Pre-conference workshop-applying lessons from other industries to reinvigorate the life sciences business model;
• Emerging business bootcamp — Pre-conference workshop: Incubating the next generation of revenue generators;
• Diagnostics and beyond: Critical communication requirements in preparing a new era of IP transaction management;
• Actions to avoid in M&A and strategic partnerships;
• Innovations in laboratory collaboration: Fostering open collaboration between global laboratory researchers;
• Pharma innovations: Breaking through bottlenecks to get from concept to commercialization;
• Creating superior collaboration networks to maximize value with external partners;
• Panel: Successful strategies in open innovation — Split sessions: Focus-open innovation;
• IP due diligence: How to react to rapid changes in R&D cycles;
• In-licensing and out-licensing innovations — IP marketplace: Strategic sourcing options to remove market barriers;
• How to protect intellectual property when labs go electronic;
• Developing an organizational culture to support the implementation of open innovation;
• Branding yourself as a partner of choice;
• Product lifecycle extension strategies — Split sessions: Focus-strategic IP portfolio management; and
• Creating an IP ecosystem to secure long term profitability of IP assets — Split sessions: Strategic IP portfolio management.

The agenda for the BioPharma IP Innovations Summit can be found here. The registration fee for the conference is $1,795 (standard rate), $1,495 (pharmaceutical/biotech rate), or $1,195 (government/academic rate). Those interested in registering for the Summit can do so here, by calling 561-674-0084, or by faxing a registration form to 561-674-0282.
Amicus Briefs in AMP v. USPTO: AARP

January 27, 2011

By Donald Zuhn —

With briefing in the Association of Molecular Pathology v. U.S. Patent and Trademark Office ("Myriad") case now complete, Patent Docs has begun reviewing the 29 amicus briefs that were filed with the Court of Appeals. Of the 29 amicus briefs, fifteen were filed in support of Defendants-Appellants and/or reversal, twelve were filed in support of Plaintiffs-Appellees and/or affirmance, and two remain to be determined (Patent Docs has not yet obtained copies of these briefs). To date, Patent Docs has provided summaries for nine of the fifteen of the briefs filed in support of Defendants-Appellants and/or reversal (see "AMP v. USPTO — Briefing Update II"). Today, we review the amicus brief submitted by the AARP.

Writing in support of Plaintiffs-Appellees and arguing for affirmance, the AARP "urg[es] the Court to find that the [BRCA] patents are invalid." According to the AARP, the Federal Circuit should find the patents to be invalid because "[p]atents such as those present in this case prohibit diagnosis and treatment based on second medical opinions and discourage full medical testing," and patents "also significantly elevate the cost of genetic testing." The AARP spends a little more than one page of its 22-page brief explaining why human genes and DNA molecules are not patent eligible under 35 U.S.C. § 101. The remainder of the AARP brief focuses on public health considerations that demand a finding of invalidity and a discussion of how gene patents limit the accessibility of competitively priced genetic testing.

With respect to the § 101 issue, the AARP argues that "DNA molecules and human genes are natural phenomena that when discovered are not the kind of 'discovery' that Section 101 was designed to protect." Citing American Wood-Paper Co. v. Fiber Disintegrating Co., 90 U.S. (23 Wall.) 566 (1874), the AARP states that in that case:

[T]he Court found that merely removing pulp from straw, wood, or other natural sources did not make it a patentable new composition of matter: "A process to obtain it [an extract] from a subject from which it has never been taken may be the creature of invention, but the thing itself when obtained cannot be called a new manufacture."

The AARP argues that "[s]imilarly, isolating a gene from the human body does not then make the gene itself, patentable." From this, the AARP concludes that "human genes and DNA molecules, regardless of whether they are isolated or not, are natural phenomena and therefore are not patent eligible under 35 U.S.C. §101" (emphasis added).

Noting that Myriad, in its opening brief, "fails to discuss potential patient harm if the [BRCA] patents are upheld," the AARP turns to public health considerations that "demand that the patents in question be denied." In particular, the AARP argues that "[i]n this case the public interest demands that the patents in question be denied since many individuals will be harmed if the patent is upheld because genetic testing will be denied to them either due to cost or unavailability of a second opinion." Pointing to the results of "a study [that] was conducted of 300 individuals who had negative test results from Myriad's BRAC analysis but came from families in the United States, each of which included four or more members with breast or ovarian cancer," the AARP brief notes that "[u]sing multiple methods of genetic testing, unlike BRAC analysis, the study found that 35 of the 300, or in other words 12% of the individuals, carried previously undetected BRCA1 or BRCA2 genetic mutations." Because "it is extremely important that those who undergo BRCA genetic testing receive accurate and thorough testing and results," the AARP contends that "individuals seeking any type of genetic testing should have the option of securing a second opinion which can have life altering results." Given the federal government's limited oversight over genetic tests, the AARP argues that it is critical that patients have the option of a second opinion.

The AARP brief next addresses the ways in which gene patents limit the accessibility of competitively priced genetic testing. Citing a Department of Health and Human Services report, the AARP notes that "[w]hile advances in genetics and genomics are driving the development of new genetic tests and services, 'problems with coverage and reimbursement are limiting their accessibility and integration into the health care system.'" The AARP also points to the "significant numbers of Americans (50.7 million) who are still uninsured," and the fact that "[t]he cost of health care frequently determines whether or not people receive health care." The brief also notes that while "Medicare is the largest provider of health insurance in the United States," "its current coverage policy of genetic testing is limited." Stating that "Medicare generally precludes coverage of genetic testing to those people who have not yet been diagnosed with cancer," the AARP argues that "[r]equiring that Medicare recipients wait until they actually have contracted cancer reduces one of the most significant benefits of the testing to those BRAC carriers who have not yet contracted cancer but may do so in the future." The brief concludes that:

Given the limited coverage of genetic testing for Medicare and Medicaid patients many patients must pay for genetic testing out of their own pockets. Rejecting the patents in this case and allowing more laboratories to do the tests will result in lower prices for the tests and greater patient access.

For information regarding this and other related topics, please see:

• "AMP v. USPTO: Appellees' Brief," January 12, 2011
• "AMP v. USPTO — Briefing Update II," December 16, 2010
• "Amicus Briefs in AMP v. USPTO: Alynylam Pharmaceuticals, Inc.," December 15, 2010
• "The Relevance of Patent Exhaustion in the Myriad Genetics Case," December 14, 2010
• "AMP v. USPTO — Briefing Update," December 14, 2010
• "Amicus Briefs in AMP v. USPTO: University of New Hampshire School of Law," December 12, 2010
• "Amicus Briefs in AMP v. USPTO: Rosetta Genomics & George Mason University," December 8, 2010
• "Academic Amici Refute ACLU Falsehoods in Gene Patenting Debate," December 7, 2010
• "Amicus Briefs in AMP v. USPTO: Genetic Alliance," November 10, 2010
• "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO," November 9, 2010
• "AIPLA Submits Amicus Brief in AMP v. USPTO," November 3, 2010
• "IPO Files Amicus Brief in AMP v. USPTO," November 2, 2010
• "AMP v. USPTO — Briefing Update," November 1, 2010
• "DOJ Tries to Be All Things to All Constituencies in Myriad Amicus Brief," October 31, 2010
• "Myriad Files Appeal Brief in AMP v. USPTO," October 28, 2010
• "AMP v. USPTO — Briefing Schedule Update," August 22, 2010
• "FCBA Submits Amicus Brief on Motion for Recusal in AMP v. USPTO," August 9, 2010
• "Appellees Move for Recusal of Chief Judge Rader in AMP v. USPTO Appeal," July 19, 2010
• "AMP v. USPTO after Bilski v. Kappos," July 6, 2010
• "Myriad Appeals AMP v. USPTO Decision," June 16, 2010
• "AMP v. USPTO: What Everyone Else Is Saying – Part II," June 8, 2010
• "AMP v. USPTO: What Everyone Else Is Saying," April 6, 2010
• "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story," April 5, 2010
• "'60 Minutes' Examines Gene Patenting Issue on Sunday, April 4th — Patent Docs Author Kevin Noonan to Appear on Program," April 2, 2010
• "AMP v. USPTO: What the Parties Are Saying About the Decision," April 1, 2010
• "Caught in a Time Warp: The (In)validity of BRCA1 Oligonucleotide Claims," March 30, 2010
• "Round One Goes to the ACLU," March 29, 2010
• "USPTO Asks out of Gene Patenting Case (Again)," January 19, 2010
President Obama Proposes, BIO Agrees

January 27, 2011

By Kevin E. Noonan —

In his State of the Union address to Congress and the nation, President Obama emphasized the need for America to return to its innovator and entrepreneurial roots, and harness the ingenuity and commercial vigor long associated with this country to effectively compete in the global economy.

The Biotechnology Industry Organization (BIO) agrees. On Wednesday, BIO President and CEO Jim Greenwood issued the following statement:

We commend President Obama for highlighting the need to increase our nation's global competitiveness and job creation by stimulating investment and research in innovation. As the President said, "The first step in winning the future is encouraging American innovation."

There is no industry better poised to meet this challenge than biotechnology. With a strong and predictable patent system, science-based regulatory systems, and appropriate tax policy and incentives, America's biotechnology sector can help drive substantial job growth in the United States and advance our nation's competitiveness over the long term, while providing cutting-edge technologies to address pressing concerns in health care, energy independence and agricultural sustainability. Innovation is how we make our living. We are just what the doctor — and the President — ordered.

• Therapeutic Discovery Project (TDP) — We continue to advocate for the extension and expansion of the Therapeutic Discovery Project (TDP) program, which awarded tax credits to small cutting-edge biotech companies to support research and development efforts to cure diseases such as cancer, Parkinson's and Multiple Sclerosis. Targeted programs like the TDP can help spur continued medical innovation, create and preserve American jobs, and position our nation for continued leadership in the global marketplace.

• Alternative Energy Sources — The President also renewed his call for the development of clean energy during tonight's speech. The biotechnology industry, which provides the key technology for producing advanced biofuels and biobased products from renewable biomass, stands ready to provide new green jobs in the United States by developing secure and sustainable sources of domestic energy.

• Regulations for Agricultural Biotechnology Products — We welcome the President's call to support technology and to review regulations that are barriers to growth. Agricultural biotechnology provides innovative solutions to help feed and clothe the world, support energy security, and reduce the impact of agriculture on the environment. The U.S. government's regulatory review on the safety of these products needs to be far more efficient in order to sustain and grown jobs in the industry and bring innovation to market.

America is the world leader in biotechnology. Our nation's biotechnology industry is comprised of scientists, entrepreneurs, and large and small companies in all 50 states engaged in translating the latest scientific discoveries into innovative new medical therapies and environmental products, increased agricultural production and farm incomes, and greener bio-based products and biofuels. Nationwide, our industry directly employs more than 1.4 million people and indirectly generates jobs for an additional 6.6 million people. These are high-quality jobs, paying substantially more than the average U.S. wage.

We look forward to working with President Obama, members of his Administration and the Congress in support of public policies that encourage investment in biotechnology innovation. The right policies will help create jobs, propel continued innovation, and increase our nation's competitiveness, and security, in the global marketplace for years to come.

The history of the last generation can be interpreted as American ingenuity — as represented by the biotechnology and computer industries — lifting the U.S. from its mid-1980's doldrums to the economic prosperity that characterized the years between 1992-2000. The success of that ingenuity can be exemplified by a simple image: in 1998 everyone had a Sony Walkman®, and in 2008 everyone had an Apple iPod. That type of innovation may be less visible in biotechnology, but the pre-eminent biotechnology companies — Amgen, Genentech, Biogen, Genzyme, and dozens of others — were American companies. Mr. Greenwood reminds us that the qualities the President extolled about our country and culture — risk-taking spirit, availability of venture capital, and acceptance of failure, to name a few — are just those qualities that support small startup companies, the hallmark of the biotechnology industry. And his statement brings to mind an apt aphorism by the anthropologist, Margaret Mead:

Never doubt that a small group of thoughtful, committed people can change the world. Indeed, it is the only thing that ever has.

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